Objectives

Due to the different evidence requirements and archetypes of HTA bodies, forecasting the value of a new product is a challenge. Value and price are correlated and can be applied to determine the price of new products. The aim of this study was to forecast and validate the price of darolutamide in England, France and Germany using a value framework approach.

Methods

Using multi-criteria decision analysis, the value scoring framework based on payer decision-making was established for high-cost oncology products. Comparators in hormone-relapsed prostate cancer (abiraterone, enzalutamide, and apalutamide) and darolutamide were scored within the value framework based on data within HTA appraisals or, if unavailable, from other published literature. Value scores were plotted against reimbursed price for each product in France and Germany, or QALY gains in England to derive a linear regression and forecast the price of darolutamide. Results were validated by comparison to reimbursed price.

Results

A strong positive correlation between value score and reimbursed price was observed for France (R² = 0.90) and Germany (R² = 0.90); similar results were derived with QALY gain in England (R² = 1.00). Based on the correlations, price of darolutamide was estimated to be £52,199 in England (vs. list price of £52,664); €37,936 in France (vs. reimbursed price of €45,104) and €37,483 in Germany (vs. post-AMNOG price of €34,488). An average difference of 8.63% (0.88% - 16.00%) was observed for the forecasting price of darolutamide and the actual price.

Conclusion

This analysis suggests that establishing the value-price or value-QALY gain relationship for a selection of drugs in the same indication can be applied to accurately forecast the reimbursed price of a new product. Limitations include a small comparator basket and forecast comparison versus list price in England. Further validation of this method is required in other indications.