In the July 2008 edition of the Life Sciences Update we reported on the partially successful challenge to the decision by NICE to base its recommendation for use of three Alzheimer’s disease treatments by the National Health Service on an economic mathematical model, the details of which it was not prepared, on grounds of confidentiality towards a third party, fully to share with those companies whose drugs were the subject of the assessment.
However, disputes as to confidentiality in relation to the models that it uses continue to undermine NICE’s assessments, as evidenced by the judgment of the English High Court on 19 February 2009 on a challenge by Servier. This related to the economic model used by NICE in developing final guidance issued in October 2008, on the use of drugs for both primary and secondary prevention of fractures in postmenopausal women with osteoporosis which had the effect of restricting access to its Protelos (strontium ranelate) product. The model here had been produced for NICE by an academic who had in turn relied on data from another academic which was provided in confidence. The Court held that NICE had not taken adequate steps to try to secure a limited waiver of confidentiality from the originator of such data that would have allowed Servier to review it, even though, as matters transpired, all the indications were that he would have been prepared so to do. Other grounds of challenge to the assessment by NICE were however rejected.