Regulatory Focus™ > News Articles > New Kidney Cancer Drug Gets Thumbs Down from NICE

New Kidney Cancer Drug Gets Thumbs Down from NICE

Posted 29 March 2013 | By Louise Zornoza

The UK's National Institute for Health and Clinical Excellence (NICE) will not recommend reimbursement for Pfizer's new kidney cancer drug Inlyta (axitinib) as a result its comparison data, the agency explained in a final draft guidance issued on 29 March 2013.

NICE was asked to look at the use of axitinib for the two populations specified in the drug's marketing authorization: those previously treated with sunitinib and those previously treated with a cytokine therapy. However, clinical experts informed the independent Appraisal 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 sunitinib or pazopanib, they said.

Although Inlyta met the criteria for being a life-extending end-of-life treatment, NICE opted not to recommend reimbursement based on Pfizer's use of an 'indirect' and 'simulated' comparison using data from another trial to establish the comparison to 'best supportive care.' 

NICE admits that the decision leaves no second-line drugs approved for reimbursement for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine.

Tags: Pfizer, UK

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