NICE consults on new kidney cancer drug

New Kidney drug
Published on Friday, 07 December 2012 11:58
Posted by Scott Buckler

NICE, the healthcare guidance body, has issued draft guidance not recommending axitinib (Inlyta, Pfizer) for the treatment of advanced kidney cancer

The preliminary decision by the independent Appraisal Committee is that axitinib should not be recommended for the treatment of advanced renal cell carcinoma after failure of prior treatment with sunitinib or a cytokine.

NICE was asked by the Department of Health to look at the use of axitinib for the two populations specified in the drug's marketing authorisation - 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.

Commenting on the draft guidance, Sir Andrew Dillon, NICE Chief Executive, said: "Before we recommend any new treatment we have to be sure the evidence on how well it works is robust and that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 manufacturer of axitinib included a direct comparison of the drug to sofafenib, a drug not recommended by NICE and not identified in the scope. The 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 within this simulated method of comparison and therefore they were concerned about its validity and reliability.

"Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Pfizer can also provide further comment on the evidence it provided and have the opportunity to submit a further patient access scheme to the Department of Health if they wish. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued."

The manufacturer of axitinib has agreed a patient access scheme with the Department of Health. The size of the discount is commercial in confidence.

This draft guidance does not mean that people currently taking axitinib will stop receiving it. Until final guidance is issued to the NHS, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations.

Source: ©NICE

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