CMS aims for broader GLP-1 access via federal programmes

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CMS aims for broader GLP-1 access via federal programmes

In the latest of a flurry of announcements ahead of the holiday period, CMS has revealed a new, voluntary access programme that aims to broaden the use of GLP-1 agonist medicines for diabetes and obesity through Medicare and Medicaid.

The Better Approaches to Lifestyle and Nutrition for Comprehensive hEalth (BALANCE) scheme will allow Medicare Part D plans and state Medicaid agencies to cover GLP-1 drugs, after negotiating prices with the federal government.

The announcement comes a few weeks after the Trump administration announced price discounts to $149 per month for GLP-1-acting drugs provided through Medicare and Medicaid, as well as for cash purchasers. That agreement covered Novo Nordisk's semaglutide products for diabetes (Ozempic) and weight loss (Wegovy), along with Eli Lilly's tirzepatide-based rivals Mounjaro and Zepbound.

The voluntary BALANCE programme will build on that agreement, according to CMS, which said it expects it to start in May 2026 for Medicaid and January 2027 for Medicare. It was announced right after proposals for mandatory drug payment models for Medicare Part D and Part B.

The negotiations will focus on guaranteed pricing – $50 per month for Medicare beneficiaries, according to CMS – along with potential price caps, standardised eligibility, coverage and access, and mandatory inclusion of lifestyle support programmes.

CMS Administrator Dr Mehmet Oz said BALANCE will build on the Trump administration's most favoured nation (MFN) initiatives – which include the launch next month of direct-to-consumer (DTC) sales channel TrumpRx – and has the goal of "democratising access to weight-loss medication, which has been out of reach for so many in need."

Additional information will be available early next year, according to CMS, which added that participation will be voluntary for manufacturers, states, and health plans, but companies interested in the scheme will have to submit a notice of intent by 8th January. A 'demonstration' of the programme will start next year, as a bridge to full implementation.

CMS said it will also closely track the model's impact on cost, outcomes, and adherence to determine whether it is delivering improved health and lower costs.

The announcement came right after Novo Nordisk opened up a new chapter of the GLP-1 story with FDA approval of a pill version of Wegovy, the first oral drug in the class to be given a green light for weight loss.