Radar on Specialty Pharmacy
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New FDA Approvals: FDA Approves Besremi | Dec. 9, 2021
Nov. 12: The FDA approved PharmaEssentia Corp.’s Besremi (ropeginterferon alfa-2b-njft) for the treatment of adults with polycythemia vera. It is the first interferon therapy that the agency has approved specifically for the condition. The drug received orphan drug designation for the indication. The recommended starting dose is 100 mcg by subcutaneous injection every two weeks. The dose can be increased by 50 mcg every two weeks up to a maximum of 500 mcg until hematological parameters are stabilized.
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News Briefs: Alignment Health Plan will cover Grail’s Galleri liquid biopsy | Dec. 9, 2021
Alignment Health Plan and Grail, LLC signed an agreement that will provide its members access to Galleri, a multicancer early detection blood test. Alignment is a national Medicare Advantage (MA) plan from Alignment Healthcare. The deal makes it the first MA plan to offer the liquid biopsy, which is used as a complement to recommended single cancer screenings and can detect more than 50 types of cancer. It is available by prescription only. New and existing plan members in select HMO and PPO plans in California and North Carolina will have access to Galleri starting Jan. 1.
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News Briefs: Oncopeptides AB is withdrawing Pepaxto from the U.S. market | Nov. 16, 2021
Oncopeptides AB is voluntarily withdrawing Pepaxto (melphalan flufenamide) from the U.S. market, the company disclosed on Oct. 22. The FDA gave the therapy accelerated approval on Feb. 26, 2021, in combination with dexamethasone for the treatment of adults with relapsed or refractory multiple myeloma who have received at least four lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent and one CD38-directed monoclonal antibody. The company said that the decision follows the Phase III OCEAN study, which “the FDA does not consider…meets the criteria of a confirmatory study.”
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New FDA Approvals: FDA Grants Additional Approval to Verzenio | Nov. 16, 2021
Oct. 13: The FDA expanded the indication of Eli Lilly and Co.’s Verzenio (abemaciclib) in combination with endocrine therapy (tamoxifen or an aromatase inhibitor) for the adjuvant treatment of adults with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of >20% as determined by an FDA-approved test. The tablet is the only CDK4/6 inhibitor approved for this indication. The FDA initially approved the drug on Sept. 28, 2017. Recommended dosing for this use is 150 mg twice daily. The monthly list price is $13,058.08.
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Prime Therapeutics Launches IntegratedRx - Oncology, Partners on MIP Accreditation
Many people fighting cancer must get their oral oncolytics from a central fill specialty pharmacy, which can add to the time it takes for a prescription to be filled, as well as potential waste when an oncologist changes a medication. Prime Therapeutics LLC recently unveiled a new program known as IntegratedRx - Oncology that the PBM says will help coordinate care for members and streamline the treatment process.
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