A New Time Horizon for the European Pharmaceutical Market
Starting in January 2025, the European Health Technology Assessment (EU-HTA) will gradually become part of the market access process for new medicines. The goal of EU Regulation 2021/2282 is to conduct clinical assessments collaboratively at the European level, reduce the burden on national processes, and avoid duplication of effort.
In 2026, the system will face its first major test: On May 15, 2026, the first German AMNOG procedure based on a prior European assessment was launched. A decision by the Federal Joint Committee (G-BA) is expected in November 2026. At this stage, this new development primarily affects oncology drugs and advanced therapy medicinal products (ATMPs). By 2030, the joint procedure is to be expanded to include all centrally approved drugs.
According to the IQWiG: “The subject of the first Joint Clinical Assessment (JCA) was the anticancer drug tovorafenib for the treatment of pediatric low-grade malignant gliomas. For Germany, the Institute for Quality and Efficiency in Health Care (IQWiG) participated as a co-assessor. Together with the National Center for Pharmacoeconomics in Ireland, it prepared the report.”
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mRNA Vaccines: From Pandemic Protection to Cancer Therapy
mRNA-based cancer treatments fall precisely within this first phase of the EU HTA regulation. Drugs of this type deliver the genetic blueprint for proteins into cells in order to specifically activate the body’s own immune system against tumor cells. This medical breakthrough is also documented in the Deutschlandfunk report “Vaccination with mRNA: First COVID-19, Now Cancer, ” which traces the path of mRNA from infectious disease biology to oncology.
Clinical trials are currently investigating the effectiveness of vaccine-based approaches that are individually tailored to the genetic changes (neoantigens) of the specific tumor. For example, studies on colorectal and pancreatic cancer are underway at St. Josef Hospital at Ruhr University Bochum. At the University Medical Center Hamburg-Eppendorf, this approach is also being tested for malignant melanoma in combination with checkpoint inhibitors to further boost the body’s own immune response.
To meet the growing demand for these personalized therapies in the future, seven Fraunhofer Institutes are collaborating on the “RNAuto” project. They have developed an automated, digitally controlled production platform that can manufacture mRNA therapeutics in a scalable and cost-effective manner using digital twins and integrated sensor technology. A concurrent EU HTA benefit assessment could bring such technological developments into clinical practice more quickly.
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Data as the Foundation of Evidence-Based Benefit Assessment
Whether an innovative therapy, such as an mRNA vaccine, is covered by health care systems depends fundamentally on the generation of valid data. In Germany, the G-BA is responsible for determining the scope of the national assessment (the so-called PICO question). As part of the Joint Clinical Assessment (JCA) at the EU level, the submitted clinical data is evaluated, while the decision regarding added benefit remains with the member states.
In this context, routinely collected health data (RCD) is becoming increasingly important alongside traditional clinical trials. An international research consortium involving LMU Munich and the University Hospital Bonn has published guidelines on the use of such routinely collected data in the journal *The BMJ*. This approach allows for the representation of large patient populations under real-world care conditions, thereby strengthening the quality and transparency of evidence-based medicine. Such data are important for institutions like the IQWiG in assessing the long-term benefits of therapies in everyday clinical practice.
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The Pharmaceutical Industry in a Global Competitive Environment
For the pharmaceutical industry, the interplay between EU HTA, clinical trial data, and production is creating a tangible need for action. Pharmaceutical innovations emerge in a competitive global environment; investments tend to flow toward regions with reliable and expedited approval and reimbursement processes. In this regard, Europe is under pressure from the United States and China. Fragmented national procedures undermine the region’s appeal as a business location, which is why there is a need for efficient integration of European processes.
At the same time, personalized therapies such as mRNA cancer vaccines—whose annual treatment costs per patient can be high (estimated at over 100,000 euros)—pose financial challenges for healthcare systems. Industry associations such as the BPI and Pharma Deutschland are therefore calling for adapted valuation and reimbursement models, such as pay-for-performance approaches, to ensure market access for oncology drugs. German policymakers are attempting to shape the regulatory framework through the Medical Research Act (MFG) and the structured “Pharma Dialogue,” which is set to be incorporated into a national pharmaceutical and medical technology strategy in 2026.
