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Too many uncertainties mean NICE turns down breast cancer drug in draft guidance

The National Institute for Health and Care Excellence (NICE), the healthcare guidance body, has today (18 April) opened a consultation on new, draft guidance which does not recommend bevacizumab (Avastin, Roche), for the first-line treatment of metastatic breast cancer, when used in combination with the chemotherapy drug, capecitabine.

Clinical effectiveness evidence submitted to the Independent Appraisal Committee compared bevacizumab (in combination with capecitabine) with capecitabine (plus placebo). 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 to show if patients would have a better quality of life than if they were treated with chemotherapy alone - an important issue raised during the appraisal. Bearing in mind these uncertainties combined with the high cost of bevacizumab, the committee concluded this treatment was not a good use of limited NHS resources.

Sir Andrew Dillon, NICE Chief Executive, said: "We understand the need for effective treatments that can help patients live for as long as possible with a good quality of life. However, the evidence submitted to our independent appraisal committee did not conclusively show that bevacizumab could do either.

"The cost-effectiveness of the treatment was also an issue; we can't recommend a drug that has not been shown to work as well as, or better than, current treatments and costs much more. We want to ensure people have access to the best treatments the NHS can afford; bevacizumab has so far not been proven to be clinically or cost-effective."

Consultees, including the manufacturer, healthcare professionals and members of the public, are now able to comment on the preliminary recommendation during this period of public consultation. Any and all comments received will be fully considered by the committee and, following this meeting, the next draft of the guidance will be issued.

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[1]. Some people will be diagnosed with advanced (metastatic) disease while others may develop metastatic breast cancer in the years following their initial diagnosis. In 2009, NICE published a clinical guideline on the diagnosis and treatment of people with advanced breast cancer, which recommends a range of treatment options, depending on the specific type of a patient's breast cancer.

Until final guidance is issued to the NHS, 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.

Ends

Footnotes and References

* 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

Notes to Editors

About the guidance

1. The draft guidance will be available at http://guidance.nice.org.uk/TA/Wave19/56 from Wednesday 18 April 2012. Please contact the NICE press office for an embargoed copy of the draft guidance.

2. The Independent Appraisal Committee heard in a 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 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 there was no decrement for adverse reactions in the utility estimates.

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 whole patient population. While it was not possible to determine the most plausible ICER, the committee was convinced that the ICER for the whole population 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. 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. 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.

6. 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

7. 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.

8. The Scottish Medicines Consortium (SMC) has not yet published guidance on the use of bevacizumab for this indication within NHS Scotland. Guidance is expected to be issued in May 2012.

9. 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.

10. NICE has published guidance on bevacizumab for the following conditions:

a. TA212: Bevacizumab in combination with oxaliplatin and either fluorouracil plus folinic acid or capecitabine for the treatment of metastatic colorectal cancer

b. TA214: Bevacizumab (in combination with a taxane) for the first-line treatment of metastatic breast cancer

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)

d. TA118: Bevacizumab and cetuximab for the treatment of metastatic colorectal cancer

e. TA178: Bevacizumab for the first-line treatment of advanced and/or metastatic renal cell carcinoma

f. TA148: Bevacizumab for the treatment of non-small-cell lung cancer (terminated appraisal)

About NICE

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:

  • 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.

3. 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

4. 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.



[1] 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: 17 April 2012

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