CER Daily Newsfeed

CMS Clarifies Factors It Will Consider In Negotiating Drug Prices

(9/8, Gabrielle Wanneh, InsideHealthPolicy) reports “...Relating to evidence available on therapeutic alternatives to the selected drugs, CMS will also consider: The extent to which the selected drug represents a therapeutic advance compared to existing therapeutic alternatives; The costs of the therapeutic alternatives; The FDA-approved prescribing information available for selected drugs and their therapeutic alternatives; The comparative effectiveness of selected drugs, including the impact for specific populations, such as individuals with disabilities, the elderly, the terminally ill, children, and other populations.” Subscription Required

Pharmaceutical Innovativeness Is Highly Variable, As CMS Will Soon Find Out When It Assesses Drugs It Selected For Negotiation

(9/9, Joshua Cohen, Forbes.com) comments “...The key question when conducting comparative effectiveness evaluations is whether the pharmaceuticals being analyzed are clinically better than existing standards of care. And if so, then HTA must probe whether the incremental benefit is worth the price premium? As was said above, among the top-selling prescription drugs sold to Medicare most were not considered high value products.” Full

Big Pharma's Battle With the Biden Administration Could Have Legs

(9/9, David Wainer, The Wall Street Journal) reports “...[Carmel Shachar, assistant clinical professor at Harvard Law,] ultimately thinks the law has a good chance of surviving, but she notes that in an era where courts have shown growing skepticism toward administrative agency action anything is possible. She says the industry argument that the government is unfairly taking their property, which is protected by patents, will be looked at seriously by some courts.” Subscription Required

Real-World Data Can Include EUA Observations, US FDA Final Guidance Says

(9/10, Bridget Silverman, Pink Sheet) reports “...Agency clarifies expectations for non-interventional studies providing RWD to support regulatory decisions while continuing to emphasis familiar themes around early interaction and stringent data practices...The considerations guidance focuses on non-interventional clinical study designs, which are not subject to IND regulations; other RWE-using trial designs, like external controls, have been highlighted in their own guidance documents. "There weren't huge changes" between the draft and final versions, Aetion head of scientific strategy Ulka Campbell observed in an interview with the Pink Sheet.” Subscription Required