OBJECTIVES: The evidence required by health technology appraisal (HTA) agencies to assess the cost-effectiveness of new therapies is often limited to quality-adjusted survival and direct costs. The inclusion of additional elements of value meaningful to patients is often excluded by HTAs. A limited number of studies have been conducted to assess the impact of including novel value elements in HTA cost-effectiveness analyses (CEAs).

METHODS: To evaluate the impact of including novel value elements in a United States (US) HTA-compliant CEA developed for CheckMate 9LA (24-month minimum follow-up). CheckMate 9LA compared nivolumab plus ipilimumab plus 2 cycles of platinum doublet chemotherapy (N+I+PDC) versus 4 cycles of PDC in first-line metastatic non-small cell lung cancer (mNSCLC). The CEA was adapted to include patients’ and caregivers’ indirect costs, patients’ hope, option value, and insurance value. These novel value elements were quantified after having identified mNSCLC-specific studies. The analysis compared the net monetary benefit (NMB) of N+I+PDC versus PDC in a traditional payer, traditional societal, and broad societal setting.

RESULTS: N+I+PDC resulted in higher costs and quality-adjusted life-years (QALYs) compared with PDC performing a traditional payer perspective CEA ($190,281 incremental costs, 1.23 incremental QALYs). The NMB was -$6,232 at a willingness-to-pay threshold of $150,000/QALY, suggesting that costs exceed benefits. A slight increase in incremental costs was observed after expanding the CEA to a traditional societal perspective ($190,281 versus $190,292). A significant improvement in incremental QALY was observed (1.23 versus 2.71) after further expanding the CEA to a broad societal perspective. This perspective, resulting in +$210,834 NMB, indicated that N+I+PDC benefits outweighed its costs.

CONCLUSIONS: HTA-compliant CEAs for N+I+PDC in first-line mNSCLC have previously demonstrated acceptable value for money in the US. This study showed that novel value elements provide a more favorable and complete value assessment and should therefore be considered by HTAs.