Long-term clinical benefit and cost-effectiveness of an 8-week multimodal knee osteoarthritis management program incorporating intra-articular sodium hyaluronate (Hyalgan^®) injections

Abstract

Background

Given the poor long-term effectiveness of focused nonsurgical knee osteoarthritis (OA) treatments, alternative therapies are needed for patients who have unsuccessfully exhausted nonsurgical options.

Methods

A telephone interview was conducted in patients who participated in a single 8-week multimodal knee OA treatment program (mean follow-up: 3.7 years, range: 2.7–4.9 years). The program consisted of five intra-articular knee injections of sodium hyaluronate (Hyalgan^®), with each injection given 1 week apart, structured physical therapy, knee bracing, and patient education. Clinical outcomes included knee pain severity, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) subscores, current medication use, and history of total knee arthroplasty. Base-case, subgroup, and sensitivity analyses were conducted to determine the incremental cost-effectiveness ratio (ICER) of the treatment program with comparisons made to historical literature controls undergoing usual care.

Results

A total of 218 patients (54%) provided long-term follow-up data. Knee pain severity decreased 60% and WOMAC subscores decreased 33%–42% compared to baseline (all p<0.001). Total knee arthroplasty was performed in 22.8% (81/356) of knees during followup. The treatment program was highly cost-effective compared to usual care with a base-case ICER of $6,000 per quality-adjusted life year (QALY). Results of subgroup analyses, one-way deterministic sensitivity analyses, and second-order probabilistic sensitivity analyses resulted in ICERs ranging from $3,996 to $10,493 per QALY. The percentage of simulations with an ICER below willingness-to-pay limits was 97.2%, 98.9%, and 99.4% for the $50,000, $100,000, and $150,000 per QALY thresholds, respectively.

Conclusion

Participation in a single 8-week knee OA treatment program, which included one cycle of five intra-articular knee injections of sodium hyaluronate given at weekly intervals, is highly cost-effective and provides clinically meaningful reductions in patient symptoms that are maintained over 3.7 years mean follow-up.

Keywords:

• arthroplasty
• economic model
• hyaluronic acid
• pragmatic
• viscosupplementation
• Hyalgan^®

Acknowledgments

This work was supported by Fidia Pharma USA Inc. (Parsippany, NJ, USA).

Author contributions

LEM, MS, and SN conceived and designed the experiments; LEM analyzed the data and wrote the first draft of the manuscript; MS, TEG, JGJ, KDV, and SN critically revised the manuscript; all authors interpreted the data, reviewed and approved of the manuscript version to be published, and agree to be accountable for all aspects of the work in ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.

Disclosure

SN is an employee of Fidia Pharma USA Inc. The authors report no conflicts of interest in this work.