Drug company, Servier, supported by the National Osteoporosis Society, successfully challenged NICE guidelines.
The company argued that NICE unfairly restricts access to its treatment for osteoporosis, Protelos. In its guidelines produced last year, NICE recommended another drug, Alendronate as a first-line treatment, but about one in four patients cannot tolerate this drug because of side-effects. For those patients NICE recommends other options, including Protelos, but only for those patients whose condition has deteriorated.
Servier believes this leaves 15 per cent of women with osteoporosis who are unable to receive treatment under the NICE guidelines.
The High Court judge agreed with Servier’s contention that NICE had failed to be as transparent as it should have been and should have disclosed details of the economic model on which it based its guidance.
NICE must now reconsider its guidance in the light of further submissions but, if it reaches the same conclusion, it does not necessarily follow that the new decision is unlawful. Other grounds of challenge, including an allegation that NICE unlawfully discriminated against disabled people, were rejected by the court.