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Cost-Effectiveness of PD-L1 Testing in Non-Small Cell Lung Cancer (NSCLC) Using In Vitro Diagnostic (IVD) Versus

Jason T Hurwitz1, Shannon Vaffis1, Amy J Grizzle2

  • 1Center for Health Outcomes and PharmacoEconomic Research, College of Pharmacy, University of Arizona, 1295 N Martin, P.O. Box 210202, Tucson, AZ, 85721-0202, USA.

Oncology and Therapy
|May 13, 2022
PubMed
Summary

Accurate PD-L1 testing for non-small cell lung cancer (NSCLC) using in vitro diagnostics (IVDs) is more effective and only slightly more costly than laboratory-developed tests (LDTs). IVDs improve patient outcomes by correctly identifying eligible patients for immune checkpoint inhibitor therapy.

Keywords:
Advanced NSCLCCost-effectivenessDiagnosticGermanyPD-L1Pembrolizumab

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Area of Science:

  • Oncology
  • Diagnostics
  • Health Economics

Background:

  • Accurate programmed death-ligand 1 (PD-L1) testing is crucial for non-small cell lung cancer (NSCLC) patients undergoing immune checkpoint inhibitor (ICI) therapy.
  • Inaccurate PD-L1 testing, including false negatives and positives, leads to suboptimal clinical and economic outcomes.
  • This study compares the cost-effectiveness of in vitro diagnostics (IVDs) versus laboratory-developed tests (LDTs) for PD-L1 testing in NSCLC within the German healthcare system.

Purpose of the Study:

  • To evaluate the cost-effectiveness of PD-L1 testing using an approved in vitro diagnostic (IVD) compared to a laboratory-developed test (LDT).
  • To determine the optimal testing strategy for allocating NSCLC patients to pembrolizumab or chemotherapy.
  • To assess the impact of testing accuracy on patient outcomes and healthcare costs in Germany.

Main Methods:

  • A decision analytical model was developed from the perspective of the German statutory health insurance system.
  • PD-L1 test accuracy data were sourced from two independent proficiency testing programs.
  • The 1-year model incorporated outcomes from the KEYNOTE-024 trial and German treatment patterns.

Main Results:

  • In vitro diagnostics (IVDs) demonstrated higher accuracy (93%) compared to laboratory-developed tests (LDTs) (73%), with fewer false negatives (7% vs. 21%).
  • The IVD group incurred slightly higher total costs (€48,878) than the LDT group (€48,682), a difference of €196.
  • The IVD group achieved substantially higher effectiveness (88% vs. 69%), an improvement of 19 percentage points, with an incremental cost-effectiveness ratio (ICER) of €1057.

Conclusions:

  • On-label in vitro diagnostic (IVD) use for PD-L1 testing in non-small cell lung cancer (NSCLC) is more effective and only marginally more expensive than laboratory-developed tests (LDTs).
  • IVDs significantly improve the alignment of PD-L1-positive NSCLC patients with appropriate immune checkpoint inhibitor therapy, adhering to German guidelines.
  • Consideration of changes in testing and reimbursement policies favoring IVDs may enhance patient outcomes in NSCLC management.