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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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Newly Approved Vaccines Face a Fragmented Policy Landscape
Newly Approved Vaccines Face a Fragmented Policy Landscape
February 13, 2024
The Inflation Reduction Act has helped to close some of the gaps in insurance coverage for vaccines, including some of the newly approved ones.
 Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
 Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
Express Scripts Adds Voquezna to Formulary for Gastroesophageal Reflux
February 13, 2024
Voquezna is a potassium-competitive acid blocker, which has a mechanism similar to proton pump inhibitors but with a more rapid action. It has a list price of $650 for a 30-count bottle.
CVS’s Health Services Revenue Grew to $186.8 Billion
CVS’s Health Services Revenue Grew to $186.8 Billion
CVS’s Health Services Revenue Grew to $186.8 Billion
February 8, 2024
CVS’s Health Services segment — which includes its PBM CVS Caremark — now accounts for more than half of CVS’s total revenue.
HHS: Patients Should Not Face High Copays for Paxlovid
HHS: Patients Should Not Face High Copays for Paxlovid
HHS: Patients Should Not Face High Copays for Paxlovid
February 8, 2024
Although HHS is no longer managing the distribution of COVID-19 drugs, Secretary Xavier Becerra has been closely monitoring distribution of the antivirals Paxlovid and Lagevrio.
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Survey: Many Support Medicare Coverage of Weight Loss Drugs
Survey: Many Support Medicare Coverage of Weight Loss Drugs
February 7, 2024
Although most older adults support Medicare coverage of medications for weight loss drugs, only one in three favor paying more in premiums for this coverage, finds University of Michigan survey.
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