A letter from 38 organizations representing patients and people with disabilities regarding their concerns about the Maryland Prescription Drug Affordability Board’s consideration of value assessments relying on the quality-adjusted life year (QALY) as suggested by the Institute for Clinical and Economic Review (ICER).
Over 20 organizations signed letters on July 21. 2021 to California Assembly member Wood and to the members of the Budget Committee calling for amendments to AB 1130 that would preclude the use of quality-adjusted life years (QALYs) by the proposed Office of Health Care Affordability. You can read the letter addressed to Assembly member Wood here, and the letter addressed to the Budget Committee here.
Every life is valuable. We strongly urge policymakers to reject policies that discriminate against people with disabilities and chronic conditions, older adults, and reinforce health inequities. You can read the full letter here.
The Institute for Clinical and Economic Review (ICER) is an independent non-profit entity. ICER is not a federal government agency and not affiliated with the FDA, nor does it have any authority to approve or deny drug access. The legislation developed by the National Association of State Health Policy (NASHP) is unusual in that it would codify referencing a report from a non-governmental entity as the sole source of information, thereby
sidestepping usual state contracting processes that would allow for public comment and state government oversight of the report’s methods and conclusions. It would also preclude reference to evidence from other, more appropriate, entities, stating, “the state shall utilize and rely upon the analyses of Prescription Drugs prepared annually by the Institute for Clinical and Economic Review (ICER) and published in its annual Unsupported Price Increase Report.”
Many states have or are considering adoption of a drug review board or commission. These boards have differing names from state to state but their goal is to allow the state to review and evaluate the reimbursement rate and/or coverage for pharmaceuticals. Most have fairly broad parameters of how they can assess a drug’s value, and specifically permit the state to rely on third-party research or contract directly with a third-party for
the purpose of fulfilling its duties. As has happened in other states such as New York and Massachusetts, without patient protections, these bills allow the new state board or commission to reference value assessments that rely on quality-adjusted life years (QALY) and similar metrics or
even to directly contract with entities such as the Institute for Clinical and Economic Review (ICER) that refer to QALYs as the “gold standard.”
The quality-adjusted life year, or QALY, is a metric commonly used to determine the value of a health care treatment. To calculate a QALY, you must assign a value to a person’s life and to the incremental improvement in quality of life with treatment. The value assigned to seniors, the chronically ill, or people with disabilities is lower than that of a young, healthy person and does not capture how people living with a condition value quality of life improvements. Therefore, QALYs often lead policymakers and payers to conclude that treatments for seniors, patients with chronic conditions or people with disabilities are not worth it.
Value Our Health developed a template letter to empower advocates in states to educate their state policymakers – including Governors, state Medicaid directors and/or legislators – about QALYs and similar metrics and how their use may violate existing federal civil rights and disability laws.
Value Our Health calls on state legislators to protect patients and people with disabilities from policies that would reference discriminatory cost effectiveness analyses based on QALYs and similar metrics, or that would use QALY-based analyses as leverage to reduce government spending by limiting access through the use of step therapy, prior authorization, cost-sharing designs, and tiered formularies. Consideration of research and analysis for Medicaid policies impacting coverage, reimbursement and incentive programs should be transparent to the public and deliberated with input from patients and people with disabilities.
The American Association of People with Disabilities, the Autistic Self Advocacy Network, the Bazelon Center for Mental Health Law, the Disability Rights Education and Defense Fund, the National Council on Independent Living, Progressive Independence, TARC, and The Arc of the United States applaud Oklahoma’s Governor Kevin Stitt for signing into law the Nondiscrimination in Health Care Coverage Act. This crucial legislation defends the equal dignity of people with disabilities by banning the use of the discriminatory Quality Adjusted Life Year (QALY) metric by state agencies and requiring the state to consult with disability organizations, including self-advocacy groups, prior to making decisions on coverage, reimbursement, and utilization management.
