Contributed by:
Anne Heyes, MBA
Vice President, Head of Value & Access, Europe
RTI Health Solutions
United States Inflation Reduction Act
The Inflation Reduction Act (IRA) aims to improve access to affordable treatments for people with Medicare in the United States. It allows Medicare to negotiate prescription drug prices with manufacturers and put an inflation cap on drug costs. The IRA was implemented in 2023, and its impacts are already being felt. Government negotiation of drug pricing within the Medicare system is becoming a reality. The first 10 drugs have been selected for the new Medicare Drug Price Negotiation Program and have begun their journey through the process. In 2024, 15 more drugs will be chosen for the program.
European Health Technology Assessment Regulation
The European Regulation on Health Technology Assessment (HTAR) is due to be introduced in January 2025 for new oncology medicines, advanced therapies (also known as cell and gene therapies), and medical technologies. As the HTAR moves along in its development, directives regarding rare disease therapies will be introduced in January 2028. And finally, regulation for all new medicines will start in January 2030. This has left some wondering if line or label extensions, known as type 2 variations at the EMA, will be included in the legislation. As of now, the answer is yes—they will.
Joint Clinical Assessments/Joint Scientific Consultations
Joint clinical assessments (JCAs) and joint scientific consultations (which give manufacturers the opportunity to seek early scientific advice) will be introduced as part of the EU HTAR. They will significantly alter the requirements and procedures for HTAs, market access, and pricing across Europe. Drug developers have been operating within the regulations of each country where they were seeking approval, as each country has their own guidelines. JCA guidelines aim to bring standardization and greater equity to HTAs to all EU member countries. The EU has proposed a sweeping revision of its pharmaceutical legislation—the largest change in 20 years. The new law, expected by 2025 or 2026, aims to shorten the period of regulatory protection. However, it incentivises the development of therapies that address high unmet medical needs as well as the use of comparative, rather than single arm, clinical trials.
While preparation for the changes that JCAs and the IRA are bringing is applicable to pretty much all drug development in the EU, the potential of being chosen for the Medicare Drug Price Negotiation is more limited, but there may be some indications as to which drugs might be chosen for negotiation.
Take a look at our additional articles on the topic of Joint Clinical Assessments
Joint Clinical Assessments and Joint Scientific Consultations: Let's All Work Together
What New Practical Realities Will Joint Clinical Assessments and Medicare Price Negotiations Bring?
Joint Clinical Assessments: Racing to the Finish Line at What Cost?
Navigating EU Joint Clinical Assessments and Joint Scientific Consultations from January 2025 Onward