Coverage With Evidence Development and Expedited Approvals: Policy Proposals For FDA and CMS

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

The plan was announced as the White House Office of Management and Budget discusses with stakeholders a widely anticipated guidance about the 340B rebate model, which is being advanced by manufacturers to enhance transparency and control ballooning discounts in the program.

States also agreed to fund patient travel to specialized treatment centers as part of their participation in the Medicaid demo of CMS-negotiated outcomes-based contracts for Vertex/CRISPR's Casgevy and bluebird bio's Lyfgenia.

The issue is attracting more attention as the 2028 deadline for implementing Medicare negotiated prices for Part B drugs approaches.