As organizations representing people with disabilities, we are writing with regard to our concerns about legislation, S.B. 734, being considered in the State of Oklahoma that would import discriminatory pricing policies from Canada to the State of Oklahoma. The American Association of People with Disabilities (AAPD) is a national cross-disability rights organization, advocating for full civil rights for the over 56 million Americans with disabilities by promoting equal opportunity, economic power, independent living, and political participation. The Association of University Centers on Disabilities (AUCD) is a membership organization that supports and promotes a national network of university-based interdisciplinary programs. The Partnership to Improve Patient Care is a coalition at the forefront of applying principles of patient-centeredness to the nation’s health care system, including the translation of evidence into patient care in a manner that achieves value to the patient.
As background, the American Association of People with Disabilities (AAPD) is a national cross-disability rights organization, advocating for full civil rights for the over 61 million Americans with disabilities by promoting equal opportunity, economic power, independent living, and political participation. The Association of University Centers on Disabilities (AUCD) is a membership organization that supports and promotes a national network of university-based interdisciplinary programs. The Partnership to Improve Patient Care (PIPC) is a coalition effort to apply principles of patient-centeredness to the nation’s health care system. We encourage policymakers to manage health costs in a manner centered on meeting the health care needs of people with disabilities and chronic conditions.
The Epilepsy Foundation is the leading national voluntary health organization that speaks on behalf of at least 3.4 million Americans with epilepsy and seizures. We foster the wellbeing of children and adults affected by seizures through research programs, educational activities, advocacy, and direct services. Epilepsy is a medical condition that produces seizures affecting a variety of mental and physical functions. Approximately 1 in 26 Americans will
develop epilepsy at some point in their lifetime. For people living with epilepsy, timely access to appropriate, physician-directed care, including epilepsy medications, is a critical concern. Epilepsy medications are the most common and cost-effective treatment for controlling and/or reducing seizures. To delay, change, limit, or deny access to medications could be extremely dangerous.
The cost of health care is high. Too high. There is discussion by federal and state lawmakers about policies to lower costs to protect patients and their families. I applaud the intent, but, as the parent of a child with cystic fibrosis (CF) and the leader of a patient advocacy organization, I believe they are missing the mark. The issue is simple. In developing these policies, policymakers are not talking to us, to learn what patients need and prioritize. Too often, they are laser focused on punishing pharmaceutical companies by relying on flawed discriminatory information that restricts access to needed treatments.
On behalf of people with disabilities, the American Association of People with Disabilities and the American Association of University Centers on Disabilities are deeply concerned that Washington State Senate Bill SB 5020 explicitly references value assessments that are developed in reliance on the discriminatory quality-adjusted life (QALY) year metric. For 30 years, advocates in the disability community have advocated against the use of discriminatory metrics to assess the value of health care and how it will be covered and reimbursed in federal programs, including Medicaid.
We are concerned that SB5020 relies on measures that discriminate against people with disabilities. Quality Adjusted Life Years (QALYs) are used by the Institute for Clinical and Economic Review (ICER), which is named in the bill, in their studies and determinations of whether price increases are supported by the evidence. QALYs have long been opposed by the disability community for discriminating against people with disabilities. QALYs place a number on the value on a year of human life, with relatively lower values for those with disabilities and chronic conditions. These values can then be used to deny access to care and treatments.
On behalf of organizations representing health care stakeholders, submitted comments to express concern with SB 5020, as it relies directly on reports conducted by the Institute for Clinical and Economic Review (ICER), an entity that embraces the quality-adjusted life year (QALY) as the gold standard for value assessment. QALYs have long been opposed by the disability community for discriminating against people with disabilities. QALYs place a number on the value on a year of human life, with relatively lower values for those with disabilities and chronic conditions. These values can then be used to deny access to care and treatments.
The U.S. health care system is undergoing a transformation in how it delivers and pays for care. As traditional fee-for-service gives way to value-based arrangements, understanding the “value” of health care has become a national priority. The National Health Council is focused on ensuring the voice of the patient and patient organizations are an integral part of the value discussion.
