Denise Myshko

Articles by Denise Myshko

The hearing will discuss the role of PBMs in healthcare and the Pharmacy Benefit Manager Transparency Act, legislation that has been submitted by Sens. Maria Cantwell and Chuck Grassley.

The FDA has approved two pediatric indications this week: Takhyzro for hereditary angioedema and Eylea for retinopathy of prematurity. The agency expanded the label of Cibinqo for atopic dermatitis in adolescents, and granted full approval to Jemperli for endometrial cancer. Additionally, the agency has set PDUFA dates for two drugs: reproxalap for dry eye and zuranolone for depression.

The FDA has approved two breast cancer therapies this week: Trodelvy to treat patients with HR+/HER2- breast cancer and Orserdu to treat patients with ER+, HER2-, ESR1-mutated disease. The agency also approved a novel therapy for CKD-related anemia and Tezspire in pre-filled pen.

Some PBMs will offer Amgen’s Amjevita biosimilar as a preferred product alongside Humira, but CVS Caremark said Humira will remain preferred and Amjevita will be placed on a non-preferred brand tier.

The FDA approved a new drug for type 2 diabetes and a new BTK inhibitor for rare blood cancer while Keytruda got another indication in lung cancer. But Evusheld lost its EUA for COVID-19. The agency accepted an sNDA for Jardiance for CKD and officials said they plan to hold advisory committee meeting for Biogen’s ALS drug.

This week the FDA approved new indications for already available therapies, including Brukinsa for chronic lymphocytic leukemia and an accelerated approval for Tukysa for HER2-positive colorectal cancer, as well as an extended-release form of risperidone for schizophrenia. The agency also issued a complete response letter for Lilly's Alzheimer’s drug and accepted an application for a NASH drug.

While ICER found that overall major payer coverage policies are in line with the organization’s fair access criteria, many payers do not provide adequate transparency into clinical coverage criteria.

The FDA has approved two medications: Rybelsus for first-line treatment of diabetes and asthma rescue combination medication. The agency has accepted an sNDA for Rexulti for Alzheimer’s agitation, and Eisai submits new Alzheimer’s drug for full approval.