NICE statement on Court of Appeal judgement on osteoporosis appraisals
At a hearing in December 2009 Servier sought to overturn an earlier ruling of the High Court, which had upheld NICE's guidance on the use of a number of drugs to prevent osteoporotic fractures. Servier argued that the Institute had failed to adequately explain why it had regarded a post-hoc sub-group analysis of Servier's drug, strontium ranelate (Protelos), as unreliable. This decision had limited the use of strontium ranelate to patients who are at high risk of osteoporotic fractures or who are unable to tolerate alendronate, another recommended drug.
The Court of Appeal did not rule that NICE had made the wrong decision, but it found that NICE should have done more to explain its decision on this post-hoc study. The Court accepted NICE's position that such studies should be used with caution.
Sir Andrew Dillon, Chief Executive of NICE, commented:”Although we are disappointed by this judgement, we will ask our independent Appraisal Committee to look afresh at this post-hoc sub group study and reconsider the weight which should be attached to it. We will do this and produce new draft guidance within three months. We welcome the fact that the Court did not find that we had necessarily made the wrong decision about the use of strontium ranelate.
“This only affects our recommendations on strontium ranelate. Those recommendations will be withdrawn pending this review. Our recommendations on the use of alendronate and other drugs for osteoporosis will remain in force, so women at risk of osteoporotic fractures will still have access to these treatments on the NHS.”
This page was last updated: 01 April 2010