Published: 07/10/2004, Volume II4, No. 5926 Page 30 31
Doctors working in osteoporosis services have a bone to pick with the National Institute for Clinical Excellence over its recommendations for treatment. Jenny Bryan investigates
Barring an unlikely last-minute change of heart from the National Institute for Clinical Excellence, osteoporosis services in England and Wales will soon face greater restrictions on which women with brittle bones they can treat, and what they can give them.
Expected NICE guidance on secondary prevention of bone fractures in post-menopausal women prioritises elderly women at greatest risk. But it raises new hurdles for women under 75 and will increase demand for bone scans, for which there are already long waiting lists in many parts of the country. From October, when the NICE guidance is scheduled for release:
Women of 75 and over who have had an osteoporotic fracture should get bone-saving treatment with bisphosphonate drugs straight away.
Women aged 65-75 who have had a fracture will need a dual-energy x-ray absorptiometry (DEXA) scan to confirm they have osteoporosis before they can start bisphosphonate treatment.
Post-menopausal women under 65 who have a fracture will only be eligible for bisphosphonate treatment if they have a very low bone mineral density, on DEXA scan, or if they have confirmed osteoporosis and a risk factor, such as a family history of osteoporosis, that is independent of their age.
Specialists are concerned that these last two groups of women under 75 will lose out, not least because access to DEXA scanning is so patchy across the country.
'A 75-year-old woman who has osteoporosis is more likely to have a fracture now than a younger woman with osteoporosis, but in 10 or 20 years' time the younger woman will be at even greater risk if we haven't done anything to prevent her getting a fracture, ' explains Professor Graham Russell, director of the Institute of Musculoskeletal Sciences in Oxford.
In cities such as London, where only one in five GPs is thought to have direct access to DEXA, Professor Tim Spector, consultant rheumatologist at Guy's and St Thomas' Hospital trust, believes physicians may be deterred from arranging scans for women under 75 because of long queues. 'The requirement for a scan could delay many of these women getting a treatment that has been shown to reduce the risk of fractures by 50 per cent, and some people may feel It is too much hassle to get scans, especially as There is nothing in the new GP contract for osteoporosis, ' he predicts.
He and other clinicians believe that some GPs may simply refer women for x-rays to check for fractures, but these will not necessarily confirm osteoporosis.
A shortage of scanners and osteoporosis nurses is delaying osteoporosis treatment in Scotland, too, where physicians will not be affected by the new NICE guidance. The Scottish intercollegiate guidelines network (SIGN) osteoporosis guidance recommends treatment for all women who have had a fracture and whose osteoporosis has been confirmed by a DEXA scan - regardless of age. But there are no additional hurdles for women under 65.
Dr Andrew Jamieson, consultant in osteoporosis at Hairmyres Hospital, South Lanarkshire, who was involved in drawing up the SIGN guidance, explains that, in reality, women over 70 and those who have had a hip fracture are likely to get osteoporosis drugs without a scan.
'SIGN took a positive approach in prioritising everyone who would benefit most from osteoporosis treatment, while NICE seems to have come from the other direction in drawing up barriers for implementing treatment, ' he suggests.
While SIGN gives equal preference to the two main types of osteoporosis drugs - bisphosphonates and the hormonal treatment raloxifene - clinicians south of the border are concerned that raloxifene and another valuable hormone treatment, parathyroid hormone (teriparatide), are being relegated to second-line treatment for women who have not responded to bisphosphonates.
'Raloxifene has additional properties - for example, in protecting against breast cancer - and so we might want to use it as first-line treatment for a woman with osteoporosis and a family history of breast cancer, ' Professor Russell explains.
He also points out that women tend to respond better to teriparatide before bisphosphonate treatment than afterwards. Dr Nicky Peel, consultant in metabolic bone medicine and clinical lead for the metabolic bone service at the Sheffield Care trust, is particularly concerned that NICE recommends teriparatide only for women over 65.'We see much younger women with osteoporosis who, from an evidence base, would benefit from teriparatide but will not be able to get it, which is very frustrating, ' she says.
She feels the guidance will be useful in supporting efforts to get a more direct route from the fracture clinic to the osteoporosis service for post-menopausal women who break bones.
Where systems do not exist at hospitals, women can find themselves discharged into the community after a fracture with no plans for osteoporosis assessment or treatment. A direct referral from fracture clinic to osteoporosis service would be especially useful for women under 75 who need bone density scans and would otherwise have to join the queue from primary care.
So how much will the new guidance cost healthcare commissioners? NICE has not attempted to cost the extra bone scans that will be required by the guidance.
Instead, it has estimated drug costs. In 2003-04, osteoporosis drugs cost the NHS just over£100m. But this does not differentiate between prescriptions for primary versus secondary prevention of fractures.
NICE puts a price on osteoporosis drugs for secondary prevention at around£36.5m in the first year after the introduction of its guidance, increasing annually as more women continue treatment. But some clinicians are concerned about the basis of NICE's calculations and the lack of costing information available.
It has been a bumpy ride for the secondary prevention of osteoporosis guidance.Originally planning to join primary and secondary prevention in a single guide, NICE followed advice to deal with one challenge at a time when it was inundated with responses to the original draft earlier this year. It has made some compromises in the current guidance, but can expect new battles over primary prevention of osteoporosis in women who have not yet had a fracture but whose bone density or history puts them at high risk.
Further information lNational Institute for Clinical Excellence.
Secondary Prevention of Osteoporotic Fragility Fractures in Post-Menopausal Women.
www. nice. org. uk
Scottish Intercollegiate Guidelines Network.
Management of Osteoporosis: a national guideline.
www. sign. ac. uk.
To contribute articles to HSJ's clinical management section, please e-mail ann. dix@emap. com
The bones of it: osteoporosis facts
About 1.5-2 million women in the UK have osteoporosis, of whom only 1020 per cent are thought to be receiving treatment.
Prevalence increases with age, and one in three women aged 80 and over are affected.
Bisphosphonates (alendronate, etidronate and risedronate) are the mainstay of treatment.They (and raloxifene) work by reducing bone loss.
Teriparatide increases bone formation.
A new osteoporosis treatment, strontium ranelate, decreases bone loss and increases bone formation, and seems to cause fewer gastric side effects than current treatments.
Women with osteoporosis tend to get wrist fractures between the ages of 55 and 65, spinal fractures from 65-75, and hip fractures over the age of 75.
Of the approximately 180,000 osteoporotic fractures in England and Wales each year,70,000 are hip fractures,25,000 are vertebral fractures and 41,000 are wrist fractures.
In 2000, it cost an estimated£1.5-1.8bn to treat osteoporotic fractures, and this is predicted to rise to£2.1bn by 2010.
Women aged 75 and over with fractures will get bone-saving treatment and drugs straight away.
Women aged 65-75 with fractures will need a DEXA scan before treatment can start.
Specialists are concerned that women under 75 will lose out because scanning is patchy around the UK.