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NICE unable to recommend new treatment for bladder cancer

In final draft guidance issued today, NICE has not been able to recommend vinflunine (Javlor, Pierre-Fabre) for the treatment of advanced or metastatic transitional cell carcinoma of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.

The draft guidance is now with consultees, who have the opportunity to appeal against it.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Commenting on the latest draft guidance NICE Chief Executive, Sir Andrew Dillon said: "When we recommend the use of expensive treatments designed to extend life, we need to be confident about the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 committee with conclusive evidence on how effective vinflunine is, particularly the extent to which it can prolong survival compared with best supportive care[1]. The committee also had concerns that the negative side effects of vinflunine, such as severe constipation, were not fully taken account of in the economic evaluation."

Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. People who are currently receiving vinflunine should have the option to continue therapy until they and their clinicians consider it appropriate to stop.

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Notes to Editors

About the guidance

1. The guidance is available at: http://guidance.nice.org.uk/TA/Wave23/13

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. 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.

4. The estimated cost per quality adjusted life year gained of vinflunine is in excess of £120,000, well above anything that NICE has previously accepted as cost effective.

About NICE

5. 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

6. 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.

7. 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

8. 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.


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

This page was last updated: 09 March 2011

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Accessibility | Cymraeg | Freedom of information | Vision Impaired | Contact Us | Glossary | Data protection | Copyright | Disclaimer | Terms and conditions

Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.