OBJECTIVES: Many countries utilize Value Assessment Frameworks (VAF) or Health Technology Assessments (HTA) to inform market access and reimbursement for innovative medicines. We sought to characterize the absolute and relative strengths, challenges, and limitations of five well-established VAFs from the perspective of the biopharmaceutical industry, and to determine if each VAF’s stated objectives aligned with observed reimbursement outcomes.

METHODS: For each country’s VAF, we first reviewed published documentation (government websites, peer-reviewed literature) to capture stated principles and procedures of assessment, appraisal, and pricing. We then qualitatively ranked the VAFs on scales of: transparency (regarding data requirements, published assessment outcomes, translation of value into price); flexibility (in comparator selection and consideration of non-RCT data); stakeholder engagement (influence of patients, industry, and clinicians in the assessment process); access to innovative medicines. Initial rankings were refined based on double-blinded interviews with 40 executives from biopharmaceutical companies, country trade association representatives, and HTA thought leaders. Finally, we conducted a precedent analysis of reimbursement outcomes for 12 recently launched innovative medicines that had been reviewed by multiple VAFs and represented a range of therapeutic areas.

RESULTS: England rated highest relative to other VAFs on stakeholder engagement and flexibility of comparator and data requirements, while Germany fared best on patient access to innovative medicines across therapeutic areas. France, South Korea, and Australia were more likely to delay access to rare disease and oncology therapies. Though more opaque in how assessments translated to reimbursement, interviewees noted a preference for the “added clinical benefit” VAFs in France and Germany, compared with ICER-based VAFs.

CONCLUSIONS: The innovative biopharmaceutical industry recognizes relative advantages and drawbacks of established VAFs, and its assessments are supported by empiric reimbursement outcomes across therapeutic areas. Countries interested in attracting multinational pharmaceutical investment and products should understand the nuances and lessons of established systems before imposing new VAF processes.