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Can a Netflix Model Work for Gene Therapy?
Can a Netflix Model Work for Gene Therapy?
Can a Netflix Model Work for Gene Therapy?
March 6, 2024
Quantile Health is offering a new solution to help small health plans and self-insured employers fund gene therapy access — with a subscription model.
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Ozempic Reduces Kidney Disease Progression, Cardiovascular Events by 24%
Ozempic Reduces Kidney Disease Progression, Cardiovascular Events by 24%
March 5, 2024
The FLOW trial was stopped early based on an interim analysis that found the study met the criteria for efficacy.
Ophthalmologists Face Insurance Issues when Using Biosimilars
Ophthalmologists Face Insurance Issues when Using Biosimilars
Ophthalmologists Face Insurance Issues when Using Biosimilars
March 4, 2024
Fran Gregory, Pharm.D., of Cardinal Health, talks about a survey of ophthalmologists and their concerns about using biosimilars for retinal conditions.
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FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
FDA Sets Action Date for Axatilimab in Graft-Versus-Host Disease
February 28, 2024
The Prescription Drug User Fee Act action date is Aug. 28, 2024.
FDA Expands Indication for Biktarvy for Those with Resistant HIV
FDA Expands Indication for Biktarvy for Those with Resistant HIV
FDA Expands Indication for Biktarvy for Those with Resistant HIV
February 27, 2024
Biktarvy can now be used to treat people with HIV who have a known or suspected M184V/I mutation, a common form of treatment resistance.
CarelonRx to Launch Digital Weight Management Program
CarelonRx to Launch Digital Weight Management Program
CarelonRx to Launch Digital Weight Management Program
February 26, 2024
CarelonRx will provide digital coaching and wellness tools and incorporate behavioral and social health screenings for members.
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 FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
FDA Approves Simlandi, Third Interchangeable Humira Biosimilar
February 26, 2024
At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
FDA Withdraws Approval of Pepaxto in Multiple Myeloma
February 23, 2024
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
Questions Remain about CMS’s Plan for Gene Therapy Access in Medicaid
February 22, 2024
Avalere’s Kolton Gustafson talks about CMS’ new model for negotiating outcomes-based agreements for sickle cell gene therapies for patients in state Medicaid programs.
The VA Replaces Humira with Hadlima on National Formulary
The VA Replaces Humira with Hadlima on National Formulary
The VA Replaces Humira with Hadlima on National Formulary
February 20, 2024
Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations.
FDA Sets Date for Full Approval, Broader Indication for Elevidys
FDA Sets Date for Full Approval, Broader Indication for Elevidys
FDA Sets Date for Full Approval, Broader Indication for Elevidys
February 16, 2024
The FDA has set a PDUFA date of June 21, 2024, to convert the accelerated approval to full approval and expand the labeling of the gene therapy Elevidys beyond the current use in children aged 4 and 5 with Duchenne muscular dystrophy.
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