OBJECTIVES: This research explored health technology assessment (HTA) outcomes for behavioral therapies to identify key evidence generation strategies for optimizing access in Europe.

METHODS: The EMA website was searched to identify branded therapies approved between 2011 and 2021. The identified therapies were screened for mental health indications, including schizophrenia, migraine, Parkinson’s, Alzheimer’s, and other psychological disorders. A deep-dive analysis of the evidence package and HTA outcomes of selected analogues in Germany, France and the UK was performed.

RESULTS: Historically, access to branded mental and behavioral health therapies has been sparse in Europe. Despite the substantial unmet need for novel mental health therapies, there is a notable disconnect between evidence requirements for favorable HTAs and feasibility to deliver from a clinical perspective. Among the analogues explored, the lack of comparative evidence and rationale for the use of placebo was partly driving unfavorable HTA outcomes. Even in indications with no clear on-label active comparator (e.g., SPRAVATO in treatment-resistant depression), HTA agencies challenged the use of placebo and still expected to see comparative evidence against off-label therapies. Despite these challenges, other supplemental evidence such as natural history studies and long-term quality of life data were considered valuable in HTAs. Additional methodologies implemented by some of these analogues to enhance access included engagement in disease awareness campaigns and strong support from medical organizations and patient support groups.

CONCLUSIONS: The research showed that HTA agencies still expect appropriate comparators to be utilized, long-term benefit of the therapy to be demonstrated, and patient-relevant outcomes to be proven. Evidence generation and value communication strategies such as commitment to long-term and real-world data collection, payer education through engagement with key opinion leaders and patient advocacy can be employed to achieve access to innovative behavioral therapies in Europe.