The UK’s National Institute of Health and Clinical Excellence has agreed to an appeal of its decision in August to prohibit prescribing of a drug for advanced colorectal cancer –Merck KGaA’s Erbitux – under the National Health Service.
The cost-effectiveness watchdog said the appeal process had now kicked off, and should reach a conclusion in November. If the appeal is successful, patients will gain access to Erbitux on the NHS; but if the appeal fails, it will mean the end of the line for many patients, said a spokesperson for Merck.
The UK is the only country in Europe where patients with metastatic colorectal cancer do not have routine access to Erbitux, despite data suggesting that it can extend survival.
The NICE ruled against the use of Erbitux (cetuximab) for advanced bowel cancer on the grounds of cost effectiveness, claiming that it was not compatible with the best use of NHS resources. Cetuximab is already licensed for use in the UK and is widely available across Europe.
Merck Pharmaceuticals UK said in a statement that it had appealed against the decision on the grounds that “the institute has prepared guidance which is perverse in the light of the evidence submitted.”
Patient groups and oncologists welcomed the decision to look again at the evidence, although there is no guarantee that the NICE’s stance will be relaxed. Earlier this week an appeal seeking to broaden the availability of drugs to treat Alzheimer’s disease failed spectacularly after the agency ruled once again they should only be used in patients with moderate disease.
Under the appeals process, the NICE will appoint five members to the Appeal Panel with no prior involvement in the appraisal of cetuximab.