Cost-effectiveness of golimumab for the treatment of patients with moderate-to-severe ulcerative colitis in Quebec using a patient level state transition microsimulation

Abstract

Objective: To conduct cost-effectiveness analyses comparing the addition of golimumab to the standard of care (SoC) for treatment of patients with moderate-to-severe ulcerative colitis (UC) who are refractory to conventional therapies in Quebec (Canada).

Methods: An individual patient state transition microsimulation model was developed to project health outcomes and costs over 10 years, using a payer perspective. The incremental benefit estimates for golimumab were driven by induction response and risk of a flare. Flare risks post-induction were derived for golimumab from the PURSUIT maintenance trial and extension study, while those for SoC were derived from the placebo arms of the Active Ulcerative Colitis Trials (ACT) 1 and 2. Other inputs were derived from multiple sources, including retrospective claims analyses and literature. Costs are reported in 2014 Canadian dollars. A 5% annual discount rate was applied to costs and quality-adjusted life-years (QALYs).

Results: Compared with SoC, golimumab was projected to increase the time spent in mild disease or remission states, decrease flare rates, and increase QALYs. These gains were achieved with higher direct medical costs. The incremental cost-effectiveness ratio for golimumab vs SoC was $63,487 per QALY.

Limitations: The long-term flare projections for SoC were based on the data available from the ACT 1 and 2 placebo arms, as data were not available from the PURSUIT maintenance or extension trial. Additionally, the study was limited to only SoC and golimumab, due to the availability of individual patient data to analyze.

Conclusion: This economic analysis concluded that treatment with golimumab is likely more cost-effective vs SoC when considering cost-effectiveness acceptability thresholds from $50,000–$100,000 per QALY.

Keywords:

• Health economics
• ulcerative colitis
• golimumab
• cost-effectiveness
• state transition model

Transparency

Declaration of funding

The cost-effectiveness study and this resulting article were funded in full by the manufacturer of golimumab, Janssen Biotech, Inc. Janssen assigned their employees PD and DN to the project, contracted with and paid Evidera for their services on the study and manuscript, and paid honoraria to the seven independent authors for their work on the project.

Declaration of financial/other relationships

AJW, SS, and CSLT are employed by Evidera, Inc. In their salaried positions, they work with a variety of companies and are precluded from receiving payment or honoraria directly from these organizations for services rendered. Evidera received payment from Janssen Biotech of Horsham, PA for the conduct of this study and the development of this manuscript. FC is the Principal at Damos, Inc., and has received payment for serving as a consultant/advisor for Janssen, Inc. Canada. ER is an Associate Professor and researcher at the Research Institute of the McGill University Health Centre. She has received grants and consultant fees from Janssen, Inc. and Bristol-Myers Squibb Canada. GA is a gastroenterologist for CIUSS est de Montreal at the Maisonneuve-Rosemont Hôpital and serves as Professor of Medicine at the Université de Montréal. He is a minor shareholder of 100 shares US of Janssen and has received honoraria/compensation for his work on speaker’s bureaus for Janssen, Takeda, Shire, and Allergan, and as a consultant for Janssen, AbbVie, Takeda, Shire, Allergen, and Lupin. He has received sponsorship from Janssen, Takeda, and Ferring, and clinical research funding from Janssen, AbbVie, Takeda, Ferring, Lilly, Shire, and Genentech. He received honoraria from Janssen for his work on this project. EJB is a gastroenterologist and the Director of the IBD Clinic at the Hôtel-Dieu de Montreal and an Assistant Professor of Medicine at Université de Montréal. He has received grants for the development of educational tools for IBD patients from AbbVie/Shire and for clinical trials from AbbVie. He has received honoraria/compensation for his participation in advisory boards and lectures/presentations from Janssen, AbbVie, Takeda, Shire, Pfizer, and Ferring and received compensation for serving on an advisory board for Merck and a speaker’s bureau for Allergan. He did receive honoraria from Janssen for his work on this project. RB is a gastroenterologist for CISSS Chaudière-Apalaches at Hôtel-Dieu de Lévis and an Associate Clinical Professor at Université Laval. He has received fees for acting as a consultant/advisor and serving on the speaker’s bureau for the following companies: AbbVie, Janssen, Pfizer, Shire, and Takeda. He received honoraria from Janssen for his work on this project. AC is the Director of the Division of Gastroenterology at Jewish General Hospital and serves as an Associate Professor of Medicine at McGill University. He has received honoraria for his work as a consultant/advisor for AbbVie, Janssen, Pfizer, Takeda, Ferring, Allergan, and Pendopharm. PP works for Centre Hospitalier Universitaire de Québec at the Hôpital du Saint-Sacrement in Québec and serves as a Professor of Medicine at Université Laval. He has served as a consultant/advisor for AbbVie Canada, Actavis, and Janssen Canada and on a speaker’s bureau for Janssen Canada. He received honoraria from Janssen for his work on this project. DN is an employee of Janssen Pharmaceutica, NV of Belgium and a shareholder in Johnson & Johnson. PD is an employee and shareholder of Janssen Biotech. Peer reviewers on this manuscript have received an honorarium from JME for their review work, but have no other relevant financial relationships to disclose.

Acknowledgments

The authors would like to acknowledge Sandra Milev from Evidera and Dan Pettitt and Timothy Gathany from Janssen, at the time of study conduct, for their participation in either this research project or the writing of this manuscript. They would further like to thank Janet Dooley of Evidera’s Production Team for her assistance in the preparation and submission of this manuscript. The authors note that there has not been any previous publication of the data in this manuscript.