NICE consults on preliminary decision not to recommend everolimus for advanced renal cell carcinoma
9 February 2010
In draft guidance, published today (9 February 2010), the National Institute for Health and Clinical Excellence (NICE) has been unable to recommend everolimus (afinitor, Novartis) for the second line treatment of advanced renal cell carcinoma.
This draft guidance is now available for public consultation. Consultees, healthcare professionals and members of the public are able to comment on the recommendations which are available from 9 February until 2 March 2010 on the NICE website. Comments received during this consultation will be fully considered by the Appraisal Committee in March. Following this, the next draft guidance will be issued.
Professor Peter Littlejohns, NICE Clinical and Public Health Director said: “We are disappointed not to be able to recommend everolimus as a second line treatment option for patients with advanced renal cell carcinoma. But NHS resources are limited and NICE has to decide which treatments represent best value to the patient as well as the NHS. Although evidence implies that this treatment is clinically effective, there is limited data about how long it can extend life. Everolimus is an expensive drug and we have to be sure the evidence on its effectiveness is robust before we recommend it. We do not want to divert NHS funds to a treatment that costs more but doesn’t help people live longer.”
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Notes to Editors
About the appraisal
The guidance is available at: http://guidance.nice.org.uk/TA/WaveCRS1/48
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. The price for a pack of 10-mg tablets (30 tablets per pack) is £2970. The daily cost of everolimus is £99. An 8-week cycle costs £5544.
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 £2822 (that is, a 5% discount).
The Appraisal Committee agreed that the ICER ranged from £65,2000 - £75,7000 per QALY gained.
6. The committee felt that everolimus did fit the criteria to be considered under end of life, however the magnitude of additional weight that would need to be assigned to the original QALY for the cost effectiveness of the drug to fall within the current threshold range would be too great, even when the patient access scheme was incorporated.
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.
