NICE says patient benefits of breast cancer drug are too small to justify its very high cost
The National Institute for Health and Care Excellence (NICE) has been asked to assess whether bevacizumab (Avastin, Roche Products), when used in combination with a taxane (a type of chemotherapy), would be a useful and cost-effective treatment option for people with breast cancer which has spread to other parts of the body. In final draft guidance published today (8 December) NICE does not recommend the drug on the grounds that it offers limited and uncertain benefit for patients compared with existing treatments.
Sir Andrew Dillon, NICE Chief Executive, said: "We know that it's immensely important for breast cancer patients, whose disease has spread, to prolong their lives as much as possible.
"Unfortunately, we did not receive any evidence from the manufacturer to show that bevacizumab can significantly lengthen a patient's life or, importantly, offer a better quality of life than existing treatments. Although the data seemed to show that the drug may slow the growth and spread of the cancer, the size of this effect varied between studies. Furthermore, it was extremely unclear that the benefits in terms of slowing tumour growth translated into benefits on overall survival, which is what really matters for patients."
Sir Andrew Dillon added: "We also are aware that the United States Food and Drug Administration and the European Medicines Agency are currently reconsidering bevacizumab's licence as a treatment for metastatic breast cancer. We have nevertheless decided to continue our appraisal. If either the FDA or the EMA announce changes to their licensing decision, which affects our advice to the NHS, we amend it accordingly."
This draft guidance is now subject to an appeal process whereby consultees can appeal against the recommendation. Final guidance is expected to be published early next year but until then, NHS bodies should make decisions locally on the funding of specific treatments.
Notes to Editors
About the guidance
1. The guidance is available to view at http://guidance.nice.org.uk/TA/Wave21/7 (from Wednesday 8 December 2010).
2. The final appraisal determination document (FAD) states:
- Bevacizumab in combination with a taxane is not recommended for the first-line treatment of metastatic breast cancer.
- Patients currently receiving bevacizumab in combination with a taxane for the first-line treatment of metastatic breast cancer should have the option to continue therapy until they and their clinicians consider it appropriate to stop.
3. The original evidence submitted by the manufacturer was based on one trial (E2100) that compared bevacizumab plus paclitaxel with paclitaxel given on a weekly basis. The trial demonstrated that patients in the bevacizumab arm experienced around 11.3 months of progression-free survival (the amount of time bevacizumab can slow the growth and spread of the cancer) compared to 5.8 months for patients given paclitaxel. However, the trial did not produce similar results for overall survival rates, showing instead that bevacizumab plus paclitaxel only offered, on average, an extra 1.7 months of life (26.5 months compared to 24.8 months for paclitaxel monotherapy).
4. The committee noted that evidence from another study (the AVADO trial) for the clinical effectiveness of bevacizumab plus docetaxel had been provided by the manufacturer after consultation on the appraisal consultation document. The committee noted the results from this study that demonstrated an improvement in progression-free survival of around two months for bevacizumab (at a dose of 15mg/m²) plus docetaxel, but only 0.8 months for bevacizumab (at a dose of 7.5mg/m²) plus docetaxel compared with docetaxel monotherapy. The hazard ratio for death was calculated as being 1.03 (95% CI 0.70 to 1.33), indicating a reduction in median overall survival of 1.7 months from 31.9 months in the docetaxel alone arm to 30.2 months in the bevacizumab plus docetaxel arm.
5. Ahead of the second Appraisal Committee meeting, the manufacturer submitted further evidence to highlight particular groups of breast cancer patients who may benefit most from the drug. These were patients who had previously received treatment with a taxane and patients with “triple-negative” breast cancer (that is, oestrogen and progesterone receptor negative, and HER2 negative). The committee concluded that the evidence did not demonstrate any robust proof that these patient groups would gain greater benefit over and above any other patient with metastatic breast cancer.
6. The committee considered the incremental cost-effectiveness ratio (ICER) of bevacizumab (the additional cost of one year of healthy life, which is expressed as the cost per quality adjusted life year, or QALY, gained). The committee concluded that the best available estimate for the ICER for bevacizumab plus paclitaxel compared with docetaxel to be over £115,000 and between £110,000 and £259,000 per QALY gained when compared with paclitaxel.
7. The manufacturer did not submit evidence on the cost-effectiveness of bevacizumab plus docetaxel, stating that it was unlikely it would provide a more cost effective outcome than the analysis of bevacizumab plus paclitaxel.
8. The manufacturer calculated the total average cost per patient of bevacizumab plus paclitaxel to be £33,649 compared with around £7,720 for paclitaxel alone (costs are taken from the British National Formulary, edition 58). Drug costs were calculated according to the recommended adult dose and the duration of treatment was estimated from the E2100 trial.
9. Bevacizumab is an angiogenesis inhibitor. It works by stopping the cancer from forming its own blood supply, stopping it growing and spreading. Tumours cannot grow any bigger than a grain of sugar without creating their own blood supply and cancer cells rely on the blood and lymphatic systems to spread around the body.
10. The NICE clinical guideline for advanced breast cancer includes recommendations for clinicians on a range of treatments options for patients with this form of the disease. The guideline is available to view at http://guidance.nice.org.uk/CG81.
1. 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
2. NICE produces guidance in three areas of health:
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This page was last updated: 08 December 2010