NCCN's Global Reach: Footprint Extends From U.S. Payers to Foreign Practices

When a handful of oncologists from competing institutions gathered their expertise and egos together in a joint effort to define appropriate care of patients with cancer, it wasn’t entirely clear the endeavor would work. Shared concerns about HMOs had brought them together in the mid 1990s, but they also vied for the same grants, philanthropic gifts, and patients.

Under the deft leadership of the late Dr. Roger J. Winn, the National Comprehensive Cancer Network (NCCN) has parlayed that first guideline, published in 1995, into the most widely used clinical practice guidelines in oncology. By the NCCN’s own account, the guidelines cover 97% of all patients with cancer. Last year alone, nearly 3.3 million PDF copies were downloaded, with select editions now available in 10 languages including Mandarin and Turkish.

The NCCN, which has seen its original budget increase from $2 million to a little more than $30 million, also successfully flexed its political muscle in recent months over the issue of risk evaluation and mitigation strategies (or REMs), and expanded its global reach through conferences in Beijing, Brazil, and Abu Dhabi.

Membership in the not-for-profit alliance was capped 2 years ago at 21 cancer centers in the United States. These member institutions fund the guidelines through dues and millions of dollars worth of free time, said Dr. David S. Ettinger, the Alex Grass professor of oncology at Johns Hopkins University, Baltimore, and chair of the NCCN’s non–small cell lung cancer and occult primary clinical practice panels.

“Fifteen years later, although there may still be some differences, the guidelines are as specific as you can get,” he said.

They also hold tremendous sway with public and private insurers, raising concerns over how they are being used and whether strict adherence can lead to “cookbook” medicine.

Insurers Base Coverage on Guidelines

The NCCN tracks and monitors guideline compliance for breast, colorectal, non-Hodgkin’s lymphoma, non–small cell lung cancer and, most recently, ovarian cancer, with compliance at about 90%-92% for recommendations with level 1 evidence and 85% overall, said NCCN chief executive officer William T. McGivney, Ph.D. For the remaining 15%, patient characteristics, patient preference, and physician disagreement with the guidelines will direct care. The transparency of the guidelines allows physicians to review the references, the category of evidence, and level of consensus, and decide on their own to use them or not, he said. Still, Dr. Ettinger acknowledges that treatment “decisions are made not wanting to fight insurance companies.”

The NCCN noticed early on that its guidelines were being used as the basis for setting coverage policy, prompting the creation in 2004 of the first NCCN Drugs and Biologics Compendium, Dr. McGivney said. The compendium is now used by such key stakeholders as the Centers for Medicare and Medicaid Services and UnitedHealthcare Inc., one of the nation’s largest private insurers.

“On the private side, you see payers basically saying “If it’s in the NCCN Compendium, it’s covered,’ which is critically important for clinicians and patients,” he said. “We have tremendous influence and collaborative influence I think, with payers.”

If a physician uses a drug covered by the compendium to treat any of the 20,000 patients UnitedHealthcare (UHC) has on active chemotherapy in any given year, the drug is automatically covered, said Dr. Lee N. Newcomer, senior vice president, oncology, for the Minnesota-based insurer. Cases involving drugs not covered by the compendium are reviewed by a medical director who looks at state laws and regulations and the employer’s specific requirements. If an employer requires that any chemotherapy recommended by a physician is covered, then the drug would be covered by UHC, even if it’s not in the compendium, he said.

Prior to UHC’s adopting the compendium, 15% of treatments given by its oncologists didn’t match NCCN recommendations. “I would argue that this was both waste and exposing patients to toxicity and drugs that wouldn’t help them,” said Dr. Newcomer, adding that noncompliance is now less than 1%.

Oncologists Rated on Quality of Care

Earlier this year, UHC unveiled the Oncology Care Analysis program that uses clinical and claims data from about 2,600 oncologists and 14,000 patients from across the country with breast, colon and lung cancer to gauge quality of care based on adherence to NCCN guidelines. Oncologists receive a report showing their individual results along with aggregate national results.

