NICE behaved 'unfairly' over osteoporosis guidance
By Nigel Praities
NICE has been forced back to the drawing board on its guidance for osteoporosis, after its attempts to restrict GP prescribing for post-menopausal women were successfully challenged in court.
A judicial review ruled the institute had been ‘procedurally unfair' in not releasing details of the economic model used by technology appraisals of osteoporosis treatments.
Judge Mr Justice Holman ordered NICE to publish its economic model and consult with stakeholders, in a development GP experts predicted could improve access to treatment for thousands of patients with the disease.
The institute's technology appraisals for treatment in post-menopausal women were released last year to a storm of protest, after recommending younger women unable to tolerate alendronate had to deteriorate before receiving an alternative.
Its economic model had been criticised as underestimating the health consequences of fractures and cost-effectiveness of treatments, after setting a series of restrictions on access to risedronate or etidtronate for women aged 50 to 54.
NICE's own advisers described the approach as unethical and unworkable and recommended GPs follow rival National Osteoporosis Guidelines instead.
This economic model will now be shared with stakeholders and the University of Sheffield, after a judicial review brought by Servier Laboratories, the National Osteoporosis Society and the Alliance for Better Bone Health.
A hearing in the next three to four weeks will look at the legal position of the appraisals, and could see NICE forced to completely scrap them.
Professor John Kanis, director of the WHO collaborating centre for metabolic bone diseases at the University of Sheffield and expert advisor to NICE on its osteoporosis clinical guideline, said he would be meeting NICE soon.
‘NICE has to make difficult judgments, but those judgments should be fair across disease states so people with osteoporosis should not be disadvantaged compared with people with other chronic diseases.'
Dr Alun Cooper, a GPSI in osteoporosis in Crawley, West Sussex, and chair of the National Osteoporosis Society's primary care forum, said NICE had caused great confusion among GPs.
‘Yet again they have been shown to be secretive - they are not open and transparent. When I was at school, I was always told to show my working.'
A spokesperson from NICE said it would invite comment on its economic model: ‘NICE will consider those comments and reconsider the guidance with an open mind,' he said.