A long legal battle to change the National Institute for Health and Clinical Excellence’s guidance for preventing fractures in patients with osteoporosis on the National Health Service has failed.

The Institute has now confirmed that its original guidance on the prevention of osteoporotic fractures in postmenopausal women remains in force, although it has amended the guidance documents to reflect its response to additional comments from stakeholders received during the legal process.

The fight over the guidance goes back to 2008 when the cost watchdog recommended that doctors use Merck & Co’s Fosamax (alendronate) as the first-line option for the primary prevention of fractures, with Procter & Gamble’s Didronel (etidronate) and Actonel (risedronate) as first alternatives if the patient is intolerant to the first choice.

Doctors should only turn to Servier Laboratories' more expensive Protelos (strontium ranelate), an innovative product that, unlike other treatments, works by building bone to promote bone strength and reduce hip and spinal fractures and is also associated with mild and transient side effects, after these options have been exhausted, it advised.

But this, Servier argued, would leave around 15% of women with osteoporosis who are unable to take bisphosphonates unprotected from the risk of fracture potentially for many years, as patients would have to wait for their bone mineral density to deteriorate before being offered an alternative therapy.

Following a first court appeal against the guidance by the firm and other groups such as the National Osteoporosis Society, Servier launched a second appeal on three different grounds, including a lack of transparency surrounding the economic model NICE used to reach its decision. The High Court agreed with this point, and ordered the watchdog to disclose its economic model and reassess its recommendations taking into account any new points from interested parties.

However, having followed the court’s orders, the independent Appraisal Committee considered that the model was fit for purpose and final draft guidance was published towards the end of last year mirroring the original recommendations.

No further appeals
At the time, Servier said it was “disappointed” that the Institute failed to revise its osteoporosis guidance, particularly as “leading UK experts” have demonstrated, using a World Health Organisation health economic model, “that it is not necessary to restrict access to treatments to the extent to which NICE has, even when working within the UK’s restricted budget”.

However, despite its objections, no further appeals were made against the draft guidance, enabling NICE to re-issue its recommendations to NHS doctors.

“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. And commenting on the guidance he said: “Crucially, NICE recommends preventative treatment for women at risk, before they suffer any fracture due to osteoporosis. This is the first NHS guidance to offer this, and is great news for those women who need treatment to help stop a fracture from occurring in the future”.