OBJECTIVES:

To understand the barriers to uptake and the value of wider adoption of Next Generation Sequencing (NGS) for patients with lung cancer (LC) in Europe.

METHODS:

A narrative literature review was conducted, searching academic literature, clinical guidelines, and policy publications. Inclusion criteria targeted people with LC in Europe, and information was extracted on i) the clinical benefit of biomarker testing; ii) cost-effectiveness; iii) barriers to access and uptake of NGS; and iv) policies/guidelines on personalised medicine in Europe.

RESULTS:

The targeted database search returned 523 scholarly citations published within five years: 430 primary research studies, 65 reviews, and 28 guidelines. Of these, 43 publications were included in the review, which revealed several key findings. First, the evidence demonstrates the clinical value of NGS; identifying a mutational driver can be life changing for someone with advanced non-small-cell LC when it facilitates targeted therapy. Second, the search identified very few European cost-effectiveness studies of NGS in LC. However, there is a general consensus that the value and cost-effectiveness of NGS is increasing as the number of therapeutically-targetable mutational drivers expands. Third, the analysis of barriers indicates that NGS is not easily valued. Some aspects of the value accrued by NGS (and advanced diagnostics in general) are beyond the scope of traditional value frameworks, making assessment more challenging. Finally, clear guidelines across Europe are lacking, which potentially restricts the possibility for clinical standardisation. The literature suggests that better guidance may support integration of tumour genotyping and precision oncology into clinical decision-making.

CONCLUSIONS:

The potential patient benefit of widespread uptake of NGS is set to increase rapidly. However, our literature review highlights a dearth of cost-effectiveness evidence and a lack of clinical guidance. There is a need to consider how advanced diagnostics can be more appropriately valued, and how treatment pathways in Europe can comprehensively implement NGS.