U.S. Oncologists Confront Pressure to Curb Cancer Costs.

Cancer care has emerged as a prime target in efforts to contain health care costs.

Health policy makers have painted a bull’s-eye on oncology. Cancer therapy costs are skyrocketing, and the care itself is sometimes seen as fragmented and unsupported by persuasive evidence of effectiveness.

Moreover, cost hasn’t typically been a consideration for American oncologists. The prevailing ethos has been that they have a duty to offer a patient any possible treatment yielding a net benefit, regardless of the cost to society.

© Kativ / iStockphoto.com

That stance is no longer tenable, experts said in interviews and presentations at the recent San Antonio Breast Cancer Symposium.

"The growth in health care spending is unsustainable. Like it or not, efforts to control costs will increase. The question isn’t ‘Should cost be a consideration in the management of cancer?’ but rather ‘How will cost decisions be made and who will be responsible?’ " said Dr. Michael J. Hassett, a medical oncologist at the Dana-Farber Cancer Institute and Harvard Medical School, Boston.

Dr. Thomas J. Smith, the Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore, concurred.

"I’ve just spent the past couple of days talking to major insurers about the new Medicare/Medicaid innovations program, and everyone says oncology is a major target," said Dr. Smith, director of palliative care at Johns Hopkins Medicine. "It’s 15%-25% of their insurance costs. And there are demonstration projects showing that episode-based payment and salaried physicians work just as well and cost less."

The Association of American Medical Colleges plans to make "cost-conscious use of society’s resources" the next scientific competency required of medical school graduates, added Dr. Smith. "So we’re going to have to figure this out and teach it to the next generation, even if we ourselves didn’t get it right."

A defining experience for Dr. Eric P. Winer came when he and other international experts met in Portugal to draw up consensus guidelines on the treatment of advanced breast cancer.

"It was a surprising moment that seems to keep coming back to me over and over again: Many of our European colleagues were quite open in saying that newer drugs that might lead to a fairly modest survival advantage would probably not be used in their countries if the drugs were costly," recalled Dr. Winer, director of the breast oncology center at Dana-Farber and a professor of medicine at Harvard.

"That’s very different from the approach taken in the [United States] until now, although I think we’re really looking to make changes here," he said. "My own view is, if we don’t take control of this as the people who are providing care, then we will lose all control."

Yet if clinicians are to assume responsibility for considering costs in making cancer treatment decisions, they will have to traverse an ethical mine field, given their multiple potentially conflicting responsibilities as patient advocates, business owners, and citizen-taxpayers, cautioned Dr. Hassett.

Money and Outcomes Don’t Match

In 2009, nearly 18% of the U.S. gross domestic product was spent on health care. Analysts at the National Cancer Institute estimate that direct medical spending on cancer care in the U.S. amounted to $124.5 billion in 2010, with breast cancer care – accounting for $16.5 billion, or 13% of the total – leading the way. By 2020, just 8 years from now, they project that direct medical spending for cancer care will approach $158 billion annually, with breast cancer accounting for up to $25 billion of that figure (Cancer Epidemiol. Biomarkers Prev. 2011;20:2006-14).

How is that money being spent? A separate study concluded that total Medicare fee-for-service spending for breast cancer care during the initial year after diagnosis amounted to $1.06 billion in 2002. Surgery accounted for 25% of that payout, followed by chemotherapy at 15%, radiation therapy at 11%, and other inpatient care at 18% (J. Natl. Cancer Inst. 2008;100:888-97).

Unfortunately, all that spending isn’t buying better outcomes. By a variety of yardsticks, including 5-year overall survival and potential years of life lost due to malignancy, Americans fare no better and in some cases do worse than citizens of countries spending far less per capita on health care, said Dr. Hassett.

In a soon-to-be-published study, he and his coinvestigators analyzed total per-patient expenditures for all Medicare Part A and Part B services for breast cancer during the year following diagnosis of the malignancy in more than 15,000 women aged 65-70 years. Patients in the lowest quintile, with a median 1-year spending of $17,315, had a 5-year overall survival of 88%, identical to that in women in the highest spending quintile, at $26,808. Both quintiles had an identical 81% rate of adherence to 27 National Comprehensive Cancer Network guideline-based quality measures.

How Much Is Too Much per QALY?

Incremental cost-effectiveness analysis is an increasingly popular tool for helping determine whether an intervention provides value for money spent, according to Elena B. Elkin, Ph.D., of the Health Outcomes Research Group at Memorial Sloan-Kettering Cancer Center, New York.

