GSK responds to NICE’s second technology appraisal consultation document on the use of Tyverb, in combination with capecitabine, for women with previously treated advanced or metastatic breast cancer

Disappointing draft recommendation for patients with advanced breast cancer and their families

London, UK

The draft recommendations announced today by NICE in the second technology appraisal consultation document (ACD) suggest that Tyverb (lapatinib) should not be used in the NHS, except in clinical trials.

“Given our involvement, it is difficult to comment without the appearance of self interest, however we strongly believe that the wrong decision has been made for patients, doctors and the NHS,” said Simon Jose, General Manager for GSK UK Pharmaceuticals. “For patients with ErbB2-positive advanced breast cancer and who have few treatment options left, Tyverb offers real hope of slowing the disease. We therefore remain wholly committed to working with the NHS and NICE to make this innovative medicine available"

Demonstrating the value of Tyverb (lapatinib)

In a pivotal clinical trial which led to its EU licence, lapatinib, in combination with capecitabine (Xeloda®), significantly increased the time it took for ErbB2-positive breast cancer to worsen (‘time to progression - TTP’) compared with using capecitabine alone.1

In its draft guidance, NICE acknowledges that lapatinib is a clinically effective option and notes that lapatinib plus capecitabine was associated with improved TTP and progression-free survival.

Lapatinib, in combination with capecitabine, is the only treatment option which is licensed for use in patients with this aggressive form of advanced breast cancer, who have limited treatment options remaining if their cancer has continued to grow despite treatment with standard chemotherapies, and trastuzumab (Herceptin®) for advanced disease.

GSK has always acknowledged that the pharmaceutical industry has a role to play in demonstrating our medicines are cost-effective within the NICE framework to achieve a positive outcome for patients and their families.

In recognition that the first ACD from NICE did not consider lapatinib to be cost effective in treating this patient population, GSK proposed an innovative patient access programme, where GSK would bear the cost of lapatinib for all eligible patients, 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. This programme was designed to provide access to all eligible patients and deliver cost-effectiveness at a threshold that should have been acceptable to NICE.

The cost-effectiveness of lapatinib plus capecitabine was supported by a comparison to trastuzumab-containing regimens, and capecitabine alone, representing the established treatment regimens in

NHS clinical practice. Whilst NICE accepted that trastuzumab is widely used following progression of the disease, NICE suggested it was unlikely to be cost-effective, and therefore did not accept trastuzumab as a valid comparator.

The way in which the decision has been made makes it very difficult to ever demonstrate the cost effectiveness of lapatinib in this patient population, even in light of the proposed patient access programme.

Implications for patients if recommendation is upheld

NICE has acknowledged that lapatinib is a clinically effective option associated with improved time to progression and progression-free survival. GSK is concerned that patients in the UK will not receive these benefits if the second ACD draft recommendation is adopted.

The NICE draft recommendation would result in patients in the UK being disadvantaged compared to several other European countries that have already acknowledged the value of lapatinib and are reimbursing the medicine, including Austria, Denmark, Germany, Greece, Ireland, Luxembourg and Switzerland.

GSK will continue to work with NICE to demonstrate the cost-effectiveness of Tyverb in all eligible patients by seeking to validate trastuzumab as a legitimate comparator. Use of Tyverb plus capecitabine will ultimately reduce the costs to the UK health system compared to the established but unlicensed clinical practice of continuing to use trastuzumab once a patient’s disease has progressed.

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

• The most common adverse events associated with lapatinib plus capecitabine were diarrhoea, rash, nausea, vomiting, fatigue and hand-foot syndrome.1,2 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

• Healthcare professionals should refer to the lapatinib Summary of Characteristics (SmPC) for full prescribing information, including warnings and precautions. 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 Ltd.

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