Authors' objectives: Aortic stenosis (AS) typically occurs in individuals greater than 65 years of age and involves progressive thickening and hardening of the leaflets (heart valve flaps) which become restricted in their opening when the heart contracts. This in turn causes a thickening of the heart muscle and a decrease of flow of blood to the body and coronary arteries. Typically, patients with AS are free from cardiovascular symptoms (e.g. angina, syncope and/or heart failure) until late in the course of the disease. However, once symptoms manifest, the prognosis is poor, especially when associated with congestive heart failure. Death in general, including sudden death, occurs primarily in symptomatic patients.

Authors' recommendations: After considering the available evidence presented in relation to safety, clinical effectiveness and cost-effectiveness of transcatheter aortic valve implantation (TAVI) via transfemoral or transapical delivery for patients with symptomatic severe aortic stenosis who are determined to be at high risk for surgical aortic valve replacement (SAVR) or who are inoperable, MSAC deferred the application to allow the applicant to re-present its economic model. The updated economic model would need to address the concerns raised by the critique and ESC, and would also need particular emphasis on the following: • incorporate the recently published 5-year PARTNER trial data; • incorporate rehospitalisation appropriately in the estimate of costs in the economic model; • decrease the initial hospitalisation cost difference (compared with SAVR) in the economic model to reflect the current length of stays for TAVI and SAVR; • provide stronger justification for assumptions relating to utilities; • perform multivariate sensitivity analyses as well as univariate sensitivity analyses; • consider using the most recently updated data from the Medtronic CoreValve trial to also inform the economic evaluation, at least in a sensitivity analysis; and • the economic model should examine transfemoral delivery only (not transapical) with a separate ICER comparing TAVI to only SAVR or only medical management. MSAC considered that the updated economic model should be made via ESC, accompanied by a contracted critique of the resubmission.

Project Status: Completed

URL for project: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/1361-public

Year Published: 2015

URL for published report: http://www.msac.gov.au/internet/msac/publishing.nsf/Content/9E366B4233A15A35CA257C9E001A0317/$File/1361Final-PSD-Accessible.pdf

English language abstract: An English language summary is available

Publication Type: Not Assigned

Country: Australia

Organisation Name: Medical Services Advisory Committee

Contact Address: MSAC (MDP 107), GPO Box 9848, Canberra, ACT 2601, Australia. Tel: +61 2 6289 6811; Fax: +61 2 6289 8799.

Contact Name: msac.secretariat@health.gov.au

Contact Email: msac.secretariat@health.gov.au

Copyright: Medical Services Advisory Committee (MSAC)