CER Daily Newsfeed

MFN Policy's Legacy May Be Building Support For Official US Health Technology Assessment Program

(5/21, Cathy Kelly, Pink Sheet) reports “...‘It’s not about whether you have an HTA body or not. I don’t think that’s the policy question,’ [CMS senior advisor for drug pricing Inmaculada Hernandez]said. ‘The policy question is how do you use results in policymaking and determining coverage and reimbursement? … Are they just going to produce results and then nobody is going to use them?’...‘I think we should consider’ establishing an HTA body in the US, said Liz Fowler, a former Center for Medicare and Medicaid Innovation director who now is a distinguished scholar at the Johns Hopkins School of Public Health and a principal at the Health Transformation Strategies consulting firm.” Subscription Required

Euro Roundup: HTA Body Publishes Guiding Principles on Data Transparency, Updates JCA Answers

(5/21, Nick Paul Taylor, Regulatory Focus) reports “...EFPIA has detected a ‘concerning’ trend in the data on European Medicines Agency (EMA) approvals that suggests most favored nation pricing (MFN) may be constraining access to new drugs...To assess the impact of MFN, EFPIA tracked the percentage of FDA-approved medicines authorized by EMA. The 12-month rolling average was above 60% in January 2024. The percentage trended downward slowly, with occasional increases, over the next 18 months. Starting in October, ‘there is an apparent acceleration in the trend,’ EFPIA said, with the percentage falling sharply through the cutoff in February.” Full

UK: NICE Changes Stance on Genmab's Cervical Cancer Drug

(5/22, Phil Taylor, PharmaPhorum) reports “...In final draft guidance, NICE has backed the commissioning of Tivdak (tisotumab vedotin) as a monotherapy for adults with recurrent or metastatic cervical cancer whose disease has progressed despite earlier systemic therapy.” Full