Best Practices

Clostridium difficile (C difficile) infection (CDI) is a leading cause of infectious diarrhea among hospitalized patients and, increasingly, in ambulatory patients.^1,2 The high prevalence of CDI and the high recurrence rates (15%-30%) led the CDC to categorize C difficile as an "urgent" threat (the highest category) in its 2013 Antimicrobial Resistance Threat Report.^3-5 The Infectious Diseases Society of America guideline recommended treatment for CDI is vancomycin or metronidazole; more recent studies also support fidaxomicin use.^4,6,7  

Patients experiencing recurrent CDI are at risk for further recurrences, such that after the third CDI episode, the risk of subsequent recurrences exceeds 50%.⁸ This recurrence rate has stimulated research into other treatments, including fecal microbiota transplantation (FMT). A recent systematic  review of FMT reports that 85% of patients have resolution of symptoms without recurrence after FMT, although this is based on data from case series and 2 small randomized clinical trials.⁹

A commonly cited barrier to FMT is patient acceptance. In response to this concern, a previous survey demonstrated that 81% of respondents would opt for FMT to treat a hypothetical case of recurrent CDI.¹⁰ However, the surveyed population did not have CDI, and the 48% response rate is concerning, since those with a favorable opinion of FMT might be more willing to complete a survey than would other patients. Accordingly, the authors systematically surveyed hospitalized veterans with active CDI to assess their knowledge, attitudes, and opinions about FMT as a treatment for CDI.

Methods

In-person patient interviews were conducted by one of the study authors at the Minneapolis VA Health Care System (MVAHCS), consisting of 13 to 18 questions. Questions addressed any prior CDI episodes and knowledge of the following: CDI, recurrence risk, and FMT; preferred route and location of FMT administration; concerns regarding FMT; likelihood of agreeing to undergo FMT (if available); and likelihood of enrollment in a hypothetical study comparing FMT to standard antibiotic treatment. The survey was developed internally and was not validated. Questions used the Likert-scale (Survey).

Patients with CDI were identified by monitoring for positive C difficile polymerase chain reaction (PCR) stool tests and then screened for inclusion by medical record review. Inclusion criteria were (1) MVAHCS hospitalization; and (2) written informed consent. Exclusion criteria were the inability to communicate or participate in an interview. Patient responses regarding their likelihood of agreeing to FMT for CDI treatment under different circumstances were compared using Wilcoxon rank sum test. These circumstances included FMT for their current episode of CDI, FMT for a subsequent episode, and FMT if recommended by their physician. Possible concerns regarding FMT also were solicited, including infection risk, effectiveness, and procedural aesthetics. The MVAHCS institutional review board approved the study.

Results

Stool PCR tests for CDI were monitored for 158 days from 2013 to 2014 (based on availability of study staff), yielding 106 positive results. Of those, 31 (29%) were from outpatients and not addressed further. Of the 75 positive CDI tests from 66 hospitalized patients (9 patients had duplicate tests), 18 of 66 (27%) were not able to provide consent and were excluded, leaving 48 eligible patients. Six (13%) were missed for logistic reasons (patient at a test or procedure, discharged before approached, etc), leaving 42 patients who were approached for participation. Among these, 34 (81%) consented to participate in the survey. Two subjects (6%) found the topic so unappealing that they terminated the interview.

The majority of enrolled subjects were men (32/34, 94%), with a mean age of 65.3 years (range, 31-89). Eleven subjects (32%) reported a prior CDI episode, with 10 reporting 1 such episode, and the other 2 episodes. Those with prior CDI reported the effect of CDI on their overall quality of life as 5.1 (1 = no limitation, 10 = severe limitation). Respondents were fairly accurate regarding the risk of recurrence after an initial episode of CDI, with the average expectedrecurrence rate estimated at 33%. In contrast, their estimation of the risk of recurrence after a second CDI episode was lower (28%), although the risk of recurrent episodes increases with each CDI recurrence.

Regarding FMT, 5 subjects indicated awareness of the procedure: 2 learning of it from a news source, 1 from family, 1 from a health care provider, and 1 was unsure of the source. After subjects received a description of FMT, their opinions regarding the procedure were elicited. When asked which route of delivery they would prefer if they were to undergo FMT, the 33 subjects who provided a response indicated a strong preference for either enema (15, 45%) or colonoscopy (10, 30%), compared with just 4 (12%) indicating no preference, 2 (6%) choosing nasogastric tube administration, and 2 (6%) indicating that they would not undergo FMT by any route (P < .001).

Regarding the location of FMT administration (hospital setting vs self-administered at home), 31 of 33 respondents (94%) indicated they would prefer FMT to occur in the hospital vs 2 (6%) preferring self-administration at home (P < .001). The preferred source of donor stool was more evenly distributed, with 14 of 32 respondents (44%) indicating a preference for an anonymous donor, 11 preferring a family member (34%), and 7 (21%) with no preference (P = .21).

Subjects were asked about concerns regarding FMT, and asked to rate each on a 5-point Likert scale (1 = not at all concerning; 5 = overwhelming concern). Concerns regarding risk of infection and effectiveness received an average score of 2.74 and 2.72, respectively, whereas concern regarding the aesthetics, or "yuck factor" was slightly lower (2.1: P = NS for all comparisons). Subjects also were asked to rate the likelihood of undergoing FMT, if it were available, for their current episode of CDI, a subsequent episode of CDI, or if their physician recommended undergoing FMT (10 point scale: 1 = not at all likely; 10 = certainly agree to FMT). The mean scores (SD) for agreeing to FMT for the current or a subsequent episode were 4.8 (SD 2.7) and 5.6 (SD 3.0); P = .12, but increased to 7.1 (SD 3.23) if FMT were recommended by their physician (P < .001 for FMT if physician recommended vs FMT for current episode; P = .001 for FMT if physician recommended vs FMT for a subsequent episode). Finally, subjects were asked about the likelihood of enrolling in a study comparing FMT to standard antimicrobial treatment, with answers ranging from 1 (almost certainly would not enroll) to 5 (almost certainly would enroll). Among the 32 respondents to this question, 17 (53%) answered either "probably would enroll" or "almost certainly would enroll," with a mean score of 3.2.  

Discussion

Overall, VA patients with a current episode of CDI were not aware of FMT, with just 15% knowing about the procedure. However, after learning about FMT, patients expressed clear opinions regarding the route and setting of FMT administration, with enema or colonoscopy being the preferred routes, and a hospital the preferred setting. In contrast, subjects expressed ambivalence with regard to the source of donor stool, with no clear preference for stool from an anonymous donor vs from a family member.

When asked about concerns regarding FMT, none of the presented options (risk of infection, uncertain effectiveness, or procedural aesthetics) emerged as significantly more important than did others, although the oft-cited concern regarding FMT aesthetics engendered the lowest overall level of concern. In terms of FMT acceptance, 4 subjects (12%) were opposed to the procedure, indicating that they were not at all likely to agree to FMT for all scenarios (defined as a score of 1 or 2 on the 10-point Likert scale) or by terminating the survey because of the questions. However, 15 (44%) indicated that they would certainly agree to FMT (defined as a score of 9 or 10 on the 10-point Likert scale) if their physician recommended it. Physician recommendation for FMT resulted in the highest overall likelihood of agreeing to FMT, a finding in agreement with a previous survey of FMT for CDI.¹⁰ Most subjects indicated likely enrollment in a potential study comparing FMT with standard antimicrobial therapy.

Strengths/Limitations

Study strengths included surveying patients with current CDI, such that patients had personal experience with the disease in question. Use of in-person interviews also resulted in a robust response rate of 81% and allowed subjects to clarify any unclear questions with study personnel. Weaknesses included a relatively small sample size, underrepresentation of women, and lack of detail regarding respondent characteristics. Additionally, capsule delivery of FMT was not assessed since this method of delivery had not been published at the time of survey administration.

Conclusion

This survey of VA patients with CDI suggests that aesthetic concerns are not a critical deterrent for this population, and interest in FMT for the treatment of recurrent CDI exists. Physician recommendation to undergo FMT seems to be the most influential factor affecting the likelihood of agreeing to undergo FMT. These results support the feasibility of conducting clinical trials of FMT in the VA system.

Clostridium difficile (C difficile) infection (CDI) is a leading cause of infectious diarrhea among hospitalized patients and, increasingly, in ambulatory patients.^1,2 The high prevalence of CDI and the high recurrence rates (15%-30%) led the CDC to categorize C difficile as an "urgent" threat (the highest category) in its 2013 Antimicrobial Resistance Threat Report.^3-5 The Infectious Diseases Society of America guideline recommended treatment for CDI is vancomycin or metronidazole; more recent studies also support fidaxomicin use.^4,6,7  

Patients experiencing recurrent CDI are at risk for further recurrences, such that after the third CDI episode, the risk of subsequent recurrences exceeds 50%.⁸ This recurrence rate has stimulated research into other treatments, including fecal microbiota transplantation (FMT). A recent systematic  review of FMT reports that 85% of patients have resolution of symptoms without recurrence after FMT, although this is based on data from case series and 2 small randomized clinical trials.⁹

A commonly cited barrier to FMT is patient acceptance. In response to this concern, a previous survey demonstrated that 81% of respondents would opt for FMT to treat a hypothetical case of recurrent CDI.¹⁰ However, the surveyed population did not have CDI, and the 48% response rate is concerning, since those with a favorable opinion of FMT might be more willing to complete a survey than would other patients. Accordingly, the authors systematically surveyed hospitalized veterans with active CDI to assess their knowledge, attitudes, and opinions about FMT as a treatment for CDI.

