Economic evaluation of BST-CarGel as an adjunct to microfracture vs microfracture alone in knee cartilage surgery

Abstract

Objectives:

Knee cartilage damage is a common cause of referral for orthopedic surgery. Treatment aims to reduce pain and symptoms by repairing cartilage. Microfracture, the current standard of care, yields good short-term clinical outcomes; however, treatment might fail after 2–3 years. A Chitosan-Beta glycerolphosphate-based medical device (BST-CarGel) is used as an adjunct to microfracture and demonstrates improvements in quantity and quality of repaired tissue, potentially reducing the risk of treatment failure. This study aimed to establish the economic value of BST-CarGel vs microfracture alone in knee cartilage repair from the societal perspective, using Germany as the reference market.

Methods:

A decision tree with a 20-year time-horizon was constructed, in which undesirable clinical events were inferred following initial surgery. These events consisted of pain management, surgery, and total knee replacement. Clinical outcomes were taken from the pivotal clinical trial, supplemented by other literature. Data and assumptions were validated by a Delphi panel. All relevant resource use and costs for procedures and events were considered.

Results:

In a group of patients with all lesion sizes, the model inferred that BST-CarGel yields a positive return on investment at year 4 (with 20-year cumulative cost savings of €6448). Reducing the incremental risk of treatment failure gap between the device and microfracture by 25–50% does not alter this conclusion. Cost savings are greatest for patients with large lesions; results for patients with small lesions are more modest.

Limitations:

Clinical evidence for microfracture and other interventions varies in quality. Comparative long-term data are lacking. The comparison is limited to microfracture and looks only at costs without considering quality-of-life.

Conclusion:

BST-CarGel potentially represents a cost-saving alternative for patients with knee cartilage injury by reducing the risk of clinical events through regeneration of chondral tissue with hyaline characteristics. Since the burden of this condition is high, both to the patient and society, an effective and economically viable alternative is of importance.

Keywords::

• Economic analysis
• Economic model
• Articular cartilage
• Knee joint
• Randomized, controlled trial
• Cartilage repair

Transparency

Declaration of funding

Funding for the study was provided to the following by Piramal Life Sciences – Bio-Orthopaedics Division, Laval, Quebec, H7V 4B3, Canada

Declaration of financial/other relationships

Data 4 Actions, Laval, Quebec, Canada. Julie Frappier is a consultant to Piramal Health Sciences. Dr William Stanish is Medical Advisor for Piramal, as the Principal Investigator of the clinical study and follow-up. He is also a member of Piramal’s Scientific Advisory Board. Dr Mats Brittberg is Medical Advisor for Piramal, and is a member of Piramal’s Scientific Advisory Board. He is also a consultant to Sanofi Biosurgery, Anika Therapeutics, BMI Medical Implants, and owns stock in Neurovive. Dr Matthias Steinwachs is a Medical Advisor for Piramal, and is a member of its Scientific Advisory Board. Dr Alberto Restrepo and David Castelo have disclosed that they are employees of Piramal Life Sciences. Lydia Crowe is an employee of Abacus International, a company that was funded by Piramal to develop this study. JME Peer Reviewers on this manuscript have no relevant financial or other relationships to disclose.

Author contributions: Julie Frappier was involved in the conception, design, lead authorship, analysis, and interpretation of data, and provided final approval of the manuscript submitted. Dr Stanish aided in data acquisition, provision of study subjects, manuscript revision, and final approval of the submitted paper. Dr Brittenberg and Dr Matthias Steinwatch contributed to the critical revision of the article and final approval of the version submitted. Lydia Crowe was involved in the conception and design, and aided in the drafting of this manuscript, providing technical and logistic support. She also provided assistance with the interpretation of the clinico-economic model used. Dr Alberto Restrepo contributed to the drafting of the manuscript, critical revision, data collection, and final approval of the submitted manuscript. David Castelo contributed to the drafting of the manuscript, provision of study materials, collection of clinical study data, administrative, and technical support.

Acknowledgments

The authors thank the following Principal Investigators for their participation at the Clinical Study Site for their help with the acquisition of data and the provision of study subjects to the Pivotal Clinical Study: Peter MacDonald, MD, Pan Am Clinic, Winnipeg, Manitoba, Canada; Nicholas Mohtadi, MD, University of Calgary Sports Medicine Center, Calgary, Alberta, Canada; Paul H. Marks, MD, Sunnybrook Health Sciences Centre, Toronto, Ontario, Canada; William Stanish, MD, Orthopaedic and Sport Medicine Clinic of Nova Scotia; Halifax, Nova-Scotia, Canada; Michel Malo, MD, Hôpital du Sacré-Coeur de Montréal, Montréal, Québec, Canada; Robert McCormack, MD, New West Sports Medicine, New Westminster, British-Columbia, Canada; Jacques Desnoyers, MD, Hôpital Charles LeMoyne, Greenfield Park, Québec, Canada; Stéphane Pelet, MD, Centre Hospitalier Affilié Universitaire de Québec, Québec, Québec, Canada; Don Johnson, MD, Sports Medicine Centre, Carleton University, Ottawa, Ontario, Canada; Jordan Leith, MD, Joint Preservation Centre of BC, Vancouver, British-Columbia, Canada; Paul Zalzal, MD, EntraLogix Clinical Group Inc., Newmarket, Ontario, Canada; Francisco Forriol, MD, FREMAP Centro de Prevención y Rehabilitación, Majadahonda, Madrid, Spain; Javier Vaquero, MD, Hospital General Universitario Gregorio Maraňón, Madrid, Spain; Santiago Bello, MD, Hospital Universitario La Paz, Madrid, Spain; Francisco Maculé, MD, Hospital Clinic i Provincial de Barcelona, Barcelona, Cataluña, Spain; Antonio Maestro, MD, Cirugia Ortopedica y Traumatologia, Medicina del Deporte, Gijón, Spain; Myung Chul Lee, MD, Seoul National University Hospital, Seoul, Korea; and Kyoung Ho Yoon, MD, Kyung Hee University Medical Center, Seoul, Korea.

The following is to acknowledge the participation of the Delphi panel who contributed to the health economics study, clinico-economic model of BST-CarGel for repair of focal articular cartilage lesions on the femoral condyle: Dr William Stanish (Principal Investigator of the pivotal trial), Orthopaedic and Sport Medicine Clinic of Nova Scotia, Dalhousie University, Halifax, Nova Scotia, Canada; Dr Patrick Lavigne, Arthroscopy/Sports Medicine, University of Montreal, Montreal, Quebec, Canada; Dr Philipp Niemeyer, Department Orthopädie und Traumatologie, Universitätsklinik Freiburg, Freiburg, Germany; Dr Elizaveta Kon, Nanobiotechnology Laboratory and Orthopaedic Clinic, Istituto Ortopedico Rizzoli, Bologna, Italy; Dr Asode Ananthram Shetty, Professor and Director of MIS Surgery, Faculty of Health and Social Sciences, Canterbury Christ Church University, Chatham Maritime, Kent, UK, and Senior Lecturer, Department of Surgery, King’s College London; Dr Alan Getgood, since 2012: Fowler Kennedy Sport Medicine Clinic, 3 M Centre, University of Western Ontario

London, Ontario, Canada, prior to 2012: University Hospitals Coventry and Warwickshire NHS Trust, Walsgrave, Coventry, UK.