News & Views: 4/19 -4/25

April 26, 2022

A new FDA report found that 1 in 4 manufacturers fail to submit or submit late status reports for post-marketing clinical trials.

The report analyzed 707 status reports from October 2019 through September 2020. Drug and biologic manufacturers were found to file their annual status reports late 13% of the time and failed to submit 11% of the time. More than a quarter of post-marketing requirements were found to be delayed or terminated, including 36 post-marketing trials that were required due to receiving an accelerated approval. To read the full report, click here.

The FDA announced their plan to study how prescription drug promotion impacts medication decisions by both consumers and providers.

The proposal focuses on medications for type 2 diabetes and psoriasis, looking specifically at how promotion of the respective drug’s efficacy, risks, and adherence impacts behavior. The FDA hopes be able to analyze the relevance of the product’s attributes and promotional claims by being able to understand tradeoffs that patients are willing to make. To read the study proposal, click here.

The Louisiana Attorney General filed a lawsuit against OptumRx for inflating prescription costs.

The lawsuit is the latest state level effort to increase transparency of PBMs. Louisiana alleges that OptumRx, PBM subsidiary of UnitedHealth, has been engaging in spread pricing and costing Louisiana Medicaid billions. In addition to spread pricing, the lawsuit details how the PBM reclassified generic drugs as brand-name drugs, but reimbursed pharmacies at the generic rate while charging the brand-name prices to other managed care organizations. The lawsuit also alleges that OptumRx inflated prices to help UnitedHealth reach their medical loss ratio. To read the entire article, click here.

IQVIA released their annual report on drug use and spending trends in the US.

The report details both short and long-term implications of the ongoing pandemic; the outlook for years ahead notes that estimations include an expected end to the pandemic. Medicine usage has continued to rise, 9.6% over the last five years, to 194 billion daily prescription doses, for both chronic and acute care treatments. Similarly, drugs dispended from pharmacies continues to grow on average 2.3% annually. While the report notes that average costs per prescription may be flat, patient out-of-pocket costs rose $4 billion in 2021 to $79 billion in total. To read the full report, click here.

CIDSA Experts in the News

Stacie Dusetzina and her colleagues at Harvard Medical School and Yale University analyzed cancer therapy prices for patients with commercial health plans in a JAMA study. The researchers analyzed prices of 25 commonly used cancer therapies and determined that the median markups range from 118.4% to 633.6% of the hospital acquisition cost depending on the drug. They concluded that policy action is necessary to prevent such excessive price markups to continue. To read the full study, click here.

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