PNS277 THE ROLE OF EARLY VALUE FRAMEWORK IN A SUCCESSFUL REIMBURSEMENT JOURNEY

Abstract

Early in the product lifecycle, industry leaders typically focus on regulatory hurdles at the expense of reimbursement considerations. Health Technology Assessment (HTA) evidence requirements differ from regulatory bodies and our objective was to elucidate early HTA-focused initiatives to facilitate an efficient reimbursement journey. Structured interviews with four industry experts and a targeted literature search were conducted to identify reimbursement obstacles and to provide complementary solutions applicable in early development phases. Interviews resulted in two recommendations and a targeted search yielded two supporting publications. The first recommendation included a comprehensive evidence review of available therapies, effectiveness, humanistic and economic outcomes in the target population, to identify data gaps which would need to be addressed. Furthermore, determining potential target population size and pricing bands, supported by assumed clinical benefits, would improve understanding of product viability. The second recommendation highlighted the benefits of early economic modelling to assess the viability of commercialization; an essential consideration before late-phase trial investment. Simple models were generally recommended, as data are likely to be limited. The targeted search found two examples of highly valuable early models. One identified a subgroup of patients (men, age 50-70) in which screening for gastric cancer would be cost-effective, potentially avoiding a costly RCT in a much larger population (Parsonnet et al., 1996). The other identified the most cost-effective solution in preventing fractures in elderly women across seven strategies, potentially reducing the number of comparators in a costly trial (Togerson et al., 1997). An early value framework composed of a comprehensive evidence review and an early economic model would provide decision-makers a clearer understanding of their target population size, current treatment paradigm and financial viability of their product. This in turn, would enable HTA-considerations in trial development and evidence generation further ensuring a smoother market access journey.