Limited benefit and high cost responsible for NICE's decision on lapatinib

Following extensive consultation with pharmaceutical companies, healthcare professionals, charities and patient groups, the National Institute for Health and Care Excellence (NICE) has today (10 June) issued draft guidance recommending lapatinib (Tyverb, GlaxoSmithKline), in combination with capecitabine (Xeloda), for women with advanced or metastatic HER2-positive breast cancer but only in the context of clinical trials.

In line with the NICE technology appraisals process this draft guidance is now with consultees, who have the opportunity to appeal against the proposed recommendation. NICE has not yet issued final guidance to the NHS.

Lapatinib has been evaluated by a committee comprising hospital doctors, GPs, nurses, and patients, amongst others. These experts examined whether the drug would be an effective life-extending treatment option for women who have already been treated for advanced or metastatic, HER2-positive breast cancer. The committee took into consideration the Institute's supplementary advice for appraising treatments that may extend life at the end of life, and a proposal by the manufacturer to pay for the cost of lapatinib for the first 12 weeks of a patient's treatment. However, even with both these factors in place, the drug did not represent good value for money when compared with the alternative, currently available treatment.

Sir Andrew Dillon, NICE Chief Executive, said: “The independent Appraisal Committee first began looking at lapatinib for women with previously treated advanced or metastatic, HER2-positive breast cancer in 2007. This has been a long and comprehensive evaluation of the evidence available but only because we want to be sure the decision reached is the right one and made for the right reasons.

“We are disappointed not to be able to recommend lapatinib but evidence suggests it only extends life by a small amount of time - around 10 weeks (2.4 months) - and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication - capecitabine on its own.”

In evaluating the clinical and cost effectiveness of lapatinib, the committee considered evidence of the drug's efficacy compared to other NHS treatments. Lapatinib was found to have only a small extra benefit compared to these medicines. The committee acknowledged that trastuzumab (Herceptin) is being prescribed to some patients even after their breast cancer has progressed (an indication for which it is not licensed) and looked at whether lapatinib, being an oral rather than intravenous drug, and the patient access scheme proposed by the manufacturer could make lapatinib a more efficient use of NHS resources than trastuzumab.

However, the committee noted considerable uncertainties when comparing the effectiveness of lapatinib and trastuzumab, in particular the effectiveness of either treatment in the group of patients likely to continue trastuzumab after their disease progresses. The lapatinib studies also involved different types of patients to the trastuzumab studies. This meant the benefits of lapatinib in comparison with trastuzumab could not be fully assessed. The committee could also not ignore the data presented which suggested that trastuzumab was not a cost effective treatment option compared to capecitabine, an alternative treatment for women with advanced or metastatic, HER2-positive breast cancer.

Sir Andrew Dillon continued: “Following the committee's original consideration of the trastuzumab evidence, the Institute asked them to reconsider whether the use of trastuzumab for this indication, although not licensed, may mean NHS resources could be used more efficiently by using lapatinib instead. However, the committee felt that it had not been presented with evidence of the drug's efficacy for specific groups of patients likely to continue treatment with trastuzumab after their disease has progressed and that recommending lapatinib could serve to displace other cost-effective NHS treatments. The NICE clinical guideline on breast cancer currently advises oncologists to stop treating patients with trastuzumab once the disease has spread outside the central nervous system.”

Maggie Alexander, Director of Policy, Education and Influencing at Breakthrough Breast Cancer, said: “We are disappointed that NICE was not able to give lapatinib a positive recommendation.

“However, it is crucial to remember that this drug would not be suitable for all, and patients should speak to their doctor regarding appropriate treatments available to them.

“We will continue to work with NICE in the future to ensure that patients with advanced or metastatic breast cancer have the best possible range of treatment options for their condition.”

Consultees have until 24 June 2010 to appeal against this final draft of the guidance. Until final guidance is published, NHS bodies should make decisions locally on the funding of specific treatments.


Notes to Editors

About the guidance

  • The draft guidance recommendations state:
  1. Lapatinib, in combination with capecitabine, is not recommended for the treatment of women with HER2-expressing, advanced or metastatic breast cancer that has progressed following treatment with anthracyclines, taxanes, and trastuzumab in the metastatic setting, except in the context of clinical trials.
  2. Women who are currently receiving lapatinib should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
  • The guidance is available to view at: (from Thursday 10 June 2010).
  • Nearly 46,000 women are diagnosed with breast cancer every year in the UK[1] and it is thought that around one in five tumours will be HER2 positive. These breast cancers over-express the HER2 protein, which helps cancer cells grow.
  • Lapatinib is an oral drug that works in a similar way to trastuzumab. It blocks signals from the HER2 receptor that lies on the surface of some cells in the body. By blocking these ‘signals', the drug stops cancer cells growing and spreading.
  • In 2007, the Independent Appraisal Committee first began assessing whether lapatinib should be made available on the NHS to women with previously treated advanced or metastatic breast cancer whose tumours over-express the HER2 protein. Following consultation with a range of stakeholders, including the drug manufacturer, draft guidance was issued in March 2009 not recommending lapatinib. This decision was appealed by the manufacturer and, in July 2009, NICE actively sought for further evidence on the benefits of lapatinib compared to existing treatments. NICE then consulted further with stakeholders. The final draft guidance being published today (10 June 2010) is a result of this extensive evidence gathering and consultation process
  • Lapatinib has been licensed for use in combination with capecitabine. The trials that were reviewed by the European Medicines Agency (EMEA) were comparisons between lapatanib plus capecitabine vs. capecitabine alone. There were no direct trials of lapatinib vs. Herceptin.
  • The combined drug cost of lapatinib plus capecitabine is approximately £25,207 per year. The manufacturer did propose a Patient Access Scheme whereby they pay for the cost of lapatinib during the first 12weeks of treatment. Although this does reduce the overall cost of lapatinib to the NHS, it was still deemed too expensive for the health service to provide.
  • It is estimated that, each year, around 2,000 patients with HER2 positive advanced or metastatic breast cancer may be eligible to receive lapatinib.
  • Since 2002, when NICE started to produce cancer guidance, NICE has published 89 individual recommendations on cancer drugs, 74% of which have been positive.

About NICE

1. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance 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 and procedures within the NHS
  • clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.

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This page was last updated: 10 June 2010

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