NICE Rules Against NHS Funding For Tyverb (Lapatinib), An Effective Treatment For Advanced Breast Cancer

NICE Rules Against NHS Funding For Tyverb (Lapatinib), An Effective Treatment For Advanced Breast Cancer

Up to 2,000 UK patients denied NHS access to Tyverb

LONDON, June 9, 2010-Today the National Institute for Health and Clinical Excellence (NICE) issued its Final Appraisal Determination (FAD) advising against NHS funding for oral Tyverb (lapatinib) in combination with Xeloda® (capecitabine) for the treatment of an aggressive form of advanced breast cancer (ErbB2/HER 2 - positive).1

Lapatinib is taken in combination with a standard chemotherapy, capecitabine and is for women with advanced disease which has returned despite treatment with standard chemotherapies and Herceptin® (trastuzumab).2 There are no other licensed ErbB2 targeted treatment options available to suppress the advanced disease once it has stopped responding to trastuzumab. Tyverb has demonstrated that it may increase survival by around three months, compared with capecitabine alone.3

The decision was made despite NICE Chief Executive, Andrew Dillon, on behalf of the Guidance Executive, urging the appraisal committee to reconsider some of the methodology used in this appraisal to ensure the guidance made the most effective use of NHS resources.4 Lapatinib could actually save the NHS money by treating patients who would otherwise receive trastuzumab out of licence, via the Tyverb Patient Access Programme whereby GSK bears the cost of the first three months of treatment with Tyverb. GSK will continue to offer the Tyverb Patient Access Programme to individual NHS Trusts.

Simon Jose, General Manager, GSK UK commented: "GSK has worked really hard to offer the best possible value to the NHS, which makes this decision particularly disappointing. It again highlights the limitations of the NICE appraisal process when evaluating cancer treatments for patients facing a relatively short life expectancy.There are 39 NHS Trusts across the UK that have signed up with GSK for the patient access scheme reflecting the clinical demand for Tyverb and recognising its potential value to the NHS, and more importantly to patients. We will continue to offer the patient access programme to the NHS despite this ruling."

Currently (>50%) of eligible patients receive trastuzumab as part of their treatment although it is not licensed in this group of patients.3 Lapatinib (plus capecitabine), in conjunction with the patient access programme, offers a cheaper, licensed alternative for patients who would otherwise receive trastuzumab containing treatment.3 Despite this NICE did not accept that lapatinib (plus capecitabine) was cost effective.1

The decision from NICE sets the UK apart from much of the rest of Europe. Lapatinib is currently funded in 18 countries including Czech Republic, Iceland, Ireland, Slovakia and Slovenia where it is actually more expensive than in the UK.

Dr Alison Jones, Medical Oncologist at the University College London Hospital and the Royal Free Hospital commented: "NICE's decision places the UK in contrast to other European countries, which allow access to this much needed treatment option for their patients. This is an effective oral treatment that can offer significant extra time and is the only option for some women. Meeting colleagues this week during ASCO, one of the world's leading cancer meetings, and hearing how treatments such as lapatinib are internationally the standard of care at this stage of the disease, highlights the gulf developing between provision of cancer drugs in the UK and other comparable countries."

The Royal College of Physicians has also expressed disappointment at the ruling for patients, describing lapatinib as an ‘effective therapy that is very likely to make a difference to their overall quality of life, contribution to society and survival.'

GSK is committed to an ongoing large clinical trials programme for lapatinib which will evaluate lapatinib both alone and in combination with other therapies (chemotherapy, hormonal therapy, and other targeted agents) across different stages of ErbB2-positive breast cancer and also in a range of other solid tumours that overexpress ErbB1 and/or ErbB2.

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Note to editors:

Notes to editors:

About Tyverb

  • Tyverb received a conditional marketing authorisation in Europe, June 2008.2
  • Tyverb, in combination with capecitabine, is indicated for the treatment of patients with advanced or metastatic breast cancer whose tumours overexpress ErbB2 (HER2). Patients should have progressive disease following prior therapy which must include anthracyclines and taxanes and therapy with trastuzumab in the metastatic setting.2
  • As an oral treatment, lapatinib gives patients the freedom to spend precious additional months with friends and family without the restrictive ties of regular hospital visits. Tyverb specifically targets the receptors inside the cell that send out signals telling the cancer cells to grow and divide and blocks their action.1, 5,6 This helps to prevent tumour growth and may cause the tumour to shrink.5,6
  • Healthcare professionals should refer to the Tyverb Summary of Characteristics (SmPC) for full prescribing information, including warnings and precautions.2


About the Tyverb Patient Access Programme

GSK proposed the patient access programme in the UK when NICE indicated early on in its review that it did not consider lapatinib to be cost effective in treating this patient population. In an effort to achieve a positive outcome for patients and greater value to the NHS, GSK bears the cost of lapatinib, for all eligible patients under the scheme, for up to the first 12 weeks of treatment. The NHS would commence payment only for the patients who continue to receive clinical benefit beyond 12 weeks. GSK will continue to honour the patient access programme for NHS trusts in the UK. There are 39 trusts already enrolled in this programme, reflecting the clinical demand for lapatinib and recognising the potential cost effectiveness for the NHS.


About ASCO

The 2010 Annual Meeting of the American Society of Clinical Oncology (ASCO).took place in Chicago from 4-8 June 2010. ASCO is the world's leading professional organization representing physicians who treat people with cancer.


GlaxoSmithKline - one of the world's leading research-based pharmaceutical and healthcare companies - is committed to improving the quality of human life by enabling people to do more, feel better and live longer. For further information please visit<>.

Tyverb® is a registered trademark of the GlaxoSmithKline group of companies.

Herceptin® and Xeloda® are registered trademarks of F. Hoffmann-La Roche Ltd.





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1. Lapatinib for the treatment of women with previously treated advanced or metastatic breast cancer. Final Appraisal Determination Document. From 10 June 2010

2. Tyverb® (lapatinib) Summary of Product Characteristics. November 2009 Last accessed 7 June 2010.

3. Breast cancer (advanced or metastatic) - lapatinib: appraisal consultation Last accessed 7 June 2010.

4. Lapatinib for the treatment of women with previously treated advanced or metastatic breast cancer. (2nd line) paper - post GE, January 2010. Last accessed 7 June 2010.

5. Johnston SRD, Leary A. Lapatinib: A novel EGFR/HER2 tyrosine kinase inhibitor for cancer. Drugs of Today 2006; 42 (7): 441-453.

6. Moy B, Goss PE. Lapatinib: Current Status and Future Directions in Breast Cancer. The Oncologist 2006; 11: 1047-1057.



For more information contact:

Diana Evans e:[email protected]

Philippa Mallaband External Communications Manager t:+44 (0)20 8990 2980 e:[email protected]