Roche is fuming over the UK’s National Institute for Health and Clinical Excellence’s decision not to allow its lung cancer drug Tarceva to be made available on the National Health Service in England and Wales and is going to appeal.

The Switzerland-based drugs giant said that the proposed guidance by NICE not to approve Tarceva (erlotinib), launched in the UK in September 2005 to treat non-small cell lung cancer in patients who have failed at least one prior chemotherapy regimen, is “particularly disappointing as it has already been accepted as being clinically and cost effective” by the Scottish Medicines Consortium in June last year. Roche added that it will appeal on the basis that “the evidence submitted has been assessed neither fairly nor appropriately and that the proposed guidance as it stands is perverse in the light of the evidence made available to the NICE Appraisal Committee.”

The firm’s anger was echoed by Nick Thatcher, professor of medical oncology at Manchester’s Christie Hospital, who said that “other European countries have had access to this treatment for over a year whilst once again English and Welsh patients are losing precious time waiting for Tarceva to be made available to them.” He added that “it is critical that NICE and the Department of Health do not yet again cause cancer patients more misery and premature death by refusing proven treatment to patients.”

Roche went on to remind “NHS commissioners, PCTs and NHS Trusts” that the appraisal process for Tarceva “has not been concluded and is still ongoing and until final guidance to the NHS is published there are no universal restrictions” on the prescribing of the drug within its licensed indication. The firm also added that the Department of Health Good Practice Guidance states that it is not acceptable to cite lack of NICE guidance as a reason for not prescribing a specific treatment. The final guidance is expected in April.

NICE not convinced

However NICE chief executive Andrew Dillon defended the decision, and said that after considering all the evidence available, as well as the comments received during consultation on the earlier draft, “the independent appraisal committee concluded that erlotinib is not an effective use of NHS resources when compared with either docetaxel or best supportive care.” When launched in 2005, Tarceva cost over £1,600 for one month’s treatment.

He said that the committee was also concerned that Tarceva would not be as effective as the existing standard treatment, docetaxel” but added that “given the rapidly changing evidence base for erlotinib,” the guidance should be considered for early review in February 2008. Mr Dillon also recommended that further research be undertaken into subgroups for whom erlotinib may provide greater benefit.”