First-ever implementation of often-discussed reimbursement approach for high-cost drugs would involve group of commercial payers to address “portability” issue and may start with Novartis’ Zolgensma.

National coverage decision does not limit Medicare payments to labeled indications or site of care. CMS expects to “leverage” existing FDA post-market data collection requirements but seeks additional data on patient-reported outcomes in some cases.

Price decisions based on straight calculation of medical costs avoided may overestimate value of a cure, Cassidy warns.

Study using US FDA’s Information Exchange and Data Transformation (INFORMED) program will focus on shift from weight-based to flat dosing for Opdivo and Keytruda.

In addition to fielding tough questions about pricing practices at the session, executives may announce new voluntary efforts to lower drug costs and will offer their own ideas for legislation.

Lower net costs held overall spending on retail prescription drugs in employer-sponsored insurance to an increase of just 0.4% in 2018, according to the latest Express Scripts Drug Trend Report.