In final guidance published today (23 January 2013), NICE, the healthcare guidance body, has not recommended vinflunine (Javlor, Pierre-Fabre) for the treatment of advanced or metastatic transitional cell carcinoma of the urothelial tract which has progressed following prior treatment with platinum-containing chemotherapy.

Commenting on the guidance, NICE Chief Executive, Sir Andrew Dillon said: “When we recommend the use of expensive treatments designed to extend life, we need to be confident about the nature and the extent of the benefit they bring. In the case of vinflunine, the manufacturer has been unable to provide the Appraisal Committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care.”

People who are currently receiving vinflunine should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

Ends

Notes to Editors

About the guidance

1. The final guidance is available from 23 January 2013.

2. Most cancers of the bladder start in the layer of cells (transitional cells) which form the lining of the bladder (transitional epithelium). The urothelial tract includes the bladder, ureters (tubes that carry urine from the kidneys to the bladder), and kidneys. Most cancers of the urothelial tract occur in the bladder.

3. The manufacturer estimated that around 800-1500 would be eligible to receive this drug according to its licence.

4. In the study submitted by the manufacturer, best supportive care included palliative radiotherapy, antibiotics, analgesics, corticosteroids and blood transfusions.

5. Although there is some evidence to indicate that vinflunine can extend life for patients with transitional cell carcinoma, there is considerable uncertainty around the estimates provided by the manufacturer.

6. The recommended dosage of vinflunine is 280-320 mg/m² administered as a 20-minute intravenous infusion every three weeks. Vinflunine is available in 50mg and 250mg vials costing £212.50 and £1062.50 respectively. The acquisition cost of vinflunine for a course of treatment is about £9817.50 excluding administration costs. This is based on an average of 4.2 cycles of treatment.

The manufacturer has not submitted a patient access scheme for consideration.

7. The Committee considered the most plausible incremental cost effectiveness ratio for vinflunine compared with best supportive care to be in excess of £120,000 per QALY gained, well above anything that NICE has previously accepted as cost effective.

8. The Committee was not persuaded that an extension to life of at least 3 months had been proven, and therefore concluded that the end-of-life advice did not apply to this appraisal.

9. Publication of a second final appraisal determination (FAD, or final draft) in November followed the return of the appraisal to the independent Appraisal Committee after an appeal against the Institute's first FAD was partially upheld. The appeal was received from the manufacturer of vinflunine, Pierre Fabre. The Appeal Panel requested that the Appraisal Committee reconsider the draft guidance, taking account of the whole population for whom vinflunine is licensed, using the comparator treatment originally outlined in the scope (best supportive care).

About NICE

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

11. 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, medical technologies (including devices and diagnostics) and procedures within the NHS
• clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

12. NICE produces standards for patient care:

• quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
• Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients

13. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.