Methods

In-person patient interviews were conducted by one of the study authors at the Minneapolis VA Health Care System (MVAHCS), consisting of 13 to 18 questions. Questions addressed any prior CDI episodes and knowledge of the following: CDI, recurrence risk, and FMT; preferred route and location of FMT administration; concerns regarding FMT; likelihood of agreeing to undergo FMT (if available); and likelihood of enrollment in a hypothetical study comparing FMT to standard antibiotic treatment. The survey was developed internally and was not validated. Questions used the Likert-scale (Survey).

Patients with CDI were identified by monitoring for positive C difficile polymerase chain reaction (PCR) stool tests and then screened for inclusion by medical record review. Inclusion criteria were (1) MVAHCS hospitalization; and (2) written informed consent. Exclusion criteria were the inability to communicate or participate in an interview. Patient responses regarding their likelihood of agreeing to FMT for CDI treatment under different circumstances were compared using Wilcoxon rank sum test. These circumstances included FMT for their current episode of CDI, FMT for a subsequent episode, and FMT if recommended by their physician. Possible concerns regarding FMT also were solicited, including infection risk, effectiveness, and procedural aesthetics. The MVAHCS institutional review board approved the study.

Results

Stool PCR tests for CDI were monitored for 158 days from 2013 to 2014 (based on availability of study staff), yielding 106 positive results. Of those, 31 (29%) were from outpatients and not addressed further. Of the 75 positive CDI tests from 66 hospitalized patients (9 patients had duplicate tests), 18 of 66 (27%) were not able to provide consent and were excluded, leaving 48 eligible patients. Six (13%) were missed for logistic reasons (patient at a test or procedure, discharged before approached, etc), leaving 42 patients who were approached for participation. Among these, 34 (81%) consented to participate in the survey. Two subjects (6%) found the topic so unappealing that they terminated the interview.

The majority of enrolled subjects were men (32/34, 94%), with a mean age of 65.3 years (range, 31-89). Eleven subjects (32%) reported a prior CDI episode, with 10 reporting 1 such episode, and the other 2 episodes. Those with prior CDI reported the effect of CDI on their overall quality of life as 5.1 (1 = no limitation, 10 = severe limitation). Respondents were fairly accurate regarding the risk of recurrence after an initial episode of CDI, with the average expectedrecurrence rate estimated at 33%. In contrast, their estimation of the risk of recurrence after a second CDI episode was lower (28%), although the risk of recurrent episodes increases with each CDI recurrence.

Regarding FMT, 5 subjects indicated awareness of the procedure: 2 learning of it from a news source, 1 from family, 1 from a health care provider, and 1 was unsure of the source. After subjects received a description of FMT, their opinions regarding the procedure were elicited. When asked which route of delivery they would prefer if they were to undergo FMT, the 33 subjects who provided a response indicated a strong preference for either enema (15, 45%) or colonoscopy (10, 30%), compared with just 4 (12%) indicating no preference, 2 (6%) choosing nasogastric tube administration, and 2 (6%) indicating that they would not undergo FMT by any route (P < .001).

Regarding the location of FMT administration (hospital setting vs self-administered at home), 31 of 33 respondents (94%) indicated they would prefer FMT to occur in the hospital vs 2 (6%) preferring self-administration at home (P < .001). The preferred source of donor stool was more evenly distributed, with 14 of 32 respondents (44%) indicating a preference for an anonymous donor, 11 preferring a family member (34%), and 7 (21%) with no preference (P = .21).

Subjects were asked about concerns regarding FMT, and asked to rate each on a 5-point Likert scale (1 = not at all concerning; 5 = overwhelming concern). Concerns regarding risk of infection and effectiveness received an average score of 2.74 and 2.72, respectively, whereas concern regarding the aesthetics, or "yuck factor" was slightly lower (2.1: P = NS for all comparisons). Subjects also were asked to rate the likelihood of undergoing FMT, if it were available, for their current episode of CDI, a subsequent episode of CDI, or if their physician recommended undergoing FMT (10 point scale: 1 = not at all likely; 10 = certainly agree to FMT). The mean scores (SD) for agreeing to FMT for the current or a subsequent episode were 4.8 (SD 2.7) and 5.6 (SD 3.0); P = .12, but increased to 7.1 (SD 3.23) if FMT were recommended by their physician (P < .001 for FMT if physician recommended vs FMT for current episode; P = .001 for FMT if physician recommended vs FMT for a subsequent episode). Finally, subjects were asked about the likelihood of enrolling in a study comparing FMT to standard antimicrobial treatment, with answers ranging from 1 (almost certainly would not enroll) to 5 (almost certainly would enroll). Among the 32 respondents to this question, 17 (53%) answered either "probably would enroll" or "almost certainly would enroll," with a mean score of 3.2.  

Discussion

Overall, VA patients with a current episode of CDI were not aware of FMT, with just 15% knowing about the procedure. However, after learning about FMT, patients expressed clear opinions regarding the route and setting of FMT administration, with enema or colonoscopy being the preferred routes, and a hospital the preferred setting. In contrast, subjects expressed ambivalence with regard to the source of donor stool, with no clear preference for stool from an anonymous donor vs from a family member.

When asked about concerns regarding FMT, none of the presented options (risk of infection, uncertain effectiveness, or procedural aesthetics) emerged as significantly more important than did others, although the oft-cited concern regarding FMT aesthetics engendered the lowest overall level of concern. In terms of FMT acceptance, 4 subjects (12%) were opposed to the procedure, indicating that they were not at all likely to agree to FMT for all scenarios (defined as a score of 1 or 2 on the 10-point Likert scale) or by terminating the survey because of the questions. However, 15 (44%) indicated that they would certainly agree to FMT (defined as a score of 9 or 10 on the 10-point Likert scale) if their physician recommended it. Physician recommendation for FMT resulted in the highest overall likelihood of agreeing to FMT, a finding in agreement with a previous survey of FMT for CDI.¹⁰ Most subjects indicated likely enrollment in a potential study comparing FMT with standard antimicrobial therapy.

Strengths/Limitations

Study strengths included surveying patients with current CDI, such that patients had personal experience with the disease in question. Use of in-person interviews also resulted in a robust response rate of 81% and allowed subjects to clarify any unclear questions with study personnel. Weaknesses included a relatively small sample size, underrepresentation of women, and lack of detail regarding respondent characteristics. Additionally, capsule delivery of FMT was not assessed since this method of delivery had not been published at the time of survey administration.

Conclusion

This survey of VA patients with CDI suggests that aesthetic concerns are not a critical deterrent for this population, and interest in FMT for the treatment of recurrent CDI exists. Physician recommendation to undergo FMT seems to be the most influential factor affecting the likelihood of agreeing to undergo FMT. These results support the feasibility of conducting clinical trials of FMT in the VA system.

Clostridium difficile (C difficile) infection (CDI) is a leading cause of infectious diarrhea among hospitalized patients and, increasingly, in ambulatory patients.^1,2 The high prevalence of CDI and the high recurrence rates (15%-30%) led the CDC to categorize C difficile as an "urgent" threat (the highest category) in its 2013 Antimicrobial Resistance Threat Report.^3-5 The Infectious Diseases Society of America guideline recommended treatment for CDI is vancomycin or metronidazole; more recent studies also support fidaxomicin use.^4,6,7  

Patients experiencing recurrent CDI are at risk for further recurrences, such that after the third CDI episode, the risk of subsequent recurrences exceeds 50%.⁸ This recurrence rate has stimulated research into other treatments, including fecal microbiota transplantation (FMT). A recent systematic  review of FMT reports that 85% of patients have resolution of symptoms without recurrence after FMT, although this is based on data from case series and 2 small randomized clinical trials.⁹

A commonly cited barrier to FMT is patient acceptance. In response to this concern, a previous survey demonstrated that 81% of respondents would opt for FMT to treat a hypothetical case of recurrent CDI.¹⁰ However, the surveyed population did not have CDI, and the 48% response rate is concerning, since those with a favorable opinion of FMT might be more willing to complete a survey than would other patients. Accordingly, the authors systematically surveyed hospitalized veterans with active CDI to assess their knowledge, attitudes, and opinions about FMT as a treatment for CDI.

Methods

In-person patient interviews were conducted by one of the study authors at the Minneapolis VA Health Care System (MVAHCS), consisting of 13 to 18 questions. Questions addressed any prior CDI episodes and knowledge of the following: CDI, recurrence risk, and FMT; preferred route and location of FMT administration; concerns regarding FMT; likelihood of agreeing to undergo FMT (if available); and likelihood of enrollment in a hypothetical study comparing FMT to standard antibiotic treatment. The survey was developed internally and was not validated. Questions used the Likert-scale (Survey).

Patients with CDI were identified by monitoring for positive C difficile polymerase chain reaction (PCR) stool tests and then screened for inclusion by medical record review. Inclusion criteria were (1) MVAHCS hospitalization; and (2) written informed consent. Exclusion criteria were the inability to communicate or participate in an interview. Patient responses regarding their likelihood of agreeing to FMT for CDI treatment under different circumstances were compared using Wilcoxon rank sum test. These circumstances included FMT for their current episode of CDI, FMT for a subsequent episode, and FMT if recommended by their physician. Possible concerns regarding FMT also were solicited, including infection risk, effectiveness, and procedural aesthetics. The MVAHCS institutional review board approved the study.

Results

Stool PCR tests for CDI were monitored for 158 days from 2013 to 2014 (based on availability of study staff), yielding 106 positive results. Of those, 31 (29%) were from outpatients and not addressed further. Of the 75 positive CDI tests from 66 hospitalized patients (9 patients had duplicate tests), 18 of 66 (27%) were not able to provide consent and were excluded, leaving 48 eligible patients. Six (13%) were missed for logistic reasons (patient at a test or procedure, discharged before approached, etc), leaving 42 patients who were approached for participation. Among these, 34 (81%) consented to participate in the survey. Two subjects (6%) found the topic so unappealing that they terminated the interview.

