Strategies for Paying for Gene and Cell Therapies | 2023 PBMI Annual National Conference
September 7th 2023As cell- and gene-based therapies become available for new and expanded indications with a higher incidence of patients, payers will be challenged to find ways to provide access to patients.
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FDA Updates for the Week of Aug. 28, 2023
September 2nd 2023The FDA has approved Reblozyl as first-line treatment in MDS-related anemia and the first generics of ADHD drug Vyvanse. The agency also issued a CRL for bevacizumab to treat wet AMD. Additionally, two companies have submitted supplemental applications. These include Janssen, which is seeking full approval for Balversa for urothelial carcinoma, and AbbVie, which is seeking approval of Skyrizi for ulcerative colitis.
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A New Stem Cell Approach Offers Hope for Those with Chemical Eye Burns
August 31st 2023Researchers at Mass Eye and Ear and Dana-Farber Cancer Institute have developed a new technique for growing stem cells harvested from the eye that meets the FDA’s regulatory requirements for tissue engineering.
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FDA Updates for the Week of Aug. 21, 2023
August 26th 2023The FDA has approved the first biosimilar of MS drug Tysabri and granted additional approvals to Abrysvo to prevent RSV in infants, to a higher dose Eylea, and to Ingrezza for a disorder associated with Huntington’s disease. The agency has also set a review date for first-in-class therapy for MDS and granted priority review to Xtandi for earlier treatment in prostate cancer.
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FDA Updates for the Week of Aug. 14, 2023
August 19th 2023It was a busy week for the FDA. Regulators approved several new therapies, including the first for a rare bone disorder, a combination product for metastatic prostate cancer and a long-acting botulinum toxin for cervical dystonia, as well as an accelerated approved for multiple myeloma. The agency also set review dates for three products, including for full approval of Tarpeyo for a rare kidney disease, an additional indication for Tibsovo for myelodysplastic syndromes and a combination antibiotic for complicated UTIs.
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Blue Shield of California to Work with Prime Therapeutics to Negotiate Drug Prices
August 18th 2023Blue Shield’s new program will unbundle pharmacy services for increased transparency with the goal of saving $500 million annually. The health plan is also teaming up Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.
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Blue Shield of California to Save $500 Million with New Pharmacy Program
August 17th 2023Blue Shield is replacing CVS Caremark with Prime Therapeutics as the company that will negotiate with drug manufacturers beginning in January 2025. The insurer is also teaming up with Mark Cuban Cost Plus Drug Company and Amazon Pharmacy.
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Tufts Evaluation Finds Health Plans Vary in Step Therapy for Camyzos
August 10th 2023Payers’ requirements for the use of Camyzos in patients with obstructive hypertrophic cardiomyopathy are generally consistent with the registration study, but they also imposed restrictions beyond the FDA indication or ICER recommendation.
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Medicaid Coverage Increases for Pheburane for Urea Cycle Disorders
August 9th 2023Current treatments urea cycle disorders, which causes ammonia to build up in the blood, have a bitter taste and smell. Pheburane was developed with a special coating that masks the taste of sodium phenylbutyrate. It has a list price of $4,375 per bottle.
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FDA Updates for the Week of July 31, 2023
August 5th 2023FDA Approves new indications for two cancer drugs: Lonsurf combination for metastatic colorectal cancer and Jemperli as frontline treatment for advanced endometrial cancer. The agency has also rejected the BLA for therapy to treat rare skin cancer.
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