It’s been a busy week at the FDA. The agency has approved mavacamten for hypertrophic cardiomyopathy, an oral therapy for yeast infections, an additional indication for Ultomiris, Rinvoq and Veklury. Additionally, Moderna seek EUA for vaccine for young children and the FDA will hold an advisory committee meeting for both Xphozah in kidney disease and Novavax’s COVID-19 vaccine.
The FDA approval in active ankylosing spondylitis is the fifth indication for Rinvoq in chronic immune-mediated diseases. It joins Xeljanz, which was the first approved JAK inhibitor for this condition in December 2021.
Javier Gonzalez, Pharm.D., Abarca’s chief growth and commercial officer, talks about Assura, the PBM’s net cost pricing solution, which provides more predictability to drug costs and guarantees an annual fixed cost.
Now called Camzyos, the therapy is first-in-class and treats the underlying cause of the disease. It is expected to be available next week.
Pramod John, CEO, and Bhargav Raman, M.D., director, clinical product, at Vivio Health, discuss how their system can match patients to therapies based on data.
The FDA is seeking input from committee members about the phosphate lowering effect seen in trials for tenapanor, which now has the brand name of Xphozah.
The FDA is expected to make decisions on several products later this week, including mavacamten, Qelbree, meloxicam-rizatriptan, surufatinib and toripalimab.
Phase 3 trials show CSF-1, a low-dose pilocarpine, met clinical endpoints for improving presbyopia, or age-related blurry vision.
The FDA has approved a generic of Zavesca for Gaucher disease and has accepted applications for a supplement indication for Enhertu and a novel therapy for CKD-related anemia. The regulatory agency also issued a CRL for Teva’s schizophrenia drug.
The EMA’s Committee for Medicinal Products for Human Use indicated that the data provided is not sufficient for marketing authorization.
Carole Florman, policy fellow at CancerCare, talks about how utilization management can have unintended consequences for patients.
Patient and patient advocate Beth Waldron used her social media platform to criticize CVS Caremark’s removal of Eliquis (apixaban) from its national formulary. CVS took notice.
Dr. Caroline Carney of Magellan Healthcare discusses the psychedelics in the pipeline for treating mental health conditions.
A Parkinson’s therapy, a treatment for seizures, a drug used in the treatment of heart failure, and a therapy for a rare disease have been removed from Prime’s Medicare formularies.
Zosyn’s label was updated to warn about the risk of a severe immune response called hemophagocytic lymphohistiocytosis.
In COVID-19 news, FDA issued an EUA for COVID-19 breath tests. The agency also okayed a third biosimilar of Avastin, extended the review of REGEN-COV, cleared first generic of Elcys, and accepted the BLA for Rolontis.
Capital Rx uses the NADAC model, which was developed by CMS for Medicare and Medicaid drug pricing.
The label of Triumeq now includes additional information about use in patients who have both HIV and hepatitis B.
ICER said Bluebird Bio could use an outcome-based pricing plan of five yearly payments totaling $2.1 million for patients treated with beti-cel who no longer need blood transfusions.
Increased use of biosimilars could reduce Medicare Part D spending by 18% and beneficiaries’ out-of-pocket costs by 12%.
A literature review found an association between increased cost-sharing and lower patient adherence, which in turn could be associated with increased hospitalizations.
The FDA approves novel therapy for schizophrenia and bipolar and grants accelerated approval to treat rare disorder. The agency also accepted the sBLA and has granted priority review for Actemra or the treatment of COVID-19 and has extended the PDUFA date for vutrisiran.
Two new subsections have been added to the warning and precautious section of Zepzelca’s label to address serious adverse events that were identified during post-market monitoring.
Drew Mihalyo of Delta Care Rx discusses the company’s pass-through pharmacy pricing model.
Treatment with Zegalogue for severe hypoglycemia has the potential to save costs and reduce emergency department visits and hospitalizations.
A proof-of-concept study showed that patients can be successfully switched from Cosentyx to Taltz with similar outcomes and lower costs.
Karthik Ganesh, CEO of EmpiRx Health, discusses how its technology and clinical focus provide strategies for patient management that results in lower costs for clients.
The PBM has removed 20 products and added a half dozen new therapies, including several generics. The changes are effective April 1, 2022.
Medicare beneficiaries without subsidies were 35% to 50% less likely to fill their prescriptions for drugs used to treat cancers, immune system disorders, and high cholesterol.
The agency has extended the review period to address pending inspection classification at third-party secondary packaging and labeling facility. The new PDUFA date is July 14, 2022.
