FDA Actions in Brief October 2012

This expanded indication for Amvuttra makes it the first and only FDA-approved treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and the polyneuropathy of hereditary transthyretin-mediated amyloidosis (hATTR-PN) in adults.

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.

Optum Rx's new cost-based program uses an internal algorithm that leverages multiple available industry data sources, such as NADAC and PAC, to inform reimbursement.

Optum Rx has eliminated reauthorization for almost 70 drugs for chronic diseases, about 10% of its overall pharmacy prior authorizations.

Regulators are expected to make a decision in the third quarter of 2025 on Kerendia to treat patients with heart failure with a left ventricular ejection fraction (LVEF) of ≥40%.

Steqeyma is one of seven Stelara biosimilars that have been approved by the FDA.