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NICE unable to endorse new treatment for prostate cancer
London, England (January 11, 1012) – NICE, the healthcare guidance body, has today published final draft guidance not recommending cabazitaxel (Jevtana, Sanofi) in combination with prednisone or prednisolone as a second line treatment for prostate cancer.
Commenting on the draft guidance published today Sir Andrew Dillon, Chief Executive of NICE said: "We need to be sure that new treatments provide sufficient benefits to patients to justify the significant resources the NHS would need to make available. Although cabazitaxel has been shown to be effective in extending life, it is also associated with a number of side effects . The committee was concerned about the nature of the health-related quality of life information provided by the manufacturer.
"Once these factors had been taken into account, the independent Committee appraising this drug concluded that it would not provide enough health benefit to justify its cost, which means it would not be a cost effective use of limited NHS resources."
The draft guidance on cabazitaxel is now with consultees, who have the opportunity to appeal against it. Until NICE issues final guidance, NHS bodies should make decisions locally on the funding of specific treatments. This draft guidance does not mean that people currently taking cabazitaxel will stop receiving it. They have the option to continue treatment until they and their clinicians consider it appropriate to stop.
1. The draft guidance will be available at http://guidance.nice.org.uk/TA/Wave23/31 from 12 January 2012.
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 Committee concluded that cabazitaxel resulted in a mean improvement of greater than 3 months in mean overall survival
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 for drugs that meet the end of life criteria, but since the supplementary advice was introduced, the highest cost per QALY of a recommended drug has been £50,000 (TA169 – Sunitinib (first-line) for renal cell carcinoma).
The Committee considered that the most plausible ICER would be above £87,500 per QALY gained.
5. The drug did meet the criteria to be considered under NICE’s end of life considerations. However, the Committee considered that the additional weight needed to bring the Incremental Cost Effectiveness Ratio (ICER) into the range considered a cost-effective use of NHS resources was too great.
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. Side effects:
The most commonly occurring adverse reactions are related to bone marrow suppression which include anaemia, leukopenia, neutropenia, and thrombocytopenia and gastrointestinal events such as diarrhoea. Other very common adverse reactions include fatigue, nausea, vomiting, constipation, asthenia, haematuria, back pain, anorexia, pyrexia, dyspnoea, abdominal pain, dysgeusia, cough, arthralgia, and alopecia.
For the Committee, haematological adverse events and diarrhoea were major concerns. The Committee noted that the incidence of neutropenia was lower among participants recruited at European centres than other centres. The Committee was concerned that in TROPIC more participants in the cabazitaxel arm died from cardiac and renal complications than in the mitoxantrone arm.
Following consultation on the draft recommendations the Committee considered three sources of data presented by the manufacturer: the results of studies evaluating cardiac toxicity associated with cabazitaxel; the conclusions of a review by an expert panel of renal events observed with cabazitaxel; and post-marketing safety data. It concluded that there is no evidence of additional risk other than that included in the summary of product characteristics.
8. The SMC does not recommend cabazitaxel for this condition.
9. 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
10. 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.
11. 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
12. 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: 11 January 2012
Quelle: National Institute for Health and Clinical Excellence (NICE), 11.01.2012 (tB).