Dr. Newcomer dismisses concerns that the program could pressure oncologists into making treatment decisions based on their standing with UHC rather than the best choice for patients who don’t fit the guidelines because such patients are excluded from the analysis. Moreover, there are no financial incentives or penalties associated with the program. “UHC has always emphasized that the information is for quality improvement,” he said. “We let physicians decide how to act on the information.”

The first pass at the data shows that compliance with the NCCN guidelines is stronger in the treatment of breast than colon or lung cancer, but also that about one-third of breast cancer patients prescribed tamoxifen or an aromatase inhibitor aren’t renewing their prescriptions. “We can bring that information back to the physician, and they can have a discussion with their patient about why they aren’t taking that medicine,” he said.

Feedback from physicians has also identified coding problems for carcinoid tumors of the colon and disagreement over whether bevacizumab (Avastin) is truly contraindicated in patients with lung cancer and brain metastases. UHC shares these concerns, along with the national aggregate data, with the NCCN.

Dr. Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston and chief scientific adviser for Susan G. Komen for the Cure, said that of all the guidelines to use, the NCCN guidelines make the most sense, but that oncologists would hear and listen more closely to the message that their practice is out of line if it were delivered by a state or national accreditation program.

“The practicing physician is less likely to trust that the insurer has a clear understanding of what the optimal practice would be,” he said. “It’s just not a credible source in the way that a committee of one’s peers might be.”

Dr. Newcomer said he’d love to see other groups take on the task but has not seen similar published quality data coming out of medical groups. “We are filling a void that’s there,” he said.

Is the Fast Lane Too Broad?

Dr. Ira Klein, clinical head of oncology condition analysis for Aetna Inc., said it doesn’t rely exclusively on the NCCN for the development of guidelines and payment. Aetna has covered drugs for indications in NCCN’s Compendium with a consensus rating of 2b or greater but looks to a variety of sources including top-tier journals and outside opinions when creating guidelines and their clinical practice policy bulletins.

“Relying solely on the NCCN would be like using the Cliff Notes,” he said.

Dr. Klein went on to say that the strength of the NCCN guidelines is that they are evidence based and very good at bringing experts together for consensus-based care when the evidence isn’t particularly strong. Their weakness is that they “could be likened to a 50-lane highway” in cases where multiple treatment options would be appropriate for one disease at one stage, Dr. Klein said.

Dr. Newcomer echoed this sentiment, faulting the NCCN for not assigning a hierarchy to its decisions. He cited the array of recommended chemotherapy regimens for breast cancer, and said, “Where I’d like to see the NCCN guidelines go is to say that of these 14, these 2 are the best.”

Still, both insurers are looking to the NCCN regarding coverage of bevacizumab, following the FDA’s Oncologic Drugs Advisory Committee July vote recommending against its use for the first-line treatment of metastatic breast cancer. Dr. Newcomer said UHC will continue to cover the drug for this indication until the NCCN makes its recommendation following the FDA’s final vote. Dr. Klein said if the FDA removes breast cancer as an indication for bevacizumab, Aetna would consider dropping its existing coverage for the drug and would take the NCCN’s position into consideration in its decision.

The speed at which the NCCN can make such a revision to its guidelines is part of what makes them so unusual. “They are assiduously up to date,” Dr. McGivney said. Staff members track the literature, news of large clinical trials, and FDA filings in order to stay abreast of changes in the evidence, with some 2010 guidelines already in their third or fourth edition.

“We really are in the information age and, of all the areas of medicine, cancer care is probably the most rapidly advancing with respect to the science and research,” he said.

This point was driven home when the American Society of Clinical Oncology (ASCO) published guidelines for stage IV non–small cell lung cancer earlier this year without encompassing emerging data on the importance of epidermal growth factor receptor mutations in treatment response.

“The advantage of systematic review-based guidelines like ASCO uses is that they are more evidence-based, strictly speaking, but take longer to conduct and require methodological expertise,” said Dr. Ethan M. Basch, chair of ASCO’s clinical practice guidelines committee. “The advantage of narrative review with consensus-based guidelines such as used by NCCN is that they can be conducted more rapidly, but are less evidence-based in terms of their degree of systematic approach and hence may be more subject to the biases of panel members.”

