Pfizer plans to allow payers to use a “warranty” approach to pay for its new costly gene therapy, the company announced after gaining FDA approval Friday (April 26) of Beqvez (fidanacogene elaparvovec-dzkt) for the treatment of adult patients with moderate to severe hemophilia B. In a statement Friday , Pfizer announced it will be “launching an innovative warranty program based on durability of patient response to treatment.” The wholesale acquisition cost for the treatment will be $3.5 million, making it...

The Congressional Budget Office highlighted several health-related policies the agency estimates would save hundreds of billions of dollars from 2023-2033 -- like lowering federal pay for Medicaid, reforming Medicare Advantage benchmarks, increasing Medicare Part B premiums and limiting provider taxes -- during Thursday (April 25) presentation at a conservative think tank-sponsored event on entitlement reform. The agency also noted that it still exploring the long-term effects of policies that would expand insurance coverage for anti-obesity medications and the diagnosis and...

FDA is soliciting comments on what policy topics should be developed, prioritized or implemented by the drug center’s Office of Clinical Pharmacology (OCP) to promote effective research on drug development. The request for comment is scheduled to be published in the Federal Register Friday (April 26). FDA says in the notice it is looking for “specific, actionable policy suggestions” from stakeholders in the field of clinical pharmacology that OCP staff can implement in the near term. Areas of particular...