OBJECTIVES

To estimate the potential budget impact of adjuvant treatment using checkpoint inhibitors and BRAF targeted treatments, for stage III resected melanoma in Ireland.

METHODS

A budget impact model was developed in line with the Guidelines for Budget Impact Assessment produced by the Health Information and Quality Authority, Ireland. The perspective was that of the drugs budget in the publicly funded health system. Time horizon was 5 years. Included regimens were nivolumab, pembrolizumab, and dabrafenib in combination with trametinib (DAB-TRAM), in line with the dosing schedules in the product licenses. Drug costs were estimated based on median treatment duration in the pivotal trials. Routine care was observation; analysis of national drug reimbursement data showed little use of interferon. It was assumed that 75% patients would receive a checkpoint inhibitor, evenly split between nivolumab and pembrolizumab, and the remaining 25% DAB-TRAM. Eligibility was estimated based on incident melanomas (2015) and a weighted average of the annual percentage change, using National Cancer Registry data. Uncertainty was considered using one-way sensitivity analysis (OWSA) and scenario analyses. Costs are VAT inclusive.

RESULTS

The predicted cost per patient treated was €139,032, €99,743 and €138,668 for pembrolizumab, nivolumab and DAB-TRAM respectively. It was estimated that 162 patients would be eligible for treatment in 2019, increasing to 188 by 2023. The estimated 5-year gross budget impact was €108.4 million. Since there were no cost-offsets, this also represents the net budget impact. Cost offsets in the metastatic setting were not considered, given the immaturity and paucity of data on retreatment in the metastatic setting. Eligible patient population and estimated drug costs were drivers of uncertainty in OWSA; estimates ranged from €86.7 million to €138 million. Estimates were robust to scenario analysis.

CONCLUSIONS

Provision of adjuvant treatments for melanoma in Ireland is expected to be associated with significant drugs budget impact.