Italian Ministry of Health has opened a 60-days public consultation for 5 new health technology assessments of medical technologies

Assessments were directed by national HTA body AGENAS. 

The comments, that have to be submitted through an electronic form available in Italian and English, will be analysed by the authoring teams and expert groups who contributed to the assessments.

The 5 health technology assessment reports are the following:

HTA Report - Medical devices for treatment-resistant hypertension

Aim: To assess the potential benefits and risks of transcatheter renal denervation for treatment-resistant hypertension in addition to optimal medical therapy (OMT) compared to OMT alone.

Methods: Searches were performed on the national hospital discharge database to describe the level of use of transcatheter renal denervation in Italy. Systematic review of literature was performed to collect evidence on effectiveness, safety, and economic impact of the renal denervation procedure.

Conclusion: Randomised controlled trial evidence shows no benefits of the procedure, but follow-up was limited to 6 months. This finding remains unexplained. Economic evaluations are unreliable as they are based on costs derived from publications, unrealistic assumptions of effectiveness, and contrived therapy regimes. Further investment in renal denervation should await the results of well-designed and adequately followed-up trials assessing the impact of renal denervation on major cardiovascular events compared to OMT. Good quality economic evaluations should be based on realistic assumptions

HTA Report - Next Generation Sequencing (NGS) – (Report in Italian with English abstract)

Aim: To describe the current state of the art of next generation sequencing (NGS) and provide useful information to plan future governance of NGS in oncology (in somatic and constitutional analysis).

Methods: Analyses of relevant aspects (analytical and clinical validity, clinical utility, regional laboratory networks, costs, ethical-social impact, and information needs) and recommendations were made by comparing NGS to the single automated sequencing according to the Sanger method using available data, including a survey of 4 Italian regions.

Conclusion: Standardization should be a requirement in all laboratory using NGS. Networking could facilitate the management and analysis of data, and an alignment across the platforms. We suggest the central governance of NGS best practices with rules for the conduct of the test, accreditation of laboratories, exchanging and storing data for reimbursement of marker companion and marker non companion tests, incentives for participation in clinical trials and stakeholders consortia for the financing and development of national and European networks for the validation and evaluation of the technology. The rapid potential improvement of a cancer patient by means 6 of a more selective approach to therapy should be supported by clinical trials that incorporate the problem of low prevalence phenotypes in various types of cancer that could benefit. Correct and punctual information should be provided to all users

HTA Report - Chirurgia robotica – (Robotic surgery; report in Italian with English abstract)

Aim: To facilitate appropriate governance of the introduction and use of robotic surgery, at both national and regional level, by assessing the effects of the use of the technology, its costs and context of use.

Methods: Literature was searched to identify evidence of effects of robotic surgery on health outcomes. A survey on 21 Italian regions was performed to study economic impact, levels of use, type of procedures performed, training, costs and organisational aspects related to the delivery of robotic surgery services.

Conclusion: The introduction and use of robotic surgery in Italy lacks an organised approach linked to performance, outcomes monitoring and robust evidence generation, in keeping with the evolution of the technology.

HTA Report - Sling operation for urinary incontinence in women and men

Aim: To focus on the impact of sling operation in women (compared to Burch colposuspension or autologous vaginal tapes) and men (compared to artificial urinary sphincter or adjustable continence therapy) with stress urinary incontinence (SUI). Conservative therapy with diapers was considered a comparator for both populations.

Methods: Searches were performed on the national hospital discharge database to describe the level of use of sling insertion versus its comparators. Evidence synthesis was performed including comparative evidence on effectiveness, safety and economic aspects of the sling procedure.

Conclusion: Only devices supported by robust clinical data should be used in women. Comparative clinical data is insufficient to support the use of male slings. All sling devices should be tested in prospective multicentre comparative studies before marketing and current legislation should be changed accordingly. Such studies should include prospective economic evaluation with reproducible measures of QoL.

Adapted HTA Report - Protesizzazione del disco intervertebrale cervicale e lombare / Cervical and lumbar total disc replacement (report in Italian with English abstract)

Aim: To update and adapt to the Italian context the HTA report on “Cervical and lumbar total disc replacements”, produced in 2015 by the Belgian Health Care Knowledge Centre (KCE), authored  by Holdt Henningsen K, Thiry N, De Laet C, Stordeur S, Camberlin C.

Methods: Systematic review of literature and collection of primary information were performed to analyse aspects related to different domains (Health problem and current use of technology, Description and technical characteristics of technology, Clinical effectiveness, Safety, Costs and economic evaluation).

Conclusion: Mean differences between CTDR and cervical fusion comparison (7 years follow up) and for LTDR and lumbar fusion or conservative treatment comparison (5 years follow up) were clinically not relevant. Although more studies onclinical relevance and larger randomized controlled are needed to confirmrelevant clinical effectiveness and the safety outcomes. The Italian economic context must be studied and further studies are needed for a good quality economic evaluation.

See announcement at the web-site of Ministry of Health in Italian here.

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