Health Technology Assessment Lifecycle Concepts: A Scoping Review Outlining the Change in Policies to Manage Uncertainties Associated With Reimbursement of Medicines.

OBJECTIVE: Health Technology Assessment (HTA) agencies aim to evaluate the value of a health technology at specific points in its lifecycle. However, much remains unclear about how HTA lifecycle concepts are employed and which stakeholders are involved. We aimed to clarify the use of HTA lifecycle concepts and how they relate to each other to facilitate implementation and outline next steps for policy development. METHODS: Following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for Scoping Reviews, we analyzed scientific and policy literature on HTA lifecycle concepts for medicines in the PubMed, Embase, and Overton databases. Data were extracted using standardized forms and analyzed both descriptively and using a directed qualitative content analysis. RESULTS: We identified 60 scientific studies and 5 policy documents covering five different HTA lifecycle concepts. Health Technology Reassessment (HTR), Health Technology Management (HTM), and Lifecycle HTA (LC-HTA) were most frequently described in scientific literature (respectively, 22, 17, and 10 studies). We found that the activities of these concepts partially overlapped, but often differed in their content. In addition to activities identified in HTR and HTM, LC- HTA included pre-market entry activities that facilitate planning of risk mitigation strategies. CONCLUSIONS: The anticipatory nature and content of activities within LC-HTA led to it emerging as the most appropriate for addressing the clinical and financial risks to the initial reimbursement decisions for contemporary medicines. Both capacity building and further development of triaging for risk-based reimbursement pathway assignment can aid in the implementation of LC-HTA in practice.