Since 2015, the U.S. Food and Drug Administration (FDA) has approved 42 total biosimilars, delivering safe and effective care for patients suffering from diseases such as cancers, rheumatoid arthritis, plaque psoriasis and chronic kidney disease. With 36 of those approved products currently on the market, biosimilars provide market-based competition for costly biologics, and cause brand biologic prices to decline by an average of 25 percent. Put simply, biosimilars bring lower prices: today they cost less than half the price of the brand product at the time of biosimilar launch, and their utilization has saved patients, taxpayers and the healthcare system nearly $24 billion since 2015.
To be sure, biosimilars are delivering on their promise of expanded patient access. Yet despite meaningfully lower prices, biosimilar adoption has trailed expectations, particularly in parts of the system where biosimilars face numerous obstacles due to reimbursement design. Making changes to provider reimbursement can encourage greater biosimilars adoption. For example, providers participating in the CMS Oncology Care Model (OCM), which holds providers accountable for the total cost of care, showed higher biosimilar adoption rates than those in other provider settings. In fact, across molecules, OCM participants were shown to be more likely to administer a biosimilar versus a biologic reference product to new patients starting therapy, suggesting that provider incentives are an important driver of biosimilar uptake.
Physicians and hospitals can play a critical role in biosimilar adoption—a fact recognized by policymakers with the inclusion of ASP+8 in the Inflation Reduction Act (IRA), a policy to increase physicians’ incentives to use biosimilars over more expensive innovator biologics. And while the ASP+8 policy included in IRA is helpful, it is insufficient to meaningfully change the adoption curve and expand patient access. Congress and the Administration must continue to examine ways to remove obstacles that may discourage providers from utilizing lower-cost biosimilars with their patients.
A shared savings program designed to reward new adoption by providers would expand patient access and return meaningful savings to patients and taxpayers. Legislation introduced this year by Rep. Richard Hudson would help strengthen biosimilar adoption and ensure savings for patients and Medicare. The Increasing Access to Biosimilars Act (HR 1352) would take a critical step toward enhancing patient access to biosimilars through the creation of a voluntary, shared savings demonstration program in Medicare Part B. Through a shared savings demonstration, providers would be encouraged to prescribe lower-cost biosimilar medicines and savings would be guaranteed to the federal government. An independent analysis conducted to assess the potential impact shows that a shared savings demonstration could save more than $4 billion for seniors and $12 billion for the Medicare program over 10 years. H.R. 1352 recently was included in a legislative hearing of health bills at Energy and Commerce, demonstrating interest in this policy by committee leadership.
Biosimilars are the key to reducing prescription drug costs and increasing access to care. We know that biosimilar competition works for patients, and the Biosimilars Council is committed to working with policymakers to build on biosimilars’ successes and remove barriers that limit options for care and leave savings on the table. The Increasing Access to Biosimilars Act would make progress on biosimilar adoption in the U.S., bringing hope to patients and improving the health of millions.