For example, breast cancer cost-effectiveness studies published in recent years have concluded that the use of raloxifene (Evista) to reduce breast cancer risk among white women starting at age 55 comes at a price tag of $22,000 per quality-adjusted life year (QALY) gained. Similarly, the use of adjuvant letrozole (Femara) instead of anastrozole (Arimidex) in patients with hormone receptor–positive breast cancer has a cost of $26,000 per QALY.

At the higher end of the spectrum, bevacizumab (Avastin) plus paclitaxel vs. paclitaxel alone in women with HER2-positive metastatic breast cancer has a cost-effectiveness of $280,000 per QALY; ixabepilone (Ixempra) plus capecitabine (Xeloda) vs. capecitabine alone in the setting of taxane- and anthracycline-resistant metastatic breast cancer has been calculated to carry a price tag of $360,000 per QALY; and digital screening mammography instead of film for all women aged 40 or older costs an estimated $930,000 per QALY gained, according to Dr. Elkin.

There is no "right" answer as to what constitutes good value for money spent on health care. A widespread view held since the early 1980s is that less than $50,000 per QALY is a favorably low incremental cost-effectiveness ratio and thus good value, whereas $50,000-$100,000 per QALY is a grey area and a judgment call. But those rules of thumb are "certainly outdated," said Dr. Elkin.

She noted that Dr. Smith and Dr. Bruce E. Hillner have calculated that by adjusting for health care inflation, an incremental cost-effectiveness ratio of $50,000 per QALY in 1982 equates to $197,000 per QALY in 2007 dollars. Moreover, using the World Health Organization definition of good value for health care money spent (that is, a figure not more than three times a nation’s per capita gross domestic product), then $140,100 per QALY in 2008 U.S. dollars would be a reasonable threshold (J. Clin. Oncol. 2009;27:2111-3).

Impact on Care Worries Oncologists

There are indications that many oncologists are concerned about the exponentially rising cost of cancer care but leery about the possible unintended consequences of efforts to control costs, such as jeopardizing quality or access.

A national survey of medical oncologists conducted by researchers at Tufts University showed that 84% said that patients’ out-of-pocket costs influence their treatment recommendations. Some 56% indicated the cost of new cancer drugs influences their treatment recommendations. Only 29% believe that more cost-sharing by patients for cancer drugs is needed. And 80% of those surveyed want to see more use of cost-effectiveness data in coverage and payment decisions (Health Aff. [Millwood] 2010;29:196-202).

When asked who should determine whether a drug provides good value, 60% of the medical oncologists responded that physicians should make this determination; 57% said nonprofit organizations, 37% said patients, 21% named the government, and 6% said insurance companies.

"I think that’s interesting, because in reality it’s probably the reverse of what actually happens," according to Dr. Hassett.

Earlier Adoption of Trial Results Urged

Dr. Laura J. Esserman suggested that one novel way to curb cancer care costs is through selective early adoption of persuasive clinical trial findings while ongoing definitive studies are still being completed. She cited intraoperative radiation therapy during breast-conserving surgery as a case in point.

Results of the international TARGIT-A (Targeted Intraoperative Radiotherapy) trial, in which 2,232 patients undergoing lumpectomy were randomized to intraoperative radiotherapy (IORT) or standard external-beam radiation, showed closely similar 4-year local recurrence rates in the conserved breast: 1.2% in the IORT group and 0.95% with external-beam radiation (Lancet 2010;376:91-102). Yet IORT costs $6,400 less and provides enormous quality of life advantages, as it replaces the conventional 6 weeks of near-daily radiation therapy with 30 minutes of intraoperative treatment.

"To wake up from your surgery and be done is a wonderful thing," commented Dr. Esserman, professor of surgery and radiology and director of the breast care center at the University of California, San Francisco.

More than 70,000 American women per year who have been diagnosed with breast cancer fit the profile of the TARGIT-A population, she said. Yet some authorities urge holding off on widespread adoption of IORT until results are in from ongoing, large, randomized trials of mastectomy vs. lumpectomy and various forms of radiation, which will take another decade or more.

"The possible harm of early adoption is negligible, and the cost of not intervening is close to $2 billion per year. I strongly feel IORT should be adopted now. I don’t think the results are going to change. We’ve already adopted it at our center, and a registry trial is being organized to help people adopt it nationally," said Dr. Esserman.

A major obstacle here is Medicare’s decision to make IORT part of a bundled-care program, which means that physicians who perform radiation therapy intraoperatively won’t get paid more for it. "This will provide an enormous disincentive to the use of IORT. The big losers here are the patients," she said.

Another opportunity to save money would be to follow the U.S. Preventive Services Task Force guidelines on mammography screening for breast cancer, rather than routinely conducting annual mammography, as many physicians still advocate, Dr. Esserman continued.

