OBJECTIVES : We aim to understand price erosion magnitude associated with indication expansion for select Oncology and Orphan products and determine other factors that influence price in Germany and France.

METHODS : Three oncology products were selected that launched post-2010 and expanded indications. Two of these products had Orphan Designation. Secondary research focused on the launched indications, target population for each indication, HTA assessments and price trajectory for each product in France and Germany.

RESULTS : In France, products that expanded into small patient populations, such as Imbruvica into WM and Gazyvaro into FL, faced minimal price erosion. Other factors that may have mitigated further price erosion could be the compelling clinical evidence submitted for some indications (e.g., Imbruvica in R/R MCL had its ASMR change from 4 to 3 after it was re-reviewed based on Phase III data). However, products that expanded into larger patient populations, such as Lynparza from ovarian cancer into mBC and prostate cancer, saw a more pronounced impact on price, with 22% erosion observed in 2019 following negotiations.

In Germany, all three products faced greater scrutiny upon expansion. Besides a significant discount given at the end of free pricing, ~3-5% decrease was observed upon expansion into smaller patient populations (e.g., Gazyvaro in FL) while ~7-10% decrease was observed upon expansion into larger indications (e.g., Lynparza in mBC and prostate cancer).

CONCLUSIONS : Manufacturers often struggle to predict the commercial impact of multi-indication strategies on value preservation in EU markets. Erosion is driven by launch price, market-specific (e.g., size of target population), and product-specific factors (e.g., strength of clinical / economic evidence). Geography nuances (e.g., free pricing in year one post-launch, a higher level of scrutiny on clinical evidence, and methodological expectations in Germany vs. France) can also impact price trajectory for orphan and oncology agents upon label expansion.