When a handful of oncologists from competing institutions gathered their expertise and egos together in a joint effort to define appropriate care of patients with cancer, it wasn’t entirely clear the endeavor would work. Shared concerns about HMOs had brought them together in the mid 1990s, but they also vied for the same grants, philanthropic gifts, and patients.

Under the deft leadership of the late Dr. Roger J. Winn, the National Comprehensive Cancer Network (NCCN) has parlayed that first guideline, published in 1995, into the most widely used clinical practice guidelines in oncology. By the NCCN’s own account, the guidelines cover 97% of all patients with cancer. Last year alone, nearly 3.3 million PDF copies were downloaded, with select editions now available in 10 languages including Mandarin and Turkish.

The NCCN, which has seen its original budget increase from $2 million to a little more than $30 million, also successfully flexed its political muscle in recent months over the issue of risk evaluation and mitigation strategies (or REMs), and expanded its global reach through conferences in Beijing, Brazil, and Abu Dhabi.

Membership in the not-for-profit alliance was capped 2 years ago at 21 cancer centers in the United States. These member institutions fund the guidelines through dues and millions of dollars worth of free time, said Dr. David S. Ettinger, the Alex Grass professor of oncology at Johns Hopkins University, Baltimore, and chair of the NCCN’s non–small cell lung cancer and occult primary clinical practice panels.

“Fifteen years later, although there may still be some differences, the guidelines are as specific as you can get,” he said.

They also hold tremendous sway with public and private insurers, raising concerns over how they are being used and whether strict adherence can lead to “cookbook” medicine.

Insurers Base Coverage on Guidelines

The NCCN tracks and monitors guideline compliance for breast, colorectal, non-Hodgkin’s lymphoma, non–small cell lung cancer and, most recently, ovarian cancer, with compliance at about 90%-92% for recommendations with level 1 evidence and 85% overall, said NCCN chief executive officer William T. McGivney, Ph.D. For the remaining 15%, patient characteristics, patient preference, and physician disagreement with the guidelines will direct care. The transparency of the guidelines allows physicians to review the references, the category of evidence, and level of consensus, and decide on their own to use them or not, he said. Still, Dr. Ettinger acknowledges that treatment “decisions are made not wanting to fight insurance companies.”

The NCCN noticed early on that its guidelines were being used as the basis for setting coverage policy, prompting the creation in 2004 of the first NCCN Drugs and Biologics Compendium, Dr. McGivney said. The compendium is now used by such key stakeholders as the Centers for Medicare and Medicaid Services and UnitedHealthcare Inc., one of the nation’s largest private insurers.

“On the private side, you see payers basically saying “If it’s in the NCCN Compendium, it’s covered,’ which is critically important for clinicians and patients,” he said. “We have tremendous influence and collaborative influence I think, with payers.”

If a physician uses a drug covered by the compendium to treat any of the 20,000 patients UnitedHealthcare (UHC) has on active chemotherapy in any given year, the drug is automatically covered, said Dr. Lee N. Newcomer, senior vice president, oncology, for the Minnesota-based insurer. Cases involving drugs not covered by the compendium are reviewed by a medical director who looks at state laws and regulations and the employer’s specific requirements. If an employer requires that any chemotherapy recommended by a physician is covered, then the drug would be covered by UHC, even if it’s not in the compendium, he said.

Prior to UHC’s adopting the compendium, 15% of treatments given by its oncologists didn’t match NCCN recommendations. “I would argue that this was both waste and exposing patients to toxicity and drugs that wouldn’t help them,” said Dr. Newcomer, adding that noncompliance is now less than 1%.

Oncologists Rated on Quality of Care

Earlier this year, UHC unveiled the Oncology Care Analysis program that uses clinical and claims data from about 2,600 oncologists and 14,000 patients from across the country with breast, colon and lung cancer to gauge quality of care based on adherence to NCCN guidelines. Oncologists receive a report showing their individual results along with aggregate national results.

