Heterogeneity in Relative Efficacy Assessments (Rea) across European Hta Bodies: Opportunity for Improving Efficiency and Speed of Access to Patients?

Abstract

of novel drugs to patients and fosters divergence in reimbursement status. The objectives were to identify differences in REA by EU-HTA agencies, discuss the impact of this variation on time to patient access and assess the potential benefits of a centralized REA. Methods: Differences in clinical assessment across EU-HTA bodies were analysed for selected EMA approved Novartis drugs (internal data and structured telephonic interviews with Novartis Country Pharma Organisations (CPOs) and drugs marketed by other companies (literature review). Results: Differences in acceptance of comparators, subgroups and end-points were seen in REA across countries. Although fingolimod, secured wide reimbursement in EU for Relapsing-Remitting Multiple Sclerosis (RRMS), HTA bodies differed in their end-points' acceptance. Example, UK accepted annual relapse rate, disability progression and MRI-lesions, while Germany didn't accept the latter as end-point. Variations were seen in countries' requirements for additional analysis to support REA. Example, Germany granted a 'small additional benefit' rating for Rapidly Evolving Severe RRMS subgroup based on indirect comparison, while, even an additional mixed treatment comparison couldn't support REA for this subgroup in UK. Amongst non-Novartis drugs; pertuzumab review by IQWIG and GBA resulted in different end-point acceptance, with negative and restricted access recommendation, respectively. For sofosbuvir, HTA bodies differed from EMA label and saw clinical value only in some patient subgroups. Example, IQWIG recommended the drug for only HCV genotype-2 whereas ZIN (Netherlands) recommended it for genotype-1 and 4. CPOs' survey indicated that centralized EU-REA could reduce time to patient access (by ~3-4 months), through avoiding repetitive clinical evaluation and saving time on pricing/reimbursement pathway. ConClusions: Harmonized REA has the potential to reduce delay in patient access, strengthen the equity of care and increase predictability of expectations from pharmaceutical companies' research programs.