"We could save $5 billion per year simply by following those guidelines. And there are now many papers demonstrating that approach certainly is very cost effective. You don’t find any significant increase in advanced cancers with annual screening," she said.

Five More Proposals to Slow Costs

Dr. Smith proposed the following five changes in oncologists’ behavior aimed at slowing the rise in cancer care costs:

• Target surveillance testing with serum tumor markers and imaging in accord with NCCN guidelines. Recommendations to cut back on surveillance testing ought to be incorporated into the American Society of Clinical Oncology’s Quality Oncology Practice Initiative (QOPI), a program of proven effectiveness in changing medical oncologists’ behavior.

• Switch to palliative care in patients with disease progression despite three consecutive chemotherapy regimens. The US Oncology Network’s pathway for metastatic non–small cell lung cancer, which takes this approach, has been shown to reduce treatment costs by 35% with exactly the same survival as in patients treated off pathway – and with better quality of life stemming from a doubled length of stay in hospice care (J. Oncol. Pract. 2010;6:12-18). The same research group reported that a similarly structured pathway for metastatic colon cancer led to a reduction in treatment costs by one-third, along with a significant 6.8-month improvement in survival compared with off-pathway treatment (Am. J. Manag. Care 2011;May [suppl. 5 Developing]: SP45-52).

• Limit chemotherapy for most patients with advanced metastatic solid tumors to patients with good performance status. This would markedly decrease the use of chemotherapy at the end of life.

• Substitute a reduction in chemotherapy dose for the current routine use of colony-stimulating factors in patients with metastatic solid cancers. "We are 3% of the world’s population and we use 75% of the world’s colony-stimulating factors. And 90% of that use isn’t supported by ASCO guidelines," the oncologist asserted. "I think that’s going to be a big target going forward. We simply can’t afford $3,500 per injection for a drug that helps with supportive care but doesn’t improve survival."

• Sequential monotherapies rather than combination chemotherapies as second- and third-line treatment for metastatic cancer. The available data suggest patients will live just as long, but with fewer toxic effects – and at lower cost.

Personalized Medicine and Palliative Care

Dr. Hassett cautioned that although conventional wisdom holds that the emerging field of "personalized medicine" will favorably impact health care costs by providing more selective therapy and improved clinical outcomes, that’s by no means a slam dunk.

"I’m just not sure. I think there’s a chance that personalized medicine could actually increase costs by introducing more expensive tests, new and more expensive drugs, and more complexity into the system," he said.

One thing he is sure of, however, is that any successful effort to reduce the rate of growth in cancer care spending will necessarily have to address the hot-button issue of end-of-life care. One-tenth of all Medicare dollars are spent on care during the final 28 days of life.

Dr. Smith concurred, adding that ASCO has a soon-to-be-published Provisional Clinical Opinion declaring that all oncologists should integrate palliative care into their usual cancer care programs.

"That should be the norm. We have to look at how we spend that money for end-of-life [care] because if we don’t fix that part, we won’t have money for adjuvant therapy and neoadjuvant therapy and funding for major research," he warned.

None of the experts cited in this article declared having any financial conflicts.

Cancer care has emerged as a prime target in efforts to contain health care costs.

Health policy makers have painted a bull’s-eye on oncology. Cancer therapy costs are skyrocketing, and the care itself is sometimes seen as fragmented and unsupported by persuasive evidence of effectiveness.

Moreover, cost hasn’t typically been a consideration for American oncologists. The prevailing ethos has been that they have a duty to offer a patient any possible treatment yielding a net benefit, regardless of the cost to society.

© Kativ / iStockphoto.com

That stance is no longer tenable, experts said in interviews and presentations at the recent San Antonio Breast Cancer Symposium.

"The growth in health care spending is unsustainable. Like it or not, efforts to control costs will increase. The question isn’t ‘Should cost be a consideration in the management of cancer?’ but rather ‘How will cost decisions be made and who will be responsible?’ " said Dr. Michael J. Hassett, a medical oncologist at the Dana-Farber Cancer Institute and Harvard Medical School, Boston.

Dr. Thomas J. Smith, the Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore, concurred.

"I’ve just spent the past couple of days talking to major insurers about the new Medicare/Medicaid innovations program, and everyone says oncology is a major target," said Dr. Smith, director of palliative care at Johns Hopkins Medicine. "It’s 15%-25% of their insurance costs. And there are demonstration projects showing that episode-based payment and salaried physicians work just as well and cost less."

The Association of American Medical Colleges plans to make "cost-conscious use of society’s resources" the next scientific competency required of medical school graduates, added Dr. Smith. "So we’re going to have to figure this out and teach it to the next generation, even if we ourselves didn’t get it right."

