It’s taken nearly a decade for the U.S. FDA to go from zero to 60 in approving biosimilars. Currently, 63 biosimilars have been approved in the U.S., thanks to 18 new approvals in 2024 that stretched the number of biologics referenced by biosimilars from 14 to 17. That’s an all-time record, CDER Director Patrizia Cavazzoni said, as she released the drug center’s annual approval report for 2024.
The discussion about taxpayer appropriations for CMS has been ongoing for decades, leading to futile speculation regarding user fees for the agency. Louis Jacques, who formerly worked at CMS, told BioWorld that Congress tends to be somewhat reactive when it comes to appropriations for CMS – a dynamic which suggests that appropriations for CMS are not likely to improve significantly in the near term.
As investors and industry alike try to read the tea leaves of what the upcoming change in administrations holds for the U.S., speculation abounds about what Trump 2.0 will mean for the biopharma and med-tech spaces.
The device industry is extraordinarily dependent on administrative activity where Medicare coverage is concerned, and this was exceptionally evident in 2024 when software and digital health coverage policies remained bogged down.
The first round of the U.S.’ Medicare negotiations accounted for a lot of digital ink and headlines in 2024. Next year is sure to bring more of the same as Medicare is to announce up to 15 Part D drugs to be negotiated in the second round by Feb. 1, even as several constitutional challenges to the process continue in federal appeals courts across the country.
Administrators at the U.S. Medicare program have proposed to cover the Cardiomems remote monitoring device for heart failure, but cardiologists are averse to several of the conditions spelled out in the draft coverage memo, including what they see as a somewhat futile demand for a comparator arm in the proposed coverage study.
Medicare coverage of FDA-designated breakthrough devices is still a policy hot topic. Although the House of Representatives generated some momentum on related legislation, the Senate is now examining the Ensuring Patient Access to Critical Breakthrough Products Act for potential passage in the lame duck session – a development that would draw enthusiastic cheers from industry.
The U.S. CMS has negotiated outcomes-based agreements with Bluebird Bio Inc. and Vertex Pharmaceuticals Inc. to make their costly sickle cell gene therapies the first treatments to become available through the voluntary Medicaid Cell and Gene Therapy Access Model.
When U.S. CMS Administrator Chiquita Brooks-LaSure announced Nov. 26 that the agency is “reinterpreting” the law in proposing a rule allowing Medicare and Medicaid to cover obesity drugs beginning in 2026, she called it a “historic step.” The rule, if finalized, could make obesity drugs like Novo Nordisk A/S’ Wegovy (semaglutide) and Eli Lilly and Co.’s Zepbound (tirzepatide) available to millions more Americans and further invigorate development of other obesity drugs. But given the lateness of the day in the Biden administration, the proposal may be more symbolic than historic.
Makers of devices and diagnostics face a new set of policy questions following the 2024 U.S. general elections, but many of the impending changes at the executive branch seem directed more toward drugs and vaccines, seemingly leaving the device and diagnostics industries largely out of harm’s way.
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