NICE splits renal cancer drugs assessment - "yes" for Pfizer's Sutent, "no" for Roche, Bayer, Wyeth

by Nick Smith

LONDON, Feb 4 (APM) - NICE on Wednesday split its controversial review of renal cancer drugs into two, saying 'yes' to Pfizer's Sutent (sunitinib) but rejecting three others - Wyeth's Torisel (temsirolimus), Bayer's Nexavar (sorafenib) and Roche's Avastin (bevacizumab).

In effect NICE has all but guaranteed that one product will reach patients, while pushing problematic appeals back down the appraisal process.

In a statement issued late on Tuesday for Wednesday release, NICE said in an attempt to get guidance out the NHS as quickly as possible it had published later-stage guidance recommending sunitinib as a first-line treatment option in advanced and/or metastatic renal cell carcinoma.

In a second set of guidance, bevacizumab, sorafenib and temsirolimus were not recommended as first-line treatment options for advanced and/or metastatic renal cell carcinoma.

Also in the second set of guidance, the two drugs also licensed for second-line treatment of advanced or metastatic renal cell carcinoma, sorafenib and sunitinib, are not recommended for this indication.

A spokeswoman for NICE told APM the sunitinib document was a so-called Final Appraisal Determination (FAD), which in the absence of an appeal will become guidance to the NHS. The second is a first draft which is now out for public consultation ahead of a later FAD.

RIGHT TO APPEAL?

Initially all four cancer drugs were assessed and rejected together, leading to a huge public outcry that dying people were being denied life-extending drugs.

Following this, new flexibilities for NICE's appraisal committees were announced by the government.

This gave them a more formal freedom to exceed NICE's generally understood maximum cost per quality-adjusted life year of 30,000 pounds (33,000 euros) under certain conditions, including low incidence and end-of-life cases.

In its statement, NICE says the approval of sunitinib comes under these new flexibilities and stresses its desire to get this treatment to patients as soon as possible.

NICE said: "Having decided that one of these treatments should be recommended for use in the NHS, we felt that it was in the interests of patients to get that advice out as quickly as possible.

Although this final recommendation is subject to appeal we very much hope it will form the basis of our guidance to the NHS."

The approval for sunitinib is specifically in patients with renal cell carcinoma (RCC) who are suitable for immunotherapy with an Eastern Cooperative Oncology Group performance status of 0 or 1.

Despite the mention of an appeal it was not clear what grounds companies with rejected drugs might use. It is unusual for patient organisations to appeal an approval from NICE.

The spokeswoman confirmed that after NICE split the assessment, the sunitinib FAD only deals with the Pfizer drug. Although she insisted all consultees - which would include Wyeth, Bayer and Roche - had the right to appeal regardless of whether their product was included or not, she could not say how they might benefit from an appeal.

In the absence of a rejection of their own drugs, it seems any appealing company could only succeed in slowing down access or stopping patients accessing any drug at all.

Pfizer is one of two companies which offered "patient access schemes" - incentives to the National Health Service that in some way reduce the price paid by the service - in order to gain NICE approval in cases which would otherwise have led to rejection.

Pfizer offered the NHS the first cycle of sunitinib in renal cell carcinoma free. "The independent advisory committee concluded that sunitinib does represent a cost effective use of NHS resources when used as a first-line treatment for advanced and/or metastatic RCC," NICE said in the statement without giving its estimated cost per QALY.

NICE also noted the Department of Health said the Pfizer scheme, "does not constitute an excessive administrative burden on the NHS".

Bayer also agreed a patient access scheme with the Department of Health, in which the first pack of sorafenib is free to the NHS, NICE said.

ns/ak

nick.smith@apmnews.com
[14114] 04/02/2009 09:31 GMT - INDUSTRY