A defining experience for Dr. Eric P. Winer came when he and other international experts met in Portugal to draw up consensus guidelines on the treatment of advanced breast cancer.

"It was a surprising moment that seems to keep coming back to me over and over again: Many of our European colleagues were quite open in saying that newer drugs that might lead to a fairly modest survival advantage would probably not be used in their countries if the drugs were costly," recalled Dr. Winer, director of the breast oncology center at Dana-Farber and a professor of medicine at Harvard.

"That’s very different from the approach taken in the [United States] until now, although I think we’re really looking to make changes here," he said. "My own view is, if we don’t take control of this as the people who are providing care, then we will lose all control."

Yet if clinicians are to assume responsibility for considering costs in making cancer treatment decisions, they will have to traverse an ethical mine field, given their multiple potentially conflicting responsibilities as patient advocates, business owners, and citizen-taxpayers, cautioned Dr. Hassett.

Money and Outcomes Don’t Match

In 2009, nearly 18% of the U.S. gross domestic product was spent on health care. Analysts at the National Cancer Institute estimate that direct medical spending on cancer care in the U.S. amounted to $124.5 billion in 2010, with breast cancer care – accounting for $16.5 billion, or 13% of the total – leading the way. By 2020, just 8 years from now, they project that direct medical spending for cancer care will approach $158 billion annually, with breast cancer accounting for up to $25 billion of that figure (Cancer Epidemiol. Biomarkers Prev. 2011;20:2006-14).

How is that money being spent? A separate study concluded that total Medicare fee-for-service spending for breast cancer care during the initial year after diagnosis amounted to $1.06 billion in 2002. Surgery accounted for 25% of that payout, followed by chemotherapy at 15%, radiation therapy at 11%, and other inpatient care at 18% (J. Natl. Cancer Inst. 2008;100:888-97).

Unfortunately, all that spending isn’t buying better outcomes. By a variety of yardsticks, including 5-year overall survival and potential years of life lost due to malignancy, Americans fare no better and in some cases do worse than citizens of countries spending far less per capita on health care, said Dr. Hassett.

In a soon-to-be-published study, he and his coinvestigators analyzed total per-patient expenditures for all Medicare Part A and Part B services for breast cancer during the year following diagnosis of the malignancy in more than 15,000 women aged 65-70 years. Patients in the lowest quintile, with a median 1-year spending of $17,315, had a 5-year overall survival of 88%, identical to that in women in the highest spending quintile, at $26,808. Both quintiles had an identical 81% rate of adherence to 27 National Comprehensive Cancer Network guideline-based quality measures.

How Much Is Too Much per QALY?

Incremental cost-effectiveness analysis is an increasingly popular tool for helping determine whether an intervention provides value for money spent, according to Elena B. Elkin, Ph.D., of the Health Outcomes Research Group at Memorial Sloan-Kettering Cancer Center, New York.

For example, breast cancer cost-effectiveness studies published in recent years have concluded that the use of raloxifene (Evista) to reduce breast cancer risk among white women starting at age 55 comes at a price tag of $22,000 per quality-adjusted life year (QALY) gained. Similarly, the use of adjuvant letrozole (Femara) instead of anastrozole (Arimidex) in patients with hormone receptor–positive breast cancer has a cost of $26,000 per QALY.

At the higher end of the spectrum, bevacizumab (Avastin) plus paclitaxel vs. paclitaxel alone in women with HER2-positive metastatic breast cancer has a cost-effectiveness of $280,000 per QALY; ixabepilone (Ixempra) plus capecitabine (Xeloda) vs. capecitabine alone in the setting of taxane- and anthracycline-resistant metastatic breast cancer has been calculated to carry a price tag of $360,000 per QALY; and digital screening mammography instead of film for all women aged 40 or older costs an estimated $930,000 per QALY gained, according to Dr. Elkin.

There is no "right" answer as to what constitutes good value for money spent on health care. A widespread view held since the early 1980s is that less than $50,000 per QALY is a favorably low incremental cost-effectiveness ratio and thus good value, whereas $50,000-$100,000 per QALY is a grey area and a judgment call. But those rules of thumb are "certainly outdated," said Dr. Elkin.

She noted that Dr. Smith and Dr. Bruce E. Hillner have calculated that by adjusting for health care inflation, an incremental cost-effectiveness ratio of $50,000 per QALY in 1982 equates to $197,000 per QALY in 2007 dollars. Moreover, using the World Health Organization definition of good value for health care money spent (that is, a figure not more than three times a nation’s per capita gross domestic product), then $140,100 per QALY in 2008 U.S. dollars would be a reasonable threshold (J. Clin. Oncol. 2009;27:2111-3).

