OBJECTIVES

: Ceritinib is a novel second-generation anaplastic lymphoma kinase (ALK) inhibitor approved in China for the treatment of patients with ALK-positive locally advanced or metastatic non-small cell lung cancer (NSCLC). This analysis was to evaluate the budget impact of ceritinib as the first-line and second-line treatment for ALK-positive advanced NSCLC, from the national insurance payer’s perspective in China during 2021-2023.

METHODS

: An excel-based budget impact model was developed. Model inputs, such as epidemiological data, treatment failure rate, survival data (OS, PFS), resource use, and direct medical costs, were obtained from expert interviews, clinical trials, published literatures and other publicly available sources. Direct medical costs included drug costs, lab and image costs, physician visit costs and costs of adverse events. Market share projections were derived from market research data. Two scenarios that listing and delisting ceritinib in the National Reimbursement Drug List (NRDL) were modeled. The robustness of the results was tested by deterministic sensitivity analyses (DSA).

RESULTS

: The introduction of ceritinib in NRDL would potentially increase 4.0 million, 48.9 million, and 52.6 million Chinese Yuan (CNY) as first-line treatment from 2021 to 2023 respectively. However, including ceritinib in the NRDL could save 3.2 million, 30.8 million and 9.2 million CNY in the second-line treatment from 2021 to 2023, respectively. In the total cost budget impact scenario, given China’s annual reimbursement expenditure was over 2,000 billion CNY in 2019, including ceritinib in the NRDL would potentially increase 1.2 million (0.00006%), 21.4 million (0.00107%), 46.9 million CNY (0.00235%) from 2021 to 2023 respectively, totaling 69.6 million in three years. DSA results indicated that the results were relatively insensitive to most parameters except for LC incidence.

CONCLUSIONS

: The analysis showed that inclusion of ceritinib in China’s national reimbursement list would result in a modest budget impact over a time horizon of 3 years.