No change for Protelos after court ruling

 NICE has again recommended the use of Protelos (strontium ranelate) in preventing osteoporotic fractures following a court ruling.

Manufacturer Servier challenged NICE’s analysis of Protelos and its guidance on other drugs used to prevent osteoporotic fractures at the Court of Appeal.

The Court found that whilst NICE had not made the wrong decision, it should have done more to explain its decision on a specific analysis of hip fractures from research carried out by Servier.

Dr Carole Longson, Director of the NICE Centre for Health Technology Evaluation, says the Institute is pleased the appraisals have now been completed and that “clarity” has now been provided.

The original guidance was published in October 2008, with an update in January 2010, for both primary and secondary prevention and recommends Protelos in circumstances where patients are unable to tolerate oral bisphosphonates, and are at a high risk of fractures.

Protelos 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.

But after a Court of Appeal hearing applied for by Servier, NICE was asked to reconsider the guidance on the use of Protelos. The ruling did not find that NICE had made the wrong decision, but it found that it should have done more to explain its decision on a specific analysis of hip fractures from the research study. The Court required that NICE should reassess the analysis relating to Protelos and produce an updated recommendation on its use.

NICE says it has “complied fully” with the Court’s judgement and asked its independent Appraisal Committed to assess the specific analysis relating to the effect of Protelos on hip fracture.

“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,” said Dr Longson.

“Along with the separate guidance published in October 2010 recommending the use of Prolia (denosumab), today’s final guidance completes a suite of options for preventing osteoporotic fracture in post-menopausal women.”