Improving Access to Behavioral and Mental Health Therapies in the EU

This research article assesses the evidence generation strategies aimed at optimizing health technology assessment (HTA) outcomes and enhancing access to therapies for neurological indications, including mental disorders, in Europe. It outlines the significant burden of mental disorders in Europe, where one in six individuals is affected daily, and highlights the challenges in accessing effective treatments. The study documents various therapies, such as AIMOVIG, QUVIVIQ, and SPINRAZA, which have submitted supplemental evidence to improve their HTA ratings. It notes that while neurological therapies generally achieved favorable outcomes, mental health therapies like BUVIDAL and ZUBSOLV faced difficulties due to insufficient evidence demonstrating sustained clinical benefits. The article emphasizes the importance of using patient-reported outcomes and real-world evidence in supporting HTA submissions. It concludes that despite the challenges, innovative evidence generation strategies could improve access to mental health therapies across Europe.