The nonprofit Innovation and Value Initiative (IVI) was created to raise the level of discussion regarding value in healthcare and find common ground in the approach to measuring value. The U.S health system is diverse, complex, and ripe for innovation. IVI brings together healthcare leaders from academia, patient advocacy organizations, payers, life sciences companies, providers, delivery systems, and patient communities to advance approaches to value that fit the American context.
QALY Ban at Section 501 of H.R. 1384
NYT Opinion by Former HHS Secretary
H.R. 3: House Democrats’ new proposal creates a process that would set prices for up to 250 drugs each year (plus insulins), including those that give patients living with rare diseases or disabilities opportunities to live their optimal quality of life. The plan uses an international reference price backstop — called the average international price (AIM) — to require that HHS-mandated prices for a selected drug do not exceed 120 percent of the drug’s average price across the U.K., Australia, France, Canada, Germany, and Japan. Patients in these countries are routinely denied medicines that they need to survive or to improve their quality of life due to the use of QALYs and average measures of clinical benefit in determining the prices of medicines and who can get them.
More than 60 leading patient advocacy and disability groups sent an outreach letter to the Institute for Clinical and Economic Review’s (ICER) new Vice President for Patient Engagement Yvette Venable. The groups applauded the creation of this new position, and look forward to working with Ms. Venable to ensure that ICER develops and implements a robust patient engagement framework. “As organizations that have worked across the spectrum of health care – including life sciences innovation, payer decision-making and value assessment – with missions to improve the quality of life for patients and people with disabilities, we hope that you will engage with us and take advantage of our real-world patient engagement experiences and lessons learned,” the letter states. “Do not hesitate to reach out to us and to the experts in this field described above as you consider patient engagement frameworks that may be fit for use within ICER.”
If you have read our response to Governor’s Cuomo’s 2019-2020 Budget you know that we thoroughly comb the budget to analyze every disability related policy we can find. However, occasionally one slips past us. This year we missed one appalling proposal from the Governor in a budget that was admittedly chock full of them. Hidden away in the Health and Mental Hygiene budget was a provision to authorize an independent body to use a method, QALYs (Quality Adjusted Life Years) that is built on disability discrimination to advise the state Drug Utilization Review Board to help determine the price the state is willing to pay for a number of vital medications.
ICER’s assessments are used by private payers, including private Medicare Advantage plans, some Medicaid programs, and the Veterans Administration (VA) to inform formulary development and utilization management, such as step therapy. ICER’s assessments are precluded by law from being used directly by Medicare. An assessment of low to intermediate value by ICER could lead Medicaid programs, the VA, private insurers, and pharmacy benefit managers to restrict access to the new treatment.
Recently, policymakers have proposed International Reference Pricing as a tactic to lower drug prices within the United States. This policy may sound attractive on paper, but there are unintended consequences for patients. Let’s hear what the experts are saying.
The Affordable Care Act very clearly states that no one has the authority to deny coverage of items or services ”solely on the basis of comparative effectiveness research“ nor to use such research ”in a manner that treats extending the life of an elderly, disabled, or terminally ill individual as of lower value than extending the life of an individual who is younger, nondisabled, or not terminally ill.“
The Institute for Clinical and Economic Review (ICER) is a private research organization that conducts cost-effectiveness assessments of medicines and health care services. Health insurers and policy-makers use these assessments to guide decisions that impact patient access, which is concerning to the patient and disability community, as their research fails them in multiple ways.
Policymakers and industry stakeholders are discussing policies that will have a significant impact on what treatments patients and persons with disabilities can access. Many of these involve the use of discriminatory standards that undervalue the lives of older adults, patients, and persons with disabilities. Value Our Health supports assessing the value of any treatment using tools that are consistent with the goals of personalized, patient-centered medicine and do not discriminate against people based on age and/or with disabilities, chronic conditions, and diseases. Adopting the following principles can help ensure that value-driven health care works for all Americans.
