It is looking unlikely that patients in England and Wales with advanced renal cell carcinoma will be getting routine NHS access to Eisai’s Kisplyx or Eusa Pharma’s Fotivda, after cost regulators issued draft guidelines turning down their use.

The National Institute for Health and Care Excellence said it is not recommending NHS funding for Kisplyx (lenvatinib) in combination with everolimus for previously treated patients because of uncertainties in the clinical evidence.

While trial data suggest that the combination boosts the length of time people live by 10.1 months versus everolimus alone, results were unreliable because the main trial included just a small number of patients, it noted.

Pitted against comparator therapies, cost-effectiveness estimates for Kisplyx plus everolimus “were much more” than what is normally considered value for money - £30,000 per quality-adjusted life year gained.

Fotivda (tivozanib) has been rejected as a treatment for people who have advanced renal cell cancer and have not yet received any treatment.

According to the appraisal committee, the evidence on whether the drug increases the overall length of time people live is “very uncertain”.

“At best, Fotivda may have a similar effect as current treatments available on the NHS, sunitinib or pazopanib, but it may not be as good therefore it is not recommended,” notes the draft guideline.

“More information about how long people live while taking tivozanib is needed. However, it would not be useful to have data on tivozanib without being able to compare it with pazopanib and sunitinib, and it is not currently possible to collect the information for pazopanib and sunitinib through the Cancer Drugs Fund.”

The European Medicines Agency’s Committee for Medicinal Products for Human Use recommended approving Fotivda back in June, but the drug is yet to receive an official marketing authorisation.