The National Institute for Health and Care Excellence issued draft guidance Thursday recommending that Merck & Co.'s Keytruda (pembrolizumab), in combination with Eli Lilly's Alimta (pemetrexed) and platinum chemotherapy, should be available through the Cancer Drugs Fund (CDF) as a treatment option for certain patients with untreated non-small-cell lung cancer (NSCLC). The agency noted that the combination therapy will be available to NHS patients in England immediately.
Specifically, the anti-PD-1 therapy is indicated as an option for untreated, metastatic, non-squamous NSCLC in adults whose tumours have no EGFR- or ALK-positive mutations. Keytruda was approved for this use in Europe in September based on findings from the Phase III KEYNOTE-189 trial, which showed a significant improvement in overall survival and progression-free survival for patients randomised to Merck's drug in combination with Alimta and platinum chemotherapy compared with Alimta and platinum chemotherapy alone.
However, NICE said that as further evidence is needed on the benefits of Keytruda, it could not be considered for routine NHS use in this indication. The agency added that since the combination therapy "has the potential to be cost effective, and was likely to extend life," it was eligible for use on the CDF. NICE indicated that Merck will continue to collect data on the treatment's effectiveness until June 2019, after which the guidance will be reviewed.
Keytruda is administered every three weeks by intravenous infusion, with a 200 mg infusion priced at 5260 pounds ($6792). NICE noted that Merck offered the NHS a confidential discount on the product, which patients can receive for a maximum of two years. Meindert Boysen, director of the NICE Centre for Health Technology Evaluation, explained "NICE recommends that this treatment is given for a maximum of two years, because it is thought that patients do not need to continue treatment beyond this point to achieve the benefits."
NICE indicated that final guidance on Keytruda in this indication will be published in January.
Last month, Merck reported that third-quarter sales of Keytruda jumped 80 percent year-over-year to $1.9 billion. For related analysis, see ViewPoints: Merck & Co.'s Keytruda tightens its grip on lung cancer market.
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