Generic and biosimilar medicines are a proven solution to lowering drug costs, and the use of these medicines saved more than $313 billion in 2019 alone. At a time of high economic insecurity, access to more-affordable generic and biosimilars means patients are more likely to fill and use a generic drug prescription.
In these unprecedented times, access to these vital medicines has never been so important. Throughout the last year, the generics industry has remained a consistent and stable partner in the pharmaceutical supply chain, and there is significant potential for savings if the right policies are put in place to ensure market competition. That is why AAM’s CEO Dan Leonard sent the letter below to members of Congress asking them to build on their previous successes and outlines key policy actions they can take to lower drug prices in the United States. You can find the text of the letter below.
Further, AAM provides a number of reports and resources, including an interactive state savings map, that highlight the value of generic and biosimilar medicines. If you have any questions or would like additional information, please don’t hesitate to contact me.
Text of letter from CEO Dan Leonard to members of Congress on AAM’s Prescription for Savings
Re: Securing Patient Access to Affordable Medicines #SecureOurMeds
January 27, 2021
Patient access to generic and biosimilar medicines has never been more critical. High launch prices on new brand biologics and annual price increases on existing brand-name drugs, combined with an increasing trend of anti-competitive tactics designed to delay or prevent competition from more affordable biosimilars and generics, are pushing access to medicines out of reach for too many patients. Meaningful action is needed to lower prescription drug costs and, as you begin the 117th Congress, we encourage you to consider a range of policy solutions to secure patient access to affordable medicines.
AAM’s Prescription for Savings outlines a number of bipartisan solutions to encourage the use of biosimilars, address abuses of the patent system, enhance U.S.-based manufacturing, tackle sustainability challenges and ensure generic medicines are able to compete on a level playing field. Together, these policies could save patients and taxpayers as much as $20 billion over the next 10 years.
Among the bipartisan legislative initiatives that will deliver meaningful savings to patients, Congress should:
- Preserve the Tools that Drive Competition and Savings. The first step: Do no harm. Developers of generic and biosimilar medicines rely on 180-day exclusivity for new generics and the ability to accelerate competition through patent settlements and the “skinny label” pathway.
- Modernize Medicare Part D. The Medicare Part D benefit should be modernized to address the perverse incentives that currently favor high-cost brand-name drugs over lower-cost generic and biosimilar medicines.
- Reduce Cost-Sharing for Seniors. The Ensuring Access to Lower-Cost Medicines for Seniors Act would ensure coverage of newly available generic and biosimilar medicines, reduce patient cost-sharing through proper formulary tier coverage and create a new specialty tier for biosimilars.
- Increase Patient Access to Biosimilars. Three policies would help increase biosimilar adoption: 1) enact a modest increase to Medicare Part B reimbursement (ASP+8%) as proposed in The BIOSIM Act; 2) create a Medicare shared-savings demonstration program as proposed in The Increasing Access to Biosimilars Act; and 3) reduce cost-sharing for patients in Medicare Part B as proposed in The ACCESS Act.
- Eliminate the Medicaid Generics Penalty. The Protecting Access to Affordable Medicines Act would fix the misguided application of the Medicaid rebate on generic medicines, reducing the risk of drug shortages and benefiting patients through sustainable access to low-cost generics.
- Enact New Tax and Other Financial Incentives to Enhance U.S.-Based Manufacturing. AAM’s blueprint outlines a six-element framework that builds on the strong foundation in place in the U.S. today that manufactures approximately 70 billion doses of medicine at nearly 150 facilities.
- Address Patent Abuse. Anti-competitive tactics to prolong a brand-name drug’s monopoly run afoul of the balance between access and innovation created as part of Hatch-Waxman (1984) and the BPCIA (2010). Congress should consider providing a date certain for generic and biosimilar entry, accelerating the biosimilar “patent dance” and strengthening the Inter-Partes Review (IPR) process.
Generic and biosimilar manufacturers are also committed partners in responding and helping to treat patients with COVID-19. Until the pandemic is over in the U.S. and around the world, AAM and its members companies understand the important role we serve in the public health response. Access to generic medicines used in the treatment of COVID-19 patients will continue to serve as a bridge until an FDA-approved vaccine is distributed broadly and every American is inoculated against COVID-19.
Ensuring the generics and biosimilars industry remains vibrant is essential to preserving patient savings and the value provided to the U.S. health care system. My committed team and I look forward to working with you now and in the years ahead to deliver meaningful savings on behalf of America’s patients.
President & CEO
By Kristin Murphy, AAM Director of Federal Affairs