National Institute for Health and Clinical Excellence (NICE)
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NICE publishes appeal decision on lapatinib
The National Institute for Health and Clinical Excellence (NICE) has today (14 October) published the outcome of an appeal hearing relating to its draft guidance on the use of lapatinib (Tyverb, GlaxoSmithKline) for certain breast cancer patients.
The current draft guidance recommends lapatinib, in combination with capecitabine (Xeloda), for people with advanced or metastatic HER2-positive breast cancer but only in the context of clinical trials. NICE subsequently received one appeal from GlaxoSmithKline and this was heard by an independent appeal panel.
Sir Andrew Dillon, NICE Chief Executive, said: “The appeal panel has ruled that the advisory committee that had been appraising lapatinib on behalf of NICE followed the correct procedures when developing the recommendations, reasonably considered the available evidence and did not exceed its powers. They therefore rejected GlaxoSmithKline's appeal on all grounds.
“However, we have decided not to issue guidance at this stage. This is because we now believe that a better way of assessing the value of lapatinib is to consider it alongside the use of trastuzumab (Herceptin) beyond progression (in other words, beyond the point at which, even after using trastuzumab, the disease begins to get worse). Even though trastuzumab isn't licensed for this, it is frequently being used in this way in the NHS. We think that it is in the interests of patients - and the NHS - to fully consider what effect using lapatinib in these circumstances might have on the use of NHS resources. We have asked the Department of Health for permission to carry out an appraisal on the use of trastuzumab for advanced and metastatic breast cancer and lapatinib together. This will include the continuing use of trastuzumab post-progression. If the Department of Health gives permission, the Institute will carry out this appraisal as quickly as possible. In the meantime, patients who are currently receiving lapatinib can carry on doing so and NHS bodies will be expected to make decisions locally on the funding and choice of treatments.”
Notes for editors
About the guidance
- The draft guidance states:
- 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.
- Women who are currently receiving lapatinib should have the option to continue treatment until they and their clinicians consider it appropriate to stop.
- The draft guidance is available to view at: http://guidance.nice.org.uk/TA/Wave13/1
- Lapatinib has been licensed for use in combination with capecitabine. The trials that were reviewed by the European Medicines Agency (EMEA) were comparisons between lapatinib plus capecitabine vs. capecitabine alone. There were no direct trials of lapatinib vs. trastuzumab. The manufacturer did supply the committee with an indirect comparison of the two in the economic analysis but the methodology used was considered not sound.
- Lapatinib is an oral drug that works by blocking signals from a number of receptors that lie on the surface of some cells in the body, including the HER2 receptor. By blocking these ‘signals', the drug stops cancer cells growing and spreading.
- 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 on treatment (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.
- NICE's clinical guideline on early and locally advanced breast cancer currently recommends two approaches to the use of trastuzumab when the disease progresses, specifically:
- For patients who are receiving treatment with trastuzumab for advanced breast cancer, discontinue treatment with trastuzumab at the time of disease progression outside the central nervous syste
- Do not discontinue trastuzumab if disease progression is within the central nervous system alone.
About NICE
1. The National Institute for Health and Clinical 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:
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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
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health technologies - guidance on the use of new and existing medicines, treatments and procedures within the NHS
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clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
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