NICE's evaluations of medicines authorized by EMA with conditional marketing authorization or under exceptional circumstances

International Journal of Technology Assessment in Health Care

25 June 2020 - Products which received conditional marketing authorisation or authorisation in exceptional circumstances by European Medicines Agency up to 1 December 2016 were identified and matched with corresponding NICE decisions issued by August 2017, the status of which was then traced to August 2019. 

The investigators assessed whether the conversion of conditional marketing authorisation to full marketing authorisation triggered a review of a NICE decision. 

The odds of a recommendation carrying a commercial arrangement for products with and without conditional marketing authorisation or authorisation in exceptional circumstances were calculated.

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Michael Wonder

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Michael Wonder