OBJECTIVES

: A drug that improves survival can increase the chance for patients to benefit from future innovations, thereby creating real option value (ROV). Few studies have estimated the ROV of drugs at the time of launch. Our objective was to estimate the ex ante ROV for first-line alectinib in anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC).

METHODS

: We developed a Markov model to estimate the expected additional life-years (LYs) and quality-adjusted life-years (QALYs) gained due to potential future arrivals of second-line drugs with first-line alectinib compared to crizotinib. Transition probabilities were derived from the phase 3 trial of first-line alectinib and phase 2 trial of second-line brigatinib. Future drug arrivals were projected using ongoing phase 2 and 3 trials in ALK-postiive NSCLC at the time of alectinib’s first-line approval. The likelihood and timing of arrival were based on published statistics on the success rate of targeted oncology drugs and the time to approval of previous ALK inhibitors in NSCLC. The potential efficacy of future drugs was projected using the overall response rate of the new drugs from their phase 2 studies at the fime of first-line alectinib launch, and the uptake was assumed to be 75%.

RESULTS

: The discounted incremental LYs and QALYs for alectinib increased by 11.0% (1.42 vs. 1.28) and 9.8% (1.14 vs. 1.04), respectively, after accounting for future drug arrivals. The incremental ROV of alectinib was sensitive to variations in the efficacy of the innovative drugs, the probability of future drug approval, and the uptake level.

CONCLUSIONS

: The ex ante ROV of alectinib was estimated to be 9-11% of its conventional value. These findings support the potential importance of considering ROV when assessing the value of new medicines in clinical areas with an anticipated high level of innovation.