ABSTRACT
OBJECTIVE: Despite the biological drugs, the treatment of moderate to severe ulcerative colitis is still a challenge, particularly in resource-limited settings. The aim of this study was to assess the efficiency of biological drugs and tofacitinib for moderate to severe ulcerative colitis in the Spanish context. METHODS: A Markov model was built to simulate the progression of moderate to severe ulcerative colitis in a cohort of patients. The model used a time horizon of 10 years. The perspective chosen was the National Health Service, with a discount rate of 3%, and a threshold of 30,000/quality adjusted life-year (QALY). It carried out a one-way sensitivity analysis and probabilistic sensitivity analysis. RESULTS: The comparison of infliximab with adalimumab and golimumab estimated an incremental cost-effectiveness ratio (ICER) of 43,928.07/QALY and 31,340.69/QALY, with a difference of - 0.43 and - 0.82 QALY, respectively. Vedolizumab vs infliximab achieved an ICER of 122,890.19/QALY with a gain of 0.46 QALY. The comparison of infliximab with tofacitinib yielded an estimated ICER of 270,503.19/QALY, with a slight gain in QALY (0.16). The one-way sensitivity analysis showed a robust study. CONCLUSION: For a threshold of 30,000/QALY, adalimumab was the most cost-effective treatment versus infliximab for moderate to severe ulcerative colitis in Spain.
Subject(s)
Adalimumab/economics , Antibodies, Monoclonal, Humanized/economics , Antibodies, Monoclonal/economics , Colitis, Ulcerative/economics , Infliximab/economics , Piperidines/economics , Pyrimidines/economics , Adalimumab/administration & dosage , Antibodies, Monoclonal/administration & dosage , Antibodies, Monoclonal, Humanized/administration & dosage , Colitis, Ulcerative/drug therapy , Colitis, Ulcerative/epidemiology , Cost-Benefit Analysis/methods , Drug Costs , Gastrointestinal Agents/administration & dosage , Gastrointestinal Agents/economics , Humans , Infliximab/administration & dosage , Markov Chains , Piperidines/administration & dosage , Pyrimidines/administration & dosage , Severity of Illness Index , Spain/epidemiologyABSTRACT
Background Biological drugs for moderate-to-severe ulcerative colitis have changed the therapeutic perspective, while small-molecule inhibitors and new promising drugs suggest new options. Aim Assess comparative efficacy and safety of biological and new small oral drugs: commercialized and under-investigation ones for patients naïve to biological drugs. Methods A systematic review was conducted to identify the randomized clinical trials phase 2 or 3, in adults with moderate-to-severe ulcerative colitis treated with biological drugs (infliximab, adalimumab, golimumab, vedolizumab and etrolizumab) or new oral small molecules (tofacitinib and ozanimod) as first line. A Bayesian network metaanalysis was performed to inform comparative efficacy and safety of different treatments. Efficacy outcomes were clinical remission, clinical response and mucosal healing for induction therapy and clinical remission, mucosal healing and sustained clinical remission for maintenance therapy. Safety was assessed with serious adverse events and rates of infections. Results 14 references were included for network meta-analysis. For induction therapy, infliximab was the best drug for induction of clinical response and remission, while ozanimod showed to be the best for induction of mucosal healing. Tofacitinib had the highest rate of maintaining clinical remission. All treatments were similar for serious adverse events, and vedolizumab and tofacitinib had the highest rates of infections. Conclusion This network meta-analysis suggests infliximab may be the best therapeutic option for moderate-to-severe ulcerative colitis. Vedolizumab seems to have better outcomes in maintenance than in induction therapy and it appears superior to golimumab and adalimumab. Tofacitinib, ozanimod and etrolizumab show encouraging results.
Subject(s)
Anti-Ulcer Agents/therapeutic use , Colitis, Ulcerative/drug therapy , Anti-Ulcer Agents/adverse effects , Antibodies, Monoclonal, Humanized/adverse effects , Antibodies, Monoclonal, Humanized/therapeutic use , Biological Products , Humans , Randomized Controlled Trials as Topic , Small Molecule LibrariesABSTRACT
OBJECTIVES: Assess the efficiency of biologic treatment for moderate to severe ulcerative colitis (UC) which are indicated and financed for this pathology by Spain. METHODS: A Markov model was constructed to simulate the progression in a cohort of patients with moderate to severe UC. The perspective chosen was National Health Service with an over 10 years of time horizon, with a discount rate of 3%, and established threshold of 30,000/quality-adjusted life-year (QALY). RESULTS: The comparison between infliximab versus adalimumab achieved an incremental cost-effectiveness ratio (ICER) of 45,582/QALY, with a 0.900 QALYs difference of efficacy and an incremental cost of 41,036. Golimumab versus adalimumab reached an ICER of 2,175,992/QALY, with a difference of 0.001 QALY in efficacy and a raising cost to 2,611. The comparison between vedolizumab with adalimumab achieved an ICER of 90,532/QALY, 0.930 QALYs of difference and an increasing cost of 84,218. The probabilistic sensitivity analysis shows that adalimumab would be cost-effective in the 65.2% of the simulations, infliximab in the 18.4%, golimumab in the 16.4% and vedulizumab for the 0%. CONCLUSIONS: Among all these drugs studied, adalimumab is the most cost-effective drug for the treatment of moderate to severe UC for a threshold of 30,000/QALY in Spain.