The majority of enrolled subjects were men (32/34, 94%), with a mean age of 65.3 years (range, 31-89). Eleven subjects (32%) reported a prior CDI episode, with 10 reporting 1 such episode, and the other 2 episodes. Those with prior CDI reported the effect of CDI on their overall quality of life as 5.1 (1 = no limitation, 10 = severe limitation). Respondents were fairly accurate regarding the risk of recurrence after an initial episode of CDI, with the average expectedrecurrence rate estimated at 33%. In contrast, their estimation of the risk of recurrence after a second CDI episode was lower (28%), although the risk of recurrent episodes increases with each CDI recurrence.

Regarding FMT, 5 subjects indicated awareness of the procedure: 2 learning of it from a news source, 1 from family, 1 from a health care provider, and 1 was unsure of the source. After subjects received a description of FMT, their opinions regarding the procedure were elicited. When asked which route of delivery they would prefer if they were to undergo FMT, the 33 subjects who provided a response indicated a strong preference for either enema (15, 45%) or colonoscopy (10, 30%), compared with just 4 (12%) indicating no preference, 2 (6%) choosing nasogastric tube administration, and 2 (6%) indicating that they would not undergo FMT by any route (P < .001).

Regarding the location of FMT administration (hospital setting vs self-administered at home), 31 of 33 respondents (94%) indicated they would prefer FMT to occur in the hospital vs 2 (6%) preferring self-administration at home (P < .001). The preferred source of donor stool was more evenly distributed, with 14 of 32 respondents (44%) indicating a preference for an anonymous donor, 11 preferring a family member (34%), and 7 (21%) with no preference (P = .21).

Subjects were asked about concerns regarding FMT, and asked to rate each on a 5-point Likert scale (1 = not at all concerning; 5 = overwhelming concern). Concerns regarding risk of infection and effectiveness received an average score of 2.74 and 2.72, respectively, whereas concern regarding the aesthetics, or "yuck factor" was slightly lower (2.1: P = NS for all comparisons). Subjects also were asked to rate the likelihood of undergoing FMT, if it were available, for their current episode of CDI, a subsequent episode of CDI, or if their physician recommended undergoing FMT (10 point scale: 1 = not at all likely; 10 = certainly agree to FMT). The mean scores (SD) for agreeing to FMT for the current or a subsequent episode were 4.8 (SD 2.7) and 5.6 (SD 3.0); P = .12, but increased to 7.1 (SD 3.23) if FMT were recommended by their physician (P < .001 for FMT if physician recommended vs FMT for current episode; P = .001 for FMT if physician recommended vs FMT for a subsequent episode). Finally, subjects were asked about the likelihood of enrolling in a study comparing FMT to standard antimicrobial treatment, with answers ranging from 1 (almost certainly would not enroll) to 5 (almost certainly would enroll). Among the 32 respondents to this question, 17 (53%) answered either "probably would enroll" or "almost certainly would enroll," with a mean score of 3.2.  

Discussion

Overall, VA patients with a current episode of CDI were not aware of FMT, with just 15% knowing about the procedure. However, after learning about FMT, patients expressed clear opinions regarding the route and setting of FMT administration, with enema or colonoscopy being the preferred routes, and a hospital the preferred setting. In contrast, subjects expressed ambivalence with regard to the source of donor stool, with no clear preference for stool from an anonymous donor vs from a family member.

When asked about concerns regarding FMT, none of the presented options (risk of infection, uncertain effectiveness, or procedural aesthetics) emerged as significantly more important than did others, although the oft-cited concern regarding FMT aesthetics engendered the lowest overall level of concern. In terms of FMT acceptance, 4 subjects (12%) were opposed to the procedure, indicating that they were not at all likely to agree to FMT for all scenarios (defined as a score of 1 or 2 on the 10-point Likert scale) or by terminating the survey because of the questions. However, 15 (44%) indicated that they would certainly agree to FMT (defined as a score of 9 or 10 on the 10-point Likert scale) if their physician recommended it. Physician recommendation for FMT resulted in the highest overall likelihood of agreeing to FMT, a finding in agreement with a previous survey of FMT for CDI.¹⁰ Most subjects indicated likely enrollment in a potential study comparing FMT with standard antimicrobial therapy.

Strengths/Limitations

Study strengths included surveying patients with current CDI, such that patients had personal experience with the disease in question. Use of in-person interviews also resulted in a robust response rate of 81% and allowed subjects to clarify any unclear questions with study personnel. Weaknesses included a relatively small sample size, underrepresentation of women, and lack of detail regarding respondent characteristics. Additionally, capsule delivery of FMT was not assessed since this method of delivery had not been published at the time of survey administration.

Conclusion

This survey of VA patients with CDI suggests that aesthetic concerns are not a critical deterrent for this population, and interest in FMT for the treatment of recurrent CDI exists. Physician recommendation to undergo FMT seems to be the most influential factor affecting the likelihood of agreeing to undergo FMT. These results support the feasibility of conducting clinical trials of FMT in the VA system.

Primary care physicians (PCPs) often don’t have the time to manage the complex medication needs of patients with chronic conditions. PCPs working in federally qualified health centers (FQHCs) while caring for low-income at-risk patients also face “particularly large barriers,” according to the Agency for Health Care Research and Quality (AHRQ). But that lack of time can contribute to low patient adherence to medication regimens.

While clinical pharmacists can help, they may not be available to FQHCs, PCP offices, and other primary care settings. To address this, innovators in Ohio established a statewide consortium or “shared learning community” that provides the resources for FQHCs to offer pharmacist-led medication therapy management (MTM) services to patients with diabetes or hypertension. The collaborating organizations include the Ohio Association for Community Health Centers, the Health Services Advisory Group, and 6 Ohio-based colleges of pharmacy.

Related: Best Practices: Utilization of Oncology Pharmacists in the VA

The program developers, Jennifer Rodis, PharmD, BCPS, FAPhA, Assistant Dean for Outreach and Engagement at Ohio State University College of Pharmacy, and Barbara Pryor, MS, RD, LD, manager, Chronic Disease Section, Ohio Department of Health, reported on the consortium’s program and successes in AHRQ’s Health Care Innovations Exchange.

Program leaders meet with participating pharmacists to orient them; those pharmacists then introduce the program to clinicians and staff at their respective practice sites. Every month, the participating pharmacists check in with program leaders from the Ohio Department of Health, the Ohio State University College of Pharmacy, and Ohio Association of Community Health Centers to give status updates and get guidance and troubleshooting advice.

Related: VA Treats Patients’ Impatience With Clinical Pharmacists

The consortium has markedly increased the number of FQHCs offering pharmacist-led MTM services, as well as boosting awareness and interest in MTM. When the program began in 2013, very few of the 41 FQCHs in Ohio had pharmacist-led MTM programs, the AHRQ report says. Nine FQHCs now participate in the consortium.

During the first year, the 3  participating sites enrolled nearly 400 eligible patients with out-of-control hypertension or diabetes. By the end of that year, 68% of hypertensive patients had controlled their blood pressure and 45% of patients with diabetes were controlling their hemoglobin A1c. What’s more, the pharmacists providing MTM addressed 75 adverse drug events and remedied 145 potential events.

Primary care physicians (PCPs) often don’t have the time to manage the complex medication needs of patients with chronic conditions. PCPs working in federally qualified health centers (FQHCs) while caring for low-income at-risk patients also face “particularly large barriers,” according to the Agency for Health Care Research and Quality (AHRQ). But that lack of time can contribute to low patient adherence to medication regimens.

While clinical pharmacists can help, they may not be available to FQHCs, PCP offices, and other primary care settings. To address this, innovators in Ohio established a statewide consortium or “shared learning community” that provides the resources for FQHCs to offer pharmacist-led medication therapy management (MTM) services to patients with diabetes or hypertension. The collaborating organizations include the Ohio Association for Community Health Centers, the Health Services Advisory Group, and 6 Ohio-based colleges of pharmacy.

Related: Best Practices: Utilization of Oncology Pharmacists in the VA

The program developers, Jennifer Rodis, PharmD, BCPS, FAPhA, Assistant Dean for Outreach and Engagement at Ohio State University College of Pharmacy, and Barbara Pryor, MS, RD, LD, manager, Chronic Disease Section, Ohio Department of Health, reported on the consortium’s program and successes in AHRQ’s Health Care Innovations Exchange.

Program leaders meet with participating pharmacists to orient them; those pharmacists then introduce the program to clinicians and staff at their respective practice sites. Every month, the participating pharmacists check in with program leaders from the Ohio Department of Health, the Ohio State University College of Pharmacy, and Ohio Association of Community Health Centers to give status updates and get guidance and troubleshooting advice.

Related: VA Treats Patients’ Impatience With Clinical Pharmacists

The consortium has markedly increased the number of FQHCs offering pharmacist-led MTM services, as well as boosting awareness and interest in MTM. When the program began in 2013, very few of the 41 FQCHs in Ohio had pharmacist-led MTM programs, the AHRQ report says. Nine FQHCs now participate in the consortium.

During the first year, the 3  participating sites enrolled nearly 400 eligible patients with out-of-control hypertension or diabetes. By the end of that year, 68% of hypertensive patients had controlled their blood pressure and 45% of patients with diabetes were controlling their hemoglobin A1c. What’s more, the pharmacists providing MTM addressed 75 adverse drug events and remedied 145 potential events.

Primary care physicians (PCPs) often don’t have the time to manage the complex medication needs of patients with chronic conditions. PCPs working in federally qualified health centers (FQHCs) while caring for low-income at-risk patients also face “particularly large barriers,” according to the Agency for Health Care Research and Quality (AHRQ). But that lack of time can contribute to low patient adherence to medication regimens.

