The National Institute for Health and Clinical Excellence (NICE) has released draft guidance which recommends against the use of GlaxoSmithKline’s (GSK) breast cancer drug, Tyverb (lapatinib), outside clinical trials.
After consultations with pharmaceutical companies, healthcare professionals, charities and patients groups, the organisation came to the conclusion that the drug was not cost-effective when compared with current alternative treatments.
Lapatinib was developed to be taken in combination with capecitabine (Xeloda) manufactured by Genentech, for women with advanced or metastatic HER2-positive breast cancer.
“We are disappointed not to be able to recommend lapatinib,” said Sir Andrew Dillon, NICE chief executive, “but evidence suggests it only extends life by a small amount of time – around 10 weeks (2.4 months) – and costs thousands of pounds more than one of the more commonly used NHS treatments for this indication – capecitabine on its own.”
The committee who came to the draft guidance decision took into consideration GSK’s proposed patient access scheme which would see the company pay for the cost of the drug for the first 12 weeks of a patient’s treatment.
The guidance is still not final however, with a group of consultees able to appeal the recommendation following further appraisal. The appeal has a deadline of June 24, 2010.
Simon Jose, general manager, GSK UK said: “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.”
The Department of Health’s (DH) response to the guidance also discussed NICE’s role under the new coalition government: “We respect the expert independence of NICE, and believe that it must be allowed to continue to issue guidance free from political interference. However, we believe that there are fundamental failings within the wider system for drug pricing and access.
“There will be significant reforms to the way in which we pay for drugs so that we can give effect to our intention that patients can access the drugs most clinically effective for them; and that the price paid by the NHS reflects value for money.”