“This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.
Yesterday, the Biosimilars Forum submitted formal comments to HHS Secretary Alex Azar on the administration’s blueprint to lower drug prices and reduce out-of-pocket costs for patients.
In a statement provided to The Center for Biosimilars®, The Biosimilars Forum summarized its comments on the blueprint in 4 areas: increasing competition, supporting better negotiation, creating incentives to lower list prices of drugs, and reducing patient out-of-pocket spending.
In terms of increasing competition, the Forum supports the FDA’s efforts to make the development, review, and approval of biosimilars more efficient, and says that that increased flexibility in the FDA’s expectations, while maintaining scientific rigor, may improve efficiency. Due to the Agency’s recent withdrawal of the draft guidance document titled “Statistical Approaches to Evaluate Analytical Similarity,” “The Forum urges FDA to inject increased flexibility into a revised draft guidance while maintaining high standards to ensure patient safety.”
In order to promote better negotiation, the Forum also raised concerns about the administration’s intention to revive the Competitive Acquisition Program (CAP) for Medicare Part B drugs as an alternative to the current average sales price process. The Forum believes that CAP may create an unnecessary inconvenience for certain patients, such as oncology patients, due to the inventory for treatment potentially not being on hand.
Additionally, the Forum noted concerns about the possibility of shifting drugs currently covered under Part B to coverage under Part D because of the potential to increase costs for patients as well as create a number of issues with delivery, the supply chain, and access to care.
In keeping with the administration’s effort to provide incentives for companies to lower the list prices of drugs, the Forum recommends that CMS develop a biosimilar dashboard, similar to its Drug Spending Dashboard, to help stakeholders better understand trends in market uptake.
Finally, last year, CMS initially proposed to include biosimilars in the definition of generic drugs, but did not move forward with this proposed change. The Forum voiced support for CMS’ recognition that biosimilars are not generics and urged the administration to continue to treat biosimilars as innovative products that provide a cost savings to biologics, for which previous “generic pricing policies” were not applicable.
The Forum further urges the administration to build off of prior policy advances to lower prescription drug costs and patient spending by continuing to promote the biosimilars market. “This is a crucial moment for the growth of biosimilars in the United States, and we are encouraged that HHS is committed to pursuing policies that reward innovation and support provider and patient access and choice,” said Juliana M. Reed, president of the Biosimilars Forum.
Challenges and Guidance in Biosimilar Assessment: An ISPOR Report on HTA Agency Approaches
May 14th 2024The ISPOR report highlights the urgent need for clear guidance on when and how to conduct health technology assessments (HTAs) for biosimilars, emphasizing the challenges faced by HTA agencies and the evolving role of HTAs in evaluating biosimilar value.
Biosimilars Policy Roundup for April 2024—Podcast Edition
May 5th 2024On this episode of Not So Different, The Center for Biosimilars® glances back at all the major biosimilar policy updates from April, including 2 FDA approvals, 1 European approval, and several insights into possible policy changes from the Festival of Biologics USA conference.
Cordavis Report Outlines Strategies for Biosimilar Development, Access in the US Health Care Market
May 8th 2024Cordavis, a CVS Healthspire company, released a report detailing the current hurdles faced in developing and commercializing biosimilars in the US and highlighting efforts by the organization to enhance access and affordability for these products.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
Cencora Analysis Shows Differences in Payer Coverage Between G-CSF Biosimilars
May 2nd 2024Data from a Cencora study showed some misalignment in payer coverage of granulocyte colony-stimulating factor (G-CSF) biosimilars, highlighting that while filgrastim biosimilars are often favored over the originator, reference pegfilgrastim still dominates over its biosimilars.