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Most Favored Nation (MFN) type drug pricing proposals that were proposed by the Centers for Medicare & Medicaid Innovation (CMMI) in December 2025 would weaken America’s innovation ecosystem and counter the goals of greater healthcare access and affordability that are shared by BIO and the Trump Administration.
“Patient advocates are concerned that the proposals were not designed with patient concerns in mind—they do NOT address affordability for patients and, in fact, risk exacerbating access barriers” explained Karin Hoelzer, Senior Director for Patient Advocacy during the Biotechnology Innovation Organization’s (BIO) January Coffee Chat “Putting Patients First – The Cost of Arbitrary Price Controls and How to Actually Improve Affordability for Patients.”
As Crystal Kuntz, Senior Vice President of Health Policy & Research at BIO clarified, CMMI proposed two “models” in December—the Global Benchmark for Efficient Drug Pricing (GLOBE) and the Guarding U.S. Medicare Against Rising Drug Costs (GUARD) models. Both are intended to import foreign price controls on the American drug development landscape; GLOBE would focus on Medicare Part B, and GUARD on Medicare Part D. Public comments about the models can be submitted until February 23rd, and, as Kuntz explained, BIO is planning to weigh in.
“Both models raise significant concerns,” explained Kuntz. “These arbitrary price controls will reduce the number of novel medicines produced in the U.S. and limit patient access to critical therapies. What’s more, patients will not see lower costs at the pharmacy counter.”
How international drug pricing models threaten patient access
Sue Peschin, President and CEO of the Alliance for Aging Research said she and fellow patient advocates oppose MFN. They are concerned the GLOBE and GUARD models will in fact lead to more access barriers and increased out-of-pocket costs for older Americans. As Peschin explained, CMMI itself has projected that the GUARD model alone will increase healthcare costs for seniors by $3.6 billion, primarily driven by an increase in Medicare beneficiaries’ cost-sharing responsibility.
“This will have a significant impact on older people who are already struggling with increasing out-of-pocket costs as a result of the Inflation Reduction Act (IRA)” explained Peschin. Since the IRA was passed, insurance plans have increasingly shifted cost-sharing responsibilities from co-pays to coinsurance, leading to a net increase in cost-sharing requirements. What’s more, the IRA has driven increases in utilization management and narrowing of drug formularies, increasingly leaving older adults struggling to access their therapies. The MFN models will exacerbate these trends, Peschin worries, while cooling vital pharmaceutical innovation in key areas that are vital for seniors including in the Alzheimer’s’ and neurocognitive impairment space.
“That is why we at the Alliance for Aging Research will provide comments to CMMI, and why I urge everyone: make your voice heard,” Peschin said. Patient organizations who may not have the bandwidth to submit their own comments can sign on to multiple sign-on letters led by the Alliance for Aging Research and other organizations, explained Peschin. “There is a lot at stake for older Americans,” reinforced Peschin.
Why importing international drug pricing is the wrong policy
Importing foreign price controls raises a number of legal and logistical issues. As the panelists explained, there are substantial differences between the U.S. and various international health systems, including their value assessment methods and legal frameworks.
Thayer Roberts, Deputy Director at the Partnership to Improve Patient Care (PIPC), explained how Quality Adjusted Life Years (QALYs) systematically discriminate against people with disabilities. QALYs are a metric health economists use in cost-effectiveness assessments to determine the value of a healthcare treatment. To calculate it, they assign a value to a person’s life.
A young person in ‘perfect’ health is assigned the value of one. Patients that are not in ‘perfect health’ receive a reduced value, inherently devaluing treatments for seniors and many people with chronic conditions or disabilities. “For instance, a person who is over 80 years old may be assigned the value of 0.7, someone who is blind may be assigned a value of 0.6, and someone who has moderate Multiple Sclerosis may be assigned a value of 0.5.” explained Roberts. “What that means is that treatments for these patient populations are systematically devalued in cost-effectiveness assessments.” This threatens innovation by considering these therapies to be “worth less” than treatments for younger, healthier patients.
