Skyclarys will be available in the second quarter of 2023 to treat patients with Friedreich’s ataxia, an ultra-rare, inherited neurodegenerative disorder. The wholesale acquisition cost is $370,000.
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BMS is seeking an indication for Opdivo as monotherapy to treat patients with stage IIB or IIC melanoma after surgery. The FDA has assigned a Prescription Drug User Fee Act date of Oct. 13, 2023.
Investigators found an association between ICER’s value assessments and how U.S. commercial health plans cover specialty drugs.
The ads focus on how PBMs promote competition in the prescription drug marketplace and provide choice for employers.
Altuviiio is a first-in-class therapy providing factor VIII replacement to prevent bleeding in patients with hemophilia A. It is expected to be available in April 2023.
Bruce Feinberg, D.O., of Cardinal Health, said significantly changes are on the horizon for biosimilars, but physician comfort with and use of biosimilars will depend on things beyond their control, including formulary placement and utilization management efforts.
CMS said it will cover monoclonal antibodies to treat Alzheimer’s disease if they are approved through the standard review process and not through an accelerated approval.
If approved, pozelimab would be the first treatment for CHAPLE disease, which causes damage to blood and lymph vessels along the upper digestive tract. The target action date for the FDA decision is Aug. 20, 2023.
CSF-1 is a low-dose pilocarpine to treat patients with age-related blurry vision. The FDA has assigned a PDUFA goal date of Oct. 22, 2023
Alnylam is seeking approval for Onpattro’s use in cardiomyopathy related to transthyretin-mediated (ATTR) amyloidosis. The FDA set an action date of Oct. 8, 2023.
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Patients who have had liver problems in the past may be at risk of liver damage from Sprycel, which is used to treat patients with chronic myeloid leukemia.
The new once-daily formulation of Austedo is used to treat adults with tardive dyskinesia and chorea associated with Huntington’s disease.
If approved, RSVpreF would be the first vaccine for administration to pregnant women to help protect against RSV disease in infants. The FDA has set an action date for August 2023.
Filspari will be available for a wholesale acquisition cost of $9,900 for a 30-day supply, and administrated through a REMS program because of the risk of liver abnormalities.
Apellis’ Syfovre will have a list price of $2,190 per vial, and Medicare is expected to be the dominant payer.
The U.S. public health emergency response to COVID-19 ends May 11, 2023, and the transition to more traditional healthcare coverage will begin later this year.
The review has been extended by three months. The new Prescription Drug User Fee Act (PDUFA) date is May 22, 2023.
At a placeholder price of $19,000, resmetirom would produce cost savings, says the drug evaluation group. Obeticholic acid’s price would need to be slashed to meet a commonly used cost-effectiveness threshold.
Lamzeda has been approved to treat patients with alpha-mannosidosis, a rare genetic condition. It will be available in the first half of this year.
Cuban, of "Shark Tank' fame and owner of the Dallas Mavericks, called drugs prices ‘insane’ and used some profanity when talking pharmacy benefit managers at the annual meeting of the Association for Accessible Medicines yesterday. Cuban has co-founded an online pharmacy that he says will make drug prices lower and transparent.
Navitus will be accessing the Humira biosimilar Amjevita through the lower wholesale acquisition cost option.
The Prescription Drug User Fee Act action date is June 5, 2023. Prevymis is already approved to prevent CMV infection in adults after an allogeneic hematopoietic stem cell transplant.
Avacincaptad pegol has the potential to slow the progression of geographic atrophy in age-related macular degeneration. The PDUFA goal date is Aug. 19, 2023.
Phase 3 data showed that the combination resulted in a 37% reduction in risk of disease progression or death in men with advanced prostate cancer.
Senators want more insight into PBM practices and the role they play in the healthcare ecosystem.
Abarca's Nicole (Gupta) Bulochnik, Pharm.D., talks about how personalized medicine could be integrated into value-based care to accelerate uptake.
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