The EmsanaRx Plus program is connecting employers to the discounted drugs offered through Mark Cuban Cost Plus Drug Company. The program will be available beginning March 1, 2023
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Oncopeptides disagrees with the FDA about Pepaxto and will make a decision about next steps by the end of the first quarter of 2023.
Cost savings were not associated with an increase in adverse drug events.
Independent pharmacies are no longer part of Tricare’s pharmacy network for uniformed service members and their families. The pharmacy groups say this will impact 400,000 beneficiaries.
Health insurance premiums, especially in the ACA Marketplace, could increase if the federal government ends purchasing of COVID-19 vaccines and boosters.
If approved the vaccine, RSVpreF, would be available for people 60 years of age and older. The Prescription Drug User Fee Act goal date for a decision is in May 2023.
Magellan Rx's businesses includes a 1.7-million member PBM. The deal is struck amid a long-time trend toward consolidation in the pharmacy benefit management industry.
Seven of the 10 top selling drugs with high price increases lack the clinical evidence to justify those increases.
TauRx’s oral anti-tau therapy HMTM has shown in a phase 3 trial that it can stabilize cognitive decline in patients with Alzheimer’s disease.
Cigna and Express Scripts have not yet made a decision about which of the Humira biosimilars will be included but they will evaluate all products in the coming months.
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A Prescription Drug User Fee Act action date for pegunigalsidase alfa is set for May 9, 2023.
If approved, clotrimazole would be the first topical drug indicated to treat otomycosis, an ear infection caused by a fungus.
In October, an FDA advisory committee voted against omburtamab, saying the trials didn’t show evidence that the therapy improves overall survival.
SUL-DUR is a targeted antibiotic designed to treat serious drug-resistant infections. The target PDUFA date is May 29, 2023, and the FDA plans to hold an advisory committee meeting to discuss this application.
Brexafemme is a non-azole oral antifungal now approved to both treat and prevent recurrent yeast infections in women.
I/Ontak is an engineered IL-2-diphtheria toxin fusion protein. The PDUFA target action date is Sept. 28, 2023.
Lecanemab is an investigational anti-amyloid beta antibody to treat mild cognitive impairment due to Alzheimer’s disease. It is currently under review by the FDA and a decision is expected by Jan. 6.
Rebyota is the first fecal microbiota product to prevent recurrence of C. diff infection, a serious and potentially life-threatening disease.
Doctors surveyed by the Association for Clinical Oncology said payer prior authorization can cause disease progression and loss of life.
Exela Pharma is recalling an additional 14 lots of sodium bicarbonate injection because of a broken vial.
If approved, Evkeeza would be the first treatment to help children as young as 5 years old control high LDL cholesterol caused by homozygous familial hypercholesterolemia. The FDA target action date is March 30, 2023.
A confirmatory trial of Tecentriq in urothelial carcinoma failed to meet the co-primary endpoint of overall survival.
If approved, reproxalap would be the first inhibitor of RASP, which contributes to ocular inflammation and changes in tear lipid composition.
If approved, SRP-9001 (delandistrogene moxeparvovec) would be the first gene therapy for Duchenne. The FDA action date is May 29, 2023.
An advisory committee had voted against poziotinib to treat patients with non-small cell lung cancer with HER2 exon 20 insertion mutations.
The reference to “maximum fair price” in the act bodes poorly for manufacturers and suggests more of a take-it-or-leave-it situation rather than a negotiation where clinical evidence would be the prevailing factor in determining price.
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