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The FDA had approved Otulfi in September 2024 to treat Crohn’s disease, ulcerative colitis, psoriasis and active psoriatic arthritis. Information on pricing is not yet available.
The Institute for Clinical and Economic Review has prepared a special report on Trelegy and Breo, two therapies that treat patients with chronic obstructive pulmonary disease that are part of CMS's drug price negotiation program.
Selarsdi and Yesintek have launched this month at prices that are 85% and 90% off the cost of Stelara.
Blue Cross Blue Shield of Michigan said it is evaluating any potential updates to the coverage process for Darzalex Faspro and there are no changes at this time.
This once-daily topical treatment is the latest phosphodiesterase-4 (PDE4) inhibitor designed for mild to moderate atopic dermatitis (AD) in children aged 2 to 5 years. The PDUFA target action date of October 13, 2025, is set for its decision on the application.
The FDA has accepted the biologics licensing application (BLA) resubmission for odronextamab, a potential treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma.
At what was supposed to be a hearing to discuss PBM reform, some in Congress veered off into discussions about Medicaid and maternal health, and even Elon Musk.
The new lower prices apply to some doses of Zepbound provided in vials but not the autoinjector pens.
There are four biosimilars of Stelara available to treat chronic autoimmune diseases — Wezlana, Selarsdi and now Pychiva and Yesintek.
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Teva and Alvotech are introducing Selarsdi at an 85% discount off the reference product Stelara. Selarsdi is available as a subcutaneous injection and for intravenous infusion.
Merilog is expected to be available in July 2025, and Sanofi will provide Merilog to patients for $35 or less for a 30-day supply.
So far, five biosimilars that reference Eylea 2 mg have been approved by the FDA. Alvotech/Teva expect to regulatory approval for its biosimilar to be completed in the fourth quarter of 2025.
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis and multiple myeloma/bone metastases from solid tumors.
Gomekli is the second ever FDA-approved treatment for rare tumor disease, NF1-PN and the first to be approved for both adult and pediatric patients.
The updated label allows physicians to prescribe Izervay without a limitation on duration for patients with geographic atrophy secondary to age-related macular degeneration.
Just as Andrew Witty of UnitedHealth Group did in a call with investors last month, CVS Health’s CEO David Joyner defended the role of PBMs in healthcare.
The PDUFA action date for an FDA decision for linvoseltamab to treat adult patients with relapsed/refractory multiple myeloma is July 10, 2025.
Emblaveo will be available in the third quarter of 2025 to treat patients with intra-abdominal infections, a common cause of sepsis in the intensive care unit.
Regulators have set a goal of Aug. 12, 2025, for brensocatib to treat patients with non-cystic fibrosis bronchiectasis, a chronic lung disease.
Susvimo is also approved to treat age-related macular degeneration, and the medication, ranibizumab, is delivered though a refillable ocular implant.
The new biosimilar, Celltrion’s Avtozma, was approved in both IV and subcutaneous forms to treat inflammatory conditions such as arthritis.
Chronic kidney disease affects about 37 million adults in the United States and is expected to rise. It is a common complication of type 2 diabetes.
A monthly 10 mg/mL maintenance dose of Leqembi had the same effects on mild Alzheimer’s symptoms as biweekly dose, research shows.
An investigational higher dose of spinal muscular atrophy drug nusinersen gains attention as the FDA and European Medicines Agency (EMA) considerate it as an alternative than the current lower FDA-approved dosage.
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