NICE is not recommending Pfizer’s new kidney cancer drug Inlyta despite the firm offering a patient access scheme.
In draft guidance, the watchdog said it was unable to endorse Inlyta (axitinib) for the treatment of advanced renal cell carcinoma (RCC) after failure of prior treatment with Pfizer’s established first-line RCC drug Sutent (sunitinib) or a cytokine.
NICE looked at the Inlyta for the two populations specified in the drug’s marketing authorisation – those previously treated with Sutent and those previously treated with a cytokine therapy.
But clinical experts informed the NICE committee that the use of cytokines is decreasing in clinical practice, with only a few people currently receiving them, the majority of patients begin treatment with NICE-recommended Sutent or GlaxoSmithKline’s RCC’s drug Votrient (pazopanib).
Sir Andrew Dillon, NICE chief executive, said: “Before we recommend any new treatment we have to be sure the evidence on how well it works is robust and that it is cost effective. We do not want to divert NHS funds to a treatment that costs more but doesn’t help people live longer.
“When evaluating a new drug, the appraisal committee looks at how effective it is when compared to a treatment previously identified as appropriate in the scope of the appraisal. The trial data provided by the Pfizer included a direct comparison of [Bayer/Onyx’ Nexavar] sorafenib, a drug not recommended by NICE and not identified in the scope.”
NICE said that Pfizer’s trial also lacked a comparison to ‘best supportive care’, which is what the majority of patients receive at the moment; therefore an ‘indirect’ and ‘simulated’ comparison was made using separate data from another trial.
When the Committee considered this comparison, they noted that limited analysis was undertaken to identify uncertainties in the model, and were concerned about its validity and reliability.
Sir Andrew added that Pfizer can provide further comment on the evidence it provided, and also has the opportunity to submit a further patient access scheme to the Department of Health.
Inlyta did, however, meet the criteria for being a life-extending end-of-life treatment and could extend life by an additional three months in the case of the prior-sunitinib population.
But in the case of the prior-cytokine group, NICE considered that these were people who could receive Sutent or Votrient, but no comparison had been available.