While clinical pharmacists can help, they may not be available to FQHCs, PCP offices, and other primary care settings. To address this, innovators in Ohio established a statewide consortium or “shared learning community” that provides the resources for FQHCs to offer pharmacist-led medication therapy management (MTM) services to patients with diabetes or hypertension. The collaborating organizations include the Ohio Association for Community Health Centers, the Health Services Advisory Group, and 6 Ohio-based colleges of pharmacy.

Related: Best Practices: Utilization of Oncology Pharmacists in the VA

The program developers, Jennifer Rodis, PharmD, BCPS, FAPhA, Assistant Dean for Outreach and Engagement at Ohio State University College of Pharmacy, and Barbara Pryor, MS, RD, LD, manager, Chronic Disease Section, Ohio Department of Health, reported on the consortium’s program and successes in AHRQ’s Health Care Innovations Exchange.

Program leaders meet with participating pharmacists to orient them; those pharmacists then introduce the program to clinicians and staff at their respective practice sites. Every month, the participating pharmacists check in with program leaders from the Ohio Department of Health, the Ohio State University College of Pharmacy, and Ohio Association of Community Health Centers to give status updates and get guidance and troubleshooting advice.

Related: VA Treats Patients’ Impatience With Clinical Pharmacists

The consortium has markedly increased the number of FQHCs offering pharmacist-led MTM services, as well as boosting awareness and interest in MTM. When the program began in 2013, very few of the 41 FQCHs in Ohio had pharmacist-led MTM programs, the AHRQ report says. Nine FQHCs now participate in the consortium.

During the first year, the 3  participating sites enrolled nearly 400 eligible patients with out-of-control hypertension or diabetes. By the end of that year, 68% of hypertensive patients had controlled their blood pressure and 45% of patients with diabetes were controlling their hemoglobin A1c. What’s more, the pharmacists providing MTM addressed 75 adverse drug events and remedied 145 potential events.

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

• Follow infection control requirements;
• Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
• Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
• “Think sepsis”—know the signs and symptoms and treat them early;
• Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
• Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

• Follow infection control requirements;
• Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
• Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
• “Think sepsis”—know the signs and symptoms and treat them early;
• Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
• Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed

Sepsis begins outside the hospital for 80% of patients, according to a recent CDC evaluation, reported in Vital Signs. CDC researchers who reviewed medical records of 246 adults and 79 children at 4 New York hospitals in Albany and Rochester found that 7 in 10 patients with sepsis had recently used health care services or had chronic diseases requiring frequent medical care.

Related: The Role of Procalcitonin in the Management of Infectious Diseases

Sepsis is most common in adults aged ≥ 65 years, infants < 1 year, people with weakened immune systems, or people with chronic conditions, such as diabetes. Nearly all the adults (97%) had at least 1 comorbidity, and 70% of children who developed sepsis had a health condition that may have put them at risk.

Although multiple infections and organisms were implicated, Staphylococcus aureus, Escherichia coli, and some types of Streptococcus were identified most often. Among adults with sepsis, 35% had a lung infection, 25% had a urinary tract infection, 11% had a gastrointestinal infection, and 11% had a skin infection.

Related: Mass Transit for Viruses

Most of the patients had recent interactions with the health care system before admission with sepsis, which likely reflects their vulnerability to infection, the researchers say, “it also suggests that health care facilities and providers could play a central role in sepsis prevention.” The CDC report advises the following for health care providers:

• Follow infection control requirements;
• Ensure that patients receive recommended vaccines (such as flu and pneumococcal);
• Educate patients and families, stressing the need to seek care if they see signs of severe infection or sepsis;
• “Think sepsis”—know the signs and symptoms and treat them early;
• Act fast—order tests to identify infection, start antibiotics and other care immediately; document dose, duration, and purpose; and
• Check patient progress frequently; reassess antibiotic therapy at 24 to 48 hours or sooner to change therapy if needed

Ellen Field, MD 
Private Practice, Rheumatology 
Lehigh Valley, Pennsylvania

Staff, Lehigh Valley Hospital
St. Luke’s Hospital
Sacred Heart Hospital
Lehigh Valley, Pennsylvania

Clinical Assistant Adjunct Professor of Medicine 
Temple University School of Medicine
Philadelphia, Pennsylvania

Q&A with

Click here to read this Best Practices supplement

Ellen Field, MD 
Private Practice, Rheumatology 
Lehigh Valley, Pennsylvania

Staff, Lehigh Valley Hospital
St. Luke’s Hospital
Sacred Heart Hospital
Lehigh Valley, Pennsylvania

Clinical Assistant Adjunct Professor of Medicine 
Temple University School of Medicine
Philadelphia, Pennsylvania

Q&A with

Click here to read this Best Practices supplement

Ellen Field, MD 
Private Practice, Rheumatology 
Lehigh Valley, Pennsylvania

Staff, Lehigh Valley Hospital
St. Luke’s Hospital
Sacred Heart Hospital
Lehigh Valley, Pennsylvania

Clinical Assistant Adjunct Professor of Medicine 
Temple University School of Medicine
Philadelphia, Pennsylvania

Q&A with

Click here to read this Best Practices supplement

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.¹ Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.^2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.^4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.^6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.^9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).¹¹

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.^6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.¹³

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.⁵ These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,¹² and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.^4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.¹ Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.^2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.^4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.^6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.^9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).¹¹

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.^6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.¹³

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.⁵ These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,¹² and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.^4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

Lung cancer remains a leading cause of cancer-related deaths, and screening with low-dose computed tomography (LDCT) has the potential to decrease the mortality rate of patients by 20%.¹ Most major cancer societies have issued lung cancer screening recommendations. For example, the National Comprehensive Cancer Network recommends annual LDCT scans for high-risk patients (those at moderate or low risk need not be screened). High-risk patients are aged between 55 and 74 years (the U.S. Preventive Services Task Force upper age limit is 80 years) and have a smoking history of ≥ 30 pack-years, or if no longer smoking, a quit date within the past 15 years. Although length of screening needed is unclear, it is advised that patients have annual LDCT scans until they have been smoke free for 15 years, develop limited life expectancy, or are no longer eligible for definitive treatment for lung cancer. A strong antismoking commitment and a multidisciplinary approach are of paramount importance.^2,3

Fleischner Society criteria are the most established guidelines for risk-stratifying pulmonary nodules (Table 1). Nodules are stratified by size and change in size over a 2-year period. There is interest in evaluating change in volume as well, but techniques are still emerging and have not been universally adopted.^4,5

Lung nodule screening likely will require significant involvement of radiologists and pulmonologists in the workup of patients with positive screens. Radiologists have demonstrated a fair amount of interobserver agreement with respect to diagnosis, but there are no data comparing pulmonologists with other pulmonologists or with radiologists.^6-8 In addition, although health care professionals have access to validated models for predicting risk of malignancy, there is evidence they do not use them.^9,10 This study was conducted to determine whether pulmonologists and radiologists experienced in thoracic abnormalities are consistent in accurately diagnosing malignant lung nodules and masses noted on CT scans.

Methods

After obtaining institutional review board approval for this study, the authors evaluated all the lung nodule or lung mass referrals that had been made to the University of Arkansas for Medical Sciences (UAMS) and Central Arkansas Veterans Healthcare System (CAVHS) interventional pulmonary clinics between March 2009 and March 2013. Of the 1,512 referrals made, 250 were randomly selected for noncontrasted CT image review and data collection. Each CT image was de-identified and then reviewed by a pulmonologist and a radiologist. The study used 4 reviewers—2 board-certified pulmonologists and 2 board-certified radiologists—all with > 3 years of experience. Both radiologists were thoracic specialists, and no residents or fellows participated. For each case, reviewers were given a brief patient history outlining smoking and other malignancies. Data collected included age, sex, race, exposure to cigarette smoking, and the gold standard of final diagnosis (FD).

In each case, a pulmonologist and a radiologist reviewed the patient’s CT images from the first visit. Reviewers were asked to determine and document the single most likely diagnosis. Diagnoses were grouped into primary lung cancer, metastatic disease, lymphoma, infectious/inflammatory etiology, benign neoplasm, and other (eg, sarcoma). A lesion with a diagnostic biopsy and stability at 2 years was deemed benign. A lesion that was culture-positive or responded rapidly to antibacterial or antifungal therapy was deemed infectious/inflammatory. Lesions were grouped by size: group 1 (≤ 10 mm), group 2 (11-30 mm), group 3 (31-50 mm), group 4 (≥ 51 mm).

Statistical Analyses

Student t tests were used to compare means. Concordance of the pulmonary reviewers and FD was assessed with the κ coefficient. The concordance was also evaluated between the radiology reviewers and FD. These statistical analyses were performed with SAS Version 9.4 (SAS Institute). P values were interpreted using the sliding-scale approach of Mendenhall and colleagues: P < .01 (highly significant); .01 < P < .05 (statistically significant); .05 < P < .10 (trending toward significance); P > .10 (not significant).¹¹

Results

Of the 250 patients selected for the study, 111 had the pertinent data available, along with a follow-up appointment > 2 years afterward at the center. The patients included 40 women and 71 men; 79 white patients, 29 black patients, and 3 patients of other races. Mean age was 58 years (range, 21-93 years).

Risk factors for malignancy were older age, larger lesion, and history of smoking. The malignancy rates for women and men were almost identical (53% and 54%, respectively), and the difference was not statistically significant (P = .40).

Diagnosis

Table 2 outlines the distribution of the reviewers’ diagnoses and the distribution of FD. Primary lung cancer was the dominant suspected diagnosis and accounted for 61%, 65%, and 54% of the cases reviewed by the pulmonologist, the radiologist, and FD, respectively. Metastatic disease was a distant second dominant diagnosis (17%, 15%, and 15%, respectively). There was no statistical difference between the reviews of the pulmonologist and radiologist, and the FD (P > .05).

