Read today’s KFF Health News
In other news:
About pharma
More Stelara Rivals Hit US, With Discounts Already Reaching 90% : Stelara (ustekinumab) biosimilars are now available from multiple suppliers in the US, after Teva, Sandoz and Biocon Biologics confirmed launches under settlements with originator J&J, while several other approved versions were also expected to imminently hit the market.
However, the latest indications suggest that price competition is going to be aggressive in the ustekinumab arena, with Biocon Biologics indicating a price 90% lower than Stelara, Teva confirming discounting at the 85% level and Sandoz entering the market at an 80% discount – evoking previous experiences with the launch of Humira (adalimumab) biosimilars at similarly high discounts in 2023.
Overpayment for Generic Drugs Under Medicare Part D: In this cross-sectional study, the large markups paid by Part D sponsors to pharmacies for selected generic drugs resulted in Medicare beneficiaries being liable for hundreds of dollars above product acquisition cost when using their Part D insurance to fill generic prescriptions. The cost to dispense (estimated at approximately $12/prescription) is unlikely to explain the markups observed, as high as $100 for 9 products and exceeding $1000 for abiraterone and imatinib.
About the public’s health
Prevalence and Control of Diabetes Among US Adults, 2013 to 2023 :This study found that the prevalence of adults with diabetes did not significantly change between 2013 and 2023, but glycemic control among those with diagnosed disease worsened in 2021-2023 after nearly a decade of stability. This trend was most pronounced among young adults. The increase of 1% in mean HbA1c levels and 20% decrease in glycemic control would increase the lifetime risk of cardiovascular events.
Potential explanations for these findings include increased sedentary behavior, reduced social support, heightened mental health stressors, and limited access to health care and medications during the pandemic.
Trends in Cervical Precancers Identified Through Population-Based Surveillance — Human Papillomavirus Vaccine Impact Monitoring Project, Five Sites, United States, 2008–2022: During 2008–2022, cervical precancer incidence decreased 79% and higher-grade precancer incidence decreased 80% among screened women aged 20–24 years, the age group most likely to have been vaccinated.
What are the implications for public health practice? Observed declines in cervical precancers are consistent with HPV vaccination impact and support Advisory Committee on Immunization Practices recommendations to vaccinate children against HPV at age 11–12 years with catch-up through age 26 years.
RFK Jr. moves to eliminate public comment on HHS decisions : Health and Human Services Secretary Robert F. Kennedy Jr. posted a document Friday proposing to strip public participation from much of the business his department conducts. The move comes during a time of major upheaval across federal health agencies, and as the public waits to see how Kennedy will enact his pledge of “radical transparency” at the department.
The statement, placed in the Federal Register, said HHS would rescind its longtime practice of giving members of the public a chance to comment on the agency’s plans. It is set to be formally published in the register on Monday, March 3.
Comment: The Administrative Procedure Act (APA) is the federal law that mandates a public comment period before issuing regulations. Key points about the APA's requirements for the comment period include:
Minimum duration: The APA requires agencies to allow at least 30 days for public comment after publishing a notice of proposed rulemaking in the Federal Register.
Consideration of comments: Agencies must consider all relevant comments submitted during the comment period before issuing a final rule.
Response to comments: When publishing the final rule, agencies must include a response to significant issues raised in the comments.
Exceptions: In some cases, agencies can issue rules without a comment period if they can justify that seeking public comment is "impracticable, unnecessary or contrary to the public interest."
According to the HHS document:In a 1971 Federal Register document, the Department adopted a policy that waived the
APA’s statutory exemption from procedural rulemaking requirements for rules and regulations
relating to public property, loans, grants, benefits, or contracts (Richardson Waiver)…
Effective immediately, the Richardson Waiver is rescinded and is no longer the policy ofthe Department. In accordance with the APA, “matters relating to agency management or
personnel or to public property, loans, grants, benefits, or contracts,” are exempt from the notice and comment procedures of 5 U.S.C. 553, except as otherwise required by law.