NICE consults on a new treatment for prostate cancer
NICE has issued new draft guidance not recommending the use of cabazitaxel (Jevtana, Sanofi), in combination with prednisone or prednisolone as a second line treatment for prostate cancer.
The draft guidance has been issued for consultation; it has not been issued to the NHS. Until final guidance is issued, NHS bodies should make decisions locally on the funding of specific treatments. Once NICE issues its final guidance on a technology, it replaces local recommendations across the country.
Commenting on the draft recommendations Sir Andrew Dillon, Chief Executive of NICE said: "When assessing the cost effectiveness of a treatment, NICE appraisal committees will take numerous factors into account. These include how effective the drug is, its side effects, the effect it can have on the patient's quality of life and also the financial cost. This enables them to determine the cost of using the drug to provide a year of the best quality of life available or quality adjusted life year (QALY).
"Appraisal committees will normally recommend treatments that cost around £30,000 per QALY or less.
"The manufacturer of cabazitaxel provided one study on the effectiveness of the drug; in this study cabazitaxel was shown to extend life by approximately 10 weeks .
"Although cabazitaxel has been shown to be effective, it is also associated with a number of adverse events. The committee was particularly concerned about the uncertainty around the effect on patients' renal and cardiac systems. It was also concerned about the validity of the health-related quality of life information provided by the manufacturer. The committee also felt that the treatment did not meet the criteria to be considered under NICE's special arrangements for end of life, as based on the current data the length of the life extension could not be considered robustly proven to be at least three months.
"Once all these factors had been taken into account it was estimated that the cost per QALY would be more than £89,000. Therefore the committee concluded that cabazitaxel would not be a cost effective use of limited NHS resources."
Consultees, including the manufacturer, healthcare professionals and members of the public are now able to comment on the preliminary recommendations which are available for public consultation. The manufacturer can also consider whether it wishes to reduce the acquisition cost to the NHS of the drug by proposing a patient access scheme, if they wish to do so. Comments received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.
Notes to Editors
About the guidance
1. The draft guidance will be available at http://guidance.nice.org.uk/TA/Wave23/31 from 30 September, until 21 October 2011.
2. The main treatment options for patients whose disease progresses after first line docetaxel include mitoxantrone and retreatment with docetaxel retreatment. Other chemotherapy regimens used in this setting were 5FU, cyclophosphamide and carboplatin/etoposide.
3. The manufacturer of cabazitaxel provided one study on the effectiveness of the drug; in this study median overall survival gain was 2.4 months and the mean overall survival gain in the manufacturer's the model was 4.2 months. There was therefore some uncertainty about the magnitude of the survival benefit.
4. If a drug meets the criteria to be considered under NICE's supplementary advice for end of life treatments, then a higher cost per QALY may be accepted. There is no set threshold cost per QALY of drugs that meet the end of life criteria, but since the supplemantary advice was introduced, the highest cost per QALY of a recommended drug has been £50,000 (TA169 - Sunitinib (first-line) for renal cell carcinoma).
5. Supplementary advice from NICE should be taken into account when appraising treatments that may extend the life of patients with short life expectancy and that are licensed for indications that affect small numbers of people with incurable illnesses. For this advice to be applied, all the following criteria must be met:
- The treatment is indicated for patients with a short life expectancy, normally less than 24 months.
- There is sufficient evidence to indicate that the treatment offers an extension to life, normally of at least an additional 3 months, compared with current NHS treatment.
- The treatment is licensed or otherwise indicated for small patient populations.
- In addition, when taking these criteria into account, the Committee must be persuaded that the estimates of the extension to life are robust and that the assumptions used in the reference case of the economic modelling are plausible, objective and robust.
Cabazitaxel did not meet the criteria because the committee did not consider the length of the life extension to be sufficiently robust.
6. Each cycle of treatment with cabazitaxel costs approximately £3,700. The median number of cycles received in the TROPIC study was 6, therefore cabazitaxel would cost a median of £22,200 per patient.
7. The SMC has not yet published guidance on cabazitaxel for this condition- http://www.scottishmedicines.org.uk/SMC_Advice/Forthcoming_Submissions/cabazitaxel_Jevtana
8. 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
9. 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.
10. 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
11. 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.
This page was last updated: 29 September 2011