President’s Cancer Panel: ‘Urgent action’ needed to address rising drug prices

The President’s Cancer Panel today issued several recommendations intended to ensure the prices of cancer drugs are aligned with their value.

The 51-page report — titled “Promoting Value, Affordability and Innovation in Cancer Drug Treatment” — concluded that “urgent action” is necessary to address the rapid increases in cancer drug costs, and that “the health and lives of patients are at stake.”

“This challenge can only be met through the input and action of all stakeholders — drug developers and manufacturers, policymakers, government, public and private payers, health care institutions and systems, providers and patients,” the report reads. “Actions to address drug costs should follow several key guiding principles — cancer drug prices should be aligned with their value to patients, all patients should have affordable access to appropriate cancer drugs, and investments in science are essential to drive future innovation. Collectively, these actions will help us reach the ultimate goal of ensuring that all patients receive the treatment they need and experience the benefits that these remarkable drugs can offer.”

Drugs account for 20% of total costs of cancer care in the United States, according to the report. However, the costs of cancer drugs are increasing much more rapidly than costs for other components of care.

Americans with cancer and their insurance providers paid an estimated $207,000 for cancer drugs for each year of life they were estimated to add, up from $54,100 in 1995.

Patients who face higher out-of-pocket costs may be less likely to adhere to treatment, thereby having a detrimental effect on outcomes.

“Like medical toxicities caused by cancer treatment, financial toxicity can impose a significant burden on patients, including a diminished quality of life, interference with high-quality care delivery and even a reduction in survival rates,” the report read.

In addition, as HemOnc Today previously reported, research has shown individuals with cancer are nearly three times more likely to go bankrupt than those without cancer.

The President’s Cancer Panel outlined six recommendations designed to align cancer drug prices with their value, ensure all patients have affordable access to cancer drugs, and promote innovation in cancer drug development.

The recommendations include:

Promote value-based pricing and use of cancer drugs.

Panel members concluded development and implementation of a widely accepted value framework for cancer drugs “is a critical step” toward value-based pricing. The framework should incorporate clinical outcomes, toxicities, impact on quality of life and costs. The panel also recommended outcomes-based pricing for cancer drugs should be explored, payment models should incentivize providers to use high-value drugs, and insurance plans should promote patients’ use of high-value drugs.

Enable meaningful communication about treatment options, including cost information, to support patients’ decision-making.

In addition to having accurate information about their prognosis and a clear understanding of recommended treatment options, patients also must have access to information about the costs of those treatment options, panelists wrote.

“Historically, discussions about cost have not been part of clinical care for cancer, but the panel agrees with recommendations by the Institute of Medicine and ASCO that patients should be informed about the costs of care; in particular, out-of-pocket costs,” the report reads. “Access to cost information potentially would enable patients to integrate costs, as they desire, into their personal value assessments of treatment options. Cost information also may help patients, families, and care teams identify ways to prevent or address financial toxicity.”

The panel also concluded discussions about treatment costs and value must be improved, and that clinical data are needed to enable value assessment and inform decision-making.

Minimize the contributions of drug costs to financial toxicity for patients with cancer and their families.

The panel determined high-quality health insurance facilitates affordable access to cancer drugs, and that patients’ out-of-pocket expenses should be limited to minimize financial toxicity caused by cancer drug costs.

The panel also identified a need for greater use of financial counseling services and patient assistance programs, as well as additional research to prevent, detect and address financial toxicity.

Stimulate and maintain competition in the generic and biosimilar cancer drug markets.

The average price for generic drugs has fallen by more than 70% since 2008, according to the report. The generic drug market saved the American health care system approximately $253 billion in 2016, including $10 billion in savings for oncology drugs.

“Patients share in these savings as out-of-pocket costs are substantially lower for generics compared with brand-name drugs,” panelists wrote. “Use of low-cost generic drugs improves patient adherence to essential medication regimens and promotes better patient outcomes. Unlike prices for brand-name drugs, which often are higher in the [United States] than in other countries, prices for most generic drugs are lower in the United States than in Canada and Europe.”

Panelists suggested the FDA reduce barriers to market entry for generic drugs and biosimilars, and that regulators and policymakers promote “healthy competition” in the generic drug market.

