The lawsuit claims that CMS’s plan to include the drug, Xphozah, along with all other oral-only phosphate lowering therapies in the End-Stage Renal Disease Prospective Payment System (ESRD) will “significantly and negatively impact patient choice of and timely access to important medications.”
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While gene therapies for treating sickle cell disease are promising, they will only be cost effective in the U.S. if priced below $2 million, according to a new modeling analysis.
Part V: Cost pressures, increasing value while improving health outcomes, and leveraging real-world evidence are top of mind.
The U.S. government has requested that a Delaware federal judge deny an AstraZeneca motion for summary judgement in its Inflation Reduction Act case, arguing that the company’s core claims are meritless.
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.