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HR 485: Is Congress Hindering Drug Price Negotiations?

Access to affordable health care is a persistent challenge for many Americans. However, a recent bill, the Protecting Health Care for All Patients Act (HR 485), is making its way through the House of Representatives, which could hinder efforts to improve affordability of prescription drugs and other health care services. The bill seeks to block the use of quality-adjusted life-years (QALYs) and similar measures in government health care programs such as Medicare and Medicaid.



QALYs are a widely accepted outcome measure used in health economic studies to assess the benefit of a therapy compared to standard care. They combine two critical health outcomes—length of life and health-related quality of life—into a single measure. QALYs are calculated by assigning weights to different health states, ranging from perfect health to death. By using QALYs, policymakers can estimate the average benefits of a treatment for a specific population.

The debate over the use and impact of QALY is beyond the scope of this posting; however, The Centers for Medicare & Medicaid Services (CMS) recently gained the authority to negotiate prescription drug prices in Medicare. The Inflation Reduction Act of 2022, which granted this authority, already prohibits the use of QALYs in these negotiations. However, HR 485 could further impede the negotiation process if CMS is unable to consider other comparative effectiveness evidence. This could undermine efforts to lower drug prices and limit patient access to needed medicines.

Supporters of H.R. 485 argue that the use of QALYs by payers could create a discriminatory environment by limiting access to drugs in the elderly population. Supporters of the bill claim that by prohibiting the use of tools which

"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, non-disabled, or not terminally ill"

the playing field between patients is leveled.

With respect to Medicare drug price negotiation, CMS is already prohibited from using QALY as a consideration when determining the maximum fair price for a negotiation eligible drug. Concerning, HR 485's language prohibits not only QALYs but also "similar measures," which could impede other forms of comparative and cost-effectiveness analyses. Eliminating yet-to-be-defined "similar measures" could remove a key tool that CMS could use to determine the negotiated price for these drugs.

Moreso, this could interfere with existing negotiations performed by various health care programs, including the Veterans Health Administration, state Medicaid programs, and Medicare Advantage plans. The bill's broad scope threatens federal programs' use of comparative effectiveness analyses, potentially hindering efforts to negotiate fair prices for prescription drugs and manage state spending on health care.

A broad prohibition on comparative and cost-effectiveness research by public agencies could have profound consequences for US pharmaceutical innovation. Banning QALYs and similar measures may discourage pharmaceutical companies from assessing health-related quality of life during clinical trials, limiting the information available to patients and clinicians when choosing treatments. Instead, policymakers should encourage the use of comparative measurement tools that incentivize research and development of products that truly improve patients' lives.

While concerns regarding health care affordability and access are valid, HR 485's approach to blocking the use of QALYs and similar measures in government health care programs should raise concerns about unintended consequences in other parts of the federal healthcare system.
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