Table 3 lists the κ results for the strength of agreement between pulmonologist and radiologist. Agreement for primary lung cancer was very good: 0.94 (95% confidence interval [CI], 0.89-0.99). With respect to group 1, agreement was perfect: 1.0 (95% CI, 1.000-1.000). Benign neoplasm had the weakest agreement. There was no statistical difference between pulmonologist and radiologist determinations across size-based groups.Agreement between pulmonologist and FD was almost perfect. The major discrepancy between the sets of reviewers remained benign neoplasm and infectious/inflammatory etiology.

Of the 111 study patients, 68 (61%) and 72 (65%) were suspected of having primary lung cancer by pulmonologist and radiologist, respectively. However, only 60 (54%) actually had primary lung cancer; the differences were not statistically significant (P = .27 and .1, respectively). No cases were reclassified as primary lung cancer on final pathology.

Infectious/inflammatory etiologies did not always have positive cultures. Those with positive cultures included Streptococcus (S) viridans, Rhodococcus equi, Blastomyces dermatitidis, S constellatus, S anginosus, S intermedius, and Histoplasma capsulatum. Benign neoplasms included radiation injuries, benign fibrous tumor of the pleura, and hamartoma.

Pulmonologists and radiologists had identical high sensitivities for primary lung cancer: 1.0 (95% CI, 0.94-1.00). Specificities were 0.84 (95% CI, 0.77-0.84) for pulmonologists and 0.77(95% CI, 0.69-0.77) for radiologists, and the difference was not statistically significant (P = .28) (Table 4).

Discussion

Computed tomography scans are performed to evaluate a variety of diseases. An estimated 7 million CT scans are performed in the U.S. annually.^6,12 As the National Lung Screening Trial recommendations are followed more routinely, almost 9 million peoplecould become candidates, adding to the already large number of CTscans to be evaluated.¹³

Radiologists would understandably read most of these patients’ scans. However, patients referred to tertiary-care centers usually bring CT images with them; even scans performed at UAMS and CAVHS centers may not be read by a radiologist in time for an appointment. The result is that the clinic pulmonologist often must base decisions on a CT reading, but without the assistance of high-fidelity computer programs or a high-definition scan.⁵ These limitations indicate why it is important to know whether assessment by a pulmonologist compares favorably with assessment by a radiologist and with the eventual diagnosis.

The malignancy rate in the referred population is not insignificant. Halbert and colleagues found a 25% malignancy rate in their study,¹² and the present study had an overall malignancy rate of 54%. The difference may be attributed to the possibility that the patients may have been prescreened prior to referral.

The reviewers overestimated the presence of malignant disease, though not to a level of statistical significance. About 88% of cases evaluated by a pulmonologist and 83% of cases evaluated by a radiologist were confirmed to be malignant. The reviewers’ sensitivity was perfect for all diagnoses except benign neoplasms, likely because these cases were classified malignant, thus increasing sensitivity but decreasing specificity.

This dynamic is important to understand, as it allows for a very high negative predictive value, which has real implications for resource management at VA hospitals, including CAVHS facility, where almost every CT scan with an abnormality is referred for pulmonologist consultation. In these cases, the radiologist not only lists the likely suspicion but includes a recommendation for follow-up or further workup based on Fleischner Society guidelines.^4,14 The patient should be informed of findings as soon as the radiologist reads the CT scan, and a plan should be made on the basis of the recommendation. The patient should not have to unnecessarily wait—a potential source of anxiety—to see another specialist who would probably make the same recommendation.

Applying this study’s findings could improve workflow and the timing of CT scans. A patient should not be referred to a pulmonologist unless specifically recommended by a radiologist, thus decreasing the scheduling burden on the specialty clinic and allowing for appropriate patients to be scheduled at reasonable intervals. In addition, having only 1 person in charge of ordering CT scans could reduce the chance of duplicating orders and performing CT scans at inappropriate times.

Most important, these results should lead to more detailed physician–patient discussions about radiologic findings, hopefully alleviating any patient anxiety. A patient who still wants to see a specialist may, but with less stress that can accompany being told that there is “something abnormal” on the imaging and that the patient needs to see a lung doctor.

Limitations

This study had a few weaknesses. It was a small trial, and its data were collected retrospectively. In addition, generalizing its results may be difficult, as its reviewers had less than 5 years of training, and reviewers with more experience likely would be more accurate and have a higher rate of agreement.

Results could have been skewed by the study’s unusually large number of patients with malignant disease. Had the study been conducted with a larger population (patients at primary care offices), accuracy and agreement might have been lower.

Conclusion

This study answered its 2 questions. Although it is universally accepted that pulmonologists can review patients’ scans, to the authors’ knowledge this is the first study that asked, “Are pulmonologists as good as radiologists in reading CT scans?” The answer is yes. Also asked was, “Do pulmonologists’ and radiologists’ diagnoses predict the final path?” The reviewers’ were very accurate except in the case of benign neoplasms.

Experienced pulmonologists and radiologists are consistent in accurately diagnosing malignant lung nodules and lung masses noted on CT scans.

In fiscal year (FY) 2015, VA conducted 2.14 million telehealth visits, reaching more than 677,000 veterans. Telehealth “remains a critical strategy in ensuring veterans can access health care when and where they need it,” Kevin Galpin, MD, acting executive director for telehealth at the VHA told the House Committee on Veterans Affairs earlier this month. “With the support of Congress, we have an opportunity to shape the future and ensure that VA is leveraging cutting-edge technology to provide convenient, accessible, high-quality care to all veterans.”

Related: Madhulika Agarwal on Telehealth at the VHA

Telemental health, in particular, also has seen significant growth. From 2002 through July 2, 2016, Galpin reported, more than 2 million telemental health visits have been provided to more than 389,400 unique veterans. And use of telehealth in the Greater Los Angeles Health Care System alone increased by 61,500, including more than 20,000 telehealth visits, which reached more than 6,000 veterans in southern California.

“For the past 10 years, I have studied many telehealth models and have been most impressed by the VA model as both exemplary and successful,” Herb Rogove, DO, FCCM, FACP, president and chief executive officer, C30 Telemedicine and former board member of the American Telemedicine Association, reported in a statement to the committee.

Related: Telejustice: Reaching Incarcerated Veterans via Telehealth

The VA is testing a new system that will allow veterans to access telehealth from their personal mobile device, smartphone, tablet, or computer. The VA Video Connect (VVC) is currently undergoing field testing for real-time access to VA care and will be fully encrypted to protect patient information. It will complement the VA’s current offerings of home telehealth, using VA-provided devices and store-and-forward telehealth, which allows users to asynchronously acquire and store clinical information (such as data, images, sound, and video) that then can be examined by a provider at another location for clinical evaluation.

Related: Patients Benefit From ICU Telemedicine

Other important telehealth developments include:

• In FY 2015, more than 57,000 rehabilitation encounters for more than 33,000 unique veterans occurred using home telehealth.
• Store-and-forward telehealth has been particularly successful for dermatologic and retinal diagnosis and triage.
• The National Telemental Health Centers have provided access and consults to more than 4,600 veterans at more than 120 sites. 
• The Tele-Intensive Care program links VA intensive care units to a central monitoring hub.
• Telesurgical consultation is being used to “enhance the diagnosis, the coordination of care, and the triage of surgical patients.”

In fiscal year (FY) 2015, VA conducted 2.14 million telehealth visits, reaching more than 677,000 veterans. Telehealth “remains a critical strategy in ensuring veterans can access health care when and where they need it,” Kevin Galpin, MD, acting executive director for telehealth at the VHA told the House Committee on Veterans Affairs earlier this month. “With the support of Congress, we have an opportunity to shape the future and ensure that VA is leveraging cutting-edge technology to provide convenient, accessible, high-quality care to all veterans.”

Related: Madhulika Agarwal on Telehealth at the VHA

Telemental health, in particular, also has seen significant growth. From 2002 through July 2, 2016, Galpin reported, more than 2 million telemental health visits have been provided to more than 389,400 unique veterans. And use of telehealth in the Greater Los Angeles Health Care System alone increased by 61,500, including more than 20,000 telehealth visits, which reached more than 6,000 veterans in southern California.

“For the past 10 years, I have studied many telehealth models and have been most impressed by the VA model as both exemplary and successful,” Herb Rogove, DO, FCCM, FACP, president and chief executive officer, C30 Telemedicine and former board member of the American Telemedicine Association, reported in a statement to the committee.

Related: Telejustice: Reaching Incarcerated Veterans via Telehealth

The VA is testing a new system that will allow veterans to access telehealth from their personal mobile device, smartphone, tablet, or computer. The VA Video Connect (VVC) is currently undergoing field testing for real-time access to VA care and will be fully encrypted to protect patient information. It will complement the VA’s current offerings of home telehealth, using VA-provided devices and store-and-forward telehealth, which allows users to asynchronously acquire and store clinical information (such as data, images, sound, and video) that then can be examined by a provider at another location for clinical evaluation.

Related: Patients Benefit From ICU Telemedicine

Other important telehealth developments include:

• In FY 2015, more than 57,000 rehabilitation encounters for more than 33,000 unique veterans occurred using home telehealth.
• Store-and-forward telehealth has been particularly successful for dermatologic and retinal diagnosis and triage.
• The National Telemental Health Centers have provided access and consults to more than 4,600 veterans at more than 120 sites. 
• The Tele-Intensive Care program links VA intensive care units to a central monitoring hub.
• Telesurgical consultation is being used to “enhance the diagnosis, the coordination of care, and the triage of surgical patients.”

In fiscal year (FY) 2015, VA conducted 2.14 million telehealth visits, reaching more than 677,000 veterans. Telehealth “remains a critical strategy in ensuring veterans can access health care when and where they need it,” Kevin Galpin, MD, acting executive director for telehealth at the VHA told the House Committee on Veterans Affairs earlier this month. “With the support of Congress, we have an opportunity to shape the future and ensure that VA is leveraging cutting-edge technology to provide convenient, accessible, high-quality care to all veterans.”

