Templates for Pharmaceuticals and Medical Devices
Submission dossier and assessment report templates used in Joint Action 3
Please see below the submission dossier and assessment report templates used for EUnetHTA assessments – REAs (including dates of latest updates):
- Pharmaceutical technologies: submission dossier template (July 2020)
- Pharmaceutical technologies: assessment report template (November 2020)
- Other technologies: submission dossier template: short form (October 2015)
- Other technologies: submission dossier template: long form (October 2015)
- Template for EUnetHTA Core HTA of Other Technologies *(i.e. Other technologies HTA Core Model assessment report template) (April 2021)
*EUnetHTA has only conducted Rapid Relative Effectiveness Assessments in Joint Action 3. The redundant parts of the full core template have been deleted in these reports.
Outputs of the Subgroup on pharma templates (SDAT-PHARMA)
In Joint Action 3, a dedicated EUnetHTA subgroup developed recommendations for future (post-Joint Action 3) submission dossier and assessment report templates for pharmaceutical technologies. Two surveys among EUnetHTA partners were carried out in the summer of 2020. One survey was conducted to identify evidence requirements for a submission dossier and to facilitate future revisions of the EUnetHTA submission dossier template. Another survey was carried out to collect feedback on the current assessment report template, to find areas of improvement, and to facilitate future revisions of the EUnetHTA assessment report template.
Please find attached the deliverables of the Pharma templates subgroup:
- Recommendations for a future submission dossier template
- Recommendations for a future assessment report template
*Appendix 2 presents a review of national assessment report headings, conducted by two subgroup member organizations, TLV and Fimea, in February – March 2020. The aim was to identify and report the tables of contents in published national HTA reports. Webpages of the agencies were scanned for examples of reports and, where available, the report on Xtandi metastasised prostate cancer was used. In case no national reports were found, the agency was contacted and a list of headings in English was obtained. The content of this review has not been validated by the different included organizations prior to publication.
Within the subgroup, no consensus was reached on the proposed new EUnetHTA Assessment Report template structure included in Appendix 2. The authors recommend that, in the future, a larger, more structured review of the content of national templates be performed in order to build on this pilot and come to an agreement.
Template development work in Joint Action 2
In EUnetHTA Joint Action 2, evidence submission templates were developed from an analysis of evidence requirements for reimbursement in Europe. It is a tool that agencies can use to request evidence from companies to support their HTA and reimbursement processes. The tool covers relative effectiveness assessment including a description of the health condition and health technology, as well as clinical effectiveness and safety information. It also includes requests for information about the methodology used to produce the HTA (for example, how studies were identified).
Template versions were prepared for both Pharmaceuticals and Medical Devices. Some of these templates are still in use in Joint Action 3 (please see above):
Evidence submission template – Pharma – long
Evidence submission template – Pharma – short
Narrative report – evidence requirements
Evidence submission template-adaptation notes
Evidence submission template – MedDev – long
Evidence submission template – MedDev – short
