Cost-effectiveness and Clinical Outcomes of Early Anti-Tumor Necrosis Factor-a Intervention in Pediatric Crohn

Bashir NS1,2, Walters TD3,4, Griffiths AM3,4, Ito S4,5, Ungar WJ1,2. Inflamm Bowel Dis. 2019 Nov 15. pii: izz267. doi: 10.1093/ibd/izz267. [Epub ahead of print]


Author information

From the Program of Child Health Evaluative Sciences, The Hospital for Sick Children Research Institute, Toronto, Ontario, Canada.

The Institute of Health Policy, Management and Evaluation, The University of Toronto, Toronto, Ontario, Canada.

Division of Gastroenterology, Hepatology and Nutrition, The Hospital for Sick Children, Toronto, Ontario, Canada.

Department of Paediatrics, University of Toronto, Toronto, Ontario, Canada.

Division of Clinical Pharmacology, Clinical Pharmacology and Toxicology, The Hospital for Sick Children, Toronto, Ontario, Canada.


BACKGROUND: Anti-tumor necrosis factor-α (anti-TNF-α) treatments are increasingly used to treat pediatric Crohn's disease, even without a prior trial of immunomodulators, but the cost-effectiveness of such treatment algorithms has not been formally examined. Drug plan decision-makers require evidence of cost-effectiveness to inform funding decisions. The objective was to assess the incremental cost-effectiveness of early intervention with anti-TNF-α treatment vs a conventional step-up strategy per steroid-free remission-week gained from public health care and societal payer perspectives over 3 years.

METHODS: A probabilistic microsimulation model was constructed for children with newly diagnosed moderate to severe Crohn's diseasereceiving anti-TNF-α treatment and concomitant treatments within the first 3 months of diagnosis compared with children receiving standard care consisting of steroids and/or immunomodulators with the possibility of anti-TNF-α treatment after 3 months of diagnosis. A North American multicenter observational study with 360 patients provided input into clinical outcomes and health care resource use.

RESULTS: Early intervention with anti-TNF-α treatment was more costly, with an incremental cost of CAD$31,112 (95% confidence interval [CI], $2939-$91,715), and more effective, with 11.3 more weeks in steroid-free remission (95% CI, 10.6-11.6) compared with standard care, resulting in an incremental cost per steroid-free remission-week gained of CAD$2756 from an Ontario public health care perspective and CAD$2968 from a societal perspective. The incremental cost-effectiveness ratio was sensitive to the price of infliximab.

CONCLUSIONS: The results suggest that although early anti-TNF-α was not cost-effective, it was clinically beneficial. These findings, along with other randomized controlled trial evidence, may inform formulary decision-making.

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