The biosimilars pathway was establish in 2010 (BPCIA) and the FDA approved the first biosimilar medicine in 2015. Thus far, the FDA has approved a total of 26 biosimilars. However, significant barriers exist to widespread biosimilar use. Only 15 biosimilars are available to patients — few with significant market uptake. Because biosimilars are lower-priced versions of brand-name biologics, there is significant opportunity for patient savings. AAM’s Biosimilars Council found that the health care system has lost nearly $2.2 billion in savings due to slow biosimilar adoption since 2015. The three legislative proposals below would help strengthen biosimilar adoption and each is designed to ensure savings for patients and Medicare.
Increase Patient Access to Lower-Cost Biosimilar Medicines
Encourage Physician Use of Lower-Cost Biosimilars – Cosponsor the BIOSIM Act (H.R. 4455)
- Currently, providers in Medicare Part B are reimbursed for administering biosimilars at ASP+6% of the brand-name biologic.
- The Bolstering Innovative Options to Save Immediately on Medicines (BIOSIM) Act, introduced by Rep. Kurt Schrader (D-OR) and Rep. Greg Gianforte (R-MT), would increase reimbursement for biosimilars by 2% to ASP+8%.
- The additional reimbursement would encourage greater physician use of biosimilars in Medicare Part B and only applies when the biosimilar’s ASP is lower than the brand-name biologic’s ASP.
- Currently marketed biosimilars have, on average, a 25% lower ASP than their respective reference products.
- The BIOSIM Act was included in H.R. 3, The Lower Drug Costs Now Act, (Sec. 804) and a similar policy was included in S. 2543, The Prescription Drug Pricing Reduction Act, (Sec. 104) passed by the Senate Finance Committee.
Incentive for Physicians, Lower Costs for Patients, and Savings for Medicare — Cosponsor Biosimilars Shared Savings Demo (H.R. 6179)
- A voluntary, national demonstration project could be established under Medicare Part B to evaluate the benefits of providing a shared savings payment for biosimilars.
- Participating providers would receive a portion, as determined by HHS Secretary, of the savings for prescribing a biosimilar with a lower cost than the brand-name biologic.
- As determined by the Secretary, a portion of this savings could also be applied to a beneficiary’s cost-sharing liability under Part B.
- The shared savings, between the provider, patients and Medicare, creates a financial incentive to administer biosimilars and guarantees additional savings for taxpayers.
Reduce Patient Cost-Sharing for Biosimilars – Cosponsor the ACCESS Act (H.R. 4597)
- Patients often pay 20 percent of the cost of prescription drugs under Medicare Part B, including for lower-cost biosimilar medicines.
- The Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act, introduced by Rep. Scott Peters (D-CA), Rep. Pete King (R-NY), and Rep. Anthony Brindisi (D-NY), would increase patient access to biosimilars by eliminating a patient’s copay.
AAM and the Biosimilars Council support a number of other policy proposals to help increase patient access to lower-cost biosimilar medicines. Support of the three legislative proposals described above would be the most impactful in the short-term to the biosimilars market. We would be glad to discuss additional solution to address the existing barriers to biosimilar access.
About the Biosimilars Council
The Biosimilars Council, a division of the Association for Accessible Medicines (AAM), works to ensure a positive environment for patient access to biosimilar medicines. The Biosimilars Council is a leading source for information about the safety and efficacy of more affordable alternatives to costly brand biologic medicines. Areas of focus include public and health expert education, strategic partnerships, government affairs, legal affairs and regulatory policy. More information is available on our about page.
AAM is driven by the belief that access to safe, quality, effective medicine has a tremendous impact on a person’s life and the world around them. Generic and biosimilar medicines improve people’s lives, improving society and the economy in turn. AAM represents the manufacturers and distributors of finished generic pharmaceuticals and biosimilars, manufacturers and distributors of bulk pharmaceutical chemicals, and suppliers of other goods and services to the generic industry. Generic pharmaceuticals are 90 percent of prescriptions dispensed in the U.S. but only 22 percent of total drug spending. Additional information is available at www.accessiblemeds.org.