Related: Madhulika Agarwal on Telehealth at the VHA

Telemental health, in particular, also has seen significant growth. From 2002 through July 2, 2016, Galpin reported, more than 2 million telemental health visits have been provided to more than 389,400 unique veterans. And use of telehealth in the Greater Los Angeles Health Care System alone increased by 61,500, including more than 20,000 telehealth visits, which reached more than 6,000 veterans in southern California.

“For the past 10 years, I have studied many telehealth models and have been most impressed by the VA model as both exemplary and successful,” Herb Rogove, DO, FCCM, FACP, president and chief executive officer, C30 Telemedicine and former board member of the American Telemedicine Association, reported in a statement to the committee.

Related: Telejustice: Reaching Incarcerated Veterans via Telehealth

The VA is testing a new system that will allow veterans to access telehealth from their personal mobile device, smartphone, tablet, or computer. The VA Video Connect (VVC) is currently undergoing field testing for real-time access to VA care and will be fully encrypted to protect patient information. It will complement the VA’s current offerings of home telehealth, using VA-provided devices and store-and-forward telehealth, which allows users to asynchronously acquire and store clinical information (such as data, images, sound, and video) that then can be examined by a provider at another location for clinical evaluation.

Related: Patients Benefit From ICU Telemedicine

Other important telehealth developments include:

• In FY 2015, more than 57,000 rehabilitation encounters for more than 33,000 unique veterans occurred using home telehealth.
• Store-and-forward telehealth has been particularly successful for dermatologic and retinal diagnosis and triage.
• The National Telemental Health Centers have provided access and consults to more than 4,600 veterans at more than 120 sites. 
• The Tele-Intensive Care program links VA intensive care units to a central monitoring hub.
• Telesurgical consultation is being used to “enhance the diagnosis, the coordination of care, and the triage of surgical patients.”

Health care costs are the fastest growing financial segment of the U.S. economy. The Centers for Medicare and Medicaid Services (CMS) estimates health care spending in the U.S. will increase from $3.0 trillion in 2014 to $5.4 trillion by 2024.¹ About 19.3% of the U.S. gross domestic product is consumed by health care, which is twice that of any other country in the world. It is often stated that the increasing cost of health care is the most significant financial threat to the U.S. economy. The cost of medications, including those for treating cancer, is the leading cause of increased health care spending.²

The cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase.³ Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government. However, that discussion is outside the scope of this article.

The affordability of health care has become a major concern for most Americans. During the recent U.S. financial crisis, most of the focus was on the bursting of the housing bubble, plummeting real estate prices, the loss of jobs, and the failure of large financial institutions. However, medical bills were still the leading cause of personal bankruptcies during this period. In 2007, 62% of personal bankruptcies in the U.S. were due to medical costs, and 78% of those bankruptcies involved patients who had health insurance at the beginning of their illness.⁴

The cost of prescription medications is causing financial difficulties for many patients, especially elderly.

Americans who have multiple chronic medical conditions and live on fixed incomes. A recently released survey by the nonpartisan Kaiser Family Foundation found that the high cost of prescription medications, especially those to treat serious medical conditions such as cancer, is the top health concern of 77% of those Americans polled.⁵ In this environment, oncology providers face many challenges in their obligation to treat cancer patients in a cost-effective manner.

This article will appear in 2 parts. Part 1 will focus on the emerging discussion of the financial impact of high-cost drugs in the U.S. The drivers of increasing oncology drug costs will also be reviewed. Part 2 will focus on the challenges of high cost medications in the VA and the role the VA Pharmacy Benefits Management (PBM) Service has in evaluating new oncology agents. Clinical guidance tools designed to aid the clinician in the cost-effective use of these agents and results of a nationwide survey of VA oncology pharmacists regarding the use of cost-containment strategies will also be presented.

Background

When discussing the value of targeted therapies, it is useful to define both targeted therapy and value. A targeted therapy is a type of treatment using drugs or other substances to identify and attack cancer cells with less harm to normal cells, according to the National Cancer Institute. ⁶ Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells (the molecular target). Other types of targeted therapies help the immune system kill cancer cells or deliver toxic substances directly to cancer cells and kill them.

Targeted therapy may have fewer adverse effects (AEs) than do other types of cancer treatment. Most targeted therapies are either small molecules or monoclonal antibodies. Although imatinib, released in 2001, is the drug that coined the phrase targeted therapy, many drugs released earlier, such as rituximab, can be considered targeted therapies due to their specific, or targeted, mechanism of action.

Value is the price an object will bring in an open and competitive, or free, market as determined by the consumer. To put the definition of value in simpler terms, Warren Buffet has been quoted as saying, “Cost is what you pay, value is what you get.” The oncology market is not entirely free and open. Market price is determined by the manufacturer, entry into the market is regulated by the FDA, purchasers (like the VA and the Centers for Medicare and Medicaid Services) have only limited ability to negotiate prices, and refusing to pay for life-saving or life-prolonging medications often is not an option. As costs for oncology drugs rapidly increase, the cost-benefit ratio, or value, is being increasingly debated. When comparing the clinical benefits these agents provide with cost, the perception of value is highly subjective and can change significantly based on who is paying the bill.

Questioning High-Cost Drugs

Charles Moertel and colleagues published a landmark trial 25 years ago, which reported that treatment with fluorouracil and levamisole for 1 year decreased the death rate of patients with stage C (stage III) colon cancer by 33% following curative surgery.⁷ Although this trial was clinically significant, there was as much discussion about the high cost of levamisole (Ergamisol) tablets as there
was about its clinical benefit for patients.

In a 1991 letter to the New England Journal of Medicine, Rossof and colleagues questioned the high cost of the levamisole in the treatment regimen.⁸ Rossof and colleagues were surprised at the drug’s price on approval, about $5 for each tablet, and detailed their concerns on how this price was determined. “On the basis of the cost to a veterinarian, the calculated cost of a hypothetical 50-mg tablet should be in the range of 3 to 6 cents,” they argued. The total cost to the patient of 1 year of treament was nearly $1,200. Their conclusion was that “…the price chosen for the new American consumer is far too high and requires justification by the manufacturer.”

A reply from Janssen Pharmaceutica, the drug’s manufacturer, offered many justifications for the price.8 According to the company, Ergamisol was supplied free to 5,000 research patients prior to FDA approval. It was also given for free to indigent patients. The company also insisted that its pricing compared favorably with its competitors, such as zidovudine, octreotide, newer generation nonsteroidal anti-inflammatories, and antihypertension drugs. “Drug pricing includes additional expensive research, physician education, compassionate use programs, and ensuring high-quality control. Janssen scientists studied immunomodulating effect of Ergamisol for 25 years with no financial return. Drug development is high-risk, so companies must be able to derive a reasonable return on sales.”⁸

The cost of levamisole was $1,200 per year in 1991, and after adjustment for inflation would cost about $1,988 in 2015, or $166 per month. If these prices caused outrage in 1990, it is easy to see how current prices of well over $10,000 per month for therapies, which often render small clinical benefits, can seem outrageous by comparison.

Public Debate Over Cancer Drug Prices

In the U.S., about 1.66 million patients will be diagnosed with cancer in 2015.⁹ Although about 30% to 40% of these patients will be effectively cured, only 3% to 4% will be cured using pharmacotherapy (usually traditional chemotherapy) as a sole modality. Therefore, the use of oncology drugs by the vast majority of cancer patients is not to cure but to control or palliate patients with advanced cancer. It is important to note that the cost of most curative regimens is cheap compared with many medications used for advanced disease. Until a few years ago, discussion of the high costs of cancer treatment was rarely made public due to the devastating nature of cancer. However, with the rapid price increases and relatively disappointing clinical benefits of the many new drugs entering the market, the question of value can no longer be ignored. Many authors havepresented commentaries and strategies addressing the issues
surrounding the high cost of cancer drugs.^10-15

It was a groundbreaking 2012 letter to the New York Times that brought the issue to public attention.¹⁶ Dr. Peter Bach and his colleagues at Memorial Sloan Kettering Cancer Center announced they would not purchase a “phenomenally expensive new cancer drug” for their patients, calling their decision a no-brainer. The drug, ziv-afilbercept (Zaltrap), was twice the price of a similar drug, bevacizumab (Avastin), but was no more efficacious in the treatment of metastatic colorectal cancer. Bach and colleagues went on to say how high drug prices are having a potentially devastating financial impact on patients and that laws protect drug manufacturers to set drug prices at what they feel the market will bear.

The financial burden put on patients has become the driving force for drug cost reform. In an attempt to control their costs, third-party payers have increased the cost burden for patients by demanding larger copays and other out-of-pocket expenses for medications. It is felt that requiring patients to have more “skin in the game” would force them to make treatment decisions based on cost. Unfortunately, this approach may lead to devastating financial consequences for patients.^18-20 The overwhelming emotions patients experience following the diagnosis of cancer make it difficult to focus on the financial impact of treatment recommendations. In addition, many oncologists are not comfortable, or even capable, of discussing costs so patients can make financially informed treatment decisions.¹⁴ Unfortunately for patients, “shopping for health care” has very little in common with shopping for a car, television sets, or any other commodity.

The VA Health Care System

The VA is government-sponsored health care and is therefore unique in the U.S. health care environment. The VA might be considered a form of “socialized medicine” that operates under a different economic model than do private health care systems. The treatment of VA patients for common diseases is based on nationally accepted evidence-based guidelines, which allow the best care in a cost-effective manner. For the treatment of cancer, the use of expensive therapies must be made in the context of the finite resources allocated for the treatment of all veterans within the system.

