GSK Appeals Against NICE Decision To Deny Women Advanced Breast Cancer Treatment, Tyverb(R) (Lapatinib), UK

Main Category: Breast Cancer
Also Included In: Cancer / Oncology
Article Date: 31 Mar 2009 - 5:00 PDT

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GlaxoSmithKline (GSK) confirmed that it is to appeal against the decision by NICE to deny NHS funding for Tyverb® (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1 If successful the appeal will enable the NHS to offer a similar level of access to lapatinib as other EU countries. Lapatinib received EMEA approval* in June 2008 and since then it has been granted funding in 16 European countries to date including Slovenia, Slovakia, France, Spain, Germany, Italy and Ireland.

Lapatinib (in combination with Xeloda® [capecitebine]) is licensed* for a particular type of aggressive breast cancer, known as ErbB2 positive.2 It is the only licensed* ErbB2 targeted treatment for these patients. Lapatinib has been shown to significantly delay the progression of the cancer, helping to control it in women whose disease returned despite treatment with standard chemotherapies and Herceptin® (trastuzumab).2,3 For these women, who have very few treatment options available, lapatinib offers a chance of precious, additional time without their disease progressing.

Simon Jose, General Manager, GSK UK commented; "We recognise that NICE has some tough funding decisions to make, but urge it to reconsider. GSK's NICE submission demonstrated that Tyverb, in conjunction with the patient access programme, could actually save the NHS money. We have appealed against the decision but will continue to offer the patient access programme to individual NHS trusts to help ensure Tyverb is available to the women who could benefit from it."

GSK will appeal the decision, which affects around 2,000 women a year, because it believes it has demonstrated that lapatinib (plus capecitabine) in conjunction with the patient access programme offers a clinically and cost effective new treatment option that meets a significant clinical need. Although NICE acknowledged that lapatinib is an effective treatment for eligible women, it was rejected on the grounds that it was not a cost effective use of NHS resources. This decision which was reached despite GSK offering a patient access programme whereby the cost of up to 12 weeks treatment would be paid by the company. Some local NHS Trusts have recognised the benefits of the patient access programme and are already signing up to the scheme.

GSK recognised in its NICE submission that lapatinib would not be cost effective versus standard chemotherapy alone, which fewer than 50% of patients with ErbB2 positive breast cancer receive in clinical practice. However NICE acknowledged that the majority of women whose disease has progressed, despite treatment with trastuzumab, continue to receive treatments containing trastuzumab (Herceptin®) and this is unlikely to be cost-effective. GSK's analysis suggests that the cost effectiveness of lapatinib in the context of the patient access programme (sensitive to the proportion of trastuzumab used in clinical practice) demonstrated a cost per QALY gain for lapatinib of just over £16,000 versus the usual care given to these patients, which includes standard chemotherapy and trastuzumab regimens.1

Dr Alison Jones, Medical Oncologist at the University College London Hospital and the Royal Free Hospital added: "Lapatinib is a clinically effective treatment option specifically licensed for these patients. It's frustrating to know that my colleagues in the US and Europe are able to use lapatinib for these patients when I and other consultants can't."

Safety Information:

Lapatinib plus capecitabine is generally well tolerated. The most common adverse events associated with lapatinib plus capecitabine were diarrhoea, rash, nausea, vomiting, fatigue and hand-foot syndrome.2,3 Diarrhoea and rash were more common with the combination whilst the incidence of hand-foot syndrome was similar between the two treatment groups.2 A decrease in left ventricular ejection fraction (LVEF) was reported by 2.5% of patients receiving lapatinib plus capecitabine vs. 1% of patients on capecitabine alone.2 Hepatobiliary events (mainly raised liver enzymes and/or bilirubin levels) have been reported commonly in association with lapatinib plus capecitabine therapy.2 Lapatinib has also been associated with reports of pulmonary toxicity.2

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

- Healthcare professionals should refer to the Tyverb Summary of Characteristics (SPC) 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.

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 http://www.gsk.com

Tyverb® is a registered trademark of the GlaxoSmithKline group of companies. Herceptin® and Xeloda® are registered trademarks of F. Hoffmann-La Roche.

References

1. Lapatinib for the treatment of women with previously treated advanced or metastatic breast cancer. Final appraisal determination, 5 March 2009 http://www.nice.org.uk/guidance/index.jsp?action=download&o=43476 Last accessed 26 March 2009

2. Tyverb® (lapatinib) Summary of Product Characteristics. http://emc.medicines.org.uk/medicine/20929/SPC/Tyverb Last accessed 26 March 2009

3. Cameron D, Casey M, Press M, et al. A phase III randomised comparison of lapatinib plus capecitabine versus capecitabine alone in women with advanced breast cancer that has progressed on trastuzumab: updated efficacy and biomarker analyses. Breast Cancer Res Treat 2008; 112:533-543

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GlaxoSmithKline