A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.
A newly introduced item of legislation proposes to eliminate co-payments for patients when they receive a biosimilar rather than an originator biologic in Medicare Part B.
The Acting to Cancel Copays and Ensure Substantial Savings for Biosimilars (ACCESS) Act, or HR 4597, was introduced this week by Representatives Scott Peters, D-California; Pete King, R-New York; and Anthony Brindisi, D-New York. The bill, which would amend Title XVIII of the Social Security Act, has now been referred to the House Energy and Commerce Committee and to the House Ways and Means Committee.
According to a statement made by Peters, “The government can and should drive down drug costs and one way we can do that is by increasing competition. If we eliminate copays on biosimilars, it will increase their widespread use and provide a market incentive to drive down overall drug costs. I am committed to lowering health care costs and expanding treatment options for all Americans, and the bipartisan ACCESS Act does just that.”
King added that the legislation is an important step in the ongoing effort to rein in drug prices for some of the most expensive drugs and that the bill could increase patient access to therapy.
Biosimilars trade group the Biosimilars Forum, which represents 8 biosimilar developers, applauded the bill’s introduction, saying in a statement that “Patients and taxpayers win with this legislation.” According to the forum, the legislation will support development of lower-cost drugs and will alleviate the financial burdens felt by American patients who struggle to afford biologic treatment.
“To date, there are 23 FDA-approved biosimilars. With only 9 available to patients, uptake continues to be low, adding costs to taxpayers and patients. This is proof enough that more needs to be done by Congress, [CMS], and others to spur and sustain a vibrant, competitive biosimilars market,” said the forum.
Introduction of the ACCESS Act comes shortly after numerous groups, including the American Cancer Society Cancer Action Network, the Association of Community Cancer Centers, Employers Health, the Pacific Business Group on Health, the Leukemia and Lymphoma Society of America, CVS Health, and others, called on HHS to end cost sharing for biosimilars in Part B. In a letter to HHS Secretary Alex Azar, the groups said that the move would not only increase affordability for patients in Part B, but could also influence the rest of the payer market, as many commercial payers often follow CMS’ payment policies.
CHMP Pushes 3 Biosimilars Forward, Spelling Hope for Ophthalmology, Supportive Care Markets
February 6th 2025The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended 3 biosimilars and new indications for reference biologics, moving them closer to final European approval and expanding patient access.
Biosimilars Policy Roundup for September 2024—Podcast Edition
October 6th 2024On this episode of Not So Different, we discuss the FDA's approval of a new biosimilar for treating retinal conditions, which took place in September 2024 alongside other major industry developments, including ongoing legal disputes and broader trends in market dynamics and regulatory challenges.
BioRationality: No More Biosimilars—Just Biogenerics
February 3rd 2025Sarfaraz K. Niazi, PhD, argues that regulatory agencies should eliminate redundant clinical efficacy testing for biosimilars, recognizing them as "biogenerics" since physicochemical and in vitro biological comparisons are sufficient to ensure safety and efficacy.
Improving Biosimilar Access Through Global Regulatory Convergence
January 15th 2025Achieving global regulatory harmonization for biosimilar vaccines and immunotherapies is essential to improving market access, reducing costs, and enhancing patient outcomes by streamlining approval processes, fostering international collaboration, and addressing regulatory disparities.