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NICE seeks views on use of two breast cancer drugs

The National Institute for Health and Care Excellence (NICE) has opened a consultation on preliminary draft guidance about the use of lapatinib (Tyverb, GlaxoSmithKline) and trastuzumab (Herceptin, Roche Products) when either is used in combination with an aromatase inhibitor (another type of breast cancer treatment) for patients with a particular type of breast cancer. Issued today (15 December), the draft guidance does not recommend either drug when used in this way for the treatment of metastatic breast cancer that is both hormone-receptor and HER2-positive.

Sir Andrew Dillon, NICE Chief Executive, said: "The evidence suggests that these drug combinations do not offer enough additional value to patients over and above currently available treatment to justify the high cost that the NHS would have to pay for them. Although trial data indicated that these treatment combinations could delay the growth and spread of the disease, an overall survival benefit was less certain. Also, patients who would be likely to receive lapatinib or trastuzumab in combination with an aromatase inhibitor are those in whom chemotherapy is not deemed suitable. However, we cannot say with certainty how many patients this would be."

NICE's preliminary guidance is now available for public consultation until 19 January 2011. Comments can be made via the NICE website; www.nice.org.uk. Any feedback received during this consultation will be considered by the committee and, following this meeting, the next version of draft guidance will be issued. This draft guidance does not constitute final guidance and until then, NHS bodies should make decisions locally on the funding of specific treatments.

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Notes to Editors

About the guidance

1. The Appraisal Consultation Document (ACD) is available to view at: http://guidance.nice.org.uk/TA/Wave0/167 (from Wednesday 15 December 2010).

2. The draft recommendations state:

  • Lapatinib or trastuzumab in combination with an aromatase inhibitor are not recommended as options for the first-line treatment of metastatic hormone-receptor-positive breast cancer that overexpresses human epidermal growth factor receptor 2 (HER2).

3. The evidence presented for lapatinib compared the drug in combination with letrozole (an aromatase inhibitor) with letrozole monotherapy. Evidence submitted by the manufacturer suggested that the median value for progression-free survival (the time point in the trial at which 50% of the population experienced disease progression) was 8.2 months for lapatinib plus letrozole compared with three months with letrozole alone, but the median overall survival value (the time point in the trial at which 50% of the population had died) for lapatinib plus letrozole was about one month more than letrozole alone (33.3 months compared with 32.3 months). The committee also concluded that the incremental cost-effectiveness ratio (ICER) ranged between £74,400 and £1,000,000 per QALY gained.

4. The evidence presented for trastuzumab compared the drug plus anastrozole (another aromatase inhibitor) compared with anastrozole alone. The data for trastuzumab plus anastrozole indicated that this treatment combination could delay the growth and spread of the disease; the median value for progression-free survival was 4.8 months compared with 2.4 months in the anastrozole monotherapy arm. The median overall survival value for patients receiving trastuzumab plus anastrozole was 28.5 months compared with 23.9 months for those receiving aromatase inhibitor monotherapy. This was a non-statistically significant difference of 4.6 months. The committee concluded that the most plausible ICER for trastuzumab in combination with anastrozole compared with anastrozole alone was likely to be between £54,300 and £73,100 per QALY gained.

5. Nearly 46,000 women are diagnosed with breast cancer every year in the UK[i]. Of these, it is estimated that up to 80% of people with the disease will have hormone receptor-positive breast cancer. This means that cancer cells depend on female hormones, such as oestrogen, to grow. These tumours can also sometimes be HER2-positive, which means that cells grow and divide more quickly. HER2-positive breast cancer is generally more aggressive because it is faster growing.

6. NICE currently recommends trastuzumab for the following indications:

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.


[i] Office for National Statistics, Cancer Statistics registrations: Registrations of cancer diagnosed in 2006, England. Series MB1 no.37. 2009, National Statistics: London. ISD Online. Information and Statistics Division, NHS Scotland, 2009, Welsh Cancer Intelligence and Surveillance Unit. Cancer Incidence in Wales. 2009, Northern Ireland Cancer Registry 2009. Cancer Incidence and Mortality

This page was last updated: 14 December 2010

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Copyright 2014 National Institute for Health and Care Excellence. All rights reserved.