Decision on osteoporosis drug Protelos unchanged, says NICE
pharmafile | January 27, 2011 | News story | Sales and Marketing | NICE, Protelos, Servier, osteoporotic fractures, strontium ranelate
NICE has published updated final guidance on preventing osteoporotic fractures following a reconsideration of the use of Servier’s Protelos.
The new ruling is the latest development in a battle between NICE and Servier over the guidelines, which was subject to a legal ruling in 2009.
NICE’s new guidance for both primary and secondary prevention of osteoporotic fractures recommends Protelos (strontium ranelate) should only be used when patients are unable to tolerate oral bisphosphonates, and if they are at high risk of osteoporotic fractures. This reaffirms the earlier guidance, first issued in 2008, and frustrates Servier’s attempts to broaden access to the drug.
The judicial review of NICE’s original decision ruled that the Institute acted unfairly in not disclosing its economic model of hip fractures – but did not pass judgement on the decision itself.
NICE was obliged to re-examined the evidence, however, but then decided no change to the guidance was needed. The new guidance published today updates the previous guidance as it includes an in-depth explanation of the reconsideration.
Dr Carole Longson, director of the NICE Centre for Health Technology Evaluation, commented: “We’re pleased that these appraisals on preventing osteoporotic fracture have been concluded and we can now provide clarity for health professionals and patients on the place of strontium ranelate in the treatment pathway amongst other recommended drugs.
“The update to the guidance relates only to the reconsideration of strontium ranelate; our recommendations on the use of other drugs for osteoporosis were not questioned by the Court. Women at risk of osteoporotic fractures continue to have access to all of these treatments on the NHS, as recommended in the previous version of the guidance.
“NICE has complied fully with the Court’s judgement – having examined the evidence on strontium ranelate again very carefully, the new independent committee reached the same conclusions as the original committee, and so the recommendations on strontium ranelate remain unchanged from those published originally. Along with the separate guidance published in October 2010 recommending the use of denosumab, today’s final guidance completes a suite of options for preventing osteoporotic fracture in post-menopausal women.”
Andrew McConaghie
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