“[Also], FDA should continue to monitor the emerging U.S. biosimilars landscape and ensure that approval processes and manufacturing oversight are functioning efficiently such that biosimilar products can be made available to the American public,” the report read.

Ensure that FDA has appropriate resources to assess cancer drug safety and efficacy efficiently.

In the past 25 years, the FDA has cut review times in half. Half of new drug applications for cancer treatments that received FDA approval between 2003 and 2016 were approved within 6 months, and nearly all received approval within 1 year, according to the report.

“The panel urges the president and Congress to ensure that the FDA has the resources and authority to assess the safety and efficacy of oncology products and to appropriately staff the Oncology Center of Excellence,” the report reads. “Adequate resources also are needed to conduct postapproval drug safety monitoring, ensure that foreign and domestic manufacturing facilities adhere to safety and quality standards, and enable efficient review of both novel and generic/biosimilar drugs.”

Invest in biomedical research to create a strong foundation for developing innovative, high-value cancer drugs.

“Failure to invest in NIH will threaten the United States’ role as a global leader in the biomedical sciences and future progress against cancer,” panelists wrote.

The panel also called for sustained commitment to cancer research from nonprofit organizations, the biopharmaceutical industry and venture capital companies.

“Rising cancer drug costs are a significant problem and cannot be ignored — the consequences for patients, families, and society are too great,” the report reads. “More than ever, affordable access to drugs will be the difference between life and death for cancer patients. ...

“This complex problem will not be solved quickly or easily, and it will not be solved by any organization or sector working alone,” panelists added. “The panel urges all stakeholders — drug developers and manufacturers, policymakers, government, public and private payers, health care institutions and systems, providers and patients — to work together to address rising costs and ensure that patients have access to innovative, high-value and affordable cancer drugs. The ultimate goal is to ensure that patients receive high-quality cancer treatment and experience the best possible health outcomes without financial toxicity.”

 

Reference:

Promoting Value, Affordability, and Innovation in Cancer Drug Treatment: A report to the president of the United States from the President’s Cancer Panel. Available at: prescancerpanel.cancer.gov/report/drugvalue/pdf/PresCancerPanel_DrugValue_Mar2018.pdf. Accessed on March 13, 2018.

 

The President’s Cancer Panel today issued several recommendations intended to ensure the prices of cancer drugs are aligned with their value.

The 51-page report — titled “Promoting Value, Affordability and Innovation in Cancer Drug Treatment” — concluded that “urgent action” is necessary to address the rapid increases in cancer drug costs, and that “the health and lives of patients are at stake.”

“This challenge can only be met through the input and action of all stakeholders — drug developers and manufacturers, policymakers, government, public and private payers, health care institutions and systems, providers and patients,” the report reads. “Actions to address drug costs should follow several key guiding principles — cancer drug prices should be aligned with their value to patients, all patients should have affordable access to appropriate cancer drugs, and investments in science are essential to drive future innovation. Collectively, these actions will help us reach the ultimate goal of ensuring that all patients receive the treatment they need and experience the benefits that these remarkable drugs can offer.”

Drugs account for 20% of total costs of cancer care in the United States, according to the report. However, the costs of cancer drugs are increasing much more rapidly than costs for other components of care.

Americans with cancer and their insurance providers paid an estimated $207,000 for cancer drugs for each year of life they were estimated to add, up from $54,100 in 1995.

Patients who face higher out-of-pocket costs may be less likely to adhere to treatment, thereby having a detrimental effect on outcomes.

“Like medical toxicities caused by cancer treatment, financial toxicity can impose a significant burden on patients, including a diminished quality of life, interference with high-quality care delivery and even a reduction in survival rates,” the report read.

In addition, as HemOnc Today previously reported, research has shown individuals with cancer are nearly three times more likely to go bankrupt than those without cancer.

The President’s Cancer Panel outlined six recommendations designed to align cancer drug prices with their value, ensure all patients have affordable access to cancer drugs, and promote innovation in cancer drug development.

The recommendations include:

Promote value-based pricing and use of cancer drugs.

Panel members concluded development and implementation of a widely accepted value framework for cancer drugs “is a critical step” toward value-based pricing. The framework should incorporate clinical outcomes, toxicities, impact on quality of life and costs. The panel also recommended outcomes-based pricing for cancer drugs should be explored, payment models should incentivize providers to use high-value drugs, and insurance plans should promote patients’ use of high-value drugs.