Impact on Care Worries Oncologists

There are indications that many oncologists are concerned about the exponentially rising cost of cancer care but leery about the possible unintended consequences of efforts to control costs, such as jeopardizing quality or access.

A national survey of medical oncologists conducted by researchers at Tufts University showed that 84% said that patients’ out-of-pocket costs influence their treatment recommendations. Some 56% indicated the cost of new cancer drugs influences their treatment recommendations. Only 29% believe that more cost-sharing by patients for cancer drugs is needed. And 80% of those surveyed want to see more use of cost-effectiveness data in coverage and payment decisions (Health Aff. [Millwood] 2010;29:196-202).

When asked who should determine whether a drug provides good value, 60% of the medical oncologists responded that physicians should make this determination; 57% said nonprofit organizations, 37% said patients, 21% named the government, and 6% said insurance companies.

"I think that’s interesting, because in reality it’s probably the reverse of what actually happens," according to Dr. Hassett.

Earlier Adoption of Trial Results Urged

Dr. Laura J. Esserman suggested that one novel way to curb cancer care costs is through selective early adoption of persuasive clinical trial findings while ongoing definitive studies are still being completed. She cited intraoperative radiation therapy during breast-conserving surgery as a case in point.

Results of the international TARGIT-A (Targeted Intraoperative Radiotherapy) trial, in which 2,232 patients undergoing lumpectomy were randomized to intraoperative radiotherapy (IORT) or standard external-beam radiation, showed closely similar 4-year local recurrence rates in the conserved breast: 1.2% in the IORT group and 0.95% with external-beam radiation (Lancet 2010;376:91-102). Yet IORT costs $6,400 less and provides enormous quality of life advantages, as it replaces the conventional 6 weeks of near-daily radiation therapy with 30 minutes of intraoperative treatment.

"To wake up from your surgery and be done is a wonderful thing," commented Dr. Esserman, professor of surgery and radiology and director of the breast care center at the University of California, San Francisco.

More than 70,000 American women per year who have been diagnosed with breast cancer fit the profile of the TARGIT-A population, she said. Yet some authorities urge holding off on widespread adoption of IORT until results are in from ongoing, large, randomized trials of mastectomy vs. lumpectomy and various forms of radiation, which will take another decade or more.

"The possible harm of early adoption is negligible, and the cost of not intervening is close to $2 billion per year. I strongly feel IORT should be adopted now. I don’t think the results are going to change. We’ve already adopted it at our center, and a registry trial is being organized to help people adopt it nationally," said Dr. Esserman.

A major obstacle here is Medicare’s decision to make IORT part of a bundled-care program, which means that physicians who perform radiation therapy intraoperatively won’t get paid more for it. "This will provide an enormous disincentive to the use of IORT. The big losers here are the patients," she said.

Another opportunity to save money would be to follow the U.S. Preventive Services Task Force guidelines on mammography screening for breast cancer, rather than routinely conducting annual mammography, as many physicians still advocate, Dr. Esserman continued.

"We could save $5 billion per year simply by following those guidelines. And there are now many papers demonstrating that approach certainly is very cost effective. You don’t find any significant increase in advanced cancers with annual screening," she said.

Five More Proposals to Slow Costs

Dr. Smith proposed the following five changes in oncologists’ behavior aimed at slowing the rise in cancer care costs:

• Target surveillance testing with serum tumor markers and imaging in accord with NCCN guidelines. Recommendations to cut back on surveillance testing ought to be incorporated into the American Society of Clinical Oncology’s Quality Oncology Practice Initiative (QOPI), a program of proven effectiveness in changing medical oncologists’ behavior.

• Switch to palliative care in patients with disease progression despite three consecutive chemotherapy regimens. The US Oncology Network’s pathway for metastatic non–small cell lung cancer, which takes this approach, has been shown to reduce treatment costs by 35% with exactly the same survival as in patients treated off pathway – and with better quality of life stemming from a doubled length of stay in hospice care (J. Oncol. Pract. 2010;6:12-18). The same research group reported that a similarly structured pathway for metastatic colon cancer led to a reduction in treatment costs by one-third, along with a significant 6.8-month improvement in survival compared with off-pathway treatment (Am. J. Manag. Care 2011;May [suppl. 5 Developing]: SP45-52).

• Limit chemotherapy for most patients with advanced metastatic solid tumors to patients with good performance status. This would markedly decrease the use of chemotherapy at the end of life.