Value assessment in general, and the use of cost-effectiveness in particular, is receiving renewed interest as a tool for controlling health care spending. Currently, the most common method for determining incremental cost-effectiveness of healthcare interventions is based on a calculation of quality-adjusted-life-years (QALY). While the model has a basic appeal for making population-level decisions (by reducing patient populations to single, aggregate numeric values), it also poses several significant concerns from the vantage point of patient-centeredness and efforts to preserve access to needed care for individual patients and people with disabilities.
Australia utilizes multiple methods to limit spending on medicines, including international reference pricing, therapeutic reference pricing, and health technology assessments with lowest cost comparators. The health technology assessments, which help to determine reimbursement for medicines covered through Australia’s public health insurance, utilizes quality-adjusted life year (QALY)-based cost-effectiveness assessments.4 Application of these stringent assessments have resulted in challenging barriers for patients in Australia where innovative new medicines are often placed out of reach for those who need them.
Canada’s current pharmaceutical pricing policies have led to significant delays and access restrictions for patients who require new and innovative medicines. In addition to regulatory approval, the current coverage and reimbursement process for new drugs includes numerous steps that can impede access: a review of all patented medicines by the Patented Medicine Prices Review Board (PMPRB), assessments that utilize the quality-adjusted-life-year (QALY) conducted by the Canadian Agency for Drugs and Technologies in Health (CADTH), and additional negotiations and product listing agreements with Provincial public drug plans. This complex and many-layered process acts as a barrier to innovate drugs and creates delays in access for patients.
To make decisions about coverage and reimbursement, Ireland uses quality-adjusted life year (QALY)-based assessments conducted by the National Centre for Pharmacoenomics (NCPE). NCPE generally recommends that Medicines which fall below €45,000 ($50,987) cost per QALY be reimbursed by the Health Service Executive (HSE), the Irish Department of Health, while medicines that fall above this threshold are usually not covered. This arbitrary cost-effectiveness threshold is applied only to medicines. Additionally, due to budgetary constraints within HSE, even when drugs are approved by NCPE, patients do not automatically receive access to the treatment. These dynamics result in significant access barriers for Irish patients who are suffering from serious and complex conditions.
Rigid assessments of treatment value, government-driven decisions on formularies and coverage, and insufficient health care budgets have long stood in the way of U.K. patients who need access to the latest innovative medicines. The high rate of rejections by the National Institute for Health and Care Excellence (NICE), the group that advises the National Health Service (NHS) on coverage decisions and makes decisions based on a cost-effectiveness threshold of between £20,000 and £30,000 ($25,700 – $38,560) per quality-adjusted life year (QALY), is one major reason why U.K. patients are often denied access to new medicines.
The American Society for Hematology stated, “ASH, however, has tried to stress why the SCD community is unique and outline our concerns about the potential adverse impact ICER’s assessment could have on recent and future progress of new therapies” – the SCD community is on the cusp of benefiting from new, potentially life-changing, treatments and cannot afford a setback. Sick Cells stated, “We urge ICER to suspend the review at this time, as this review is premature and inappropriate. The lack of published quality of life and real-world data for these new treatments severely limits ICER’s ability to measure the benefit of them.” Several advocates commented as individuals with their personal stories living with sickle cell disease that ICER’s assessment was unable to capture.
On February 18, 2020, the Washington State Senate passed SBB 6088, a bill establishing the prescription drug affordability board (board). The legislation did not bar the Board from utilizing discriminatory quality-adjusted life years (QALYs) as the metric for determining whether treatments exceed certain thresholds. The Board also would not have included representation from patients or people with disabilities, only “five members who have expertise in health care economics or clinical medicine appointed by the governor.” The bill was vetoed by the Governor and may be reconsidered in the next legislative session.
On February 5, 2020, the Massachusetts Health Policy Commission (HPC) finalized regulations outlining their approach to assessing the value of prescription drugs. As groups representing patients and people with disabilities, the affordability of health care is a significant priority. That being said, HPC’s regulations put patient access at risk, and may ultimately do more harm than good for patients. They set the stage for third-party analyses by groups like the Institute for Clinical and Economic Review (ICER) and rely on international reference pricing, which relies on QALY-based assessments in determining the “value” of treatments.