ICER Recommends Significant Discount on WAC for Checkpoint Inhibitors in NSCLC

Following a 4-week open period for public comments from patient groups, clinicians, the manufacturers of the drugs, and other stakeholders on its draft report, the Institute for Clinical and Economic Review (ICER) has released its final report assessing the comparative clinical effectiveness and value of treatments for non—small cell lung cancer (NSCLC). Based on ICER’s evaluation, a significant reduction in the wholesale acquisition cost (WAC) of approved checkpoint inhibitors would be necessary to achieve a pre-determined value-based price benchmark.

For their assessment, ICER evaluated the health and economic outcomes of tyrosine kinase inhibitors (TKIs) and programmed death 1 (PD-1) agents in the treatment of advanced NSCLC. Both TKIs and PD-1 inhibitors were evaluated in EGFR-positive (EGFR+) NSCLC, and PD-1 agents were also evaluated in EGFR-negative (EGFR—) NSCLC. The ICER report found the following:

Clinical effectiveness of agents

For patients with EGFR+ advanced NSCLC, the report found high certainty that TKI therapy is better tolerated than platinum-based chemotherapy and achieves at least equal gains in overall survival (OS), and moderate certainty that TKI therapy provides a clinically meaningful overall survival benefit. The evidence was insufficient to distinguish between the TKI drugs reviewed.

For patients with EGFR— advanced NSCLC, the report found that a substantial minority of patients respond to second-line treatment with PD-1 immunotherapies, but for those who do respond, there is high certainty of important gains in OS. The report states that existing evidence is insufficient for first-line use of PD-1 immunotherapy in NSCLC, as well as use following progression on TKI therapy.

Comparative value

The study aimed to estimate the long-term costs, outcomes, and cost-effectiveness of treatment for advanced NSCLC for the following populations:

1. First-line therapy with TKIs versus platinum-based chemotherapy for EGFR+ patients:

• Cost-effectiveness estimates were quite similar across the TKIs, ranging from $110,840 to $147,244 per quality-adjusted life year (QALY) gained
• The average discount to achieve a cost-effectiveness threshold of $100,000 per QALY would be about 21%.

2. Second-line therapy with PD-1 immunotherapy versus docetaxel in EGFR— patients who progressed on a first-line chemotherapy doublet.

The report calculated the following cost-effectiveness estimates for PD-1 immunotherapies:

• $219,179 per QALY gained for atezolizumab
• $240,049 for pembrolizumab
• $415,950 for nivolumab.

The report claims, however, that differences in labeled indications for each drug makes it difficult to directly compare the different drugs, along with the fact that different assays are used to test the expression of PD-1 and programmed death ligand-1.

The report states that to achieve the ICER value-based price benchmark of $100,000 to $150,000 per QALY, would need:

• A 31% to 53% discount from the WAC list price for atezolizumab
• A 39% to 61% discount in WAC list price for pembrolizumab
• A 57% to 68% discount from the WAC list price for nivolumab.