Most-favoured-nation pricing for prescription drugs in US Medicare: a cohort study.

The prices of new medicines in the USA are among the highest in the world. The Centers for Medicare and Medicaid Services released mandatory most-favoured-nation payment models for prescription drugs covered under Medicare part B (GLOBE) and part D (GUARD). Under these payment models, manufacturers would be required to pay Medicare additional rebates for net drug prices exceeding the lowest international list price in a basket of 19 reference countries adjusted by gross domestic product per capita on purchasing power parity basis. In this study, we aimed to model the impact of the GLOBE and GUARD models for Medicare spending. In this cohort study of the GLOBE and GUARD payment models in US Medicare, we linked Medicare spending and prices with estimated current rebates, ex-manufacturer prices, and international sales data using Medicare data and commercial databases of sales and pricing from 19 model-specified reference countries (ie, Australia, Austria, Belgium, Canada, Czechia, Denmark, France, Germany, Ireland, Israel, Italy, Japan, Netherlands, Norway, South Korea, Spain, Sweden, Switzerland, and the UK) for all potential model-eligible brand-name drugs. The primary outcomes were estimated reductions in net Medicare spending under the GLOBE and GUARD payment models and median ratio of estimated reductions in Medicare spending to annual sales in the referenced country. In scenario analyses, we estimated changes in potential savings if the reference basket was narrowed to G7 countries and if manufacturers with separate agreements with the Department of Health and Human Services were exempt from model inclusion. The study included 195 brand-name drugs accounting for Medicare spending of US$87·9 billion. The estimated reductions in net Medicare spending were $5·2 billion (16·1%) under GLOBE and $6·4 billion (17·6%) under GUARD. In scenario analyses, potential savings would be reduced by 12·2% if the reference basket was narrowed to G7 countries and 71·3% if manufacturers with separate agreements were exempt from model participation. The median ratio of estimated reductions in Medicare net spending under GLOBE and GUARD to annual sales in the binding lowest referenced country was 3·8 (IQR 1·0-22·8). For 101 (73·2%) of 138 drugs, estimated reductions in Medicare spending would exceed annual sales in the binding referenced country. Most-favoured-nation pricing for brand-name medicines in Medicare was projected to decrease net spending. Potential reductions in net Medicare spending would be substantially greater than sales in the reference countries, suggesting that shifts in manufacturer behaviour with model implementation could reduce possible savings. Arnold Ventures.