Short-term CR adds biosimilars to Part D, but discourages biosimilar adoption in Part B
WASHINGTON, D.C. (February 6, 2018) – The Association for Accessible Medicines (AAM) and the Biosimilars Council issued the following statement on the biosimilars provisions in the short-term continuing resolution (CR) released last night:
“Biosimilar medicines offer enormous potential to lower prescription drug costs for patients, the health care system and taxpayers,” said Executive Director of the Biosimilars Council and Senior Vice President of Policy for AAM Christine Simmon, “and we applaud policymakers for taking steps to improve access to them, especially for seniors. But they must not undermine these efforts by also creating barriers that will limit the development of the biosimilars market in the U.S.”
“On the one hand, the House of Representatives pursues a goal we support – increasing patient access to life-saving medicines by placing biosimilars and high-priced brands on a level playing field in Medicare Part D. At the same time, however, the CR would place biosimilars at a significant disadvantage in outpatient settings, undermining the opportunity for physician adoption. If the goal is to create a robust biosimilars market in the U.S., we encourage Congress to ensure that biosimilars and high-priced brands are treated equally across all settings of care. This is essential to expanding patient access to cost-saving biosimilar medicines.”
Two provisions of the short-term continuing resolution impact biosimilars.
- Section 2709 (page 503) – Non-budget neutral transitional pass through payment change for certain products
The Centers for Medicare and Medicaid Services (CMS) provides pass-through payments for biosimilars under current law. The proposed language explicitly prohibits biosimilars from receiving pass-through status, harming the development of the biosimilars market, and protecting brand biologics who previously received these payments. AAM and the Biosimilars Council oppose this section.
- Section 2714 (page 514) – Sunsetting the exclusion of biosimilars from the Medicare Part D coverage gap
Under current law, the Medicare Part D coverage gap discount program does not include biosimilars. This impedes patient access to biosimilars. The proposed language fixes this flaw by requiring biosimilars to offer the same discounts offered by brand biologics and allows biosimilars to compete on a level playing field. AAM and the Biosimilars Council support this section.
“Congress has an opportunity to take action to meaningfully lower prescription drugs costs for millions of patients and support the development of the biosimilars market in the U.S.,” added Simmon. “We look forward to continuing to work with lawmakers to adopt these changes.”
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 89 percent of prescriptions dispensed in the U.S. but only 27 percent of total drug spending. Additional information is available at www.accessiblemeds.org.
About the AAM 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 at www.biosimilarscouncil.org.