NICE turns down first-line Keytruda for lung cancer

Patients in England and Wales with newly-diagnosed non-small cell lung cancer (NSCLC) are unlikely to get access to MSD's immuno-oncology drug Keytruda, after draft guidance from the National Institute for Health and Care Excellence (NICE).

The cost-effectiveness agency has published draft guidelines turning down Keytruda as a first-line treatment for adults with NSCLC in line with its EU approval last December, i.e. in patients whose tumours express PD-L1 with at least a 50% tumour proportion score and have no epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) mutations.

The consultation document also suggests that the drug does not meet the criteria for inclusion in the Cancer Drugs Fund (CDF), which recently came under the remit of NICE.

Keytruda provides an alternative to platinum-based chemotherapy in these patients, and according to NICE has an "extension-to-life benefit". However, the agency indicated that the most plausible incremental cost-effectiveness ratio (ICER) for pembrolizumab compared with standard of care "cannot be identified".

Even with a confidential discount, the high cost of the drug, which has a list price of around £2,360 per 100mg vial, meant that the Quality Adjusted Life Year (QALY) was likely to be in excess of £50,000 - well above its usual threshold for cost-effectiveness.

MSD (known as Merck & Co in North America) described the draft guidance as "disappointing", and its recently-appointed UK managing director Louise Houson said the company was working with NICE and NHS England to try to find a way around the problem.

"This is a much needed medicine as there are very few treatments available for these patients which increase the survival rate without significantly affecting quality of life," she said. MSD said that it is confident it can break the impasse so the 1,500 or so eligible patients in England will be able to access the drug.

MSD was able to overturn NICE's earlier rejection of Keytruda as a second-line therapy after chemotherapy, and may be able to repeat the trick by agreeing a bigger discount for front-line Keytruda.

The first-line indication is critical for MSD as it chases down rival immuno-oncology drug Opdivo (nivolumab) from Bristol-Myers Squibb, which currently outsells Keytruda but failed to hit the mark in its own first-line NSCLC test. Opdivo was turned down by NICE in draft guidance as a second-line NSCLC therapy last November.