ICYMI: Biosimilars are a Recognized, Bipartisan Solution to Lowering Health Care Costs; Nominee for FDA Commissioner Reinforces Need to Increase Access for Biosimilars

WASHINGTON, DC (November 20, 2019) – In a STAT News op-ed, the Biosimilars Forum underscored the bipartisan support for biosimilars in Congress as a lower-cost alternative to expensive biologics. 

“Bipartisan solutions that help Americans save money and access needed treatments are a no-brainer, especially given their rarity,” wrote Biosimilars Forum President Juliana Reed. “Despite the tough political climate, Congress has rightfully recognized that increasing access to biosimilars is a necessary part of the solution to America’s rising health care costs.”

Biosimilars can save the U.S. as much as $150 billion over the next decade and policymakers are recognizing the potential cost benefits. Members of Congress are working across the aisle to answer Americans calls for lower drug prices and introduce a series of bills that provide greater access to biosimilars. This includes:

  • Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act by Congressmen Scott Peters (D-CA), Pete King (R-NY) and Anthony Brindisi (D-NY). This bipartisan bill would waive patients’ out-of-pocket costs for biosimilars under Medicare Part B.

  • Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act by Congressmen Kurt Schrader (D-OR) and Greg Gianforte (R-MT) would enhance provider reimbursement by increasing the ASP add-on payment rate for biosimilars in Medicare Part B. A similar bill was part of the Senate Finance Package in July.

  • Most recently, bipartisan introduction of legislation from Congressmen Paul Tonko (D-NY) and Bob Gibbs (R-OH) would direct the U.S. Department of Health & Human Services (HHS) to create a biosimilar access measure in the Centers for Medicare & Medicaid Services’ (CMS) Star Ratings Program. This measure will help Congress and the industry better understand the barriers that exist to access lower-cost biosimilars in the Medicare Advantage and Part D health plans, allowing for future reforms to the market.

During the Senate’s confirmation hearing for Dr. Stephen M. Hahn to serve as the FDA Commissioner, the nominee cited the importance of patient access to biosimilars:

“The biosimilar pathway is crucial. I am very much in favor of transparency and anti-competitive processes, or practices should be eliminated,” Hahn said.

Biosimilars are safe, effective and FDA-approved treatments that represent the second generation of lower-cost medicines. Yet, recent state-by-state analysis found U.S. usage rates of the nine biosimilars available are in the low to mid-single digits for a vast majority of states, resulting in billions of dollars in lost savings across the country. The FDA plays a critical role in educating patients, physicians and payers about the safety and efficacy of lower cost biosimilars. 

To learn more about these money-saving policies and the Biosimilars Forum, click here.