UK: Servier successfully challenges further aspects of National Institute of Clinical Excellence (NICE) recommendation

23 April 2010

Trevor Cook

We reported in the March 2009 Life Sciences Update on Servier’s partially successful challenge to a recommendation by NICE that had the effect of restricting the availability of its Protelos (strontium ranelate) product on the National Health Service in England & Wales on grounds of cost and efficacy as against other products for the prevention of osteoporotic fractures in post menopausal women.  That challenge related to the confidentiality of the economic mathematical model used by NICE, but two other grounds of challenge were rejected.  Servier appealed one of the other grounds, namely that during its proposals NICE failed properly to take into account efficacy data derived from a particular published study, when the same data had been accepted by the European Medicines Agency (EMA) in deciding to grant a marketing authorisation for the product.  In its decision of 31 March 2010 the English Court of Appeal allowed that appeal and directed that NICE undertake a fresh assessment.