Understanding and navigating the changing U.S. market access environment
The Inflation Reduction Act (IRA), a landmark policy change signed into law in 2022, represents the most significant health care legislation since the 2010 Affordable Care Act. Intended to provide substantial financial relief for millions of people, the goal of the IRA is to ensure and protect health benefits, lower drug costs for seniors and strengthen the future standing of Medicare. The following healthcare provisions will be or have presently been implemented as a result of the IRA:
- Medicare prescription drug price negotiations
- Drug manufacturer rebates for price increases beyond the inflation rate
- Reduction in out-of-pocket spending for Medicare beneficiaries
- Limits to monthly cost sharing for insulin
- Elimination of cost-sharing for adult vaccines
- Expanded eligibility for Part D low-income subsidies
- Further delay in the drug rebate rule
These changes, specifically the ability for Medicare to negotiate drug prices, have widespread impacts on biopharmaceutical companies’ revenues and return on investment made into their pipelines.
This new regulation represents a monumental shift to ensure affordable health care for millions of senior Americans, but has sparked concerns among various stakeholders across the health care continuum. As manufacturers face growing scrutiny to demonstrate a product’s comparative effectiveness against available therapies, how it addresses key unmet needs, and its impact on a variety of patient outcomes and evidence in specific populations of interest, many questions will hinder the path forward for certain assets.
