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.
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CarelonRx will provide digital coaching and wellness tools and incorporate behavioral and social health screenings for members.
At the moment, Simlandi (adalimumab-ryvk) has the high-concentration, citrate-free, interchangeable Humira (adalimumab) market to itself.
Regulators indicated that the confirmatory study did not confirm Pepaxto’s clinical benefit and that there was no evidence of safety or efficacy.
The economy and healthcare costs are the issues voters want to hear about going into the 2024 presidential election, finds a survey by KFF.
If approved, this would be the sixth indication for Dupixent and the only biologic therapy for COPD. The target action date is June 27, 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.
Patients with multiple myeloma who switched from weekly to biweekly dosing of Tecvayli were able to maintain their response with fewer infections.
Linvoseltamab is bispecific antibody designed to treat relapsed/refractory multiple myeloma. The FDA’s target action date is Aug. 22, 2024
Payers now covering Hadlima include United Healthcare, Prime Therapeutics and associated Blues plans, and some managed Medicare organizations.
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If approved, datopotamab deruxtecan would be the first TROP2-directed antibody drug conjugate to treat patients with non-small cell lung cancer. The FDA’s action date is in the fourth quarter of 2024.
Amtagvi was approved to treat patients with advanced melanoma. It is a one-time cell therapy that will be administered at authorized treatment centers and have a wholesale acquisition cost of $515,000.
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.
Rebates, falling prices, and rebate walls, where drug manufacturers agree to a certain price in exchange for an exclusive contract with payers, limit competition and create a dynamic of misaligned incentives.
Regulators have a set a date of June 15, 2024, to review new indication for Augtyro, which is already available to treat lung cancer with ROS1-positive lung and has a list price of $29,000 for a 30-day supply.
Onivyde is also approved to treat patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy.
Rocket’s application for Kresladi is being extended by three months for regulators to review additional information submitted at the request of the FDA. The new Prescription Drug User Fee Act (PDUFA) date is now June 30, 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.
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.
Eohilia is a liquid formulation of budesonide that will be available by the end of February. It will have a wholesale acquisition cost of $1,875 per month.
The FDA has set a Prescription Drug User Fee Act target action date of Aug. 14, 2024, for seladelpar to treat adults with primary biliary cholangitis.
The FDA has set a Prescription Drug User Fee Act date of Aug. 10, 2024, for Human Acellular Vessel to repair arteries in patients with extremity vascular trauma.
The FDA had issued a complete response letter (CRL) in July 2023 for IPX203 and asked for additional pharmacokinetic data of carbidopa, one of the drugs the oral, extended release therapy.
In three states — California, Florida, and Texas — more than 100,000 Part D enrollees exceeded $2,000 in spending on prescription drugs in 2021, finds a new analysis from KFF.
CVS’s Health Services segment — which includes its PBM CVS Caremark — now accounts for more than half of CVS’s total revenue.
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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