The battle between Keytruda and Opdivo to obtain top spot in the PD-1 inhibitor market is set to take another turn with Merck, Sharp & Dohme’s candidate on track for rejection by NICE in first-line lung cancer treatment.

In its first draft guidance, the UK cost-effectiveness body deemed the supposed overall survival benefit incurred by Keytruda to be unclear due to it being based on early data.

This is despite the average 29 months of extra life Keytruda provides – a figure at least three months higher than current standard chemotherapy – and the extra slack NICE cut the drug for being a life-extending, end-of-life therapy.

The ultimate deciding factor was MSD’s cost-effectiveness estimate of more than £50,000 per Quality Adjusted Life Year gained. The usual maximum number NICE considers cost-effective is £30,000.

In addition, Keytruda does not meet the criteria for reimbursement via the Cancer Drugs Fund, according to NICE.

Keytruda has already received clearance in the EU and the US as a first-line therapy for people with metastatic non-small cell lung cancer with specific mutations, however, an eventual rejection from NICE would be a big setback for MSD as it continues to chase Bristol Myers-Squibb to become the top dog in the PD-1 inhibitor market.

In response to the draft guidance, the likely course of action for MSD will be to further lower the drug’s price – a move that led to NICE approval for Keytruda as a second-line therapy for lung cancer in December. The drug’s list price stands at £2,630 per 100mg vial.

Louise Houson, UK managing director of MSD, commented on the decision: “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. 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.”