Dr. Newcomer dismisses concerns that the program could pressure oncologists into making treatment decisions based on their standing with UHC rather than the best choice for patients who don’t fit the guidelines because such patients are excluded from the analysis. Moreover, there are no financial incentives or penalties associated with the program. “UHC has always emphasized that the information is for quality improvement,” he said. “We let physicians decide how to act on the information.”

The first pass at the data shows that compliance with the NCCN guidelines is stronger in the treatment of breast than colon or lung cancer, but also that about one-third of breast cancer patients prescribed tamoxifen or an aromatase inhibitor aren’t renewing their prescriptions. “We can bring that information back to the physician, and they can have a discussion with their patient about why they aren’t taking that medicine,” he said.

Feedback from physicians has also identified coding problems for carcinoid tumors of the colon and disagreement over whether bevacizumab (Avastin) is truly contraindicated in patients with lung cancer and brain metastases. UHC shares these concerns, along with the national aggregate data, with the NCCN.

Dr. Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston and chief scientific adviser for Susan G. Komen for the Cure, said that of all the guidelines to use, the NCCN guidelines make the most sense, but that oncologists would hear and listen more closely to the message that their practice is out of line if it were delivered by a state or national accreditation program.

“The practicing physician is less likely to trust that the insurer has a clear understanding of what the optimal practice would be,” he said. “It’s just not a credible source in the way that a committee of one’s peers might be.”

Dr. Newcomer said he’d love to see other groups take on the task but has not seen similar published quality data coming out of medical groups. “We are filling a void that’s there,” he said.

Is the Fast Lane Too Broad?

Dr. Ira Klein, clinical head of oncology condition analysis for Aetna Inc., said it doesn’t rely exclusively on the NCCN for the development of guidelines and payment. Aetna has covered drugs for indications in NCCN’s Compendium with a consensus rating of 2b or greater but looks to a variety of sources including top-tier journals and outside opinions when creating guidelines and their clinical practice policy bulletins.

“Relying solely on the NCCN would be like using the Cliff Notes,” he said.

Dr. Klein went on to say that the strength of the NCCN guidelines is that they are evidence based and very good at bringing experts together for consensus-based care when the evidence isn’t particularly strong. Their weakness is that they “could be likened to a 50-lane highway” in cases where multiple treatment options would be appropriate for one disease at one stage, Dr. Klein said.

Dr. Newcomer echoed this sentiment, faulting the NCCN for not assigning a hierarchy to its decisions. He cited the array of recommended chemotherapy regimens for breast cancer, and said, “Where I’d like to see the NCCN guidelines go is to say that of these 14, these 2 are the best.”

Still, both insurers are looking to the NCCN regarding coverage of bevacizumab, following the FDA’s Oncologic Drugs Advisory Committee July vote recommending against its use for the first-line treatment of metastatic breast cancer. Dr. Newcomer said UHC will continue to cover the drug for this indication until the NCCN makes its recommendation following the FDA’s final vote. Dr. Klein said if the FDA removes breast cancer as an indication for bevacizumab, Aetna would consider dropping its existing coverage for the drug and would take the NCCN’s position into consideration in its decision.

The speed at which the NCCN can make such a revision to its guidelines is part of what makes them so unusual. “They are assiduously up to date,” Dr. McGivney said. Staff members track the literature, news of large clinical trials, and FDA filings in order to stay abreast of changes in the evidence, with some 2010 guidelines already in their third or fourth edition.

“We really are in the information age and, of all the areas of medicine, cancer care is probably the most rapidly advancing with respect to the science and research,” he said.

This point was driven home when the American Society of Clinical Oncology (ASCO) published guidelines for stage IV non–small cell lung cancer earlier this year without encompassing emerging data on the importance of epidermal growth factor receptor mutations in treatment response.

“The advantage of systematic review-based guidelines like ASCO uses is that they are more evidence-based, strictly speaking, but take longer to conduct and require methodological expertise,” said Dr. Ethan M. Basch, chair of ASCO’s clinical practice guidelines committee. “The advantage of narrative review with consensus-based guidelines such as used by NCCN is that they can be conducted more rapidly, but are less evidence-based in terms of their degree of systematic approach and hence may be more subject to the biases of panel members.”

