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

Explore Related HEOR by Topic


Your browser is out-of-date

ISPOR recommends that you update your browser for more security, speed and the best experience on ispor.org. Update my browser now

×