Servier Laboratories has successfully overturned a court ruling that essentially upheld a decision by the National Institute for Health and Clinical Excellence to reject important clinical data on its osteoporosis drug Protelos during a cost appraisal.

The long-running saga over NICE’s osteoporosis guidance - which basically states that patients unable to tolerate first line therapy with bisphosphonates have to wait for their bone mineral density to deteriorate before they are offered an alternative treatment such as Servier’s Protelos (strontium ranelate) - took another turn yesterday after the Court of Appeal ruled in favour of the drugmaker throwing out the previous decision.

A Judicial Review in February last year found that NICE had acted unlawfully in failing to allow access to the economic model underpinning its guidance for the prevention of osteoporotic fractures in postmenopausal women, forcing a re-evaluation of the Institute’s recommendations, which then subsequently remained unchanged.

However, Servier initially lost on its complaint that NICE refused to accept a post hoc analysis of clinical data regarding Protelos, 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.

Now, a Court of Appeal has found that NICE should indeed have done more to explain its decision to ignore the findings of this post hoc study, which was, after all, specifically requested by the European Medicines Agency, the firm noted.

New hope for new guidance
The decision will certainly give patients a new ray of hope as NICE’s Appraisal Committee will now have to give the data from this study full consideration and produce new draft guidance on the use of Protelos in the National Health Service “within three months”, said NICE chief executive Andrew Dillon.

“We hope that NICE will now take proper account of our clinical data and issue new guidance which enables all the appropriate patients to access Protelos,” said Michael Sumpter, Servier’s chief executive.

“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,” added Professor Cyrus Cooper, Chair of the International Osteoporosis Foundation Scientific Committee.