A draft guidance issued by the UK's cost-effectiveness watchdog that would have allowed the breast cancer drug Herceptin to be prescribed for patients with early-stage disease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(NICE) confirmed to PharmaTimes World News this morning that an unidentified group had challenged the agency's draft guidance that Herceptin (trastuzumab), made by Roche, should be prescribed in accordance with the approved product labelling.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.
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Mystery group is Newbury PCT according to Reuters.
Reuters Health News has reported that Newbury PCT has appealed against NICE's positive decision on the use of Herceptin™ (trastuzumab) for early breast cancer, arguing that it was "perverse," one of the three grounds for a NICE appeal.
The chairman of the PCT said in a statement that the appeal was designed to clarify the practical implementation of the ruling for the benefit of patients and the population. The PCT had the right to appeal because it was chosen as one of two PCTs by NICE to act as interested parties in their roles as local health providers. The appeal is set for July 26.
Cheers Jim.
Clarification of who gets what and when will help budgeting for the additional cost.
Jack
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