The Protecting Health Care for All Patients Act would advance the recommendation of the National Council on Disability calling for the bar on use of the quality-adjusted life year (QALY) and similar metrics that discriminate to be extended to all federal programs, including Medicaid.
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.
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.
November 6, 2020, Quality-Adjusted Life Years and the Devaluation of Life with Disability: The National Council on Disability (NCD)—an independent federal agency– released a study examining “Quality-Adjusted Life Years” (QALYs) as a health care cost-effectiveness measure that guides coverage decisions regarding drugs and treatments by private and public health insurers. In its study, NCD found sufficient evidence of discriminatory effects of the measure to warrant concern, including: concerns raised by bioethicists, patient rights groups, and disability rights advocates; and the inability of patients to obtain coverage of needed healthcare in countries where QALYs are used frequently. NCD also found that when the state of Oregon attempted to apply QALYs to its Medicaid state plan in the 1990s, it was found to violate the Americans with Disabilities Act as inherently discriminatory.