Contributed by:
Anne Heyes, MBA
Vice President, Head of Value & Access, Europe
RTI Health Solutions
US Inflation Reduction Act (IRA)
The Inflation Reduction Act 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 act 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 HTA Regulation
European Regulation on health technology assessment 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 regulation 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 (JCAs)/Joint Scientific Consultations (JSCs)
Joint clinical assessments and joint scientific consultations (which give manufacturers the opportunity to seek early scientific advice) will be introduced as part of the EU regulations. 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 had their own guidelines. JCA guidelines aim to bring standardization and greater equity to health technology assessments to all EU member countries. The European Union 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 JCA and IRA are bringing are 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.