NICE draft guidance continues not to recommend bevacizumab (Avastin) for metastatic breast cancer
Final draft guidance published today (6 July) by the National Institute for Health and Care Excellence (NICE) does not recommend bevacizumab (Avastin, Roche), when used in combination with a type of chemotherapy called capecitabine as a treatment for a particular set of people with breast cancer that has spread to other parts of the body (metastatic disease).
NICE is appraising bevacizumab (in combination with capecitabine) for the first-line treatment of metastatic breast cancer in people for whom treatment with other chemotherapy options including taxanes or anthracyclines is not considered appropriate. This latest draft of guidance has been developed by an independent Appraisal Committee following a thorough review of the available evidence and a public consultation earlier this year.
Sir Andrew Dillon, NICE Chief Executive, said: “Breast cancer is one of the most common cancers and we understand how vital it is that patients receive effective treatments, especially once the cancer spreads to other parts of the body.
“However, although the evidence on which this draft guidance is based did suggest that bevacizumab plus capecitabine could delay cancer from progressing for longer than capecitabine alone, there was no evidence to show bevacizumab led to an improvement in overall survival. There was also no information available on whether or not bevacizumab could improve a patient's quality of life - an important point raised by the patient expert during the appraisal.
“Taking these uncertainties into account as well as the high cost of the drug, the committee concluded that bevacizumab was not a cost-effective use of NHS resources.”
The Appraisal Committee noted that no objections to the draft guidance were received during the consultation period but consultees do now have an opportunity to appeal against the draft recommendations. If no appeals are lodged, publication of the final guidance is expected in August 2012. Until then, 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.
Notes to Editors
About the guidance
1. The draft guidance will be available from Friday 6 July 2012. Please contact the NICE press office for an embargoed copy of the draft guidance.
2. The independent Appraisal Committee originally met to discuss this appraisal in March 2012. The committee was aware of the statement submitted by a clinical specialist that the most important outcome for patients with metastatic breast cancer is progression-free survival (the length of time it takes for a person's cancer to begin growing again). However, the committee also heard from the patient expert that, while progression-free survival is important, it must be accompanied by an improvement in a person's quality of life which would allow them to carry out normal daily activities. After assessing the clinical trial data, the committee concluded that, although the median progression-free survival benefit (the time point in the trial at which the 50% of people's cancers began to progress once again) associated with bevacizumab plus capecitabine was 2.9 months more than capecitabine monotherapy, it was unclear whether that benefit translated into an improvement in overall survival. There was also no data available regarding its effects on health-related quality of life.
3. The manufacturer's cost-effectiveness figures were based on a specific subgroup of patients who had previously received a taxane, and not on the whole capecitabine cohort. There were also several other uncertainties in the data presented to the Committee, arising, for instance, from the impact of crossover and lack of modelling of subsequent treatments on overall survival results. The Committee also noted that no allowance had been made for a reduction in the quality of life of patients due to side effects of treatments.
4. The committee concluded that, given these uncertainties, it was not possible to arrive at a plausible Incremental Cost Effectiveness Ratio (ICER) per QALY gained for bevacizumab plus capecitabine compared with capecitabine alone for the subgroup of patients who had previously received a taxane. However, the committee was convinced that the ICER would be higher than the most optimistic ICER of £82,000 per QALY gained estimated for the subgroup of patients who were previously treated with a taxane. The Committee considered that the ICER for bevacizumab plus capecitabine compared with capecitabine alone for the whole population would be even higher. Therefore, the committee concluded that bevacizumab in combination with capecitabine as a first-line treatment for metastatic breast cancer was not a cost-effective use of NHS resources.
5. The first draft of this guidance was published for consultation from April until May 2012. No major objections to the draft guidance were recorded and, although the committee received comments from clinical experts regarding dosage levels of capecitabine in current UK clinical practice, this information had no bearing on the draft recommendations.
6. Bevacizumab was not considered to fulfil NICE's end-of-life criteria. The committee concluded the patient population for which the drug is licensed is too large.
7. Bevacizumab is available in 100-mg and 400-mg vials for £242.66 and £924.40, respectively (excluding VAT; ‘British National Formulary' [BNF] edition 63). The cost of bevacizumab (excluding VAT and assuming wastage) for a patient weighing 72.1 kg is approximately £2,576.78 at a dosage of 15mg/kg every 3 weeks. This amounts to an average monthly cost of around £3,689.12. Costs may vary in different settings because of negotiated procurement discounts
8. The manufacturer has not submitted a Patient Access Scheme to the Department of Health for this appraisal. These schemes are agreed between the manufacturer and Department of Health to make the treatment in question more cost-effective for the NHS.
9. The Scottish Medicines Consortium (SMC) does not recommend bevacizumab with capecitabine for the first-line treatment of metastatic breast cancer.
10. Breast cancer is one of the most common cancers in this country. In the UK, over 48,000 women and around 300 men are diagnosed with breast cancer each year. Some people will be diagnosed with advanced (metastatic) disease while others may develop metastatic breast cancer in the years following their initial diagnosis.
11. In 2009, NICE published a clinical guideline on the diagnosis and treatment of patients with advanced breast cancer. This guideline includes recommendations for clinicians on a range of treatment options for patients.
12. NICE has published guidance on bevacizumab for the following conditions:
c. TA242: Bevacizumab (in combination with non-oxaliplatin chemotherapy) for the treatment of metastatic colorectal cancer after first-line chemotherapy (review of technology appraisal 150 and part review of technology appraisal guidance 118)
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 Office for National Statistics, Cancer Statistics registrations: Registrations of cancer diagnosed in 2008, England. Series MB1 no.39. 2010, National Statistics: London; ISD Online. Information and Statistics Division, NHS Scotland, 2010; Welsh Cancer Intelligence and Surveillance Unit. Cancer Incidence in Wales. 2010; Northern Ireland Cancer Registry 2010. Cancer Incidence and Mortality
This page was last updated: 04 July 2012