The commission will review PBM business practices, including the impact of rebates on formulary design, the costs of prescription drugs to patients, and methods to determine pharmacy reimbursement.
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Dupixent is the first biologic medicine approved to treat moderate-to-severe atopic dermatitis from infancy through adulthood.
Approved in March, Tlando is an oral testosterone that doesn’t require dose titration.
A more accurate number of rare diseases is more than 10,000, and just 500 of these disorders have treatment options available for patients, according to RARE-X.
Xcenda’s review of the three largest PBMs—CVS Caremark, Express Scripts, and OptumRx—finds they are excluding medicines in classes where generics are not available or for serious conditions, such as oncology and autoimmune disorders.
The FDA approved Orgovyx in December 2021 to treat patients with advanced prostate cancer.
Riabni is now approved to treat all available Rituxan indications.
An Xcenda survey of payers found that cost-effectiveness analyses from the Institute for Clinical and Economic Review (ICER) are used in price negotiations and to implement prior authorizations.
Reblozyl was being reviewed to treat anemia in adults with non-transfusion dependent beta thalassemia, an inherited blood disorder. BMS indicated it couldn’t appropriately address FDA’s questions about risk-benefit.
New launches this week include: new strength of Alimta, a generic of Esbriet, a generic of Toradol, and a generic of Florinef.
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The FDA has extended review time to allow for review of additional analyses of data from the company’s clinical studies. The new PDUFA date is Sept. 29, 2022.
The label now includes a new section about the risk of substituting an oral azacitidine product, Onureg, for the injection therapy.
The FDA is asking for additional data to support effectiveness of pegzilarginase to treat a rare metabolic disease. If approved, pegzilarginase would be the first treatment for ARG1 deficiency.
More than 5,700 trials worldwide are investigating PD-1/PD-L1 inhibitors, and new trials of these therapies were of combination regimens.
Byooviz, the first FDA approved ophthalmology biosimilar for macular degeneration, will be priced 40% lower than the reference product. It will be commercially available on July 1, 2022.
The regulatory agency indicated there is an issue surrounding the protocol design.
If approved, Dupixent would be the first and only medicine in the United States specifically indicated to treat prurigo nodularis, or persistent itch with thick skin lesions. The PDUFA target action date for the FDA decision is Sept. 30, 2022.
The FDA indicated the risk of death outweighs the benefits of Ukoniq, which was approved in February 2021 to treat specific lymphomas.
In high-deductible plans, patients had the highest out-of-pockets costs and abandoned and discontinued therapy at greater rates than other benefit designs.
Evrysdi is now approved to treat spinal muscular atrophy in children and adults of all ages.
Opdivo-based treatments are now approved for five indications in upper gastroesophageal cancers.
The bill would allow the Federal Trade Commission to impose penalties on PBMs of up to $1 million for unfair and deceptive practices.
Kymriah is now approved in three indications and is the only CAR-T cell therapy approved in both adult and pediatric settings.
The Access to Oncology Medicines Coalition brings together pharma companies and other organizations to help countries develop the capacity and access to essential cancer medicines.
This is the fifth biosimilar of Neulasta and the third biosimilar from Amneal to receive FDA approval.
The FDA has assigned a Prescription Drug User Fee Act target action date of Nov. 30, 2022. Regulators indicated they plan to hold an advisory committee meeting to discuss the application.
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