The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would establish a shared savings model for biosimilars, was introduced to the House of Representatives.
The Increasing Access to Biosimilars Act of 2023 (HR 1352), a bill that would direct HHS to establish a demonstration project within Medicare that would improve biosimilar accessibility, was introduced to the House of Representatives.
The bill was written by Representative Richard Hudson (R-North Carolina) and was referred to the Committee on Energy and Commerce and the Committee on Ways and Means.
If the bill becomes law, HHS will be required to establish and implement a 3-year nationwide demonstration project under part B of title 18 of the Social Security Act within 1 year of the date of enactment. The project will be used to evaluate the benefits of providing a shared savings payment for future biosimilar products.
Participation in the demonstration project would be voluntary and participating providers may quit the project at any time. Additionally, the HHS secretary would have the power to terminate a providers’ participation at any time. Participating in the project would not interfere with a provider’s eligibility from participating in other models authorized under section 1115A of the Social Security Act, such as the Oncology Care Model and the Oncology Care First Model.
Juliana M. Reed, executive director of the Biosimilars Forum, praised the bill in a statement, saying, “The members of the Biosimilars Forum and I thank Congressman Hudson for introducing this vital piece of legislation, which would help make biosimilars more accessible. Biosimilars can save the health care system $133 billion by 2025 if they are fully available and accessible to the patients who need them. Health equity and maximizing cost-savings for patients are at the forefront of the Biosimilars Forum’s mission. A shared savings reimbursement model can significantly close health equity gaps and deliver treatments to individuals and communities who need them most.”
Regarding payment, the bill states that in addition to the payment that would otherwise be made for a biosimilar that would be dispensed by a participating provider, an additional payment determined by the HHS secretary must be made. The secretary would base the amount on the cost to the provider for furnishing the biosimilar and the cost to the provider if they furnished the reference product. However, the additional payment must not result in the increases to a Medicare beneficiary’s coinsurance. Providers would only receive the additional payment if the amount for the biosimilar is less than the payment amount for the originator.
“2023 is a watershed year for biosimilars in the United States – led by the launch of eight Humira biosimilars, referencing the world’s best-selling drug. This make-it-or-break-it year for the biosimilars industry requires the full support of policymakers and stakeholders to provide patients with the lower-cost treatments they deserve. I look forward to working with lawmakers on both sides of the aisle to get this moment right and deliver lower-cost biosimilars for patients,” said Reed.
At the end of the 3-year period, the HHS secretary would have to submit to Congress a report on whether the project should be expanded or extended.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Decoding the Patent Puzzle: Navigating the Legal Landscape of Biosimilars
March 17th 2024On this episode of Not So Different, Ha Kung Wong, JD, an intellectual patent attorney and partner at Venable LLP, details the confusing landscape that is the US patent system and how it can be improved to help companies overcome barriers to biosimilar competition.
Alvotech’s Stelara Biosimilar, Selarsdi, Receives FDA Approval
April 16th 2024Alvotech’s Selarsdi (ustekinumab-aekn), a biosimilar referencing Stelara (ustekinumab), gained FDA approval, making it the second ustekinumab biosimilar and second for the company to be given the green light for the American market.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.