PAGE BREAK

Enable meaningful communication about treatment options, including cost information, to support patients’ decision-making.

In addition to having accurate information about their prognosis and a clear understanding of recommended treatment options, patients also must have access to information about the costs of those treatment options, panelists wrote.

“Historically, discussions about cost have not been part of clinical care for cancer, but the panel agrees with recommendations by the Institute of Medicine and ASCO that patients should be informed about the costs of care; in particular, out-of-pocket costs,” the report reads. “Access to cost information potentially would enable patients to integrate costs, as they desire, into their personal value assessments of treatment options. Cost information also may help patients, families, and care teams identify ways to prevent or address financial toxicity.”

The panel also concluded discussions about treatment costs and value must be improved, and that clinical data are needed to enable value assessment and inform decision-making.

Minimize the contributions of drug costs to financial toxicity for patients with cancer and their families.

The panel determined high-quality health insurance facilitates affordable access to cancer drugs, and that patients’ out-of-pocket expenses should be limited to minimize financial toxicity caused by cancer drug costs.

The panel also identified a need for greater use of financial counseling services and patient assistance programs, as well as additional research to prevent, detect and address financial toxicity.

Stimulate and maintain competition in the generic and biosimilar cancer drug markets.

The average price for generic drugs has fallen by more than 70% since 2008, according to the report. The generic drug market saved the American health care system approximately $253 billion in 2016, including $10 billion in savings for oncology drugs.

“Patients share in these savings as out-of-pocket costs are substantially lower for generics compared with brand-name drugs,” panelists wrote. “Use of low-cost generic drugs improves patient adherence to essential medication regimens and promotes better patient outcomes. Unlike prices for brand-name drugs, which often are higher in the [United States] than in other countries, prices for most generic drugs are lower in the United States than in Canada and Europe.”

Panelists suggested the FDA reduce barriers to market entry for generic drugs and biosimilars, and that regulators and policymakers promote “healthy competition” in the generic drug market.

“[Also], FDA should continue to monitor the emerging U.S. biosimilars landscape and ensure that approval processes and manufacturing oversight are functioning efficiently such that biosimilar products can be made available to the American public,” the report read.

PAGE BREAK

Ensure that FDA has appropriate resources to assess cancer drug safety and efficacy efficiently.

In the past 25 years, the FDA has cut review times in half. Half of new drug applications for cancer treatments that received FDA approval between 2003 and 2016 were approved within 6 months, and nearly all received approval within 1 year, according to the report.

“The panel urges the president and Congress to ensure that the FDA has the resources and authority to assess the safety and efficacy of oncology products and to appropriately staff the Oncology Center of Excellence,” the report reads. “Adequate resources also are needed to conduct postapproval drug safety monitoring, ensure that foreign and domestic manufacturing facilities adhere to safety and quality standards, and enable efficient review of both novel and generic/biosimilar drugs.”

Invest in biomedical research to create a strong foundation for developing innovative, high-value cancer drugs.

“Failure to invest in NIH will threaten the United States’ role as a global leader in the biomedical sciences and future progress against cancer,” panelists wrote.

The panel also called for sustained commitment to cancer research from nonprofit organizations, the biopharmaceutical industry and venture capital companies.

“Rising cancer drug costs are a significant problem and cannot be ignored — the consequences for patients, families, and society are too great,” the report reads. “More than ever, affordable access to drugs will be the difference between life and death for cancer patients. ...

“This complex problem will not be solved quickly or easily, and it will not be solved by any organization or sector working alone,” panelists added. “The panel urges all stakeholders — drug developers and manufacturers, policymakers, government, public and private payers, health care institutions and systems, providers and patients — to work together to address rising costs and ensure that patients have access to innovative, high-value and affordable cancer drugs. The ultimate goal is to ensure that patients receive high-quality cancer treatment and experience the best possible health outcomes without financial toxicity.”

 

Reference:

Promoting Value, Affordability, and Innovation in Cancer Drug Treatment: A report to the president of the United States from the President’s Cancer Panel. Available at: prescancerpanel.cancer.gov/report/drugvalue/pdf/PresCancerPanel_DrugValue_Mar2018.pdf. Accessed on March 13, 2018.