More Insurance Company Denials
One Michigan insurance company made the decision to deny a life-saving CAR-T treatment because gene therapies aren’t drugs, despite a state law requiring coverage for cancer therapies. A ProPublica story looks at one case in which an insurer denied covering Kymriah. The patient died at the age of 50 from an aggressive form of lymphoma.
History of the PBM Industry
A recent article in JAMA Health Forum provides an overview of how the role of pharmacy benefit manager has evolved. In this paper, Ge Bai, Ph.D., of the Johns Hopkins Carey Business School, David A. Hyman, M.D., of Georgetown University and T. Joseph Mattingly II, Pharm.D., indicate that PBMs may adapt their business models to minimize the impact of any legislative or regulatory approaches of reform.
Class Action Suit is Filed Against United Healthcare
A California-based law firm has a class-action suit against United Health Group, alleging that United Healthcare Medicare Advantage illegally used an algorithm to deny rehabilitation for people with Medicare, according to a StatNews article. Previously, StatNews had reported about the use of the algorithm.
FDA Approves Two More Denosumab Biosimilars, Conexxence and Bomyntra
March 27th 2025The fourth pair of denosumab biosimilars, Conexxence and Bomyntra, are expected to launch in the United States in mid 2025, as a result of a global settlement with Amgen, according to a company news release.
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FDA Approves First Drug for Excess Hunger in Prader-Willi Syndrome
March 27th 2025Vykat XR will be available in April to treat the intense hunger that is a hallmark of the rare genetic disease Prader-Willi syndrome. The price is based on a patient’s weight, and the average patient in the clinical trials would have had an average annual cost of $466,200 for the first year.
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FDA Approves Amvuttra for ATTR-CM in Extended Label
March 21st 2025This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.
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