Patients with lung cancer are unlikely to get routine NHS access to MSD's immunotherapy Keytruda in England and Wales after cost regulators concluded that it could not be considered a cost-effective use of resources.

The National Institute for Health and Care Excellence has published draft guidelines rejecting the drug for untreated metastatic non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 with at least a 50 percent tumour proportion score and have no epidermal growth factor receptor- or anaplastic lymphoma kinase-positive mutations.

The Committee concluded that although there was sufficient evidence that Keytruda (pembrolizumab) had an important extension-to-life benefit in people with untreated stage IV metastatic PD-L1-positive NSCLC compared with standard of care, the magnitude of the overall survival gain was uncertain because the data is immature.

Taking into account the uncertainties in the clinical- and cost- effectiveness evidence, the Committee said the most plausible incremental cost effectiveness ratio (ICER) for Keytruda compared with standard of care cannot be identified.

However, it considered the most plausible figure was likely in excess of £50,000 per QALY gained, and thus higher than the range usually considered a cost-effective use of NHS resources, even when incorporating a confidential patients access scheme which the company has agreed with the Department of Health.

"This initial consultation document from NICE is very disappointing and we are working with both NICE and NHS England to ensure we can find a solution as quickly as possible," said Louise Houson, UK managing director, MSD.

"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…We look forward to working in partnership with NICE – alongside healthcare professionals, patients and all those affected by the devastating impact of lung cancer – to make sure this medicine can be used appropriately within the NHS."

The firm stressed that it is confident that based on further technical responses, additional discussions with NICE and the responses of all stakeholders to this appraisal consultation document during the forthcoming consultation period, it can work with the Institute to find a route for patient and healthcare professionals to access Keytruda for the treatment of first-line NSCLC.

It is estimated that around 1,500 patients in England who would be eligible for treatment with the drug in this setting.