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Civil war at NICE over osteoporosis advice

By Nigel Praities

NICE has been plunged into civil war over guidance on osteoporosis after its own clinical advisers branded two new appraisals of drug treatment ‘unworkable'.

The technology appraisals - on primary and secondary prevention of osteoporosis in postmenopausal women – have been strongly criticised by experts and face a legal challenge from a leading drug manufacturer.

NICE has refused to budge, after intense opposition and multiple appeal hearings over draft versions of the appraisals, and the final versions were published last week.

A forthcoming NICE clinical guideline on osteoporosis will have to include the recommendations from the final technology appraisals, but members of the guideline development group lined up to condemn the appraisals.

Pulse has also learned Servier Laboratories has been granted a judicial review to take place in January.

Professor Juliet Compston, professor of bone medicine at the University of Cambridge and a NICE adviser for the forthcoming clinical guideline on osteoporosis, said the appraisals made it very difficult for GPs.

‘What we have now is out of date quite badly and is unworkable and unethical. To follow it would not be good medicine,' she said.

Professor Compston said the appraisals would have to be redone as the NICE guideline development group would ‘find it very difficult' to incorporate the appraisals into the NICE clinical guideline.

She advised GPs to follow the recently released National Osteoporosis Guideline – known as NOGG – instead.

Dr Sally Hope, a GP in Woodstock, Oxfordshire, and RCGP representative working with NICE on the forthcoming NICE osteoporosis clinical guideline, said the guidance was so complex it was ‘clinically unworkable'.

‘As a practising GP is that we know that 30-40% of people cannot tolerate a bisphosphonate, and the recommendations for strontium are so much more stringent because its about £300/year rather than £77, we will be left diagnosing osteoporosis and not being allowed to treat it.

The NOGG guidelines, published last month, directly contradict NICE on the way GPs should prescribe treatments for osteoporosis.

The guidance uses the FRAX tool to assess the fracture risk of patients and removes the stipulation made by NICE that patients who are intolerant of alendronate or have a contraindication to it should show deterioration in T-scores before being moved to an alternative drug.

Instead, it recommends GPs consider a range of bisphosphonates and other therapies such as strontium ranelate and raloxifene second line if alendronate is not well tolerated.

NICE vs. their clinical experts

NICE: Patients who are intolerant or have a contraindication to alendronate have to show deterioration in T-scores before being offered alternatives
Experts: This is age discrimination and is clinically unworkable

NICE: Alendronate recommended for secondary prevention, but subject T-scores of 2.5 or below
Experts: Too stringent. All women with a fragility fracture should be offered treatment

NICE: No clear guidance on probability of developing a fracture for primary prevention
Experts: Use FRAX tool

NICE: No guidance for men or corticosteroid-induced osteoporosis
Experts: Follow NOGG guidance as it includes advice on these groups

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