Yesterday, PCMA submitted comments on the proposed Guarding U.S. Medicare Against Rising Drug Costs (GUARD) and Global Benchmark for Efficient Drug Pricing (GLOBE) models, warning that meaningful transparency is essential to ensure American seniors can access medicines at the lowest, “Most Favored Nation” (MFN) price in the world.
For years, drug manufacturers have argued that high prices were unavoidable and blamed others in the drug supply chain for affordability challenges. Their recent agreements with the White House prove otherwise. Sixteen major manufacturers have already agreed to provide MFN-level pricing—proof that their sky-high list prices are a choice.
Still, this leaves an important question: how will GUARD and GLOBE guarantee savings for seniors and taxpayers, rather than manufacturers?
Stakeholders have already raised concerns that some of the largest pharmaceutical manufacturers may be exempt from GUARD and GLOBE entirely. If the companies responsible for the highest prices aren’t held responsible for their high list prices, American patients will still be stuck paying too much for their medications.
GUARD and GLOBE leave U.S. list prices—and the costs faced by health plans, pharmacies, and hospitals—unchanged. In practice, this means manufacturers can comply with the models without making medicines any more affordable for seniors or the employers who sponsor health coverage for millions of Americans.
These dynamics raise serious concerns for patient access. Only 25% of beneficiaries will be eligible for any relief offered by GUARD and GLOBE (solely based on their home zip code), and, because manufacturers retain control over the list price both in the U.S. and abroad, they can manipulate the math to make it look like Americans are paying less, even if other countries still pay a lower net price.
As proposed, the government absorbs any rebates resulting from GLOBE and GUARD while the rest of the supply chain continues to shoulder inflated list prices and higher inventory costs. These pressures can delay care for beneficiaries who rely on high-cost therapies. In some cases, for heavily demanded products, like GLP-1s, GLOBE and GUARD could further compress rebate structures and reduce contracting flexibility. At the same time, direct-to-consumer cash-pay channels create additional fragmentation and confusion for Medicare patients, amplifying access and adherence challenges.
The bottom line is simple: drug companies have demonstrated that they can provide lower prices when it benefits them. They should not be permitted to secure tariff relief, participate in federal pricing models, and still retain the ability to set—and raise—prices that burden beneficiaries, employers, and taxpayers. Any reforms designed to lower drug costs must ensure that savings flow to patients and the public, not back into the pockets of the manufacturers who created the affordability crisis in the first place.
Read the full comment letters here:
PCMA Comments on CMS-5545-P GLOBE_23Feb2026.pdf
PCMA Comments on CMS-5546-P GUARD_23Feb2026.pdf
