Original Title: Evaluation des ultrasons focalisés de haute intensité (HIFU) pour le traitement des fibromes utérins symptomatiques

Authors' objectives: The aim of the evaluation was to assess the appropriateness of French health insurance reimbursement of USgHIFU and MRgHIFU for the treatment of symptomatic uterine fibroids. To this end, the objectives of the evaluation were defined as follows: 1) Assess the benefit/risk balance of USgHIFU and MRgHIFU compared with the two conventional conservative treatments of the uterus (myomectomy on the one hand, and uterine artery embolization on the other); 2) Define the conditions under which USgHIFU and MRgHIFU are performed; 3) Assess the organizational impact of the possible deployment of USgHIFU and MRgHIFU in France.

Authors' results and conclusions: Concerning the assessment of the benefit/risk balance of each of the two HIFU guidance modalities compared with the two conventional treatments (objective 1), the evaluation highlighted : - comparative literature that is non-existent or of low validity, and mostly not directly applicable to the French healthcare context ; - heterogeneous expert opinions regarding the benefits and risks of USgHIFU and MRgHIFU, highlighting the uncertainties arising from the data in the literature. With regard to the definition of the conditions of implementation and the assessment of the organizational impact (objectives 2 and 3), the data in the literature are insufficient (few in number and not applicable to the French context) and expert opinion is limited by the lack of practice in France. Taking into account the facts analyzed and the opinions gathered, the benefit/risk balance of each of the two modalities of HIFU guidance compared with each of the two conventional treatments, their conditions of implementation and their possible organizational impact cannot be assessed in the current state of knowledge.

Authors' recommendations: The HAS has not recommended the reimbursement by the French National Health Insurance of treatment procedures for symptomatic uterine fibroids using US-guided high-intensity focused ultrasound (USgHIFU) and MRI-guided high-intensity focused ultrasound (MRgHIFU), on the grounds that the expected service is deemed insufficient in the current state of knowledge.

Authors' methods: The evaluation method included: i) a systematic bibliographical search carried out according to PICOTS selection criteria, with critical analysis of published facts following GRADE methodology, ii) consultation of individual experts (professionals and patients) and iii) collection of the views of stakeholders (professional bodies and patient associations) concerned by the subject. The facts analyzed and opinions gathered during this evaluation were compiled and structured in a report. This report was examined by the HAS Commission for Recommendations, Relevance, Pathways and Indicators (CRPPI), then validated by the HAS College, which formulated the HAS opinion.

Authors' identified further research: Given i) the theoretical advantages of USgHIFU and MRgHIFU, notably their minimally invasive nature, ii) the expectations of patients and professionals with regard to these treatments, iii) the lack of French and European data, and iv) the encouraging feedback from the only French center practicing MRgHIFU, interviewed as part of the assessment, the HAS encourages the implementation of studies of the following types: - well-conducted randomized controlled trials to answer the question of the efficacy, safety and organizational impact of each of the two modalities of HIFU guidance compared with conventional treatments, in order to fill gaps in the literature while ensuring a strict and secure framework of care for patients ; - cohorts of treated patients to document any rare complications and short-, medium- and long-term reproductive health data. The HAS is awaiting new French and/or European data to be produced in order to re-evaluate these procedures at a later date.

Project Status: Completed

URL for project: https://www.has-sante.fr/jcms/p_3445536/fr/evaluation-des-ultrasons-focalises-de-haute-intensite-pour-le-traitement-des-fibromes-uterins-symptomatiques-rapport-d-evaluation

URL for protocol: https://www.has-sante.fr/upload/docs/application/pdf/2023-06/cadrage_hifu_fibromes_uterins.pdf

Year Published: 2024

URL for published report: https://www.has-sante.fr/upload/docs/application/pdf/2024-07/rapport_hifu_fibromes.pdf

Requestor: - Patients ; - Health professionals from medical and paramedical specialties involved in performing the procedure and/or referring patients; - French health insurance

URL for additional information: has-sante.fr/upload/docs/application/pdf/2024-07/annexes_rapport_hifu_fibromes.pdf

English language abstract: There is no English language summary available

Publication Type: Mini HTA

Country: France

Organisation Name: Haute Autorité de Santé

Contact Address: 2 avenue du Stade de France, 93218 Saint-Denis La Plaine Cedex, France. Tel: +33 01 55 93 71 88; Fax: +33 01 55 93 74 35;

Contact Name: has.seap.secretariat@has-sante.fr

Contact Email: has.seap.secretariat@has-sante.fr

Copyright: <p>Haute Autorite de Sante/French National Authority for Health (HAS)</p>