By any measure, the methods behind ICER’s new report are bad for U.S. consumers, patients, and people with disabilities. Our newest "Data Mine" blog overviews the biggest potential problems to watch out for in this upcoming report.
ICER’s upcoming report on “Launch Price and Access” for drugs offers yet another example of why some proposals for “value-based” price-setting in healthcare may be dangerous for patients. Those relying on metrics – like those used by ICER -- that devalue patients ultimately dilute individual differences and discourage access to new treatments. These standards should be left in Europe where they originated – not imported into the U.S.
By any measure, the methods behind ICER’s new report are bad for U.S. consumers, patients, and people with disabilities. Here are the biggest potential problems to watch out for:
1) Reliance on Discriminatory Cost-Effectiveness Standards: If ICER is pulling Health-Benefit Price Benchmarks (HBPB) from prior reports, they are in effect relying on quality-adjusted life years (QALYs), a measure of cost effectiveness well known to devalue disabled lives viewed by ICER as the “gold standard.” ICER’s attempts to paper this over by including an unproven “equal value for life-years gained” metric that fails to address the fundamental problems with cost-effectiveness analysis.
2) Invalid Methods: ICER seeks to establish “morbidity and mortality opportunity cost” due to excessive drug spending predicated on a methodology that is not valid. We don’t disagree that more can be done in the U.S. to ensure medicines are affordable and accessible for all patients, but, as described below, ICER needlessly undermines the point by using dubious methods to quantify the health opportunity cost of excessive spending.
3) Mischaracterizes the Type and Degree of Access Challenges: ICER over-simplifies the complex access challenges facing patients in the U.S. and at the same time fails to recognize how many patients, including older adults and patients living with disabilities, are devalued – and as a result face significant access barriers – in foreign health systems.
Reliance on Cost-Effectiveness Standards
ICER’s protocol for modeling their evaluation of the launch prices and patient access will assess the prices of these drugs in relation to ICER's Health Benefit Price Benchmark (HBPB), all of which relied on the use of QALYs and therefore taint the report from the start as a potential tool for discrimination. Patients and people with disabilities have long opposed the use of this measure devaluing disabled lives to determine whether care should be made accessible to them. For the disability community, the role of “cost effectiveness” studies devaluing people with disabilities and older adults has been a source of great frustration for over 30 years. Patients and people with disabilities again are caught in the middle of a fight about health system costs.
As a segment of this report, ICER will also estimate the equal value of life year gained (evLYs or evLYGs), which value life extension over quality-of-life improvement and use the same discriminatory and biased measures to calculate quality of life improvement that are attributed to the QALY. To be clear, the evLYG is not a commonly used measure of cost effectiveness, as stated by ICER. Instead, it is a measure ICER created as a response to over 30 years of advocacy from people with disabilities against the QALY. ICER developed and rolled out the evLYG while aware of the disability community’s opposition to it as a measure that failed to address the QALY’s shortcomings in measuring quality of life improvement. Despite this reality, payers have still looked to ICER’s assessments and used them as justification to restrict access to care.
Invalid Methods of Estimating the Impact of Opportunity Costs
ICER starts their protocol for modeling their evaluation of the launch prices and patient access on two factual notes. First, ICER acknowledged that launch prices differ from prices patients actually pay. Second, ICER recognized the role of utilization management in restricting drug access. Yet, ICER fails to incorporate either of these into their model. It assumes the launch price as the price patients actually pay and it fails to share information on how payer utilization management strategies restricting access to care are influenced by their own discriminatory value assessments relying on QALYs and evLY or evLYG.
ICER’s methods are wholly unreliable. ICER seeks to calculate “overspending on prescription drugs” while openly acknowledging it does not know the actual prices of selected drugs. ICER’s protocol calculates health opportunity costs based on launch prices they acknowledge not to be actual prices and predicts losses in insurance coverage from spending based on such prices – knowing they are not actual prices. ICER then translates this into increased morbidity and mortality attributable to resulting insurance losses – losses it cannot quantify in any reliable way without knowing the actual prices.
Mischaracterizes the Type and Degree of Access Challenges:
As part of its rationale for this report, ICER also claims other countries provide more access to care than the United States. Yet, for many populations internationally that do not fall into averages and may not benefit from a one-size-fits-all health care system, access and health outcomes are far from ideal. Access to care internationally is largely dependent on disability status, disadvantaging access to treatments and cures for older adults, disabled populations and especially rare diseases. People living with disabilities, rare diseases, chronic conditions and cancer often have worse outcomes in other countries, often due to having little to no access to novel therapies. Life-changing drugs for cystic fibrosis have been available to patients in the U.S. for over 5 years but only recently available on a limited basis in countries like Canada. Novel treatments for cancer and rare diseases are widely known to be delayed in their approval in other countries and are often approved with severe restrictions on who can access them. The United Kingdom openly uses cost effectiveness as a criteria for approving drugs, using measures that devalue disabled lives in their calculations.
Shockingly, in many countries people with disabilities have a better chance of qualifying for assisted suicide than accessing treatment or accommodations. Put plainly, the government views ending their lives as a better use of money than improving their quality of life.
Conclusion
These are not all the shortcomings of ICER’s methodology for its upcoming new report, just a few of the lowlights. At best, ICER’s protocol for modeling this report will result in inaccurate and misleading conclusions. At worst, it will be used as another tool to devalue quality of life for people with disabilities, leading to even more access limitations. In their bid to make the case for using cost effectiveness benchmarks for reimbursement in health care, ICER ends up making the case against it by revealing why its work always ends up used for subjective, bureaucratic value judgments masquerading as objective, science-based decision-making.
