The Chamber of Commerce has asked for a preliminary injunction to halt the program before Oct. 1, the deadline for pharma companies to agree to Medicare negotiations on pricing for the first 10 drugs.
Monitoring rebates from drugmakers will be critical as provisions of the Inflation Reduction Act are implemented, including drug price negotiations, the Government Accountability Office contends.
The main goal of the August 2022 legislation was to lower the prices of prescription drugs. But it ended up being much more complicated than that, and how its components are rolled out through 2026 will have ramifications across research and development.
The legislation was signed into law in August 2022, and the Centers for Medicare and Medicaid Services has already penalized 70 drugs and biologics thus far.
J&J’s pharmaceutical unit Janssen filed its complaint in U.S. District Court for the District of New Jersey. It broadly follows the other related lawsuits, arguing that the program is unconstitutional and amounts to “confiscation of constitutionally protected property.”
Previously, the CMS only covered a single round of PET imaging for patients enrolled in clinical studies. Yesterday’s proposal seeks to remove this cap and leave it up to CMS contractors to determine which patients should be covered by the health insurance program.
The U.S. government on Friday released its revised guidance for its Medicare drug price negotiation program, and said it clarified how it will identify the treatments and will allow drug companies to publicly discuss the negotiation at their discretion.
UCLA researchers estimated annual spending of $2 billion for a low-end estimate of 86,000 patients receiving Leqembi, and $5.1 billion if around 216,000 eligible patients were treated with the drug.
The government will launch the negotiation process in September by naming the first drugs it plans to target. They are expected to be the 10 pharmacy-based prescription drugs it spends the most on for the year ended May 2023.
As early as 2023, pharmaceutical manufacturers and payers will have to contend with one of the more imminent potential impacts of the law: inflationary rebates for Medicare utilization.