Servier was given a boost on news that it will be allowed to challenge a High Court ruling earlier this year which effectively sided with the National Institute for Health and Clinical Excellence’s rejection of new data for the osteoporosis drug Protelos.

A Judicial Review in February instigated by Servier ruled that NICE had indeed acted unlawfully in failing to allow access to the economic model underpinning its guidance for the prevention of osteoporotic fractures in postmenopausal women, essentially forcing a re-evaluation of the Institute’s recommendations, which is still ongoing.

However, Servier lost on one legal challenge regarding its complaint that NICE, for reasons unknown, as a spokesperson told PharmaTimes UK News, refused to accept a post hoc analysis of clinical data regarding Protelos (strontium ranelate), which the firm claims not only “clearly showed the efficacy of Protelos in reducing the risk of hip fracture” but was also accepted by European regulators as the basis for its approval in this indication.

The company has long argued that current guidelines for the prevention of osteoporotic hip fractures in postmenopausal women unfairly restrict access to the drug, as patients unable to tolerate first line therapy with bisphosphonates have to wait for their bone mineral density to actually deteriorate before they are offered an alternative treatment such as Protelos. This, Servier argues, would leave the 15% of women with osteoporosis who cannot take bisphosphonates unprotected from the risk of fracture - potentially for many years.

£2.3 billion a year
And as David Reid, chair of the National Osteoporosis Society, previously pointed out: “The truth is that we are spending £2.3 billion a year treating hip fractures, but spend very little preventing those fractures from occurring in the first place”.

Commenting on the news, Professor Tim Spector, Consultant Rheumatologist at St Thomas’ Hospital, London, said: “While the previous court ruling means that the original NICE guidance is already under review, today’s decision means there is a greater chance of the appropriate data being considered. This will hopefully result in new guidance that is simpler and more flexible, giving clinicians a real choice in prescribing for women with osteoporosis, who all have individual needs.”