ASSESSING THE RETURN ON INVESTMENT (ROI) OF HEOR & RWE TO THE BIOPHARMACEUTICAL INDUSTRY: CASE EXAMPLE OF ECONOMIC MODELING IN HEALTH TECHNOLOGY ASSESSMENT (HTA) SUBMISSIONS
Author(s)
David Thompson, PhD1, Vera Mastey, MS2, Montserrat Vera-Llonch, MD, MSc, MSPH3, Rob Abbott, MA4, Jan E. Hansen, PhD5, Sandra Nestler-Parr, MPhil, MSc, PhD6, Christopher M. Blanchette, MA, MBA, MSc, PhD7, Ravinder Dhawan, PhD8, Riad Dirani, PhD9, Murtuza Bharmal, MS, PhD10, Craig Roberts, MBA, PharmD11;
1Rubidoux Research LLC, Founder & Principal Consultant, Manchester, MA, USA, 2Regeneron Pharmaceuticals, Sleepy Hollow, NY, USA, 3Ionis, Carlsbad, CA, USA, 4ISPOR, Lawrenceville, NJ, USA, 5Sanofi, Scottsdale, AZ, USA, 6Biocryst Pharmaceuticals, Weybridge, United Kingdom, 7Novo Nordisk, Doylestown, PA, USA, 8Pfizer, New York, NY, USA, 9Teva Pharmaceuticals, West Chester, PA, USA, 10AstraZeneca, Boston, MA, USA, 11Merck, North Wales, PA, USA
1Rubidoux Research LLC, Founder & Principal Consultant, Manchester, MA, USA, 2Regeneron Pharmaceuticals, Sleepy Hollow, NY, USA, 3Ionis, Carlsbad, CA, USA, 4ISPOR, Lawrenceville, NJ, USA, 5Sanofi, Scottsdale, AZ, USA, 6Biocryst Pharmaceuticals, Weybridge, United Kingdom, 7Novo Nordisk, Doylestown, PA, USA, 8Pfizer, New York, NY, USA, 9Teva Pharmaceuticals, West Chester, PA, USA, 10AstraZeneca, Boston, MA, USA, 11Merck, North Wales, PA, USA
OBJECTIVES: Economic modeling has long been an essential component of HTA submissions. But model quality has been reported to vary widely across manufacturer submissions, which can impact the duration and outcome of HTA deliberations. The objective of this study was to understand the ROI to a biopharmaceutical company of investing additional upfront resources to enhance model quality in HTA submissions.
METHODS: We constructed a decision-analytic model to characterize the risks, costs, timing/range of agency recommendations, and potential commercial outcomes of the HTA submission process, highlighting the impact of investment in high-quality modeling. We linked each terminal node of the decision tree to a net present value (NPV) calculation that characterizes research and HTA submission costs and product revenue accrual over time and then discounts their values back to the modeling investment decision. Data from the published literature were used to estimate model parameters for a hypothetical product in development with projected $250 million annual revenue potential in the countries represented by the HTA agencies. A range of scenarios related to HTA outcomes (unrestricted recommendation, restricted recommendation, not recommended) was examined and extensive sensitivity analyses were performed.
RESULTS: In a conservative scenario in which no influence on HTA recommendation is assumed, investing an additional $500,000 to ensure high-quality economic modeling is associated with a 3-month reduction in the duration of HTA deliberations, leading to an expected NPV advantage of 13,734,000 and 27-fold ROI. In a hypothetical scenario in which a 5-percentage-point increase in the likelihood of unrestricted recommendation is incorporated, expected NPV advantage and ROI rise to $40,130,000 and 80-fold. Results were robust to a range of plausible investments in economic modeling.
CONCLUSIONS: Biopharmaceutical company investments to enhance the quality of economic modeling for HTA submissions can yield a strong ROI, as mediated by streamlined HTA deliberations and potentially higher likelihood of achieving favorable recommendations.
METHODS: We constructed a decision-analytic model to characterize the risks, costs, timing/range of agency recommendations, and potential commercial outcomes of the HTA submission process, highlighting the impact of investment in high-quality modeling. We linked each terminal node of the decision tree to a net present value (NPV) calculation that characterizes research and HTA submission costs and product revenue accrual over time and then discounts their values back to the modeling investment decision. Data from the published literature were used to estimate model parameters for a hypothetical product in development with projected $250 million annual revenue potential in the countries represented by the HTA agencies. A range of scenarios related to HTA outcomes (unrestricted recommendation, restricted recommendation, not recommended) was examined and extensive sensitivity analyses were performed.
RESULTS: In a conservative scenario in which no influence on HTA recommendation is assumed, investing an additional $500,000 to ensure high-quality economic modeling is associated with a 3-month reduction in the duration of HTA deliberations, leading to an expected NPV advantage of 13,734,000 and 27-fold ROI. In a hypothetical scenario in which a 5-percentage-point increase in the likelihood of unrestricted recommendation is incorporated, expected NPV advantage and ROI rise to $40,130,000 and 80-fold. Results were robust to a range of plausible investments in economic modeling.
CONCLUSIONS: Biopharmaceutical company investments to enhance the quality of economic modeling for HTA submissions can yield a strong ROI, as mediated by streamlined HTA deliberations and potentially higher likelihood of achieving favorable recommendations.
Conference/Value in Health Info
2026-05, ISPOR 2026, Philadelphia, PA, USA
Value in Health, Volume 29, Issue S6
Code
HTA53
Topic
Health Technology Assessment
Topic Subcategory
Decision & Deliberative Processes
Disease
No Additional Disease & Conditions/Specialized Treatment Areas