President Donald Trump’s efforts to lower drug prices in the United States have been met with challenges and uncertainties. In a recent executive order, Trump called for the implementation of a most favored nation pricing model, which would align drug prices in the U.S. with the lowest price paid by any nation worldwide. This move is seen as a way to reduce the financial burden on American patients and bring drug prices in line with those in other developed countries.
However, the logistics of implementing such a pricing model are complex. The executive order tasks the Secretary of Health and Human Services with setting most favored nation price targets for pharmaceutical manufacturers. Calculating these targets will require careful consideration of factors such as timing of drug launches, pricing by regulatory authorities, dosing, and formulation differences. Additionally, the challenge of locating proprietary net prices in international jurisdictions adds another layer of complexity.
One key concern is how the most favored nation pricing model will impact drugs without generic or biosimilar competition. While the executive order focuses on branded medicines without competition, questions arise about drugs that have competition in other countries but not in the U.S.
The president’s plan includes a rulemaking process to enforce most favored nation pricing if drug manufacturers do not voluntarily reduce prices. The Center for Medicare and Medicaid Innovation (CMMI) has the authority to test payment methods and care models to achieve cost savings and improve healthcare quality. However, past CMMI models have had limited success in achieving these goals.
The implementation of a most favored nation pricing model through CMMI raises logistical and legal questions. Would the model be voluntary or mandatory for healthcare providers? The potential for court challenges from physician groups and the pharmaceutical industry looms large. Additionally, the timeframe for implementing the pricing model is uncertain, with the Trump administration aiming for immediate results.
While executive orders and CMMI demonstration projects have been used to address drug pricing, a more permanent and comprehensive solution may require congressional approval. The path forward for lowering drug prices in the U.S. remains uncertain, as challenges and uncertainties persist in implementing a most favored nation pricing model.