To be clear, ICER’s protocol for this “Launch Price and Access” would never survive a rigorous peer review, so we don’t anticipate it gaining much attention. To the extent it does get referenced, patients and people with disabilities should be aware of its methodological flaws.
By any measure, the methods behind ICER’s new report are bad for U.S. consumers, patients, and people with disabilities. Here are the biggest potential problems to watch out for:
1) Reliance on Discriminatory Cost-Effectiveness Standards: If ICER is pulling Health-Benefit Price Benchmarks (HBPB) from prior reports, they are in effect relying on quality-adjusted life years (QALYs), a measure of cost effectiveness well known to devalue disabled lives viewed by ICER as the “gold standard.” ICER’s attempts to paper this over by including an unproven “equal value for life-years gained” metric that fails to address the fundamental problems with cost-effectiveness analysis.
2) Invalid Methods: ICER seeks to establish “morbidity and mortality opportunity cost” due to excessive drug spending predicated on a methodology that is not valid. We don’t disagree that more can be done in the U.S. to ensure medicines are affordable and accessible for all patients, but, as described below, ICER needlessly undermines the point by using dubious methods to quantify the health opportunity cost of excessive spending.
3) Mischaracterizes the Type and Degree of Access Challenges: ICER over-simplifies the complex access challenges facing patients in the U.S. and at the same time fails to recognize how many patients, including older adults and patients living with disabilities, are devalued – and as a result face significant access barriers – in foreign health systems.
Reliance on Cost-Effectiveness Standards
ICER’s protocol for modeling their evaluation of the launch prices and patient access will assess the prices of these drugs in relation to ICER's Health Benefit Price Benchmark (HBPB), all of which relied on the use of QALYs and therefore taint the report from the start as a potential tool for discrimination. Patients and people with disabilities have long opposed the use of this measure devaluing disabled lives to determine whether care should be made accessible to them. For the disability community, the role of “cost effectiveness” studies devaluing people with disabilities and older adults has been a source of great frustration for over 30 years. Patients and people with disabilities again are caught in the middle of a fight about health system costs.
As a segment of this report, ICER will also estimate the equal value of life year gained (evLYs or evLYGs), which value life extension over quality-of-life improvement and use the same discriminatory and biased measures to calculate quality of life improvement that are attributed to the QALY. To be clear, the evLYG is not a commonly used measure of cost effectiveness, as stated by ICER. Instead, it is a measure ICER created as a response to over 30 years of advocacy from people with disabilities against the QALY. ICER developed and rolled out the evLYG while aware of the disability community’s opposition to it as a measure that failed to address the QALY’s shortcomings in measuring quality of life improvement. Despite this reality, payers have still looked to ICER’s assessments and used them as justification to restrict access to care.
Invalid Methods of Estimating the Impact of Opportunity Costs
ICER starts their protocol for modeling their evaluation of the launch prices and patient access on two factual notes. First, ICER acknowledged that launch prices differ from prices patients actually pay. Second, ICER recognized the role of utilization management in restricting drug access. Yet, ICER fails to incorporate either of these into their model. It assumes the launch price as the price patients actually pay and it fails to share information on how payer utilization management strategies restricting access to care are influenced by their own discriminatory value assessments relying on QALYs and evLY or evLYG.
ICER’s methods are wholly unreliable. ICER seeks to calculate “overspending on prescription drugs” while openly acknowledging it does not know the actual prices of selected drugs. ICER’s protocol calculates health opportunity costs based on launch prices they acknowledge not to be actual prices and predicts losses in insurance coverage from spending based on such prices – knowing they are not actual prices. ICER then translates this into increased morbidity and mortality attributable to resulting insurance losses – losses it cannot quantify in any reliable way without knowing the actual prices.
Mischaracterizes the Type and Degree of Access Challenges:
As part of its rationale for this report, ICER also claims other countries provide more access to care than the United States. Yet, for many populations internationally that do not fall into averages and may not benefit from a one-size-fits-all health care system, access and health outcomes are far from ideal. Access to care internationally is largely dependent on disability status, disadvantaging access to treatments and cures for older adults, disabled populations and especially rare diseases. People living with disabilities, rare diseases, chronic conditions and cancer often have worse outcomes in other countries, often due to having little to no access to novel therapies. Life-changing drugs for cystic fibrosis have been available to patients in the U.S. for over 5 years but only recently available on a limited basis in countries like Canada. Novel treatments for cancer and rare diseases are widely known to be delayed in their approval in other countries and are often approved with severe restrictions on who can access them. The United Kingdom openly uses cost effectiveness as a criteria for approving drugs, using measures that devalue disabled lives in their calculations.
Shockingly, in many countries people with disabilities have a better chance of qualifying for assisted suicide than accessing treatment or accommodations. Put plainly, the government views ending their lives as a better use of money than improving their quality of life.
Conclusion
These are not all the shortcomings of ICER’s methodology for its upcoming new report, just a few of the lowlights. At best, ICER’s protocol for modeling this report will result in inaccurate and misleading conclusions. At worst, it will be used as another tool to devalue quality of life for people with disabilities, leading to even more access limitations. In their bid to make the case for using cost effectiveness benchmarks for reimbursement in health care, ICER ends up making the case against it by revealing why its work always ends up used for subjective, bureaucratic value judgments masquerading as objective, science-based decision-making.
To be clear, ICER’s protocol for this “Launch Price and Access” would never survive a rigorous peer review, so we don’t anticipate it gaining much attention. To the extent it does get referenced, patients and people with disabilities should be aware of its methodological flaws.
