A High Court judge has ordered the National Institute for Health and Clinical Excellence (NICE) to rethink its decision to restrict prescription of a potentially effective drug treatment for osteoporosis.
Mr Justice Holman said that NICE’s failure to disclose to the drug’s manufacturers and other interested parties the economic model underpinning its decision was wrong.
Servier Laboratories, which markets its drug strontium ranelate as Protelos, had brought the judicial review challenge, backed by the Alliance for Better Bone Health and the National Osteoporosis Society.
The judge ordered NICE to negotiate with the author of the economic model and make sure that it is fully disclosed, within reason, to Servier and all other consultees, allowing them to make further representations.
If NICE still came to the same conclusion after reconsidering the issue in the light of further submissions, it would not necessarily follow that the new decision was unlawful, he said.
Last October NICE took the decision that only a small sub-group of patients should receive a publicly-funded supply of the medicine – and then only as a “third line” treatment. This left the majority with a cheaper alternative which many cannot take because of its side effects.
Copyright Press Association 2009