• Substitute a reduction in chemotherapy dose for the current routine use of colony-stimulating factors in patients with metastatic solid cancers. "We are 3% of the world’s population and we use 75% of the world’s colony-stimulating factors. And 90% of that use isn’t supported by ASCO guidelines," the oncologist asserted. "I think that’s going to be a big target going forward. We simply can’t afford $3,500 per injection for a drug that helps with supportive care but doesn’t improve survival."

• Sequential monotherapies rather than combination chemotherapies as second- and third-line treatment for metastatic cancer. The available data suggest patients will live just as long, but with fewer toxic effects – and at lower cost.

Personalized Medicine and Palliative Care

Dr. Hassett cautioned that although conventional wisdom holds that the emerging field of "personalized medicine" will favorably impact health care costs by providing more selective therapy and improved clinical outcomes, that’s by no means a slam dunk.

"I’m just not sure. I think there’s a chance that personalized medicine could actually increase costs by introducing more expensive tests, new and more expensive drugs, and more complexity into the system," he said.

One thing he is sure of, however, is that any successful effort to reduce the rate of growth in cancer care spending will necessarily have to address the hot-button issue of end-of-life care. One-tenth of all Medicare dollars are spent on care during the final 28 days of life.

Dr. Smith concurred, adding that ASCO has a soon-to-be-published Provisional Clinical Opinion declaring that all oncologists should integrate palliative care into their usual cancer care programs.

"That should be the norm. We have to look at how we spend that money for end-of-life [care] because if we don’t fix that part, we won’t have money for adjuvant therapy and neoadjuvant therapy and funding for major research," he warned.

None of the experts cited in this article declared having any financial conflicts.

Cancer care has emerged as a prime target in efforts to contain health care costs.

Health policy makers have painted a bull’s-eye on oncology. Cancer therapy costs are skyrocketing, and the care itself is sometimes seen as fragmented and unsupported by persuasive evidence of effectiveness.

Moreover, cost hasn’t typically been a consideration for American oncologists. The prevailing ethos has been that they have a duty to offer a patient any possible treatment yielding a net benefit, regardless of the cost to society.

© Kativ / iStockphoto.com

That stance is no longer tenable, experts said in interviews and presentations at the recent San Antonio Breast Cancer Symposium.

"The growth in health care spending is unsustainable. Like it or not, efforts to control costs will increase. The question isn’t ‘Should cost be a consideration in the management of cancer?’ but rather ‘How will cost decisions be made and who will be responsible?’ " said Dr. Michael J. Hassett, a medical oncologist at the Dana-Farber Cancer Institute and Harvard Medical School, Boston.

Dr. Thomas J. Smith, the Harry J. Duffey Family Professor of Palliative Care at Johns Hopkins University, Baltimore, concurred.

"I’ve just spent the past couple of days talking to major insurers about the new Medicare/Medicaid innovations program, and everyone says oncology is a major target," said Dr. Smith, director of palliative care at Johns Hopkins Medicine. "It’s 15%-25% of their insurance costs. And there are demonstration projects showing that episode-based payment and salaried physicians work just as well and cost less."

The Association of American Medical Colleges plans to make "cost-conscious use of society’s resources" the next scientific competency required of medical school graduates, added Dr. Smith. "So we’re going to have to figure this out and teach it to the next generation, even if we ourselves didn’t get it right."

A defining experience for Dr. Eric P. Winer came when he and other international experts met in Portugal to draw up consensus guidelines on the treatment of advanced breast cancer.

"It was a surprising moment that seems to keep coming back to me over and over again: Many of our European colleagues were quite open in saying that newer drugs that might lead to a fairly modest survival advantage would probably not be used in their countries if the drugs were costly," recalled Dr. Winer, director of the breast oncology center at Dana-Farber and a professor of medicine at Harvard.

"That’s very different from the approach taken in the [United States] until now, although I think we’re really looking to make changes here," he said. "My own view is, if we don’t take control of this as the people who are providing care, then we will lose all control."

Yet if clinicians are to assume responsibility for considering costs in making cancer treatment decisions, they will have to traverse an ethical mine field, given their multiple potentially conflicting responsibilities as patient advocates, business owners, and citizen-taxpayers, cautioned Dr. Hassett.

Money and Outcomes Don’t Match

In 2009, nearly 18% of the U.S. gross domestic product was spent on health care. Analysts at the National Cancer Institute estimate that direct medical spending on cancer care in the U.S. amounted to $124.5 billion in 2010, with breast cancer care – accounting for $16.5 billion, or 13% of the total – leading the way. By 2020, just 8 years from now, they project that direct medical spending for cancer care will approach $158 billion annually, with breast cancer accounting for up to $25 billion of that figure (Cancer Epidemiol. Biomarkers Prev. 2011;20:2006-14).

