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New Gene Therapy Approval

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On November 22, 2022, the FDA approved CSL Behring’s Hemgenix, a gene therapy for treatment of adults with hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes. Although hemophilia B is a rare condition, intravenous infusions to treat hemophilia B range from $550,000-$750,000 annually. Hemgenix is administered as a single dose intravenous infusion. Hemgenix will cost approximately $3.5 million, which will make it the most expensive medicine approved to date in the world for a single-use therapy.

https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b

Considerations for Insulin Product Substitutions

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Insulin is a standard of care for the treatment of diabetes and accounts for a large amount of sales in the diabetic drug therapy space. There is often confusion on when an insulin product can be substituted by a pharmacist. Unbranded insulin products are packaged and marketed without a brand-name under the same Biologics License Application as the brand-name product and are considered equivalent and interchangeable. This includes Novolog®/ Insulin Aspart (unbranded), Humalog®/ Insulin Lispro (unbranded), and Semglee (yfgn)®/Insulin Glargine (yfgn) (unbranded). …

Updates to the Adult Vaccination Schedule

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On February 17, 2022, the U.S. Advisory Committee on Immunization Practices' (ACIP) recommended vaccination schedule for U.S. adults 19 years of age and older was shared with some important changes to zoster (shingles), pneumococcal,…

US Government To Provide Free At Home COVID-19 Tests

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The US Government has launched a website that allows for every home in the US to order four (4) free at-⁠home COVID-⁠19 tests.…

Coverage of Antiviral Agents Paxlovid and Molnupiravir

Coverage of Antiviral Agents Paxlovid and Molnupiravir hero image

Recently, the FDA approved the first COVID-19 oral antiviral agents. Pfizer’s Paxlovid® (nirmatrelvir tablets and ritonavir tablets, co-packaged for oral use) and Merck’s molnupiravir have been granted emergency use authorization (EUA) by the U.S. Food and Drug Administration (FDA) in the treatment of mild-to-moderate COVID-19 for people at high risk for progression to severe COVID-19.…

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