FDA Actions in Brief September 2012

If approved, Molbreevi could be the first FDA-approved treatment for patients with autoimmune pulmonary alveolar proteinosis, a rare lung disease.

In this week's episode of Tuning Into The C-Suite podcast, MHE's Briana Contreras chatted with David Calabrese, R.Ph, MHP, who is senior vice president and chief pharmacy officer of pharmacy care services company, OptumRx. David is also a member of Managed Healthcare Executives’ Editorial Advisory Board. During the discussion, he shared the OptumRx Quarter 2 Drug Pipeline Insights Report of 2020. Some of the information shared includes the three notable drugs currently being reviewed or those that have been recently approved by the FDA. Also discussed were any interesting industry trends to watch for.

The Institute for Clinical and Economic Review assessed the formularies of 11 payers, covering 57 million people, to determine access for drugs that the organization had reviewed in 2022 for cost-effectiveness.

Originally approved in 2009, Stelara patents began expiring in 2023, leading to an influx of recent biosimilars.

The boxed warning follows a safety warning the FDA issued in September about the risk of liver injury from the use of Veozah to treat hot flashes.

A new bill in Congress would require pass-through prices in both Medicare, and Medicaid and require transparency of PBM practices in the commercial space.