The Centers for Medicare & Medicaid Services (CMS) has finalized the Global Benchmark for Efficient Drug Pricing (GLOBE) Model, a mandatory Medicare Part B drug-payment model that will benchmark selected medicines against international prices from January 2027. The final rule substantially narrows the model's expected fiscal impact, with the CMS now estimating the finalized model will generate USD 298 million in Original Medicare Part B benefit savings, down from USD 8.4 billion projected under the proposed rule, alongside USD 111 million in beneficiary cost-sharing and premium savings.
Eligibility is focused on certain single-source drugs and sole-source biological products in areas including oncology, rheumatology, immunology, ophthalmology, and endocrinology with more than USD 100 million in annual Original Medicare Part B spending.
The CMS will test two approaches to setting an international benchmark across 19 reference countries, including Australia, Canada, France, Germany, Japan, and the United Kingdom. One method will use commercially available data to estimate the lowest international price, while a second will use voluntarily submitted manufacturer net-pricing data to calculate an average international price. Manufacturers are not required to submit international net-pricing data.
Participation is mandatory for manufacturers of qualifying products. The model modifies the calculation of Medicare Part B inflation rebates for selected beneficiaries, with manufacturers owing an incremental GLOBE rebate when applicable. Beneficiaries may also pay lower coinsurance when the international benchmark falls below the relevant Medicare payment amount; Medicare will correspondingly increase its share of provider payment so that providers continue to receive the applicable Part B allowed amount.
The final rule excludes biosimilars and their reference biologicals once a biosimilar enters the US market, as well as orphan-only drugs, plasma-derived products, and certain cell and gene therapies. CMS added the latter three exclusions following public comments.