GlaxoSmithKline (GSK) has expressed serious concern at the implications for UK patients if the National Institute for Health and Clinical Excellence (NICE)’s preliminary rejection of the National Health Service (NHS) use of Tyverb (lapatinib) in certain breast cancer patients is allowed to stand.

NICE’s Appraisals Committee has said, in a second NICE technology appraisal consultation document (ACD), that Tyverb should not be used in combination with Roche’s Xeloda (capecitabine) for the routine treatment of women with advanced or metastatic breast cancer whose tumours overexpress HER2, except in the context of clinical trials. The use of the two drugs in these patients cannot be judged a cost-effective use of NHS resources, even taking into account the patient access scheme proposed by GSK, it adds.

Under the scheme, which GSK had put forward in recognition that the first ACD did not consider Tyverb to be cost-effective in this patient population, the firm proposed that it should pay the initial treatment costs of patients who qualified for the drug’s use for up to 12 weeks. The NHS would then pay the costs of continued treatment beyond 12 weeks for those who responded to it, based on criteria determined by the individual patient’s clinician, and the scheme would continue until the release of updated guidance from NICE, it suggested.

GSK’s evidence to NICE had supported Tyverb plus Xeloda’s cost-effectiveness with a comparison to regimens containing Roche’s Herceptin (trastuzumab), and Tyverb alone, representing the established treatment regimens in NHS clinical practice. However, NICE has responded that, while Herceptin is widely used following disease progression it is unlikely to be cost-effective, and the appraisal therefore did not accept it as a valid comparator.

The company responded that 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.”

Simon Jose, general manager for GSK UK, added that while it was difficult to comment without the appearance of self-interest on the second ACD’s rejection of both the treatment and the patient access scheme, “we strongly believe that the wrong decision has been made for patients, doctors and the NHS.”

The firm points out that, in a pivotal clinical trial which led to Tyverb’s European Union (EU) licence, use of the drug in combination with Xeloda had significantly increased the time it took for ErbB2-positive breast cancer to worsen compared with Tyverb alone. Moreover, NICE’s draft guidance had acknowledged Tyverb to be a clinically effective option and that its use with Xeloda was associated with improved time to progression (TTP) and progression-free survival, it adds.

While other European countries – including Austria, Denmark, Germany, Greece, Ireland, Luxembourg and Switzerland – have already acknowledged the value of Tyverb and are reimbursing it, patients in the UK will not receive these benefits if the second ACD draft recommendation is adopted, says GSK. Its use in combination with Xeloda is the only treatment option 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 Herceptin for advanced disease, it adds.

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

- The closing date for comments on this Single Technology Appraisal (STA) for Tyverb is November 4, and the third Appraisal Committee meeting will be held November 19.