Servier is to challenge a High Court decision that supported NICE guidance restricting access to its osteoporosis drug Protelos (strontium ranelate).
The company has been granted permission by the Court of Appeal to challenge the decision made at a Judicial Review in February this year.
Servier won its claim that NICE should be obliged to provide the economic model used in its guidance for the prevention of osteoporotic fractures in postmenopausal women. However, the company is disputing one legal point: what it claims was the misinterpretation of its clinical data on the reduction of risk of hip fracture by Protelos.
Michael Sumpter, CEO of Servier, commented: “We are delighted with today’s decision granting Servier the right to appeal on the basis of the irrational consideration by NICE of data submitted by Servier during the appraisal process.”
The company claims that NICE refused to accept a post hoc analysis of trial data, which was specifically requested by the EMEA scientific committee and clearly showed the efficacy of Protelos in reducing the risk of hip fracture.
Servier says that it challenged NICE at Judicial Review because it believes the osteoporosis guidance “unfairly and unnecessarily restricts access to Protelos for many patients who could benefit from it”.
In January 2009, Servier challenged NICE on three grounds: lack of transparency around the economic model used to evaluate cost effectiveness, misinterpretation of Servier’s clinical data around hip fracture data, and unlawful discrimination on the basis of disability.
As a result of the February ruling, NICE has shared a copy of the economic model with the stakeholders who submitted evidence for the current guidance. The current guidance is also being re-evaluated.
Consultant Rheumatologist Professor Tim Spector said: “Many of my patients are unable to tolerate the treatment recommended by NICE under the current guidance, but I have to wait for their disease to deteriorate before I can give them an alternative treatment. 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.”