HTA

appeals

Application systems for HTA, coding and pricing vary across Europe and in most cases decisions are final with no mechanism for appeal. Many systems however allow for new applications if the evidence base changes. In France any new pharmaceutical product sold to hospitals has to be listed on the national formulary. This requires a review by the Transparency Commission (CT). If the manufacturer disagrees with the decision of the CT the decision can be challenged and a hearing is organized. In addition it is possible to seek informal advice and make a presentation prior to submission. In Germany it is possible to seek a review of a dossier prior to submission for formal HTA from the KBV Innovation Service.

NICE processes include the possibility of appeal on a number of grounds. Guidance is usually issued as a draft with a set time for comments from stakeholders. When the final guidance is issued stakeholders can enter appeals. These are more likely to be successful if the committee has misinterpreted data or not recognized the significance of key data. Translucency has managed successful appeals on behalf of clients: as with dossier preparation our approach is to build a persuasive case from the evidence base.