The VA provides lifelong free or minimal cost health care to eligible veterans. For veterans receiving care within the VA, out-of-pocket expenses are considerably less than for non-VA patients. Current medication copays range from free to $9 per month for all medications, regardless of acquisition cost. This is in stark contrast to the private sector, where patients must often pay large, percentage- based copays for oncology medications, which can reach several thousand dollars per month. VA patients are not subject to percentage-based copays; therefore, they are not a financial stakeholder in the treatment
decision process.

Prior to 1995, the VA was a much criticized and poorly performing health care system that had experienced significant budget cuts, forcing many veterans to lose their benefits and seek care outside the VA. Beginning in 1995 with the creation of PBM, a remarkable transformation occurred that modernized and transformed the VA into a system that consistently outperforms the private sector in quality of care, patient safety, and patient satisfaction while maintaining low overall costs. The role of the VA PBM was to develop and maintain the National Drug Formulary, create clinical guidance documents, and manage drug costs and use.

Part 2 of this article will more closely examine the high cost of cancer drugs. It will also discuss the role of VA PBM and other VA efforts to control cost

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here for the digital edition.

Health care costs are the fastest growing financial segment of the U.S. economy. The Centers for Medicare and Medicaid Services (CMS) estimates health care spending in the U.S. will increase from $3.0 trillion in 2014 to $5.4 trillion by 2024.¹ About 19.3% of the U.S. gross domestic product is consumed by health care, which is twice that of any other country in the world. It is often stated that the increasing cost of health care is the most significant financial threat to the U.S. economy. The cost of medications, including those for treating cancer, is the leading cause of increased health care spending.²

The cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase.³ Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government. However, that discussion is outside the scope of this article.

The affordability of health care has become a major concern for most Americans. During the recent U.S. financial crisis, most of the focus was on the bursting of the housing bubble, plummeting real estate prices, the loss of jobs, and the failure of large financial institutions. However, medical bills were still the leading cause of personal bankruptcies during this period. In 2007, 62% of personal bankruptcies in the U.S. were due to medical costs, and 78% of those bankruptcies involved patients who had health insurance at the beginning of their illness.⁴

The cost of prescription medications is causing financial difficulties for many patients, especially elderly.

Americans who have multiple chronic medical conditions and live on fixed incomes. A recently released survey by the nonpartisan Kaiser Family Foundation found that the high cost of prescription medications, especially those to treat serious medical conditions such as cancer, is the top health concern of 77% of those Americans polled.⁵ In this environment, oncology providers face many challenges in their obligation to treat cancer patients in a cost-effective manner.

This article will appear in 2 parts. Part 1 will focus on the emerging discussion of the financial impact of high-cost drugs in the U.S. The drivers of increasing oncology drug costs will also be reviewed. Part 2 will focus on the challenges of high cost medications in the VA and the role the VA Pharmacy Benefits Management (PBM) Service has in evaluating new oncology agents. Clinical guidance tools designed to aid the clinician in the cost-effective use of these agents and results of a nationwide survey of VA oncology pharmacists regarding the use of cost-containment strategies will also be presented.

Background

When discussing the value of targeted therapies, it is useful to define both targeted therapy and value. A targeted therapy is a type of treatment using drugs or other substances to identify and attack cancer cells with less harm to normal cells, according to the National Cancer Institute. ⁶ Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells (the molecular target). Other types of targeted therapies help the immune system kill cancer cells or deliver toxic substances directly to cancer cells and kill them.

Targeted therapy may have fewer adverse effects (AEs) than do other types of cancer treatment. Most targeted therapies are either small molecules or monoclonal antibodies. Although imatinib, released in 2001, is the drug that coined the phrase targeted therapy, many drugs released earlier, such as rituximab, can be considered targeted therapies due to their specific, or targeted, mechanism of action.

Value is the price an object will bring in an open and competitive, or free, market as determined by the consumer. To put the definition of value in simpler terms, Warren Buffet has been quoted as saying, “Cost is what you pay, value is what you get.” The oncology market is not entirely free and open. Market price is determined by the manufacturer, entry into the market is regulated by the FDA, purchasers (like the VA and the Centers for Medicare and Medicaid Services) have only limited ability to negotiate prices, and refusing to pay for life-saving or life-prolonging medications often is not an option. As costs for oncology drugs rapidly increase, the cost-benefit ratio, or value, is being increasingly debated. When comparing the clinical benefits these agents provide with cost, the perception of value is highly subjective and can change significantly based on who is paying the bill.

Questioning High-Cost Drugs

Charles Moertel and colleagues published a landmark trial 25 years ago, which reported that treatment with fluorouracil and levamisole for 1 year decreased the death rate of patients with stage C (stage III) colon cancer by 33% following curative surgery.⁷ Although this trial was clinically significant, there was as much discussion about the high cost of levamisole (Ergamisol) tablets as there
was about its clinical benefit for patients.

In a 1991 letter to the New England Journal of Medicine, Rossof and colleagues questioned the high cost of the levamisole in the treatment regimen.⁸ Rossof and colleagues were surprised at the drug’s price on approval, about $5 for each tablet, and detailed their concerns on how this price was determined. “On the basis of the cost to a veterinarian, the calculated cost of a hypothetical 50-mg tablet should be in the range of 3 to 6 cents,” they argued. The total cost to the patient of 1 year of treament was nearly $1,200. Their conclusion was that “…the price chosen for the new American consumer is far too high and requires justification by the manufacturer.”

A reply from Janssen Pharmaceutica, the drug’s manufacturer, offered many justifications for the price.8 According to the company, Ergamisol was supplied free to 5,000 research patients prior to FDA approval. It was also given for free to indigent patients. The company also insisted that its pricing compared favorably with its competitors, such as zidovudine, octreotide, newer generation nonsteroidal anti-inflammatories, and antihypertension drugs. “Drug pricing includes additional expensive research, physician education, compassionate use programs, and ensuring high-quality control. Janssen scientists studied immunomodulating effect of Ergamisol for 25 years with no financial return. Drug development is high-risk, so companies must be able to derive a reasonable return on sales.”⁸

The cost of levamisole was $1,200 per year in 1991, and after adjustment for inflation would cost about $1,988 in 2015, or $166 per month. If these prices caused outrage in 1990, it is easy to see how current prices of well over $10,000 per month for therapies, which often render small clinical benefits, can seem outrageous by comparison.

Public Debate Over Cancer Drug Prices

In the U.S., about 1.66 million patients will be diagnosed with cancer in 2015.⁹ Although about 30% to 40% of these patients will be effectively cured, only 3% to 4% will be cured using pharmacotherapy (usually traditional chemotherapy) as a sole modality. Therefore, the use of oncology drugs by the vast majority of cancer patients is not to cure but to control or palliate patients with advanced cancer. It is important to note that the cost of most curative regimens is cheap compared with many medications used for advanced disease. Until a few years ago, discussion of the high costs of cancer treatment was rarely made public due to the devastating nature of cancer. However, with the rapid price increases and relatively disappointing clinical benefits of the many new drugs entering the market, the question of value can no longer be ignored. Many authors havepresented commentaries and strategies addressing the issues
surrounding the high cost of cancer drugs.^10-15

It was a groundbreaking 2012 letter to the New York Times that brought the issue to public attention.¹⁶ Dr. Peter Bach and his colleagues at Memorial Sloan Kettering Cancer Center announced they would not purchase a “phenomenally expensive new cancer drug” for their patients, calling their decision a no-brainer. The drug, ziv-afilbercept (Zaltrap), was twice the price of a similar drug, bevacizumab (Avastin), but was no more efficacious in the treatment of metastatic colorectal cancer. Bach and colleagues went on to say how high drug prices are having a potentially devastating financial impact on patients and that laws protect drug manufacturers to set drug prices at what they feel the market will bear.

The financial burden put on patients has become the driving force for drug cost reform. In an attempt to control their costs, third-party payers have increased the cost burden for patients by demanding larger copays and other out-of-pocket expenses for medications. It is felt that requiring patients to have more “skin in the game” would force them to make treatment decisions based on cost. Unfortunately, this approach may lead to devastating financial consequences for patients.^18-20 The overwhelming emotions patients experience following the diagnosis of cancer make it difficult to focus on the financial impact of treatment recommendations. In addition, many oncologists are not comfortable, or even capable, of discussing costs so patients can make financially informed treatment decisions.¹⁴ Unfortunately for patients, “shopping for health care” has very little in common with shopping for a car, television sets, or any other commodity.

The VA Health Care System

The VA is government-sponsored health care and is therefore unique in the U.S. health care environment. The VA might be considered a form of “socialized medicine” that operates under a different economic model than do private health care systems. The treatment of VA patients for common diseases is based on nationally accepted evidence-based guidelines, which allow the best care in a cost-effective manner. For the treatment of cancer, the use of expensive therapies must be made in the context of the finite resources allocated for the treatment of all veterans within the system.

The VA provides lifelong free or minimal cost health care to eligible veterans. For veterans receiving care within the VA, out-of-pocket expenses are considerably less than for non-VA patients. Current medication copays range from free to $9 per month for all medications, regardless of acquisition cost. This is in stark contrast to the private sector, where patients must often pay large, percentage- based copays for oncology medications, which can reach several thousand dollars per month. VA patients are not subject to percentage-based copays; therefore, they are not a financial stakeholder in the treatment
decision process.

Prior to 1995, the VA was a much criticized and poorly performing health care system that had experienced significant budget cuts, forcing many veterans to lose their benefits and seek care outside the VA. Beginning in 1995 with the creation of PBM, a remarkable transformation occurred that modernized and transformed the VA into a system that consistently outperforms the private sector in quality of care, patient safety, and patient satisfaction while maintaining low overall costs. The role of the VA PBM was to develop and maintain the National Drug Formulary, create clinical guidance documents, and manage drug costs and use.

Part 2 of this article will more closely examine the high cost of cancer drugs. It will also discuss the role of VA PBM and other VA efforts to control cost

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

Click here for the digital edition.

