NICE reconsideration of strontium ranelate results in no change to draft guidance on preventing osteoporotic fracture
The National Institute of Health and Clinical Excellence (NICE) today (8 December) publishes draft guidance which includes a reconsideration of the use of strontium ranelate (Protelos) in preventing osteoporotic fractures.
The final appraisal determinations for both primary and secondary prevention of osteoporotic fractures have been produced in line with a Court judgement, following a Court Appeal by the manufacturer of strontium ranelate. The Court ruling did not find that NICE had made the wrong decision, but it found that NICE should have done more to explain its decision on a specific analysis of hip fractures from a research study carried out by the manufacturer of strontium ranelate. The Court required that NICE should reassess the analysis relating to strontium ranelate, and produce a fresh decision on the drug's use.
The draft guidance recommends that strontium ranelate should be used in circumstances where patients are unable to tolerate oral bisphosphonates, other recommended drugs, and who are at high risk of osteoporotic fractures. The thorough reconsideration of the analysis has resulted in no change to the draft recommendations on strontium ranelate, compared with the final guidance recommendations issued in 2008 and updated in January 2010.
Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, commented: “The draft guidance published today only relates to the reconsideration of strontium ranelate. Our recommendations on the use of other drugs for osteoporosis were not questioned by the Court, so women at risk of osteoporotic fractures will still have the same access to these treatments on the NHS.
“NICE has complied fully with the Court's judgement, having asked our independent Appraisal Committee to look afresh at the specific analysis relating to the effect of strontium ranelate on hip fracture. Having examined the evidence on this drug again very carefully, the new independent committee has reached the same conclusions as the original committee, and so the recommendations on strontium ranelate remain unchanged.”
This draft guidance is now with consultees who have the opportunity to appeal against the proposed recommendations.
Notes to Editors
About the NICE guidance on preventing osteoporotic fracture
1. Following a Court of Appeal hearing applied for by Servier, the manufacturer of strontium ranelate, NICE was asked by the Court of Appeal to reconsider the guidance on the use of strontium ranelate. This reconsideration is included in the final appraisal determinations (FADs) published on 8 December 2010. These draft recommendations relating to strontium ranelate remain unchanged from the updated guidance issued in January 2010.
2. The existing primary prevention guidance and secondary prevention guidance are both available on the NICE website. This guidance was originally published in October 2008, with an update in January 2010 after consultation on the economic model (the recommendations remained unchanged).
Strontium ranelate was already recommended in this guidance as a treatment option for postmenopausal women who cannot take the recommended first line treatment alendronate, and who have specified risk factors.
3. NICE has also separately recommended denosumab (Prolia) as a treatment option for certain postmenopausal women who are at increased risk of primary and secondary osteoporotic fractures if other treatments available on the NHS are unsuitable. This guidance was published in October 2010.
4. The National Institute for Health and Care Excellence (NICE) is the independent organisation responsible for providing national guidance and standards on the promotion of good health and the prevention and treatment of ill health.
5. NICE produces guidance in three areas of health:
- public health - guidance on the promotion of good health and the prevention of ill health for those working in the NHS, local authorities and the wider public and voluntary sector
- health technologies - guidance on the use of new and existing medicines, treatments, medical technologies (including devices and diagnostics) and procedures within the NHS
- clinical practice - guidance on the appropriate treatment and care of people with specific diseases and conditions within the NHS.
6. NICE produces standards for patient care:
- quality standards - these reflect the very best in high quality patient care, to help healthcare practitioners and commissioners of care deliver excellent services
- Quality and Outcomes Framework - NICE develops the clinical and health improvement indicators in the QOF, the Department of Health scheme which rewards GPs for how well they care for patients.
7. NICE provides advice and support on putting NICE guidance and standards into practice through its implementation programme, and it collates and accredits high quality health guidance, research and information to help health professionals deliver the best patient care through NHS Evidence.
Background to this ruling
8. The Appeal judgement was given on 31 March 2010. It ruled that NICE should reassess the analysis relating to strontium ranelate and make a fresh decision on its use in primary and secondary of osteoporotic fracture.
9. The appeal was heard on 17 December 2009 at the Appeal Court. Servier challenged part of an earlier ruling of the High Court from 19 February 2009 on NICE's guidance on the use of various drugs to prevent osteoporotic fractures.
10. On 19 February 2009 the High Court ruled in favour of NICE on 2 of the 3 grounds brought against the Institute in this case.
11. The High Court ruled in favour of NICE on the two grounds of discrimination and handling clinical data. The High Court judge respected NICE's scientific judgment on the trial data and ruled that the reasons why NICE made the recommendations it did were properly explained in the guidance. It is this point that Servier challenged.
12. Regarding the 3rd point the judge agreed that NICE was correct in not releasing “in confidence” information but nevertheless considered that, although NICE had asked for permission to release the information, NICE could have done more to arrange for that information to be available.
NICE has since obtained agreement for the confidential information to be released, and has made this information and the executable model available to our consultees for comment. (This resulted in the updated guidance published in January 2010.)
1. Defined for primary prevention by a combination of low bone mineral density, age and a number of other clinical risk factors such as parental history of hip fracture, high alcohol intake and rheumatoid arthritis.
This page was last updated: 08 December 2010