In the U.S., Medicare has long been banned from using QALYs because of their discriminatory nature. QALYs are widely used in health technology assessments in other countries, explained Roberts. In fact, according to Roberts, nearly all the countries proposed as reference countries in the GLOBE and GUARD models use QALYs, either directly or indirectly. “Importing foreign price controls from these countries imports their discriminatory health assessment practices. It circumvents the key protections Congress intended, and that our community has fought to protect.”
Roberts has seen first-hand how these discriminatory practices impact patients in other countries, citing the experiences of several patients in other OECD countries that are still struggling to get access to therapies that have long been available to U.S. patients. You may see the stories PIPC has collected here:
That is why PIPC is planning to weigh in with their concerns. “We understand that not every patient organization has the bandwidth to write their own comments, which is why we are leading a sign-on letter, and we welcome every patient organization who is interested to join us” explained Roberts. “This is not some abstract health economics issue; this is a patient access issue. Patients in other OECD countries do not have timely access to the treatments American patients do – and often, it is the patient’s life on the line. I urge everyone to take this seriously. Learn about the issue and engage in it, have your voice heard.” You may access and sign on to PIPC’s comments here.
What patients in other OECD countries are facing
“We at Aimed Alliance want improved access to prescription drugs for patients, but we believe that U.S.-based solutions tailored to our unique system are the only way to ensure meaningful savings for consumers. Systems abroad are very different from those in the U.S. and importing foreign price controls risks importing their reimbursement models that do not reflect U.S. access priorities,” explained Olivia Backhaus, Staff Attorney at Aimed Alliance. “Part of the challenge that we see patients in other countries face is that their systems ultimately lead to increased hospitalizations and poorer patient outcomes,” stated Backhaus. “We have long heard this anecdotally and last year we conducted research to better understand what patients in other countries are experiencing.”
What Aimed Alliance found is that the healthcare systems in other countries are fundamentally different from those in the U.S., and patients in other countries often do not have timely access to the same therapies and specialists that U.S. patients do. “The average wait time in the U.S. to see a specialist is 31 days. In the U.K., it’s about 18 weeks,” said Olivia Backhaus, Staff Attorney at Aimed Alliance. “Most new drugs first launch in the U.S.; major OECD countries often experience delays of almost a year or more,” continued Backhaus. And, as Backhaus explained, U.S. consumers have access to far more new drugs than patients in other countries. “Healthcare systems in other countries are structured very differently from the U.S., and those differences really matter to patients,” said Backhaus.
A new study just released by the National Pharmaceutical Council corroborates and further explains why these differences matter so much to American patients – including the timeliness of access and the ability to incorporate patient perspectives in the value assessments.
What to do instead
Fortunately, there are much better ways to address affordability than MFN. Currently, as much as half of the cost of innovative medicines goes to middlemen, hospital markups, and other hidden supply chain fees – rather than to patients or innovation.
Bipartisan policies to simplify the system would expand access to medicines, cut out middlemen, and reduce out-of-pocket costs. One area the panelists agreed on is the need for PBM reform. “Middlemen get in the way between patients and their doctors. They second-guess the doctors’ clinical judgements and treat their prescriptions purely as recommendations. And patients are getting the short end of the stick in all of this.” added Peschin. Luckily, just last week, Congress took some steps in this direction, although more remains to be done.
Enforcing existing restrictions on utilization management and formulary design is another area that would improve affordability for patients explains Peschin. “Insurers find more and more ways to shirk costs back onto seniors, causing many to wonder what their insurance even really covers. CMS could be doing a lot more to make sure that plans are not abusing or overusing utilization management,” said Peschin. “We need to make CMS more accountable: we pay for this, and we want to see more transparency and accountability”
Ultimately, the panelists agreed, implementing MFN type price controls like GLOBE and GUARD will have drastic impacts on the pipeline of innovative medications and hurt patient access. Importing foreign price controls that would sacrifice access and innovation, while threatening to increase poorer patient outcomes, is not the answer. Instead, there are tangible things with broad bipartisan support that can be done to improve patient access.
The answer is to simplify our inherently complex American healthcare system.
