NICE Refuses Funding for Advanced Breast Cancer Treatment, Tyverb (lapatinib)

GSK reiterates commitment to 12 week free access programme

LONDON, March 5, 2009--NICE today issued its final appraisal determinationadvising against NHS funding for Tyverb® (lapatinib), a treatment for an aggressive form of advanced breast cancer (ErbB2-positive).1  Lapatinib (in combination with Xeloda® [capecitebine]) offers a new treatment option for women whose disease has returned despite treatment with standard chemotherapies and Herceptin® (trastuzumab).2 There are very few treatment options available for these women and lapatinib offers a chance of additional time without their disease progressing.3 Lapatinib is the only licensed ErbB2 targeted treatment* for these patients.

GlaxoSmithKline (GSK) will consider appealing the decision. Simon Jose, General Manager, GSK UK commented; “We disagree with the NICE decision and believe Tyverb is a valuable and important treatment for eligible women. In recognition of the cost effectiveness challenges with drugs that treat patients with a short life expectancy, we offered the Tyverb Patient Access Programme to help ensure it was made available on the NHS. It is difficult to comment without the appearance of self interest. However, there is clearly more work to be done by all parties when flexible access programmes from industry and the recent changes by NICE for patients with a short life expectancy still fail to give them access to valuable medicines.”

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.

During the lapatinib assessment NICE proposed new advice for the assessment of treatments in small patient populations with a short life expectancy.4 Lapatinib is licensed for a particular type of breast cancer that affects around 2000 women a year.1Therefore lapatinib qualified for review under the new advice.

GSK submitted a sub-group analysis that met the overall survival (OS) criterion of this new NICE advice. However NICE concluded that whilst the data analysis could be useful in guiding future research, as it stands it would not change their conclusions. NICE’s decision reflects the difficulty in demonstrating significant survival benefits in patients at this advanced stage of disease.1 Furthermore, trials are often halted early for ethical reasons to allow patients to cross over to the active arm because of the effectiveness demonstrated by the medicine under study, as in the case of lapatinib.5

In its final appraisal determination NICE acknowledges that lapatinib is a clinically effective option, noting that lapatinib plus capecitabine demonstrated improved time to progression (TTP) and progression free survival (PFS) –  significantly delaying the progression of the cancer and controlling the disease.1

GSK’s NICE submission demonstrated that lapatinib, in conjunction with the patient access programme, could actually save the NHS money in patients who would have received trastuzumab (Herceptin®) containing regimens. NICE acknowledged this is the majority (>50%) of eligible patients, however NICE concluded that trastuzumab is not likely to be cost effective in this setting and therefore lapatinib plus capecitabine would not be cost effective.

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

Notes to editors

About Tyverb

- 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

- * Tyverb received a conditional marketing authorisation in Europe, June 2008.2

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 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

 
 
Cautionary statement regarding forward-looking statements
Under the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Factors that may affect GSK' s operations are described under 'Risk Factors' in the 'Business Review' in the company' s Annual Report on Form 20-F for 2007.

Enquiries:

UK Media enquiries:
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 (020) 8 990 2144
 
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US Media enquiries:
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European Analyst/Investor enquiries:
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 Sally Ferguson
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 Gary Davies
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US Analyst/ Investor enquiries:
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 (215) 751 5419

 Jen Hill
 (215) 751 7002

References

1. NICE FAD publication. Accessed March 2009

2. Tyverb® (lapatinib) Summary of Product Characteristics. Accessed 3 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

4. Appraising life extending end of life treatments. January 2009. Accessed 3 March 2009

5. Geyer CE, Forster J, Lindquist D et al. lapatinib plus capecitabine for HER2-positive advanced breast cancer. N Engl J Med 2006; 355: 2733-43. 
 

Posted: March 2009


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