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Regulatory News | 03 October 2016 | By Zachary Brennan
In a new report on non-small cell lung cancer (NSCLC) treatments, the Institute for Clinical and Economic Review (ICER) found that for PD-1 immunotherapies, which are also often used to treat melanoma, the cost may be too high in terms of lengthening progression-free and overall survival.
PD-1 immunotherapies target the checkpoint signaling pathway involving the programmed death 1 (PD-1) receptor, which can help protect tumor cells from being destroyed by the immune system. Immunotherapy aimed at inhibiting such a checkpoint through the PD-1 receptor or its ligand, PD-L1, have demonstrated benefit in at least some patients with NSCLC, though the cost of such treatment has been estimated at about $150,000 annually, according to ICER.
The 227-page report released last week is part of ICER’s estimates on the cost-effectiveness of various treatments.
In this case, ICER focused on four different patient populations: PD-1 immunotherapy as first-line therapy for advanced NSCLC without a driver mutation, first-line tyrosine kinase inhibitor (TKI) therapy for EGFR+ (a type of mutation) advanced NSCLC, PD-1 immunotherapy as second-line therapy (after a platinum doublet, which is a type of chemotherapy) for advanced NSCLC without a driver mutation and as second- or third-line therapy after TKI therapy in EGFR+ advanced NSCLC.
Estimates and Discounts
ICER estimates that the cost effectiveness for PD-1 immunotherapies were $219,179 per quality-adjusted life year (QALY) gained for Roche's cancer immunotherapy Tecentriq (atezolizumab) (note that atezolizumab has not yet been approved by FDA for NSCLC in the US), $240,049 for Merck’s Keytruda (pembrolizumab) and $415,950 for Bristol-Myers Squibb’s Opdivo (nivolumab).
But ICER says that in order to achieve $100,000 to $150,000/QALY for each of the treatments, cost reductions must occur.
For atezolizumab, ICER says a 47%-62% discount should be made from the wholesale acquisition cost (WAC) list price to bring it down to $3,265 to $4,528 per 1200 mg vial. For pembrolizumab, the value-based price benchmark is $1,191 to $1,697 per 100 mg vial, which would mean a discount of 61%-73% to achieve ICER’s thresholds, and the value-based price benchmark for nivolumab is $861 to $1,181 per 100 mg vial, so ICER is calling for a 52%-65% discount from the WAC list price.
However, ICER, which also released a draft evidence report last Friday on treatments for plaque psoriasis, notes “there is substantial uncertainty in these [PD-1 immunotherapy] estimates, and the results are not directly comparable because of differences in labeled or expected indications for each drug as well as the type of assay used for PD-1/PD-L1 expression.”
In its conclusion, ICER says that targeted regimens for first- and second-line use in NSCLC do appear to confer clinical benefits in terms of lengthening progression-free and overall survival, as well as improved quality of life.
In addition, the estimated cost-effectiveness of each of the TKIs “appears to fall within commonly-accepted thresholds.”
Institute for Clinical and Economic Review, Evidence Report - Non-Small Cell Lung Cancer
Tags: NSCLC, lung cancer, ICER