NICE consults on a new treatment for prostate cancer
01 February 2012
NICE, the healthcare guidance body, has issued newdraft guidance not recommending the use of abiraterone (Zytiga, Janssen) in combination with prednisone or prednisolone for the treatment of castration-resistant metastatic prostate cancer that has progressed on or after docetaxel-containing therapy.
The draft guidance has been issued for consultation; it has not been issued to the NHS.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: "Abiraterone is a drug that could potentially extend life by more than three months, compared with placebo. For patients one of the key benefits of this drug is that it can be taken orally at home. We are therefore disappointed not to be able to recommend it for use on the NHS. However, it is an expensive drug and the independent advisory committee that made this decision did not feel the drug provided enough benefit to patients to justify the price the NHS is being asked to pay, even with the discount that the manufacturer has offered."
The committee also felt that the treatment did not meet the criteria to be considered under NICE's special arrangements for drugs treating people at the end of their life as the population for which it is licensed cannot be considered to be small.
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 further reduce the acquisition cost to the NHS of the drug by proposing a revised patient access scheme. 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received during this consultation will be fully considered by the Committee and following this meeting the next draft guidance will be issued.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 The draft guidance will be available at http://guidance.nice.org.uk/TA/Wave26/4 from 2 February 2012.
2. The main treatment options for patients whose disease progresses after first-line docetaxel include mitoxantrone, best supportive care, and re-treatment with docetaxel (which is not recommended by current NICE guidance).
3. Abiraterone could potentially extend life by more than 3 months.
4. The Committee concluded that the most plausible ICER (cost per quality-adjusted life year) would be at least £63,200 per QALY after taking into account the discount agreed between the manufacturer and the Department of Health.
5. Abiraterone did not meet the criteria for an end-of-life treatment as the Committee did not consider the population for which abiraterone is licensed to be small.
6. Abiraterone costs £2,930 for a 30-day supply of 120 tablets. It is taken as a single dose of 1 g per day, taken as four 250-mg tablets. The manufacturer of abiraterone (Janssen) has agreed a patient access scheme with the Department of Health which makes abiraterone available at a discounted price. The size of the discount is commercial in confidence.
7. The SMC has not yet published guidance on abiraterone for this condition.
8. The National Institute for Health and Clinical 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.
 Castration-resistant prostate cancer is defined by disease progression despite androgen-deprivation therapy and may present as one or any combination of a continuous rise in serum levels of prostate-specific antigen, progression of pre-existing disease, or appearance of new metastases.