Shire Questions NICE Guidance

June 14, 2006

Shire Pharmaceuticals is considering an appeal against recent guidance

Shire Pharmaceuticals is considering an appeal against recent guidance from the UK's National Institute for Health and Clinical Excellence (NICE) regarding access to treatment for Alzheimer's Disease (AD). NICE's Final Appraisal Determination stated that patients newly diagnosed with mild AD should not have access to drug treatments on the UK National Health Service (NHS), and that donepezil, galantamine and rivastigmine should only be considered as options in the treatment of moderately severe AD.

"NICE's refusal to recommend treatment on the NHS for those with mild dementia is based solely on financial grounds," a spokesperson for Shire told PEE. "The cholinesterase inhibitor drugs . . . are acknowledged by all including NICE as clinically effective. However, NICE states in its judgement that this class of drugs is not cost effective for patients diagnosed in the early stages of the disease - a treatment that on average costs less than £2.50 a day."

Shire, who markets AD drugs Reminyl and Reminyl XL, is currently consulting with industry colleagues and other stakeholders about a possible appeal against the NICE final determination. "If this recommendation comes into force," Shire said, "a two-tier system will develop. Those who can afford private treatment will be able to access and pay for Reminyl XL. Those who cannot afford the treatment will have to cope without that effective support."