Abstract

Objective: To evaluate the cost-effectiveness of dabrafenib plus trametinib combination therapy versus vemurafenib as first-line treatment in patients with BRAF V600 mutation-positive unresectable or metastatic melanoma from a healthcare system perspective in China. Methods: This study employed a partitioned survival model with three health states (progression-free survival, post-progression survival and dead) to parameterize the data derived from Combi-v trial and extrapolated to 30 years. Health states’ utilities were measured by EQ-5D-3L, also sourced from the Combi-v trial. Costs including drug acquisition costs, disease management costs and adverse event costs were based on the Chinese Drug Bidding Database and physician survey in China. The primary outcomes of the model were lifetime costs, life-years (LYs), quality-adjusted life-years (QALYs) and incremental cost-effectiveness ratio (ICER). Deterministic and probabilistic sensitivity analyses were conducted, respectively. Result: Dabrafenib plus trametinib is projected to increase a patient’s life expectancy by 0.95 life-years over vemurafenib (3.03 vs. 2.08) and 1.09 QALY gains (2.48 vs. 1.39) with an incremental cost of $3833. The incremental cost-effectiveness ratio (ICER) was $3511 per QALY. In the probabilistic sensitivity analyses, at a threshold of $33,357 per QALY (three times the gross domestic product (GDP) per capita in China in 2020), the probability of dabrafenib plus trametinib being cost-effective was 90%. In the deterministic sensitivity analyses, the results were most sensitive to the dabrafenib plus trametinib drug costs, vemurafenib drug costs and discount rate of cost. Conclusion: Dabrafenib plus trametinib therapy yields more clinical benefits than vemurafenib. Using a threshold of $33,357 per QALY, dabrafenib plus trametinib is very cost-effective as compared with vemurafenib in China.

Highlights

  • Melanoma is an aggressive type of malignant tumor arising from melanocytes, typically in the skin, and presents severe clinical, economic and societal burden [1]

  • The time horizon was 30 years, starting from patients entering the model. This analysis was conducted from a Chinese healthcare system perspective; only direct healthcare costs related to treatment of metastatic melanoma were considered

  • This study is the first analysis after the 2020 National Reimbursement Drug List (NRDL) updated to evaluate the health and economic outcomes of dabrafenib plus trametinib treatment as a first-line treatment for patients with BRAF V600 mutation-positive unresectable or metastatic melanoma in China

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Summary

Introduction

Melanoma is an aggressive type of malignant tumor arising from melanocytes, typically in the skin, and presents severe clinical, economic and societal burden [1]. Melanoma is a relatively common malignancy in the West, but has a lower incidence in Asians [2,3]. In 2018, global new cases of melanoma of skin were estimated to be 287,723, accounting for 1.6% of all sites of cancer, and 60,712 cases died, accounting for 0.6% of all cancers [4]. Melanoma is relatively rare in China, which had an estimated 8000 new cases and 3200 deaths in 2015 [5]. Dacarbazine (DTIC) was the only first-line treatment approved for advanced or metastatic melanoma in China, despite the limited clinical benefits [7,8]

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