An in-depth analysis conducted using GlobalData’s Price Intelligence (POLI) & Health Technology Assessment (HTA) database has shed light on the evolving HTA landscape within France and Germany from 2019 to 2023. HTAs, as defined by the World Health Organization, play a pivotal role in evaluating new health technologies against existing treatments, significantly influencing pricing and reimbursement decisions. This study reveals the dynamic nature of health technology assessment evaluations in these two key European markets, offering insights into the future of healthcare innovation assessment.
Over the past five years, France and Germany have seen a 7% average annual increase in health technology assessment decisions. In 2023 alone, 148 decisions were made across 89 brands, marking a slight decrease from the previous year. Despite a relatively stable volume of evaluations, the distribution between the two countries has seen notable shifts. France experienced a decrease in decisions, a trend linked to a revised early access scheme introduced in 2021. Conversely, Germany has witnessed a consistent rise in evaluations since 2020, culminating in an 11% increase in 2023 compared to the prior year.
A Comparative Insight into France and Germany’s Health Technology Assessment Decisions
The period from 2019 to 2023 has predominantly seen positive or neutral health technology assessment outcomes, enabling either full or partial reimbursement for products. France, however, has been conservative in awarding its highest innovation ratings, with Pfizer’s Nimenrix being a rare recipient of an ASMR I rating in 2021. The majority of decisions in France in 2023 fell under an ASMR III rating. Germany displayed greater leniency in granting high innovation ratings, with a notable number of decisions deemed of considerable benefit. The year 2023 marked a shift in Germany with neutral decisions outnumbering positive ones for the first time, potentially leading to more rigorous price negotiations.
Oncology dominated HTA assessments in both countries in 2023, with a significant portion of unique indications evaluated within this therapeutic area. The vast majority of oncology decisions resulted in reimbursement, highlighting the sector’s continued investment priority. Immunology, infectious disease, cardiovascular disorders, dermatology, respiratory, and ophthalmology also saw positive reimbursement outcomes, with no negative decisions reported.
Orphan Medicines and Health Technology Assessment Dynamics
The evaluation of orphan medicines saw a 17% increase in 2023, predominantly within Germany, as France experienced a decline in orphan drug assessments since 2021. Despite this, France’s modifications to its early access scheme have made it an appealing market for orphan drugs, facilitating earlier launches under this program before undergoing traditional HAS assessment.
While the overall number of health technology assessment evaluations remained stable into 2023, there has been a noticeable reallocation of assessments between France and Germany. As France leans more on its early access to innovative drugs, the count of HTA evaluations has decreased. Germany, on the other hand, has expanded its evaluations but faced a rise in less favorable outcomes. With the anticipated introduction of EU-wide joint HTAs in 2025, starting with oncology and advanced therapy medicinal products, a significant transformation in the HTA landscape is expected, promising to reshape the way health technologies are assessed across Europe.
Resource: Pharmaceutical Technology, March 18, 2024

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