The updated vaccines include the KP.2 strain of the Omicron variant, which is believed to be contributing to the increases in COVID-19 infections this summer.
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Avalere’s Kylie Stengel talks about the regional shifts in formularies and utilization management in Medicare Part D prescription drug plans.
The FDA has assigned a Prescription Drug User Fee Act of Dec. 20, 2024, for Zynquista (sotagliflozin) to control glycemic levels in adults with type 1 diabetes and chronic kidney disease.
The FDA identified at a third party fill and finish manufacturer. The issues have been resolved, and reinspection is expected in the next few months.
This therapy is a first-in-class treatment for chronic graft-versus-host disease, which develops in roughly 42% of those who receive a stem cell of bone marrow transplant.
Livdelz is an oral therapy to treat patients with primary biliary cholangitis, a progressive autoimmune disease. It is expected to be available in pharmacies next week.
This first-in-class treatment targets multiple disease mechanisms such as itch and inflammation associated with this condition.
Prademagene zamikeracel is a cell therapy in development to treat patients with recessive dystrophic epidermolysis bullosa (RDEB), a rare connective tissue disorder.
Zymfentra launched in March 2024 as the first subcutaneous formulation of infliximab for patients with ulcerative colitis and Crohn’s disease. It has a list price of $6,181.08 for two shots over four weeks.
No information, however, is available about which insurance plans are providing coverage of Anktiva or what the utilization management requirements are.
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Enzeevu is biosimilar to Eylea (aflibercept), which was FDA-approved in 2019.
In June, an FDA advisory committee voted against approval of midomafetamine capsules (MDMA) for adults living with posttraumatic stress disorder (PTSD).
Neffy is the first epinephrine product that does not need to be administered by injection and the first new epinephrine delivery method in 35 years. It will be available at a starting price of $25.
New analysis shows that differences in the methods used to set drug payment amounts under Part B versus under Part D result in different payment amounts for the same drugs.
Crexont kept symptoms at bay for an extra 30 minutes a day when compared with other Parkinson’s drugs.
In a recent survey, payers said their priorities include addressing the impacts of Medicare’s Drug Price Negotiation Program and the Part D redesign.
SelfJect is priced at parity with the Acthar Gel multi-dose vial and syringe.
Cigna officials cite significant growth in Evernorth Health Services and Express Scripts for the increase in revenue.
CVS Caremark is requiring step therapy through a generic prescription proton pump inhibitor before providing coverage.
Zunveyl, a prodrug of galantamine that addresses the gastrointestinal side effects, will be available in the first quarter of 2025.
Higher costs per claim, coupled with an increased number of patients using specialty drugs, has contributed to higher spend.
Leqselvi is approved to treat adults with severe alopecia. One-third of patients in clinical trials experienced 80% scalp hair coverage at 24 weeks.
Duvyzat was approved in March 2024 and works to reduce the inflammation and loss of muscle experienced by patients with Duchenne muscular dystrophy.
Epysqli is a monoclonal antibody that is approved to treat two rare conditions that break down red blood cells.
Boehringer Ingelheim’s high- and low-concentration adalimumab-adbm will be available through GoodRx for $550 for two-pack, which represents a 92% discount from the Humira list price.
If approved, tabelecleucel would be the first therapy specifically to treat Epstein-Barr virus related post-transplant lymphoproliferative disease. The FDA’s action date is Jan. 15, 2025.
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