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HHS, FDA Advances for Clinical Trials Will Boost Information on Biosimilars Use Among Senior Citizens


As HHS prepares to begin a study that will summarize the use and spending of biosimilars within Medicare Part B plans, the FDA updates its clinical trial guidance to expand enrollment access to senior patients.

As HHS prepares to begin a study that will summarize the utilization patterns of biosimilars within Medicare plans, the FDA updated its guidance to expand clinical trial enrollment to include senior patients.

The HHS Office of Inspector General announced that it will conduct a study on the use and spending of biosimilars within Medicare Part B pans.

The study, which is expected to begin in 2023, will present the use spending trends of biosimilars compared with their reference products covered by Part B plans over time. It will also be used to determine how much Medicare and beneficiaries pay for covered biosimilars and reference biologics in 2021 for the purposes of comparing the costs to determine how much Medicare and beneficiaries could have spent if biosimilars were used more frequently or if different reimbursement policies were adopted.

Juliana M. Reed, the executive director of the Biosimilars Forum, released a statement offering the Forum’s support for the trial’s commencement.

“We welcome the Inspector General looking into this matter because it is another important step in addressing slow uptake rates for biosimilars in Medicare Part B," she said. "This lack of use hinders Americans’ access to lower-cost safe and effective biosimilars, which should be widely available to all who need them….HHS officials rightly identify the lack of provider reimbursement incentives as possible obstacles to better biosimilar uptake rates. The Biosimilars Forum has been advocating for Congress to address these misaligned incentives as one way to increase patient access to lower cost medicines."

Medicare Part B covers physician-administered drugs used to treat cancers and other serious illnesses. Reimbursement policies that do not favor biosimilars is a major barrier to biosimilar use and can prevent Medicare plans and its enrolled patients from seeing the savings that biosimilars are known to provide.

“More competition is paramount to achieving the full cost-savings potential of biosimilars, which we know could reduce drug costs by $133 billion over the next five years if their use increases,” Reed continued. "While we look forward to seeing the results of this study, we expect it will be yet another example of why we are so committed to working with Congress and HHS officials to increase access to biosimilars for patients and providers."

In addition to the increase in HHS efforts to quantify biosimilar usage within Medicare plans, the FDA updated its guidance for clinical trials, which now includes recommendations for the increased representation of older adults in clinical trials testing potential cancer treatments.

The guidance clarified that “older adults” includes patients who aged 65 years and older and emphasized that patients over 75 years old should are particularly important to include. In the agency’s announcement of the update, the FDA said the adequate involvement of older adults in trials for cancer therapies will better enable evaluation of the benefits of a drug vs the risks in this population and will increase the generalizability of clinical trial results.

“Including information in the labeling describing use in older adults helps to promote the safe and effective use of these products and better informs treatment decisions in clinical practice,” the agency wrote. "Older adults are underrepresented in cancer clinical trials despite representing a growing segment of the population of cancer patients. Therefore, more information is needed to better inform treatment decisions for older adults with cancer."

Changes from the draft guidance to the finalized version included:

  • the capture of comorbidity information
  • clarifications that this guidance applies to trials of all sizes
  • added recommendations on the decentralization of recruitments efforts for community oncologists
  • improved the definition of “adequate representation"
  • clarification trial design stratification
  • added references to other guidances
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