PPM2 The Potential Healthcare and Economic Impact of the Implementation of the in Vitro Diagnostic Regulation on Non-Small-Cell Lung Cancer Patients in the European Union

The In Vitro Diagnostic Regulation (IVDR) will come into full effect on 26th May 2022 in the European Union (EU) and unless exempted, laboratory developed tests (LDTs) will need to be replaced by commercial kits at greatly increased costs to healthcare systems. We investigated the potential impact of IVDR on patients with metastatic non-small-cell lung cancer (NSCLC) in the EU. Prevalent lung cancer cases were identified from the International Agency on Research for Cancer 2020 predictions, and proportion of metastatic NSCLC patients determined. 42% of patients will have an actionable mutation and were split into LDT-biomarker sub-groups (EGFR, T790M, BRAF, ALK, ROS1, PD-L1 (>50%), and NTRK). Impact on patients with an actionable mutation and on lost annual treatment costs were determined for the biomarker subgroups under three scenarios – 100% LDT discontinuation due to IVDR (worst-case scenario), 25% LDT discontinuation (most plausible scenario) and 10% LDT discontinuation (over-optimistic scenario). Estimated number of patients with metastatic NSCLC in the EU was 258,299; 118,755 had an actionable mutation. At 100% LDT discontinuation, treatment of 42,546 patients may be compromised, equating to an economic impact of IVDR on pharmaceutical spend of €3.3 billion. A 10% LDT discontinuation would impact on 4,380 patients and lead to lost revenue of €335 million (M), whilst in the most plausible scenario (a 25% LDT discontinuation due to IVDR), 11,541 patients may not receive their therapy, with a revenue reduction of €857M. Restrictions on LDT use under IVDR potentially could negatively impact the treatment of 4,380-42,546 NSCLC patients in the EU, disrupt a multi-billion-euro revenue stream for the pharmaceutical industry and lead to higher diagnostics costs. However, if laboratories can pivot and adapt to the IVDR and its sequelae, the impact on patients, healthcare systems and pharmaceutical medicines can be reduced.