Cathy Kelly
Senior Writer
Latest From Cathy Kelly
FDA’s Real-World Evidence Project Finds That Pragmatic Clinical Trials Are Easier To DUPLICATE
Results from the US Food and Drug Administration’s RCT DUPLICATE demonstration are in. The findings both legitimize certain real-world evidence studies and also highlight the challenges involved in using RWE to replicate randomized clinical trials.
Preapproval Information Exchange Between Sponsors, Insurers Clarified In House User Fee Bill
By codifying FDA guidance, pending legislation aims to encourage industry to become more comfortable with even unsolicited communications to payers about investigational drugs.
A Case For Transparency: J&J Suit Targets Opaque PBM Affiliate’s Efforts To Exploit Copay Programs
Lawsuit highlights the lack of transparency into pharmacy benefit manager activities and how their programs can influence drug pricing. A Senate hearing on PBMs held shows increasing momentum behind a Federal Trade Commission study on potential anti-competitive activity in the market sector.
Medicare Part D Cost Sharing Rule Will Save Manufacturers Nearly $17bn
Despite objections from pharmacy benefit managers and insurers, the Centers for Medicare and Medicaid Services moves ahead with rule to transfer concessions directly to beneficiaries.
Lilly’s Tirzepatide For Obesity Faces Uphill Road To Medicare Part D Acceptance
Eli Lilly’s drug could join Novo Nordisk’s Wegovy on the market in the next year or so as treatments offering significantly more weight loss than previous drugs have been able to. Could that open the door to greater access?
Lilly Phase III Alzheimer’s Data Will Set Stage For Unrestricted Medicare Coverage Request
Donanemab results due next year have a good chance of persuading CMS to offer unrestricted coverage, Lilly argues, even though the drug might just have accelerated approval at that point. ‘We believe that having two positive pivotal trials should meet that high level of evidence.’