In its latest draft guidance, NICE has been unable to recommend everolimus (Afinitor, Novartis) for the second line treatment of advanced renal cell carcinoma because it does not provide enough benefit to patients to justify its high cost.

Following publication of the first Final Appraisal Determination (FAD) the manufacturer of everolimus, Novartis, submitted an amended patient access scheme. The consultation was therefore suspended to allow the Appraisal Committee to consider the additional evidence on the total costs of use of everolimus in the NHS. This is the second FAD for this appraisal and the draft guidance is now with consultees, who have the opportunity to appeal against it. NICE has not yet issued final guidance to the NHS.

Commenting on the draft recommendations, Sir Andrew Dillon, Chief Executive at NICE said:“NICE asked the independent Appraisal Committee to consider the newly amended patient access scheme and a further cost effectiveness analysis that NICE asked the manufacturer to provide. However, the committee felt that there was still too much uncertainty around how cost effective everolimus is to enable the committee to recommend the drug.

“We know that patients with renal cancer want to try all the treatment options and are disappointed not to be able to recommend everolimus as a second line treatment option. However, we have to ensure that the money available to the NHS, for treating cancer and other conditions is used to best effect, particularly when NHS funds, like the rest of the public sector, is under considerable financial pressure.”

Novartis has asked NICE not to disclose the content of the revised patient access scheme.

Notes to Editors

About the appraisal

1. Further information is available on the Renal cell carcinoma (second line metastatic) - everolimus page.

2. Renal cell carcinoma is a kidney cancer (tumour) that starts in cells lining the small tubes that help to make urine. In advanced disease, the tumour has spread inside the kidney, but may or may not have spread to nearby lymph glands. In metastatic renal cell carcinoma, the tumour has spread beyond the lymph glands to other parts of the body.

3. Evidence suggests that everolimus increased survival by more than 3 months compared with best supportive care.

4. The manufacturer of everolimus has agreed a patient access scheme with the Department of Health in which the first treatment pack of everolimus is free to the NHS and following treatment packs cost £2,822 (a 5% acquisition cost discount). A revised patient access scheme was subsequently agreed, the details of which are confidential.

5. The number of people diagnosed with advanced RCC each year is less than 4000 and those eligible for everolimus (that is received first-line sunitinib and still fit enough to receive a second-line treatment) would be lower.

6. The committee felt that everolimus did fit the criteria to be considered under end of life. However, when taking into account both the value of the ICERs and the uncertainty around the ICERs, the Committee concluded that it could not recommend everolimus for the second-line treatment of advanced renal cell carcinoma as a cost-effective use of NHS resources.

About NICE

7. The National Institute for Health and Clinical Excellence (NICE) is the independent organisation responsible for providing national guidance on the promotion of good health and the prevention and treatment of ill health.

8. NICE produces guidance in three areas of health:

• public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
• health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.