Findings

All eight systems negotiate the prices of brand-name prescription drugs soon after approval and rely on formal clinical assessments that compare newly approved drugs with existing therapies. Systems differed on characteristics such as whether the body performing clinical assessments is separate from the negotiating authority, how added health benefit is assessed, whether explicit willingness-to-pay thresholds are employed, and how specific approaches for priority disease areas are taken.

High-income countries around the world adopt different approaches to conducting price negotiations on brand-name drugs but coalesce around a set of practices that are largely absent from the current Medicare negotiation framework. U.S. policymakers might consider adding some of these characteristics in the future to improve negotiation outcomes.

Impact nationally and internationally

Countries around the world have developed sophisticated systems to negotiate drug prices effectively, and the findings in the study suggest that there is much the U.S. can learn from these established frameworks. Unlike other high-income countries, the U.S. lacks formal health technology assessments (HTAs), which have been key in strengthening drug price negotiations elsewhere. When price negotiations take place at market entry, it ensures quicker and longer-lasting savings by setting affordable prices. Many health systems negotiate prices as drugs are approved, enabling immediate, cost-effective access. In contrast, Medicare can only begin negotiations seven to 11 years after FDA approval, allowing manufacturers to set high prices for years. While this delay supports industry profits and incentivizes innovation, it results in higher drug costs and slower access to affordable treatments for patients. Implementing strategies from other countries could significantly improve negotiation outcomes for Medicare and ultimately benefit American patients.

Beginning in January 2025, the European Union (EU) will adopt a standardized framework for clinical assessment of newly approved drugs (6). The framework for joint clinical assessment will be implemented across member states in stages, beginning first with oncology drugs and advanced therapies, such as gene therapies. The process will run in parallel with the regulatory review process; when manufacturers submit market authorization applications to the European Medicines Agency, they will provide information at the same time to a European Commission secretariat to inform the HTA process. Member states are obliged to include the joint clinical assessment in their national HTA review (along with additional clinical analyses they may choose to undertake) and will each complete their own cost-effectiveness analyses, price negotiations, and reimbursement decisions. This centralized joint clinical assessment process may help standardize evaluations of new therapies. A more uniform drug assessment process may be especially important given the challenges countries face in addressing uncertainty in clinical evidence and the increasing number of drugs approved based on nonrandomized trials, single-arm studies, surrogate measures as study endpoints, and short follow-up times.

Impact on my career

Equity in health has been one of my main motivations for pursuing further education and has continued as a guiding star throughout my career. The fellowship has been a unique opportunity to join a community of people from across the world. They have inspired me to see new opportunities to advance health policy on equitable access to medicines and health care.

The need for international knowledge sharing and exchange of experiences is becoming more critical in the coming years to ensure access to medicines and health care. Given the current geopolitical landscape, enhancing cross-border public health policies is more important than ever. The initiative of the European Health Union highlights the importance of a more unified and prepared approach to ensure access to medicines and medical technology, collaboration on health preparedness and crisis response, and reinforcing healthcare infrastructure. The Harkness experience has given me a deeper understanding of the changes needed today to address the challenges of health care in the future. International collaborations as a strategic platform and mechanism to advance policy changes are something I will continue to build upon in my career.

Future Research

The study did not include comprehensive data on access to medications or drug spending in each system, which restricted the ability to assess the overall performance of different negotiation frameworks. The study focused on the processes and procedures that shape drug price negotiation. However, there are numerous exogenous factors, including how societies value health and how much countries can afford to pay, that may affect final agreed-on prices. Additionally, although interviewees underscored the primary importance of added therapeutic benefit and the certainty of evidence in drug price negotiations, they were not asked to formally rank different factors. Future research should quantify how officials (and the frameworks in which they operate) trade off different values when negotiating prices.