Balloon Spacer Implant is an "Intermediate Value" Innovation Relative to Partial Repair for Full-Thickness Massive Rotator Cuff Repairs: A Cost-Utility Analysis.

ABSTRACT

PURPOSE: The purpose of this study was to evaluate the cost-utility of a Balloon Spacer implant relative to partial repair (PR) for the surgical treatment of full-thickness massive rotator cuff tears (MRCT). METHODS: A decision-analytic model comparing Balloon Spacer versus PR was developed using data from a prospective, randomized, single-blinded, multi-center controlled trial of 184 randomized patients. Our model was constructed based on the various event pathways a patient could have after the procedure. The probability that each patient progressed to a given outcome and the quality-adjusted life years (QALY) associated with each outcome were derived from the clinical trial data. Incremental cost utility ratio (ICUR) and incremental net monetary benefit (INMB) were calculated based on a probabilistic sensitivity analysis using Monte Carlo simulations of 1,000 hypothetical patients progressing through the decision-analytic model. One-way sensitivity and threshold analyses were performed by varying cost, event probability, and QALY estimates. RESULTS: Balloon Spacer had an ICUR of $106,851 (95% CI, $96,317 to $119,143) relative to PR for surgical treatment of MRCT. Across all patients, Balloon Spacer was associated with greater 2-year QALY gain compared to PR (0.20 ± 0.02 for Balloon Spacer versus 0.18 ± 0.02 for PR), but with substantially higher total 2-year cost ($9,701 ± $939 for Balloon Spacer versus $6,315 ± $627 for PR). PR was associated with a positive INMB of $1,802 (95% CI, $1,653 to $1,951) over Balloon Spacer at the $50,000/QALY willingness-to-pay (WTP) threshold. CONCLUSIONS: Compared to PR, Balloon Spacer is an "intermediate value" innovation for treatment of MRCT over a 2-year postoperative period with an ICUR value that falls within the $50,000 to $150,000 WTP threshold.