CER Daily Newsfeed

Toward Equitable Access to Cell and Gene Therapies: Rethinking Co-Payments

(4/16, William H. Shrank, MD, MSHS, Ellen Kelsay, BA, A. Mark Fendrick, MD, The American Journal of Managed Care) comments “...The health care system should establish value-based insurance design for cell and gene therapies as an explicit goal. A natural consequence would be the elimination of co-payments for high-value cell and gene therapies in specific clinical scenarios. Access to cures—with potential to alter the course of a lifetime—should be guided by probability of clinical benefit and not be gated by a patient’s ability to pay.” Full

HHS To Shake Up FDA-Designated Breakthrough Device Payments

(4/16, Christian Robles, Jalen Brown, Inside Health Policy) reports “...Under the new proposal, breakthrough devices would have to demonstrate that, compared to existing technology, they ‘substantially improve’ Medicare beneficiaries’ health conditions for bonus Medicare payments, according to CMS' draft IPPS rule. Under current rules, breakthrough devices, which include artificial intelligence-powered software, only need to prove they are expensive tools for heightened reimbursement.” Subscription Required

Video: Dare to Dream: A Mission to Advance Pediatric Cancer Research

(4/16, Pharmacy Times) “...[Gwen Nichols, chief medical officer of Blood Cancer United,] highlights that traditional clinical trial models are too slow for rare pediatric diseases, prompting a shift toward using real-world data and large-scale patient databases. By partnering with data platforms like Tempus, the initiative aims to streamline research, reduce trial size requirements, and accelerate drug approvals.” View Video