CER Daily Newsfeed

Pharma Awaits Rule on Combo Drugs in Medicare Price Negotiations

(3/16, Nyah Phengsitthy, Bloomberg Law) reports “...A proposed regulation sitting at the [OMB] is likely to address whether the US government will select fixed-dose combination treatments for future rounds of the Medicare Drug Price Negotiation Program...The drug industry has pushed back on the provision as it would allow the agency to slash the prices of negotiation-eligible drugs, along with their fixed-dose combination versions, if the agency determines there's no clinically meaningful difference between the products...John O'Brien, CEO of the National Pharmaceutical Council, said in an editorial published in February that the therapies ‘can mean the difference between an hours-long infusion and a much shorter subcutaneous injection-an example of the ways patient-reported outcomes for a particular cancer treatment play an outsized role in their overall treatment experience.’” Subscription Required

FDA Invites Sponsors to Participate in Next Cycle of Advancing Real-World Evidence Program

(3/17, Joanne Walker, The Evidence Base) reports “...Speaking recently about the program in a recent webinar, Marie Bradley, Senior Advisor for Real-World Evidence Analytics at FDA, encouraged sponsors to engage with the agency early in the evidence development process. Discussions, she noted, should occur ‘as early as possible, before any sort of solid decisions are made,’ helping sponsors identify potential data or study design challenges before significant resources are committed.” Full

Harnessing Real-World Data to Bring Life-Saving Drugs to the Public Sooner

(3/17, UC Berkeley School of Public Health) comments “...‘Clinical trials, particularly large Phase 2 and 3 trials, are one of the biggest reasons it can take more than a decade and over a billion dollars to bring a new drug to patients. CTML is working with the FDA and pharmaceutical partners to help change that,’ said Dr. Michael C. Lu, Dean of UC Berkeley School of Public Health. ‘By combining the power of machine learning with the rigor of modern biostatistics, our researchers are developing new methodologies—such as using real-world health data to simulate placebo trials—that could make clinical trials faster, more efficient, and more affordable while maintaining the highest standards of scientific rigor.’” Full

ACO Leaders Say Mandatory Models Could Expand Value-Based Care, But Incentives Must Be Right

(3/16, Jalen Brown, Inside Health Policy) reports “...‘We’re supportive of mandatory models in the right circumstances,’ [Accountable for Health CEO Mara McDermott] said, adding that mandatory participation could help ‘maximize a savings opportunity’ as policymakers continue pushing [CMMI] to show measurable cost reductions. She added that mandatory models could also help engage providers who have not joined voluntary value-based payment initiatives, despite years of opportunities to do so. McDermott also argued that evidence from accountable care organizations and other alternative payment models shows value-based approaches can improve care quality while reducing costs. ‘The models have outperformed on better care,’ she said. ‘The quality is clearly better.’” Subscription Required