How is that money being spent? A separate study concluded that total Medicare fee-for-service spending for breast cancer care during the initial year after diagnosis amounted to $1.06 billion in 2002. Surgery accounted for 25% of that payout, followed by chemotherapy at 15%, radiation therapy at 11%, and other inpatient care at 18% (J. Natl. Cancer Inst. 2008;100:888-97).

Unfortunately, all that spending isn’t buying better outcomes. By a variety of yardsticks, including 5-year overall survival and potential years of life lost due to malignancy, Americans fare no better and in some cases do worse than citizens of countries spending far less per capita on health care, said Dr. Hassett.

In a soon-to-be-published study, he and his coinvestigators analyzed total per-patient expenditures for all Medicare Part A and Part B services for breast cancer during the year following diagnosis of the malignancy in more than 15,000 women aged 65-70 years. Patients in the lowest quintile, with a median 1-year spending of $17,315, had a 5-year overall survival of 88%, identical to that in women in the highest spending quintile, at $26,808. Both quintiles had an identical 81% rate of adherence to 27 National Comprehensive Cancer Network guideline-based quality measures.

How Much Is Too Much per QALY?

Incremental cost-effectiveness analysis is an increasingly popular tool for helping determine whether an intervention provides value for money spent, according to Elena B. Elkin, Ph.D., of the Health Outcomes Research Group at Memorial Sloan-Kettering Cancer Center, New York.

For example, breast cancer cost-effectiveness studies published in recent years have concluded that the use of raloxifene (Evista) to reduce breast cancer risk among white women starting at age 55 comes at a price tag of $22,000 per quality-adjusted life year (QALY) gained. Similarly, the use of adjuvant letrozole (Femara) instead of anastrozole (Arimidex) in patients with hormone receptor–positive breast cancer has a cost of $26,000 per QALY.

At the higher end of the spectrum, bevacizumab (Avastin) plus paclitaxel vs. paclitaxel alone in women with HER2-positive metastatic breast cancer has a cost-effectiveness of $280,000 per QALY; ixabepilone (Ixempra) plus capecitabine (Xeloda) vs. capecitabine alone in the setting of taxane- and anthracycline-resistant metastatic breast cancer has been calculated to carry a price tag of $360,000 per QALY; and digital screening mammography instead of film for all women aged 40 or older costs an estimated $930,000 per QALY gained, according to Dr. Elkin.

There is no "right" answer as to what constitutes good value for money spent on health care. A widespread view held since the early 1980s is that less than $50,000 per QALY is a favorably low incremental cost-effectiveness ratio and thus good value, whereas $50,000-$100,000 per QALY is a grey area and a judgment call. But those rules of thumb are "certainly outdated," said Dr. Elkin.

She noted that Dr. Smith and Dr. Bruce E. Hillner have calculated that by adjusting for health care inflation, an incremental cost-effectiveness ratio of $50,000 per QALY in 1982 equates to $197,000 per QALY in 2007 dollars. Moreover, using the World Health Organization definition of good value for health care money spent (that is, a figure not more than three times a nation’s per capita gross domestic product), then $140,100 per QALY in 2008 U.S. dollars would be a reasonable threshold (J. Clin. Oncol. 2009;27:2111-3).

Impact on Care Worries Oncologists

There are indications that many oncologists are concerned about the exponentially rising cost of cancer care but leery about the possible unintended consequences of efforts to control costs, such as jeopardizing quality or access.

A national survey of medical oncologists conducted by researchers at Tufts University showed that 84% said that patients’ out-of-pocket costs influence their treatment recommendations. Some 56% indicated the cost of new cancer drugs influences their treatment recommendations. Only 29% believe that more cost-sharing by patients for cancer drugs is needed. And 80% of those surveyed want to see more use of cost-effectiveness data in coverage and payment decisions (Health Aff. [Millwood] 2010;29:196-202).

When asked who should determine whether a drug provides good value, 60% of the medical oncologists responded that physicians should make this determination; 57% said nonprofit organizations, 37% said patients, 21% named the government, and 6% said insurance companies.

"I think that’s interesting, because in reality it’s probably the reverse of what actually happens," according to Dr. Hassett.

Earlier Adoption of Trial Results Urged

Dr. Laura J. Esserman suggested that one novel way to curb cancer care costs is through selective early adoption of persuasive clinical trial findings while ongoing definitive studies are still being completed. She cited intraoperative radiation therapy during breast-conserving surgery as a case in point.

