Agreement on the national HTA programme for medical devices has been reached between the central and regional authorities during the last Assembly. The main player in this context will be the Cabina di Regia per l’HTA, a national steering committee for HTA created in 2015-2016 by the Ministry of Health including representatives of the Ministry of Health, four Regions, The national agency for regional healthcare (AGENAS), and the Italian medicine agency (AIFA).
The steering committee will coordinate activities aimed at the production of the following deliverables:
- List of technologies notified for evaluation;
- List of technologies prioritized for assessment;
- HTA reports for prioritized technologies;
- Recommendations for appropriate use within the healthcare system (appraisal reports);
- Working plan for the coordination of the activities related to the national HTA programme.
The deliverables will be disseminated among all the decisional levels of the national healthcare system, from the national commission for the essential level of care (Commissione Nazionale LEA) to the regional directorates that will circulate them across hospitals and regional procurement units.
The main elements of the programme are here described:
Notification of technologies and prioritization of assessments
An online notification form will manage notifications. Any stakeholder, including manufacturers and patients or citizens, will have the chance to submit a technology for assessment. The steering committee will be responsible for the prioritization of assessments and, to assure transparency, independence, and equity, seven prioritization criteria have been defined.
HTA reports production
The national agency for regional healthcare (AGENAS) will coordinate assessment activities performed by public and private collaborative centers disseminated across the country. The expertise of collaborative centers will be assessed according to a set of criteria defined by AGENAS together with the national institute of health (ISS). Draft HTA reports will be externally peer-reviewed and open to public consultation for 30 days. Final versions will be released to the public after approval from the steering committee.
Definition of recommendations for appropriate use
The steering committee will be responsible for the production of recommendations based on the judgment provided by a national appraisal network within 60 days from the production of the HTA report. Four kinds of recommendation will be possible
- The technology does not have (yet) prerequisites for widespread use;
- The introduction of the technology will lead to benefits;
- The technology is recommended for use only within research framework aimed to generate scientific evidence;
- The technology can be used only after data on real effectiveness and costs have been collected.
Stakeholders affected by the recommendations can contest the decision and claim for re-definition of recommendations within 30 days.
Links with procurement
HTA reports will be disseminated among regional procurement units and will have an actual role in final decisions about procurement. Procurements units will have to report periodically to the steering committee about the use of the HTA documents within the decisional process.
Working groups
Three working groups will assist the steering committee in the different tasks:
- National appraisal network working group
- Methods, training, and communication working group
- Programme monitoring working group
Please, find a link to the full-text of the National HTA Programme (in Italian) here.
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