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NICE, the healthcare guidance body, has issued new final draft guidance recommending axitinib (Inlyta, Pfizer), for advanced kidney cancer [1].

Renal cell carcinoma is a kidney cancer that starts in cells lining the small tubes that help to make urine. In advanced disease, the cancer has spread inside the kidney, and may or may not have spread to nearby lymph glands. NICE has previously recommended two drugs for advanced renal cell carcinoma, sunitinib and pazopanib- both as first-line treatments.

Commenting on the draft guidance, Professor Carole Longson, Health Technology Evaluation Centre Director said: “NICE was asked by the Department of Health to look at axitinib for people who have already been treated with a cytokine or a drug known as a kinase inhibitor. This draft guidance recommends that the NHS provides axitinib for these patients. Although, this recommendation has not changed since the previous draft guidance, the updated draft includes some clarification around prescribing axitinib.

“The independent appraisal committee carefully considered the available evidence, including the discount offered by the company that market the drug and concluded that axitinib should be offered by the NHS.”

As NICE was asked by the Department of Health to look at the use of axitinib within its licensed indication for those previously treated with sunitinib (a kinase inhibitor), the use of axitinib after treatment with other tyrosine kinase inhibitors, such as pazopanib, is not subject to statutory funding.

The draft guidance is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. 

For more information call the NICE press office on 0300 323 0142 or out of hours on 07775 583 813.

Notes to Editors

Explanation of terms

1. Axitinib is recommended as an option for treating adults with advanced renal cell carcinoma after failure of treatment with a first line tyrosine kinase inhibitor or a cytokine, only if the company provides axitinib with the discount agreed in the patient access scheme. At the time of publication (December 2014), axitinib has a UK marketing authorisation only for use after failure with first-line sunitinib or a cytokine.  If it is considered for use after any other first-line treatments, the prescriber should obtain and document informed consent and follow the relevant guidance published by the General Medical Council. As NICE was asked by the Department of Health to look at the use of axitinib for those previously treated with sunitinib (a kinase inhibitor), the use of axitinib after treatment with other tyrosine kinase inhibitors is not subject to statutory funding.

About the guidance

4. The draft guidance will be available at /guidance.nice.org.uk/TAG/305 from 16 December 2014.
5. For end-of-life considerations, the Committee concluded that that axitinib was shown to be a life-extending, end-of-life treatment for the prior-sunitinib group although uncertainty remained around the prior-cytokine group, uncertainty remained around the naive comparison, and the end-of-life criteria could only be considered met if best supportive care were the only comparator. The Committee concluded that axitinib could be considered a cost-effective use of NHS resources in the prior-sunitinib population under the supplementary criteria for appraising life-extending, ‘end-of-life’ treatments. The Committee concluded that, because axitinib almost met the end-of-life criteria and was comparable to the other alternatives (sunitinib and pazopanib), a cost per QALY above but close to the upper limit of the normal range was acceptable  and could be considered a cost-effective use of NHS resources for the prior-cytokine group.
6. The Committee concluded that the most plausible cost per QALY (Quality Adjusted Life Year) for axitinib after sunitinib would be around halfway between £33,500 and £52,900, and after cytokine £33,000. After a cytokine £55,300 per QALY.
7. Axitinib is available in 1-mg and 5-mg film-coated tablets at net prices of £703.40 and £3,517 per 56-tablet pack. It is administered orally at a recommended starting dose of 5 mg twice daily. This dose may be increased to 7 mg and then up to 10 mg, or decreased to 3 mg and then down to 2 mg, depending on individual safety and tolerability. The manufacturer has agreed a patient access scheme with the Department of Health. The size of the discount is commercial in confidence. 

About NICE

The National Institute for Health and Care Excellence (NICE) is the independent body responsible for driving improvement and excellence in the health and social care system. We develop guidance, standards and information on high-quality health and social care. We also advise on ways to promote healthy living and prevent ill health.

Our aim is to help practitioners deliver the best possible care and give people the most effective treatments, which are based on the most up-to-date evidence and provide value for money, in order to reduce inequalities and variation.

Our products and resources are produced for the NHS, local authorities, care providers, charities, and anyone who has a responsibility for commissioning or providing healthcare, public health or social care services.

To find out more about what we do, visit our website:www.nice.org.uk and follow us on Twitter: @NICEComms.