Results of the international TARGIT-A (Targeted Intraoperative Radiotherapy) trial, in which 2,232 patients undergoing lumpectomy were randomized to intraoperative radiotherapy (IORT) or standard external-beam radiation, showed closely similar 4-year local recurrence rates in the conserved breast: 1.2% in the IORT group and 0.95% with external-beam radiation (Lancet 2010;376:91-102). Yet IORT costs $6,400 less and provides enormous quality of life advantages, as it replaces the conventional 6 weeks of near-daily radiation therapy with 30 minutes of intraoperative treatment.

"To wake up from your surgery and be done is a wonderful thing," commented Dr. Esserman, professor of surgery and radiology and director of the breast care center at the University of California, San Francisco.

More than 70,000 American women per year who have been diagnosed with breast cancer fit the profile of the TARGIT-A population, she said. Yet some authorities urge holding off on widespread adoption of IORT until results are in from ongoing, large, randomized trials of mastectomy vs. lumpectomy and various forms of radiation, which will take another decade or more.

"The possible harm of early adoption is negligible, and the cost of not intervening is close to $2 billion per year. I strongly feel IORT should be adopted now. I don’t think the results are going to change. We’ve already adopted it at our center, and a registry trial is being organized to help people adopt it nationally," said Dr. Esserman.

A major obstacle here is Medicare’s decision to make IORT part of a bundled-care program, which means that physicians who perform radiation therapy intraoperatively won’t get paid more for it. "This will provide an enormous disincentive to the use of IORT. The big losers here are the patients," she said.

Another opportunity to save money would be to follow the U.S. Preventive Services Task Force guidelines on mammography screening for breast cancer, rather than routinely conducting annual mammography, as many physicians still advocate, Dr. Esserman continued.

"We could save $5 billion per year simply by following those guidelines. And there are now many papers demonstrating that approach certainly is very cost effective. You don’t find any significant increase in advanced cancers with annual screening," she said.

Five More Proposals to Slow Costs

Dr. Smith proposed the following five changes in oncologists’ behavior aimed at slowing the rise in cancer care costs:

• Target surveillance testing with serum tumor markers and imaging in accord with NCCN guidelines. Recommendations to cut back on surveillance testing ought to be incorporated into the American Society of Clinical Oncology’s Quality Oncology Practice Initiative (QOPI), a program of proven effectiveness in changing medical oncologists’ behavior.

• Switch to palliative care in patients with disease progression despite three consecutive chemotherapy regimens. The US Oncology Network’s pathway for metastatic non–small cell lung cancer, which takes this approach, has been shown to reduce treatment costs by 35% with exactly the same survival as in patients treated off pathway – and with better quality of life stemming from a doubled length of stay in hospice care (J. Oncol. Pract. 2010;6:12-18). The same research group reported that a similarly structured pathway for metastatic colon cancer led to a reduction in treatment costs by one-third, along with a significant 6.8-month improvement in survival compared with off-pathway treatment (Am. J. Manag. Care 2011;May [suppl. 5 Developing]: SP45-52).

• Limit chemotherapy for most patients with advanced metastatic solid tumors to patients with good performance status. This would markedly decrease the use of chemotherapy at the end of life.

• Substitute a reduction in chemotherapy dose for the current routine use of colony-stimulating factors in patients with metastatic solid cancers. "We are 3% of the world’s population and we use 75% of the world’s colony-stimulating factors. And 90% of that use isn’t supported by ASCO guidelines," the oncologist asserted. "I think that’s going to be a big target going forward. We simply can’t afford $3,500 per injection for a drug that helps with supportive care but doesn’t improve survival."

• Sequential monotherapies rather than combination chemotherapies as second- and third-line treatment for metastatic cancer. The available data suggest patients will live just as long, but with fewer toxic effects – and at lower cost.

Personalized Medicine and Palliative Care

Dr. Hassett cautioned that although conventional wisdom holds that the emerging field of "personalized medicine" will favorably impact health care costs by providing more selective therapy and improved clinical outcomes, that’s by no means a slam dunk.

"I’m just not sure. I think there’s a chance that personalized medicine could actually increase costs by introducing more expensive tests, new and more expensive drugs, and more complexity into the system," he said.

One thing he is sure of, however, is that any successful effort to reduce the rate of growth in cancer care spending will necessarily have to address the hot-button issue of end-of-life care. One-tenth of all Medicare dollars are spent on care during the final 28 days of life.

Dr. Smith concurred, adding that ASCO has a soon-to-be-published Provisional Clinical Opinion declaring that all oncologists should integrate palliative care into their usual cancer care programs.

"That should be the norm. We have to look at how we spend that money for end-of-life [care] because if we don’t fix that part, we won’t have money for adjuvant therapy and neoadjuvant therapy and funding for major research," he warned.

None of the experts cited in this article declared having any financial conflicts.