ICER to Develop a Value Benchmark for NSCLC Treatment Regimens

A scoping document explaining the review process to evaluate existing treatment options for non-small cell lung cancer (NSCLC) has been released by the Institute for Clinical and Economic Review, or ICER. The report, which will be reviewed by a Midwest Comparative Effectiveness Public Advisory Council (CEPAC) in September of this year, will evaluate clinical and economic outcomes of tyrosine kinase inhibitors (TKIs) and programmed death 1 (PD-1) agents used to treat NSCLC with a mutated epidermal growth factor receptor (EGFR+). Additionally, PD-1 agents will be valued in NSCLC without a driver mutation.

As with its previous analyses, evidence used will be from clinical trial findings, reviews, and comparative cohort studies if necessary. This information will be supplemented with conference proceedings, regulatory documents, and data submitted by manufacturers.

Researchers at ICER plan to focus on 4 populations of patients with NSCLC, in inpatient, outpatient and clinical settings:

• Treatment-naïve (for advanced disease) EGFR+ patients (P1)
• Patients without a driver mutation, and treatment-naïve for advanced disease (P2)
• Patients without a driver mutation who have progressed after first-line with a platinum-based chemotherapy doublet (P3)
• EGFR+ tumors that have progressed on first or second-line TKIs (P4)

The interventions that will be included in the evaluation are:

• For P1: TKIs erlotinib, gefitinib, and afatinib (comparator will be platinum-based chemotherapy doublet)
• For P2: A sequence of a PD-1 inhibitor (nivolumab, pembrolizumab, or atezolizumab) followed by a platinum-based chemotherapy doublet at progression (comparator will be sequence of platinum-based chemotherapy doublet followed by PD-1 inhibitor at progression)
• For P3: PD-1 inhibitor after progression on a platinum-based chemotherapy (comparator will be single-agent chemotherapy)
• For P4: PD-1 inhibitor after progression on a first- or second-line TKI inhibitor (comparator will be a platinum-based chemotherapy doublet)

The following clinical outcomes will be evaluated:

• Overall survival
• Disease progression-related measures such as progression-free survival and time to progression
• Objective response rate
• Symptom control
• Health-related quality of life
• Treatment-related adverse events (AEs)

A simulation model will simultaneously be developed to assess lifetime effectiveness of regimens compared with the standard treatments, especially the first- and second-line regimens. Costs will encompass those for current and subsequent treatments, AE management, and any associated care; quality-adjusted life year (QALY) gained will be the output of the analysis. Additionally, similar to earlier reports, ICER will also provide an estimate of the 5-year budgetary impact of each regimen.

The scoping document can be found here.