BBCIC Wins $1.3 Million FDA Grant
The Biologics & Biosimilars Collective Intelligence Consortium (BBCIC) announced receiving a two-year grant for a new study focused on increasing the efficiency of biosimilar drug development and review.
The study is entitled “Improving the Efficiency of Regulatory Decisions for Biosimilars and Interchangeable Biosimilars by Leveraging Real-World Data to Produce Real-World Evidence,” which reflects BBCIC’s recognized strengths: the generation and analysis of real-world data to produce real-world evidence.
“The challenges in using real-world data and the relevance of real-world evidence for regulatory decision-making about biosimilars is a major obstacle in the industry,” said Cate Lockhart, Executive Director of the BBCIC. “I’m thrilled the FDA has selected our study for funding, as it will have important benefits for the research community at-large, providing analytical tools for tests of interchangeability and other regulatory questions.”
Medicare Gives Biosimilar Prescribers Payment Boost
A provision of the Inflation Reduction Act increased Medicare part B payments for physicians who buy-and-bill specific biosimilars. The provider’s reimbursement increases from the average sales price (ASP) of the reference product plus 6% to ASP plus 8%. The change went into effect on October 3, 2022 and is slated to last for 5 years. It is part of an effort by the federal government to incentivize use of less-expensive biosimilars.
This is an important change that has been sought for many years by biosimilar advocates. It applies only to part B products subject to buy-and-bill reimbursement, but it should produce real, significant savings through greater biosimilar uptake.
Study Outlines Method for Increasing Oncology Biosimilar Uptake, Savings
Researchers from eviCore and CIGNA published the results of a study that tested a method for incenting the use of biosimilars. eviCore instituted a policy that asked providers to preferentially prescribe a biosimilar before a reference product for the following oncology medications: trastuzumab, bevacizumab, and rituximab. They compared the uptake of biosimilars in a medical group in which the policy was instituted with another group that did not have preferred products (control group).
Over a one-year period (ending June 30, 2021), uptake of trastuzumab biosimilars increased by 30 percentage points, bevacizumab biosimilars jumped by 23 points, and rituximab biosimilars rose by 32 points compared with the control group. This translated into $0.15 (5.4%) lower per member per month medical claim costs.