News from Wednesday, October 4, 2023
Articles
CMS Moves Forward with Medicare Drug Price Negotiations
(10/3, Denise Myshko, Managed Healthcare Executive) reports “...ICER’s modeling did not use quality-adjusted life year (QALY) as its framework assessment. For this review of Eliquis and Xarelto, ICER instead relied on the equal value life year (evLY), a measure that values all life-extending treatment effects equally for all patients, regardless of preexisting disability or age. The use of evLY was done in keeping with CMS guidance. CMS has said the negotiation process will consider the selected drug’s clinical benefit, the extent to which it fulfills an unmet medical need, and its impact on people who rely on Medicare.” Full
Patients Up Next For Drug Price Input
(10/3, Lauren Gardner, Katherine Ellen Foley and David Lim, Politico) reports “...The next public step in CMS' implementation of the watershed negotiations will focus on gathering patient input on the first drugs chosen - a key factor in how the agency will calculate the drugs' prices. The listening sessions will launch Oct. 30 and run through Nov. 15, just as the Biden administration is ramping up talks with the affected companies, POLITICO's Robert King writes.” Full
Delegation Of Chronic Care Management In The Medicare Shared Savings Program
(10/4, Sean Cavanaugh, William H. Shrank and Farzad Mostashari, Health Affairs Forefront) comments “...To achieve the highest-value care for Medicare beneficiaries, we need better integration between risk-taking primary care providers and more specialized services that provide deeper disease-specific expertise. This is a shared priority for CMS and the ACO community, and is a stated goal of the Innovation Center. We believe that part of the solution lies close at hand and merely requires the enactment of a small regulatory change. This change is consistent with CMS’s strategy of using ACOs as the ‘chassis for care transformation’ and could catalyze the deeper coordination between primary care and specialty care that CMS has been seeking to create.” Full
Brazil Publishes Real-World Evidence Guide
(10/4, Francesca Bruce, Pink Sheet) reports “...The Brazilian medicines regulator has published a guide for companies conducting real-world evidence studies. Already in force, it is open to comments until 2024 and updates may be made.” Subscription Required
Press Releases
CADTH Appoints New Members to Expert and Advisory Committees
(10/3, CADTH Press Release) “CADTH has appointed new members to its 3 expert review committees: the Canadian Drug Expert Committee, the pan-Canadian Oncology Drug Review Expert Review Committee, and the Health Technology Expert Review Panel. CADTH has also appointed new members to its Post-Market Drug Evaluation Advisory Committee.” Full
Journals
Editorial: It Shouldn’t Be a Battle: Customizing Shared Decision Making to Meet Patients’ Preferences
Dale E. Lupu, Melissa M. Sanchez, Nieltje Gedney
October 3, 2023, American Journal of Kidney Diseases
American Journal of Kidney Diseases
Sequential Regression and Simulation: A Method for Estimating Causal Effects from Heterogeneous Clinical Trials Without a Common Control Group
Vivek A Rudrapatna, et al.
October 3, 2023, BMC Medical Research Methodology
Comparative Effectiveness Is the Common Denominator in Health Services Research: Experimental Effects Are Promising, Real-World Effects Are Compelling
Franz Porzsolt
October 5, 2023, Journal of Complementary & Integrative Medicine