A draft guidance issued by the UK’s cost-effectiveness watchdog that would have allowed the breast cancer drug Herceptin to be prescribed for patients with early-stage disease has been sent to appeal.
The National Institute of Health and Clinical Excellence (NICE) confirmed to PharmaTimes World News this morning that an unidentified group had challenged the agency’s draft guidance that Herceptin (trastuzumab), made by Roche, should be prescribed in accordance with the approved product labelling.
Herceptin was recently cleared by the European Medicines Agency (EMEA) to have its uses extended to include women with early-stage breast cancer in addition to those with more advanced forms of the disease.
A spokesperson for NICE told PharmaTimes that neither the identity of the group nor the basis for the appeal could be made public. But grounds for such appeals include if NICE did not follow statutory processes, had delivered a ‘perverse’ ruling or had exceeded its powers. A hearing on the matter will be held on July 26.
Herceptin has been a controversial treatment for the UK’s National Health Service, with legal challenges from women seeking access to the drug coming against a backdrop of healthcare payers struggling to allocate funds to pay for treatment. Health Secretary Patricia Hewitt took the unusual step earlier this year of ‘fast-tracking’ the NICE's deliberations on Herceptin.