OBJECTIVES

Indication expansion has been the cornerstone of lifecycle management of biopharmaceutical products to cater to unmet needs of different patient populations. While standardized HTA assessments in EU tend to evaluate indications on their own merit, accompanying patient volume impacts the pricing of subsequent indications after launch. The objective of this research was to identify trends correlating the HTA ratings and patient population on price erosion in both oncology and non-oncology drugs, in France & Germany.

METHODS

We reviewed nivolumab, that has gone through multiple indication expansion since its approval; HTA ratings and expected patient volume per indication were extracted from HAS & G-BA evaluation documents, whereas pricing data were obtained from IHS Markit database. Cost per patient per year was calculated based on duration of treatment highlighted in the EMA label.

RESULTS

In France, nivolumab launched in three indications (melanoma, NSCLC and RCC) almost simultaneously, all with ASMR III, with either substantial or important, SMR ratings. It’s subsequent indication in cHL noticed a dramatic drop of 21% in list price, despite an insignificant increase in patient volume – likely driven by inferior ASMR V rating. In Germany, nivolumab obtained ‘considerable benefit’ in melanoma and NSCLC, same as in RCC when launched. However, a 30% increase in patient volume for RCC resulted in 13% price erosion (despite similar HTA assessments). ‘No additional benefit’ rating for cHL resulted in additional 9.5% list price erosion despite an insignificant increase in patient population. Similar analysis of key non-oncology product is currently underway.

CONCLUSIONS

Despite comparative effectiveness data requirement in HTA countries, patient volume still has considerable impact on price erosion and effective list price due to indication expansion. Launch sequencing for lifecycle management of biopharmaceutical innovations must take these analyses into consideration for effective planning in EU.