Health care costs are the fastest growing financial segment of the U.S. economy. The Centers for Medicare and Medicaid Services (CMS) estimates health care spending in the U.S. will increase from $3.0 trillion in 2014 to $5.4 trillion by 2024.¹ About 19.3% of the U.S. gross domestic product is consumed by health care, which is twice that of any other country in the world. It is often stated that the increasing cost of health care is the most significant financial threat to the U.S. economy. The cost of medications, including those for treating cancer, is the leading cause of increased health care spending.²

The cost of cancer care is the most rapidly increasing component of U.S. health care spending and will increase from $125 billion in 2010 to an estimated $158 billion in 2020, a 27% increase.³ Most experts agree that the current escalation of costs is unsustainable and, if left unchecked, will have a devastating effect on the quality of health care and an increasing negative financial impact on individuals, businesses, and government. However, that discussion is outside the scope of this article.

The affordability of health care has become a major concern for most Americans. During the recent U.S. financial crisis, most of the focus was on the bursting of the housing bubble, plummeting real estate prices, the loss of jobs, and the failure of large financial institutions. However, medical bills were still the leading cause of personal bankruptcies during this period. In 2007, 62% of personal bankruptcies in the U.S. were due to medical costs, and 78% of those bankruptcies involved patients who had health insurance at the beginning of their illness.⁴

The cost of prescription medications is causing financial difficulties for many patients, especially elderly.

Americans who have multiple chronic medical conditions and live on fixed incomes. A recently released survey by the nonpartisan Kaiser Family Foundation found that the high cost of prescription medications, especially those to treat serious medical conditions such as cancer, is the top health concern of 77% of those Americans polled.⁵ In this environment, oncology providers face many challenges in their obligation to treat cancer patients in a cost-effective manner.

This article will appear in 2 parts. Part 1 will focus on the emerging discussion of the financial impact of high-cost drugs in the U.S. The drivers of increasing oncology drug costs will also be reviewed. Part 2 will focus on the challenges of high cost medications in the VA and the role the VA Pharmacy Benefits Management (PBM) Service has in evaluating new oncology agents. Clinical guidance tools designed to aid the clinician in the cost-effective use of these agents and results of a nationwide survey of VA oncology pharmacists regarding the use of cost-containment strategies will also be presented.

Background

When discussing the value of targeted therapies, it is useful to define both targeted therapy and value. A targeted therapy is a type of treatment using drugs or other substances to identify and attack cancer cells with less harm to normal cells, according to the National Cancer Institute. ⁶ Some targeted therapies block the action of certain enzymes, proteins, or other molecules involved in the growth and spread of cancer cells (the molecular target). Other types of targeted therapies help the immune system kill cancer cells or deliver toxic substances directly to cancer cells and kill them.

Targeted therapy may have fewer adverse effects (AEs) than do other types of cancer treatment. Most targeted therapies are either small molecules or monoclonal antibodies. Although imatinib, released in 2001, is the drug that coined the phrase targeted therapy, many drugs released earlier, such as rituximab, can be considered targeted therapies due to their specific, or targeted, mechanism of action.

Value is the price an object will bring in an open and competitive, or free, market as determined by the consumer. To put the definition of value in simpler terms, Warren Buffet has been quoted as saying, “Cost is what you pay, value is what you get.” The oncology market is not entirely free and open. Market price is determined by the manufacturer, entry into the market is regulated by the FDA, purchasers (like the VA and the Centers for Medicare and Medicaid Services) have only limited ability to negotiate prices, and refusing to pay for life-saving or life-prolonging medications often is not an option. As costs for oncology drugs rapidly increase, the cost-benefit ratio, or value, is being increasingly debated. When comparing the clinical benefits these agents provide with cost, the perception of value is highly subjective and can change significantly based on who is paying the bill.

Questioning High-Cost Drugs

Charles Moertel and colleagues published a landmark trial 25 years ago, which reported that treatment with fluorouracil and levamisole for 1 year decreased the death rate of patients with stage C (stage III) colon cancer by 33% following curative surgery.⁷ Although this trial was clinically significant, there was as much discussion about the high cost of levamisole (Ergamisol) tablets as there
was about its clinical benefit for patients.

In a 1991 letter to the New England Journal of Medicine, Rossof and colleagues questioned the high cost of the levamisole in the treatment regimen.⁸ Rossof and colleagues were surprised at the drug’s price on approval, about $5 for each tablet, and detailed their concerns on how this price was determined. “On the basis of the cost to a veterinarian, the calculated cost of a hypothetical 50-mg tablet should be in the range of 3 to 6 cents,” they argued. The total cost to the patient of 1 year of treament was nearly $1,200. Their conclusion was that “…the price chosen for the new American consumer is far too high and requires justification by the manufacturer.”

A reply from Janssen Pharmaceutica, the drug’s manufacturer, offered many justifications for the price.8 According to the company, Ergamisol was supplied free to 5,000 research patients prior to FDA approval. It was also given for free to indigent patients. The company also insisted that its pricing compared favorably with its competitors, such as zidovudine, octreotide, newer generation nonsteroidal anti-inflammatories, and antihypertension drugs. “Drug pricing includes additional expensive research, physician education, compassionate use programs, and ensuring high-quality control. Janssen scientists studied immunomodulating effect of Ergamisol for 25 years with no financial return. Drug development is high-risk, so companies must be able to derive a reasonable return on sales.”⁸

The cost of levamisole was $1,200 per year in 1991, and after adjustment for inflation would cost about $1,988 in 2015, or $166 per month. If these prices caused outrage in 1990, it is easy to see how current prices of well over $10,000 per month for therapies, which often render small clinical benefits, can seem outrageous by comparison.

Public Debate Over Cancer Drug Prices

In the U.S., about 1.66 million patients will be diagnosed with cancer in 2015.⁹ Although about 30% to 40% of these patients will be effectively cured, only 3% to 4% will be cured using pharmacotherapy (usually traditional chemotherapy) as a sole modality. Therefore, the use of oncology drugs by the vast majority of cancer patients is not to cure but to control or palliate patients with advanced cancer. It is important to note that the cost of most curative regimens is cheap compared with many medications used for advanced disease. Until a few years ago, discussion of the high costs of cancer treatment was rarely made public due to the devastating nature of cancer. However, with the rapid price increases and relatively disappointing clinical benefits of the many new drugs entering the market, the question of value can no longer be ignored. Many authors havepresented commentaries and strategies addressing the issues
surrounding the high cost of cancer drugs.^10-15

It was a groundbreaking 2012 letter to the New York Times that brought the issue to public attention.¹⁶ Dr. Peter Bach and his colleagues at Memorial Sloan Kettering Cancer Center announced they would not purchase a “phenomenally expensive new cancer drug” for their patients, calling their decision a no-brainer. The drug, ziv-afilbercept (Zaltrap), was twice the price of a similar drug, bevacizumab (Avastin), but was no more efficacious in the treatment of metastatic colorectal cancer. Bach and colleagues went on to say how high drug prices are having a potentially devastating financial impact on patients and that laws protect drug manufacturers to set drug prices at what they feel the market will bear.

The financial burden put on patients has become the driving force for drug cost reform. In an attempt to control their costs, third-party payers have increased the cost burden for patients by demanding larger copays and other out-of-pocket expenses for medications. It is felt that requiring patients to have more “skin in the game” would force them to make treatment decisions based on cost. Unfortunately, this approach may lead to devastating financial consequences for patients.^18-20 The overwhelming emotions patients experience following the diagnosis of cancer make it difficult to focus on the financial impact of treatment recommendations. In addition, many oncologists are not comfortable, or even capable, of discussing costs so patients can make financially informed treatment decisions.¹⁴ Unfortunately for patients, “shopping for health care” has very little in common with shopping for a car, television sets, or any other commodity.

The VA Health Care System

The VA is government-sponsored health care and is therefore unique in the U.S. health care environment. The VA might be considered a form of “socialized medicine” that operates under a different economic model than do private health care systems. The treatment of VA patients for common diseases is based on nationally accepted evidence-based guidelines, which allow the best care in a cost-effective manner. For the treatment of cancer, the use of expensive therapies must be made in the context of the finite resources allocated for the treatment of all veterans within the system.

The VA provides lifelong free or minimal cost health care to eligible veterans. For veterans receiving care within the VA, out-of-pocket expenses are considerably less than for non-VA patients. Current medication copays range from free to $9 per month for all medications, regardless of acquisition cost. This is in stark contrast to the private sector, where patients must often pay large, percentage- based copays for oncology medications, which can reach several thousand dollars per month. VA patients are not subject to percentage-based copays; therefore, they are not a financial stakeholder in the treatment
decision process.

Prior to 1995, the VA was a much criticized and poorly performing health care system that had experienced significant budget cuts, forcing many veterans to lose their benefits and seek care outside the VA. Beginning in 1995 with the creation of PBM, a remarkable transformation occurred that modernized and transformed the VA into a system that consistently outperforms the private sector in quality of care, patient safety, and patient satisfaction while maintaining low overall costs. The role of the VA PBM was to develop and maintain the National Drug Formulary, create clinical guidance documents, and manage drug costs and use.

Part 2 of this article will more closely examine the high cost of cancer drugs. It will also discuss the role of VA PBM and other VA efforts to control cost

Author disclosures
The author reports no actual or potential conflicts of interest with regard to this article.

Disclaimer
The opinions expressed herein are those of the author and do not necessarily reflect those of Federal Practitioner, Frontline Medical Communications Inc., the U.S. Government, or any of its agencies. This article may discuss unlabeled or investigational use of certain drugs. Please review the complete prescribing information for specific drugs or drug combinations—including indications, contraindications, warnings, and adverse effects—before administering pharmacologic therapy to patients.

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