OBJECTIVES: After crizotinib approval in 2011 for patients with non-small-cell lung carcinoma (NSCLC), an increase in anaplastic lymphoma kinase (ALK) testing has been observed. The objective of this review was to understand the recommended tests and coverage policies for ALK testing.

METHODS: A structured literature review was conducted using Medline^® and handsearching of relevant websites on 15^th May 2018. Studies reporting the recommended tests and coverage policies across Organisation for Economic Co-operation and Development (OECD) countries were included.

RESULTS: ALK mutation testing is highly recommended at diagnosis in patients with advanced adenocarcinoma NSCLC. Fluorescence in situ hybridisation (FISH) is considered the gold standard, while immunohistochemistry (IHC) is potentially supportive in identifying patients for further investigation. Due to high failure rates, reverse transcription polymerase chain reaction (RT-PCR) is not recommended frequently. Across OECD countries, coverage policies for ALK testing differs. In Europe, reimbursement comes from different sources, including insurance companies, manufacturers, and the global hospital budget. In France and Italy, public and private agencies reimburse testing costs, while manufacturers reimburse in Spain. In the UK, ALK testing is assumed to be part of routine diagnostic testing. The Czech Republic, Hungary, Israel, Poland, Slovakia, Slovenia, and Turkey follow European guidelines, and testing costs are partly or fully reimbursed by the national health authorities. In the US, most of the managed care policies provide coverage. In Canada, source of funding varies across provinces. In Australia, costs are funded through government policies. Germany and Republic of Korea lag in reimbursement, however there was limited evidence to support the findings. No information was found around the coverage policies in 20 other countries.

CONCLUSIONS: Clinical guidelines support ALK testing in patients with NSCLC. Variability in coverage policies for testing was observed across OECD countries. A comprehensive understanding of coverage policies is required to increase treatment access to the wider population.