Original Title: Avis: Évaluation du Synvisc et du Synvisc One dans le cadre de la prise en charge de l’arthrose du genou

Authors' objectives: The Institut national d’excellence en santé et en services sociaux (INESSS) was asked by the Bureau de l’innovation to produce a guidance on the relevance of including Synvisc™ and Synvisc One™ as products covered by the public insurance plan for patients with knee osteoarthritis.

Authors' results and conclusions: RESULTS: • INESSS examined six prospective, randomized clinical trials comparing Synvisc-One™ with a corticosteroid (triamcinolone hexacetonide), with these two drugs combined, or with a saline solution (used as a placebo). These studies have certain limitations, which were taken into account when interpreting the results. • Major adverse events were very rare, both for patients who received a Synvisc™ or Synvisc-One™ injection and those who received a corticosteroid injection, and furthermore seem unrelated to this type of injection, in the authors’ opinion. • In the four observational studies examined, which involved a total of more than 1,300 patients, a significant improvement in overall health status was perceived, particularly regarding the function and pain components one year after injection of Synvisc™ or Synvisc-One™. • In the opinion of the experts, the safety profile of Synvisc™ and Synvisc-One™ described across the clinical studies is very comparable to that observed in the real-world care setting. • Data from three retrospective observational studies indicate that the patients who received Synvisc™ or Synvisc-One™ injections underwent surgery later than those who did not receive viscosupplementation.

Authors' recommendations: Based on the available data, the Institut national d'excellence en santé et en services sociaux (INESSS) is of the opinion that public coverage of Synvisc™ and Synvisc-One™ for patients with knee osteoarthritis (KOA) could be a fair and reasonable option, provided the manufacturer assists mitigating the economic burden. To promote the optimal use of Synvisc™ and Synvisc-One™, INESSS is of the opinion that their coverage should be governed by the following criteria: • the documented failure or inability to follow conservative treatments; • the need to document any clinical benefit, in terms of pain relief and improved function, after the first injection cycle before continuing to another treatment cycle; • the injection procedure should be performed by a clinician who is experienced and qualified to administer this type of injection.

Authors' methods: A review of data from the scientific literature and data provided by the manufacturer was performed in order to document the efficacy, safety and efficiency of Synvisc™ and Synvisc One™. Experiential and contextual data from the expert consultations are also presented. In addition, the perspectives of patients with knee osteoarthritis were obtained through a questionnaire developed by INESSS and disseminated by the Arthritis Society.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-du-synviscmd-et-du-synvisc-onemd-dans-le-cadre-de-la-prise-en-charge-de-larthrose-du-genou.html

Year Published: 2022

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/evaluation-du-synviscmd-et-du-synvisc-onemd-dans-le-cadre-de-la-prise-en-charge-de-larthrose-du-genou.html

English language abstract: An English language summary is available

Publication Type: Full HTA

Country: Canada

Province: Quebec

Organisation Name: Institut national d'excellence en sante et en services sociaux

Contact Address: L'Institut national d'excellence en sante et en services sociaux (INESSS) , 2021, avenue Union, bureau 10.083, Montreal, Quebec, Canada, H3A 2S9;Tel: 1+514-873-2563, Fax: 1+514-873-1369

Contact Name: demande@inesss.qc.ca

Contact Email: demande@inesss.qc.ca

Copyright: Gouvernement du Québec