We Work For Health Urges CMS to Withdraw Harmful GLOBE and GUARD Pricing Models

We Work For Health recently submitted formal comment letters urging the Centers for Medicare & Medicaid Services to reject and withdraw both the Global Benchmark for Efficient Drug Pricing (GLOBE) model for Medicare Part B and the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) model for Medicare Part D. 

If implemented, these models will significantly harm American life sciences innovation, the millions of workers whose livelihoods depend on it and the patients these policies purport to help.  

Innovation at Risk 

At the heart of both proposals is a fundamental misunderstanding of how biopharmaceutical innovation works. Developing a single new medicine takes an average of 12-15 years and costs more than $2 billion – and only 12% of drug candidates that enter clinical trials ever earn FDA approval. Companies make those long-term bets based on their expectations of the future market environment. Policies that inject uncertainty into that environment don't just slow innovation – they stop it before it starts. 

A recent report from the IQVIA Institute makes this threat concrete. The study examined the top 50 widely used medicines by U.S. sales and found that nearly one-third of their approved indications were developed in the "late life" of those drugs' lifecycles (more than five years after first approval for small molecules or more than nine years after approval for biologics).  

These late-life indications are not marginal additions: 

• 65% addressed severe diseases 

• 42% carried FDA orphan drug designations targeting rare conditions 

• 45% represented the first new treatment approved for a condition in more than five years 

• 20% were the first therapy ever approved for their disease 

  
  

These are precisely the breakthroughs that MFN-based pricing models would deter before they ever reach patients. 

Further, both the GLOBE and GUARD models would compound the damage done by the Inflation Reduction Act, which has already begun reshaping where and how American companies invest. Before the IRA, U.S. pharmaceutical companies licensed virtually no new medicines from China. By 2024, a third of new compounds were sourced from Chinese biotech firms – and FDA-registered clinical trials by Chinese firms have grown by 400% since 2018. These models would hand China an even greater competitive advantage at precisely the moment we can least afford it. 

No Clear Benefit for Patients 

Perhaps most troublingly, these models fail on their own terms. The GUARD model is projected to actually increase costs for Medicare Part D beneficiaries by $3.6 billion through higher premiums and out-of-pocket expenses. And across both models, independent research projects the loss of 210 new drug approvals and 290 additional post-approval indications over a 10-year period – 500 fewer medicines and a corresponding loss of life for an estimated 6.6 million people worldwide. 

There is a Better Way

We Work For Health is not simply opposing these proposals – we are calling for smarter solutions that achieve the shared goal of making medicines more affordable without sacrificing the innovation ecosystem that produces them. Our letters urge the Administration to pursue market-based reforms, including accelerating generic and biosimilar approvals, eliminating anti-kickback protections that shield PBMs from accountability, de-linking PBM compensation from drug prices, and restoring NIH and FDA funding to support promising research and faster approvals. 

America can lower costs and lead the world in medical innovation. Unfortunately, these models would accomplish neither. 

Read our full comment letters here: 

• GLOBE Model

• GUARD Model