Meysam Olfatifar
1 
, Hamid Asadzadeh Aghdaei
2* , Ayda Hasanpour Dehkordi
3 , Shabnam Shahrokh
1, Mohamad Amin Pourhoseingholi
1 , Hedieh Balaii
2 , Mohsen Rajabnia
1 , Maria Ivanchuk
4 , Pavlo Ivanchuk
5 , Saeed Hashemi Nazari
6* , Siamak Sabour
7,8 , Pejman Rohani
9 , Gholamhossein Mehralian
10 , Soheila Khodakarim
11 , Behzad Hatami
1 , Habib Malekpour
2, Ghazal Sherkat
12 , Mohammad Reza Zali
1* , Sajjad Rahimi Pordanjani
13,14 1 Gastroenterology and Liver Diseases Research Center, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
2 Basic and Molecular Epidemiology of Gastrointestinal Disorders Research Centre, Research Institute for Gastroenterology and Liver Diseases, Shahid Beheshti University of Medical Sciences, Tehran, Iran
3 Nickan Research Institute, Isfahan, Iran
4 Biological Physics and Medical Informatics Department, Higher State Educational Establishment of Ukraine, Bukovinian State Medical University, Chernivtsi, Ukraine
5 Internal Medicine, Physical Rehabilitation, Sports Medicine and Physical Training Department, Higher State Educational Establishment of Ukraine, Bukovinian State Medical University, Chernivtsi, Ukraine
6 Prevention of Cardiovascular Disease Research Centre, Department of Epidemiology, School of Public Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran
7 Department of Clinical Epidemiology, School of Health and Safety, Shahid Beheshti University of Medical Sciences, Tehran, Iran
8 Safety Promotions and Injury, Prevention Research Centre, Shahid Beheshti University of Medical Sciences, Tehran, Iran
9 Pediatric gastroenterology, Hepatology and Nutrition Research Center, Research Institute for Children Health, Shahid Beheshti University of Medical Sciences, Tehran, Iran
10 School of Pharmacy, Shahid Beheshti University of Medical Sciences, Tehran, Iran
11 Department of Biostatistics, School of Medicine, Shiraz University of Medical Sciences, Shiraz, Iran
12 Medical Student at Medicine Faculty of Mashhad Branch, Islamic Azad University, Mashhad, Iran
13 Social Determinants of Health Research Center, Semnan University of Medical Sciences, Semnan, Iran
14 Department of Epidemiology and Biostatistics, Semnan University of Medical Sciences, Semnan, Iran
Abstract
Introduction: As two biological agents, infliximab (IFX) and biosimilar adalimumab (CinnoRA®) are routinely used in the clinical management of ulcerative colitis (UC) in Iran.
Objectives: This study was done to evaluate the cost-effectiveness of IFX versus CinnoRA for the treatment of moderate-to-severe UC patients.
Patients and Methods: To accomplish this, we developed a hybrid decision-tree/microsimulation (MS) approach for modeling UC’s natural history. We populated our model with available data on probabilities, costs, utilities / disutilities, and emergent adverse effects. Costs were reported in Iranian Rial (IRR) and in April 2021 US dollars ($). One-way and multiple sensitivity analyses were used to determine the uncertainty of the model’s parameters.
Results: For five, 10, and lifetime horizon times, patients on IFX received slightly more quality-adjusted life-year (QALY) per year in remission and experienced about 3 to 5 times less surgery than CinnoRA patients. With willingness-to-pay (WTP) thresholds of 1800 ($7826.08), 820($3565.21), and 520 ($2260.86) million IRR for these horizon times, IFX was cost-effective with 100% certainty. Our findings were highly sensitive to the number of adverse effects.
Conclusion: Our results demonstrated that IFX is more effective and more costly than CinnoRA, and if we ignore the predicted surgeries, CinnoRA is nearly as effective as IFX. However, these findings should be cautiously interpreted without a robust clinical trial of CinnoRA in UC patients. Since the impact of CinnoRA may have been over/underestimated.