When a handful of oncologists from competing institutions gathered their expertise and egos together in a joint effort to define appropriate care of patients with cancer, it wasn’t entirely clear the endeavor would work. Shared concerns about HMOs had brought them together in the mid 1990s, but they also vied for the same grants, philanthropic gifts, and patients.

Under the deft leadership of the late Dr. Roger J. Winn, the National Comprehensive Cancer Network (NCCN) has parlayed that first guideline, published in 1995, into the most widely used clinical practice guidelines in oncology. By the NCCN’s own account, the guidelines cover 97% of all patients with cancer. Last year alone, nearly 3.3 million PDF copies were downloaded, with select editions now available in 10 languages including Mandarin and Turkish.

The NCCN, which has seen its original budget increase from $2 million to a little more than $30 million, also successfully flexed its political muscle in recent months over the issue of risk evaluation and mitigation strategies (or REMs), and expanded its global reach through conferences in Beijing, Brazil, and Abu Dhabi.

Membership in the not-for-profit alliance was capped 2 years ago at 21 cancer centers in the United States. These member institutions fund the guidelines through dues and millions of dollars worth of free time, said Dr. David S. Ettinger, the Alex Grass professor of oncology at Johns Hopkins University, Baltimore, and chair of the NCCN’s non–small cell lung cancer and occult primary clinical practice panels.

“Fifteen years later, although there may still be some differences, the guidelines are as specific as you can get,” he said.

They also hold tremendous sway with public and private insurers, raising concerns over how they are being used and whether strict adherence can lead to “cookbook” medicine.

Insurers Base Coverage on Guidelines

The NCCN tracks and monitors guideline compliance for breast, colorectal, non-Hodgkin’s lymphoma, non–small cell lung cancer and, most recently, ovarian cancer, with compliance at about 90%-92% for recommendations with level 1 evidence and 85% overall, said NCCN chief executive officer William T. McGivney, Ph.D. For the remaining 15%, patient characteristics, patient preference, and physician disagreement with the guidelines will direct care. The transparency of the guidelines allows physicians to review the references, the category of evidence, and level of consensus, and decide on their own to use them or not, he said. Still, Dr. Ettinger acknowledges that treatment “decisions are made not wanting to fight insurance companies.”

The NCCN noticed early on that its guidelines were being used as the basis for setting coverage policy, prompting the creation in 2004 of the first NCCN Drugs and Biologics Compendium, Dr. McGivney said. The compendium is now used by such key stakeholders as the Centers for Medicare and Medicaid Services and UnitedHealthcare Inc., one of the nation’s largest private insurers.

“On the private side, you see payers basically saying “If it’s in the NCCN Compendium, it’s covered,’ which is critically important for clinicians and patients,” he said. “We have tremendous influence and collaborative influence I think, with payers.”

If a physician uses a drug covered by the compendium to treat any of the 20,000 patients UnitedHealthcare (UHC) has on active chemotherapy in any given year, the drug is automatically covered, said Dr. Lee N. Newcomer, senior vice president, oncology, for the Minnesota-based insurer. Cases involving drugs not covered by the compendium are reviewed by a medical director who looks at state laws and regulations and the employer’s specific requirements. If an employer requires that any chemotherapy recommended by a physician is covered, then the drug would be covered by UHC, even if it’s not in the compendium, he said.

Prior to UHC’s adopting the compendium, 15% of treatments given by its oncologists didn’t match NCCN recommendations. “I would argue that this was both waste and exposing patients to toxicity and drugs that wouldn’t help them,” said Dr. Newcomer, adding that noncompliance is now less than 1%.

Oncologists Rated on Quality of Care

Earlier this year, UHC unveiled the Oncology Care Analysis program that uses clinical and claims data from about 2,600 oncologists and 14,000 patients from across the country with breast, colon and lung cancer to gauge quality of care based on adherence to NCCN guidelines. Oncologists receive a report showing their individual results along with aggregate national results.

Dr. Newcomer dismisses concerns that the program could pressure oncologists into making treatment decisions based on their standing with UHC rather than the best choice for patients who don’t fit the guidelines because such patients are excluded from the analysis. Moreover, there are no financial incentives or penalties associated with the program. “UHC has always emphasized that the information is for quality improvement,” he said. “We let physicians decide how to act on the information.”

