PND47 Cladribine tablet, as a dominant comparator to Natalizumab in high-disease activity relapsing multiple sclerosis patients, in the context of a developing country

Objectives
Cladribine tablet is the first oral immune reconstitution therapy and is used in high disease activity relapsing multiple sclerosis (HDA-RMS). Objective of present study is to conduct a cost-utility analysis (CUA) of Cladribine tablets in comparison to Natalizumab, another available disease modifying therapy in Iran, using decision analytic modelling.
Methods
A 5-year Markov cohort model of HDA-RRMS patients was developed from Iranian societal perspective. Expanded Disability Status Scale was used to develop 21 health states for patients on and off treatment. Clinical data, disability progression and relapse rate, were extracted from network Meta-analysis, due to lack of head to head trials. State-related utility scores were extracted from literature. Quality adjusted life years (QALY) and life years gained (LYG) were measurements of efficacy. Direct and indirect costs were identified by clinical expert and previous studies and calculated in Iranian Rial rates (IRR) then converted to US$; with 2019 governmental conversion rate. Costs and QALYs were discounted by %7.2 and %3.5, respectively. Deterministic and probabilistic sensitivity analysis (D/PSA) were conducted to evaluate robustness of model and its sensitivity to model components.
Results
Results indicated that Cladribine tablets dominated Natalizumab. 5-year cost per patient was 69,842 and 76,449 USD for Cladribine tablet and Natalizumab, respectively; with drug acquisition cost as main component (%92 in both arms). LYG was comparable between comparators and QALY difference per patient was 0.003, favoring Cladribine tablets. DSA showed that the results were sensitive to cost discount rate and patients’ weight and no or less sensitivity was seen with main clinical variables. PSA showed that Cladribine tablet is cost-effective with a probability of %57.5 in Iran willingness to pay threshold of 2,709 USD (1 gross domestic product per capita).
Conclusions
Cladribine tablet dominated Natalizumab in HDA-RMS patients from Iranian societal perspective and is a more cost-effective option.