Osteoporosis patients in the UK have been dealt a blow after NHS cost regulator NICE refused to change its original treatment recommendations for the disease despite a long legal wrangle and reconsideration of evidence ordered by the High Court earlier this year.

Back in 2007, the National Institute for Health and Clinical Excellence recommended that doctors use Merck & Co’s Fosamax (alendronate) as the first-line option for the primary prevention of fractures in patients with osteoporosis, with Procter & Gamble’s Didronel (etidronate) and Actonel (risedronate) as first alternatives if the patient is intolerant to Fosamax.

Only after these options have been exhausted should patients be switched onto the more expensive therapy, Servier Laboratories' 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.

However, Servier argued that these recommendations 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 they would have to wait for their bone mineral density to deteriorate before being given an alternative treatment.

Consequently, the group launched a second appeal against NICE’s guidance earlier this year (following an earlier appeal by the firm and other groups including the National Osteoporosis Society, which upheld several key points) on three grounds: lack of transparency surrounding the economic model used to assess cost effectiveness; misinterpretation of clinical data around hip fracture data; and unlawful discrimination on the basis of disability.

In February, the High Court agreed with Servier that the Institute had indeed failed to be as transparent as it should have been and so ordered the watchdog to disclose its economic model forming the basis of the guidelines, as well as re-evaluate its recommendations in light of any new comments from interested parties.

Servier, the NOS and various other professional organisations then argued that NICE’s economic modelling was flawed and should be modified, which would improve patient access to a range of relatively inexpensive treatments.

However, at the time of the High Court ruling Justice Holman stressed that as long as NICE followed correct procedures it could still lawfully reach the same conclusions on its guidance, and so it has, leaving its original 2007 recommendations in force.

Unsurprisingly, Servier says it is “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”.

Innovation restricted
Michael Sumpter, the company’s chief executive, said many osteoporosis patients will now have to wait until they are at greater risk of fractures before receiving adequate treatment, and voiced concern over “the immediate impact of this decision on patients with osteoporosis and the longer term implications for all patients in the UK if innovative treatments like Protelos continue to be restricted by NICE”.

Claire Severgnini, chief executive of the NOS, has also slammed the recommendations.
“This final set of guidance is inflexible and unethical and leaves clinicians with unnecessarily limited options to treat a condition that leads to 300,000 fragility fractures a year,” she said, and pointed out that such fractures “cost a fortune in NHS and social care costs, £2billion a year for hip fractures alone, yet we put precious little effort or money into preventing those fractures from occurring in the first place”.

NICE is scheduled to kick off a comprehensive review of osteoporosis treatments in July next year, but, in the meantime, the Society has called on clinicians to use their discretion, as recommended by NICE itself, “to treat people at risk of fractures effectively and appropriately”.

Servier says it is currently considering whether or not to appeal the guidance, and is also poised to make its objections on the Institute’s interpretation of its clinical data heard at an appeal on December 17.