Original Title: Avis: ponts trabéculaires iStent® et iStent inject® pour la chirurgie micro-invasive du glaucome (CMIG)

Authors' objectives: iStent® and iStent inject® trabecular bypasses are provided to patients with open angle glaucoma. However, access to such devices remains limited in the Quebec health system. The Institut national d’excellence en santé et en services sociaux (INESSS), at the request of the Bureau de l’innovation, assessed the pertinence of increasing access to public coverage for those devices.

Authors' results and conclusions: RESULTS: (EFFECTIVENESS , SAFETY AND QUALITY OF LIFE) To appreciate the therapeutic value of iStent® and iStent inject® devices, four randomized controlled studies (RCT) were selected. Separate studies were conducted for both devices, each including the following interventions and comparators, i.e.: Implantation of two devices per eye and phacoemulsification (phaco ) vs. phacoemulsification alone; Implantation of two devices per eye w/o phaco vs. pharmacotherapy. COST UTILITY ANALYSIS: This economic evaluation concluded to an incremental cost-utility ratio (ICUR) of approximately CAN$112,000/QALY (quality-adjusted life year) when two devices are used concurrently with phacoemulsification vs. phacoemulsification alone – implantation and phacoemulsification performed together is common practice for the use of these devices (more than 89% of the cases). Regarding the comparison between the implantation of two devices without phacoemulsification vs. pharmacotherapy, the ICUR is about CAN$26,000/QALY. This result must be qualified, for its absence of planned phacoemulsification surgery over a relevant time-horizon of 15 years. Moreover, it is important to stress that the estimated gain in QALY is quite low. Considering the short follow-up period for RCTs and the potential for bias in the studies available, there remains uncertainty as to whether the lower IOP level and reduction in medication intake can be maintained over time. In a scenario where benefits would not last beyond the follow-up data available, the ICUR could rise to as much as CAN$503,000/QALY (w. phaco) and to as much as CAN$111,000/QALY (w/o phaco). POTENTIAL BUDGET IMPACT: According to the base scenario used for the budget impact analysis (BIA) conducted by the INESSS, access to public coverage for those devices for patients with POAG may lead to an estimated budget cost increase of some CAN$29 M in the first three (3) years. In scenarios where the market shares of the devices vary from 1% to 100% in patients with POAG necessitating cataract surgery, the budget cost increase over a time-horizon of three (3) years would range from CAN$4,9 M to CAN$95,8 M respectively vs the case of no access to public coverage.

Authors' recommendations: The Institut national d'excellence en santé et en services sociaux (INESSS) is of the opinion that a decision in favour of public coverage of iStent® and iStent inject® trabecular bypasses would be fair and reasonable if significant measures to reduce the cost were implemented and their use governed by the following criteria: Patients who do not respond to at least two (2) hypotonic drugs or with a documented medical condition that prevent optimal administration of eye drops. Poor candidates for filtration surgery. OTHER CONSIDERATIONS: 1.Considering the uncertainties in terms of therapeutic value and cost-effectiveness, access to this service should be re-evaluated in light of new available data. The suggested time-horizon for a re-evaluation is three (3) years. 2.Any extension of the proposed criteria should only come to fruition in an evidence development context with the financial support of the manufacturer.

Authors' methods: To carry out this mandate and supplement the information provided by the manufacturer, INESSS conducted a systematic research of scientific literature on iStent® and iStent inject® trabecular bypasses. This research was complemented by a review of grey literature, contextual and experiential data gathered through consultations with an expert committee and Foundation Fighting Blindness Canada as well as the information retrieved from clinical administrative data from Quebec government databases. A model-based cost-utility analysis was conducted to evaluate the cost effectiveness of iStent® and iStent inject® in the perspective of the Quebec health system. Also, the potential budgetary impact of an increased access to those devices for a period of three (3) years was also performed.

Project Status: Completed

URL for project: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/ponts-trabeculaires-istentr-et-istent-injectr-pour-la-chirurgie-micro-invasive-du-glaucome-cmig.html

Year Published: 2020

URL for published report: https://www.inesss.qc.ca/publications/repertoire-des-publications/publication/ponts-trabeculaires-istentr-et-istent-injectr-pour-la-chirurgie-micro-invasive-du-glaucome-cmig.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