ADJUSTING THE COMMERCIAL VALUE OF EARLY-STAGE BIOMEDICAL TECHNOLOGIES FOR COST-EFFECTIVENESS- A VALUE-BASED APPROACH USING REAL OPTIONS
Author(s)
Shin D1, Regier DA2, Liggins R3
1University of British Columbia, Burnaby, BC, Canada, 2University of British Columbia, Vancouver, BC, Canada, 3Center for Drug Research and Development, Vancouver, BC, Canada
Presentation Documents
OBJECTIVES Cost-effectiveness analyses (CEA) of new drugs facilitate reimbursement decisions, thereby influencing the drug’s commercial value. The application of CEA to support early-stage investment decisions for drug candidates has been limited. The study developed a value-based real options pricing (VB-ROP) model to commercially value a phase II somatostatin receptor type-2 antagonist (SSTR2a) that prevents hypoglycemia for insulin-dependent type 1 diabetes patients. METHODS A VB-ROP model was constructed through consultation with industry players and investors. The model was developed in two stages: the first was a probabilistic Markov model with inputs informed through literature review; the second was a binomial lattice option pricing model to inform go/no-go decisions. The CEA assumed the SSTR2a to deliver a 50% clinical improvement relative to standard of care (basal-bolus insulin). The estimated annual value-based price using headroom analysis assumed a willingness to pay (WTP) of $50,000 USD per quality-adjusted life year (QALY) using a discount rate of 1.5%, which was incorporated into the real options model with inputs informed through market data and industry papers. RESULTS The annualized value-based price was $5,106 [95% CI $4160, $6071] USD with a 50% probability of being cost-effective at $50,000 USD/QALY. The real option value of investing in the phase II development of the SSTR2a was $6.55 million USD upon positive phase I results, which suggests exercising the option to invest in the technology. Sensitive model parameters include discount rate, market share, WTP, quality-of-life utilities, and the relative risk of non-severe hypoglycemia. Real options for phase III development should not be exercised if the phase II results for the SSTR2a are weak. CONCLUSIONS The VB-ROP model can be used to collectively evaluate clinical, economic, industry data to develop commercialization strategies for early-stage drug candidates using a value-based framework.
Conference/Value in Health Info
2019-05, ISPOR 2019, New Orleans, LA, USA
Value in Health, Volume 22, Issue S1 (2019 May)
Code
PDB91
Topic
Economic Evaluation, Health Policy & Regulatory, Methodological & Statistical Research, Organizational Practices
Topic Subcategory
Cost-comparison, Effectiveness, Utility, Benefit Analysis, Industry, Modeling and simulation, Reimbursement & Access Policy
Disease
Diabetes/Endocrine/Metabolic Disorders