Servier fails to overturn NICE osteoporotic guidance
pharmafile | February 2, 2010 | News story | Sales and Marketing | NICE, Servier, osteoporosis
Servier’s challenge to NICE guidance on preventing osteoporotic fractures has proved unsuccessful, with the watchdog’s original decision still standing.
This marks the end of a legal battle started in 2008 when Servier, which markets Protelos (strontium ranelate), challenged the method by which NICE arrived at its decision.
“I’m delighted that, having been forced to go through a long legal process, our original recommendations on preventing fractures caused by osteoporosis have been found to be robust,” said Professor Peter Littlejohns, NICE clinical and public health director.
Merck’s Fosamax (alendronate) remains the recommended treatment option for both primary and secondary prevention of fractures.
After the original guidance was published in October 2008, Servier asked for a judicial review on the basis that NICE acted unfairly in not disclosing the economic model it used to produce guidelines.
Servier criticised what it saw as a lack of transparency, which it said was unfair and potentially compromised patient care.
Last February the judge agreed that NICE should release the data, something NICE said it was previously unable to do because “it was deemed confidential by a third party”.
Crucially, the ruling was never against the fairness of the decision itself and, after further comments from stakeholders, the independent Appraisal Committee decided the recommendations did not need to change.
This means that if a postmenopausal woman with osteoporosis can’t take Fosamax or the Procter & Gamble drugs Actonel (risedronate) or Didronel (etidronate), then Protelos “is recommended under certain circumstances as a possible alternative”.
Lilly’s Evista (raloxifene) is not recommended for preventing fractures in women with osteoporosis who have not had a fracture.
The guidance will be reviewed, as originally planned, in July this year.
Osteoporosis is a skeletal disorder where the bone tissue deteriorates, leading to increased bone fragility.
It is estimated that more than two million women – at greater risk than men because bone loss accelerates after the menopause – have osteoporosis in England and Wales.
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