On Wednesday, the Trump administration published a final rule that would bring MFN pricing to Medicare Part B for select drugs. The selections, however, appear to be more exclusive than originally expected.
First teased last December, CMS will launch the Global Benchmark for Efficient Drug Pricing (GLOBE) Model on January 1 to align Part B payments with international prices. Distinct from Medicare Part D prescription drug plans, Part B covers drugs and biologics that are administered in an outpatient or clinical setting.
One detail caught the eye of reporters: broad exemptions have narrowed the program’s scope to just four companies. While CMS did not disclose which four, Pink Sheet deduced that Biogen, its Apellis subsidiary, Daiichi Sankyo and Takeda appear to fit the rule’s criteria.
All companies that signed voluntary drug pricing deals with the Trump administration are exempt from GLOBE, a shift from initial announcement. Drugs for rare diseases are also excluded. These exemptions caused CMS to slash estimated savings from $11.9 billion under the proposed model to $440 million—a 96% drop.
A similar MFN pricing pilot for Medicare Part D, acronym-ed GUARD, remains in the proposal stage. While it’s unclear if GUARD will feature similar exemptions to GLOBE, experts have theorized that the pair of models were always intended to be “a stick to coerce manufacturers into voluntary MFN commitments.”
– Andrew Wishon, Editor-in-Chief