Report: Unmet Need Can Trump Modest Data In Quest For Reimbursement
Executive Summary
A higher level of evidence did not correlate well with subsequent payor reimbursement, according to a comparison of the coverage success for devices approved via HDE and PMA conducted by Avalere Health for the Pew Charitable Trusts. Perceptions of unmet need tended to serve a bigger factor for coverage, the report said.
You may also be interested in...
Ex-CMS Louis Jacques On Partnering With FDA And Keeping It Local
In this second portion of a two-part Q&A with Louis Jacques, he talks to “The Gray Sheet” about the importance of CMS’ growing collaboration with FDA, tensions between national and local Medicare coverage policymaking and the impact of resource constraints on CMS. Jacques left his post as CMS coverage director last month.
Japan Grants Global-First Approval To Zolbetuximab, 15 Other New Drugs
Astellas's first-in class CLDN18.2-targeting antibody receives its first approval worldwide, while crovalimab and a number of drugs for rare diseases also receive nods from regulators and are now awaiting reimbursement price-listing.
Hanmi-OCI Merger Hits Wall As Brothers Win Shareholder Vote, Board Seats
The planned merger of Korea's Hanmi Pharm Group with OCI Group hits a major speed bump as the two sons of Hanmi's founder and other candidates recommended by them secture board seats. But it remains to be seen how the Lim brothers will fulfil their ambitious promises.