Cost-effectiveness analysis of arthroscopic injection of a bioadhesive hydrogel implant in conjunction with microfracture for the treatment of focal chondral defects of the knee – an Australian perspective

Abstract

Aim

JointRep is a bioadhesive hydrogel arthroscopically injected to facilitate cartilage regeneration. The cost-effectiveness of JointRep with microfracture surgery compared to microfracture alone was evaluated from the Australian healthcare system perspective, in patients with symptomatic focal chondral defects (Outerbridge Grade 3 or 4) of the knee who had failed conservative treatment and were indicated for surgery.

Materials and methods

A de novo Markov model comprising two health states- ‘Alive’ and ‘Dead’ was developed. Model transition probability was based on the general population mortality rates. Clinical outcomes were assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores, a validated patient-reported tool measuring pain, stiffness, and physical function. The utility was derived by mapping WOMAC scores to EQ-5D scores using a published algorithm. Cost inputs were based on published Australian costs from AR-DRGs, Medicare Benefits Schedule, and Prostheses List. Model outcomes included costs, Quality-adjusted life years (QALYs), and incremental cost-effectiveness ratio (ICER). Base-case analysis was conducted for a time horizon of 3 years and a cycle length of 1 year. Cost and health outcomes were discounted at 5% per annum. Sensitivity and scenario analyses were also conducted.

Results

Total QALYs were estimated to be higher for JointRep with microfracture surgery (2.61) compared to microfracture surgery alone (1.66), an incremental gain of 0.95 QALY. JointRep with microfracture surgery was associated with an incremental cost of $6,022 compared to microfracture surgery alone, thus leading to an ICER of $6,328. Results were substantially robust to varying parameters in the sensitivity analyses conducted, alternative model settings and assumptions in scenario analyses.

Limitations

The clinical inputs used in the model were based on data from short duration, non-randomized, post-market clinical trial.

Conclusions

JointRep with microfracture surgery is a cost-effective treatment option compared to microfracture alone from the Australian health care system perspective.

Keywords:

• JointRep
• microfracture surgery
• cost-effectiveness
• Australia
• osteochondral defects

JEL Classification Codes:

• C20
• C2
• C
• C40
• C4
• C

Transparency

Declaration of funding

The study was funded by Device Technologies Australia Pty. Ltd and Oligo Medic Inc

Declaration of financial/other interests

Device Technologies Australia Pty Ltd and Oligo Medic Pty Ltd provided funding to conduct this study but had no role in the preparation of this article.

The Pipino 2018⁹ trial was sponsored by Oligo Medic but otherwise independent of Oligo Medic. The extent of the sponsorship was only to provide the JointRep device used in the trial free of cost. The authors of the trial do not have any financial interest in JointRep or Oligo Medic.

Peer reviewers on this manuscript have received an honorarium from JME for their review work but have no other relevant financial relationships to disclose.

Author contributions

GP, SG, HR, and AG made significant contributions to the concept and study design. GP, SG, HR, AG, and BS helped with the data acquisition and data analysis. All authors contributed equally towards data interpretation, manuscript draft preparation and revision, and gave final approval for manuscript publication. All authors agree to be accountable for all aspects related to this study.

Acknowledgements

The authors thank Dr Allan J Wailoo and Dr Monica Hernandez Alava from Health Economics and Decision Science, School of Health and Related Research (ScHARR), University of Sheffield, Sheffield, UK for the re-estimation of the relationship between WOMAC and EQ5D-3L using the Australian tariffs.

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