NICE consults on new treatment for bladder cancer
In preliminary draft guidance issued for public consultation today, NICE has not been able to recommend vinflunine (Javlor, Pierre-Fabre) for the treatment of advanced or metastatic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.
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.
Commenting on the latest draft guidance NICE Chief Executive, Sir Andrew Dillon said: "The manufacturer submitted one comparative study for the independent Appraisal Committee to consider. The study compared vinflunine to best supportive care; however it failed to provide the committee with conclusive evidence about the clinical effectiveness of vinflunine, particularly the extent to which it survival is prolonged compared with best supportive care. When we recommend the use of expensive treatments designed to extend life, we need, for the sake of the patients who may wish to use them, to be confident about the nature and the extent of the benefit they bring. 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.
"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.
”The committee also had concerns that adverse effects of vinflunine such as severe constipation were not fully taken account of in the economic evaluation."
Consultees, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
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
Notes to Editors
About the guidance
1. The guidance is available at: http://guidance.nice.org.uk/TA/Wave23/13
2. The National Institute for Health and Care 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.
3. 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.
This page was last updated: 23 November 2010