Center for Health System Sustainability

The Inflation Reduction Act instructs Medicare to negotiate prices of top-selling drugs and sets statutory upper limits (“ceilings”) on negotiated prices. Medicare can negotiate prices below the ceilings based on how prices and clinical benefits of these drugs compare with those of therapeutic alternatives. In August 2024, Medicare published the negotiated prices for the first 10 drugs selected for negotiation; these prices will come into effect in 2026 and will apply to all Medicare Part D plans. We analyzed how negotiated prices in the US compared with net prices before negotiation, ceiling prices, and list prices in 6 other high-income countries.

Biologics approved by the US Food and Drug Administration (FDA) receive 12 years of guaranteed protection from biosimilar competition compared with 5 years of protection from generic competition for new small-molecule drugs. Under the 2022 Inflation Reduction Act, biologics are exempt from selection for Medicare price negotiation for 11 years compared with 7 years for small-molecule drugs. Congress codified these differing legal protections on the premise that biologics require more time and resources to develop and have weaker patent protection, necessitating additional protections for manufacturers to recoup their development costs and generate adequate returns on investment.

Little is known about how long it takes for new medicines to reach countries with different income levels. We analyzed data, sourced from IQVIA, on the timing of new drug launches in seventy-five low-, middle-, and high-income markets from 1982 to 2024. The sample captured the majority of essential medicines (as designated by the World Health Organization in the twenty-third Model List of Essential Medicines) that first came into medical use anywhere globally from 1982 onward. Kaplan-Meier estimates were used to quantify delays in launches across countries. Our analysis comprised 119 medicines with 6,871 observed launches. Nearly three-quarters (74 percent) of first launches occurred in just eight countries (in order of the most first launches, the US, the Netherlands, Sweden, Switzerland, the United Kingdom, France, Germany, and Japan). From the first launch globally, the median time to availability was 2.7 years for high-income countries, 4.5 years for upper-middle-income countries, 6.9 years for lower-middle-income countries, and 8.0 years for low-income countries. The gap between richer (high- and upper-middle-income) and poorer (lower-middle- and low-income) countries remained largely unchanged over time. Strategies to address the disparities highlighted by this analysis are urgently needed.

In their Letter to the Editor, Olivença and colleagues question the benefit of adopting health technology assessment (HTA) in the US, and suggest it could result in fewer drugs being available to patients. They raise 3 main critiques of our study.1

First, Olivença et al note that patients in countries with HTA have voiced concerns about inadequate access to new therapies, citing 5 media reports from negative coverage decisions in England. The extent to which these reports represent the broader views of society is unclear. Recent decades have seen global consensus that universal health coverage is desirable for health care systems. Achieving universal coverage requires decisions about which services should be made available to maximize population health. As many new drugs offer little or no added therapeutic value,2 no coverage may be acceptable unless pharmaceutical companies offer reasonable prices (otherwise, funds would not be available to pay for other health services). In our study, we observed good coverage in all countries of high-value drugs following HTA review.

Most high-income countries except the US rely on health technology assessment (HTA) to ensure that prices paid for new medicines reflect the value they provide.1,2 Health technology assessment bodies assess the relative clinical or economic impact of new drugs to guide pricing and coverage decisions. These assessments usually occur after marketing authorization by a medicines regulatory body (eg, European Medicines Agency), and patients may have little or no access to therapies not assessed favorably by HTA bodies. As Medicare considers using comparative effectiveness data to negotiate drug prices, examining HTA decisions abroad can inform US policymakers about how HTA affects the availability and coverage of new medicines.3 We analyzed HTA outcomes and review times in 6 countries (Australia, Canada, England, France, Germany, and Switzerland) for novel therapeutic agents approved by the US Food and Drug Administration (FDA).