“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 Due to the Agency’s recent withdrawal of the draft guidance document titled “Statistical Approaches to Evaluate Analytical Similarity,” “The Forum urges FDA to inject increased flexibility into a revised draft guidance while maintaining high standards to ensure patient safety.”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.