The first pass at the data shows that compliance with the NCCN guidelines is stronger in the treatment of breast than colon or lung cancer, but also that about one-third of breast cancer patients prescribed tamoxifen or an aromatase inhibitor aren’t renewing their prescriptions. “We can bring that information back to the physician, and they can have a discussion with their patient about why they aren’t taking that medicine,” he said.

Feedback from physicians has also identified coding problems for carcinoid tumors of the colon and disagreement over whether bevacizumab (Avastin) is truly contraindicated in patients with lung cancer and brain metastases. UHC shares these concerns, along with the national aggregate data, with the NCCN.

Dr. Eric P. Winer, director of the Breast Oncology Center at the Dana-Farber Cancer Institute in Boston and chief scientific adviser for Susan G. Komen for the Cure, said that of all the guidelines to use, the NCCN guidelines make the most sense, but that oncologists would hear and listen more closely to the message that their practice is out of line if it were delivered by a state or national accreditation program.

“The practicing physician is less likely to trust that the insurer has a clear understanding of what the optimal practice would be,” he said. “It’s just not a credible source in the way that a committee of one’s peers might be.”

Dr. Newcomer said he’d love to see other groups take on the task but has not seen similar published quality data coming out of medical groups. “We are filling a void that’s there,” he said.

Is the Fast Lane Too Broad?

Dr. Ira Klein, clinical head of oncology condition analysis for Aetna Inc., said it doesn’t rely exclusively on the NCCN for the development of guidelines and payment. Aetna has covered drugs for indications in NCCN’s Compendium with a consensus rating of 2b or greater but looks to a variety of sources including top-tier journals and outside opinions when creating guidelines and their clinical practice policy bulletins.

“Relying solely on the NCCN would be like using the Cliff Notes,” he said.

Dr. Klein went on to say that the strength of the NCCN guidelines is that they are evidence based and very good at bringing experts together for consensus-based care when the evidence isn’t particularly strong. Their weakness is that they “could be likened to a 50-lane highway” in cases where multiple treatment options would be appropriate for one disease at one stage, Dr. Klein said.

Dr. Newcomer echoed this sentiment, faulting the NCCN for not assigning a hierarchy to its decisions. He cited the array of recommended chemotherapy regimens for breast cancer, and said, “Where I’d like to see the NCCN guidelines go is to say that of these 14, these 2 are the best.”

Still, both insurers are looking to the NCCN regarding coverage of bevacizumab, following the FDA’s Oncologic Drugs Advisory Committee July vote recommending against its use for the first-line treatment of metastatic breast cancer. Dr. Newcomer said UHC will continue to cover the drug for this indication until the NCCN makes its recommendation following the FDA’s final vote. Dr. Klein said if the FDA removes breast cancer as an indication for bevacizumab, Aetna would consider dropping its existing coverage for the drug and would take the NCCN’s position into consideration in its decision.

The speed at which the NCCN can make such a revision to its guidelines is part of what makes them so unusual. “They are assiduously up to date,” Dr. McGivney said. Staff members track the literature, news of large clinical trials, and FDA filings in order to stay abreast of changes in the evidence, with some 2010 guidelines already in their third or fourth edition.

“We really are in the information age and, of all the areas of medicine, cancer care is probably the most rapidly advancing with respect to the science and research,” he said.

This point was driven home when the American Society of Clinical Oncology (ASCO) published guidelines for stage IV non–small cell lung cancer earlier this year without encompassing emerging data on the importance of epidermal growth factor receptor mutations in treatment response.

“The advantage of systematic review-based guidelines like ASCO uses is that they are more evidence-based, strictly speaking, but take longer to conduct and require methodological expertise,” said Dr. Ethan M. Basch, chair of ASCO’s clinical practice guidelines committee. “The advantage of narrative review with consensus-based guidelines such as used by NCCN is that they can be conducted more rapidly, but are less evidence-based in terms of their degree of systematic approach and hence may be more subject to the biases of panel members.”