Economic evaluation of cladribine tablets in high disease activity (HDA) relapsing multiple sclerosis (RMS) patients in Lebanon.

BACKGROUND: Cladribine tablets are a newly launched short course oral treatment approved for high disease activity (HDA) relapsing multiple sclerosis (RMS). The current analysis assessed the cost-utility and budgetary impact of introducing cladribine tablets in HDA-RMS patients compared with other HDA-RMS therapies in Lebanon. METHODS: The global cost-utility and budget impact models were adapted from Lebanese National Social Security Fund (NSSF) perspective. The data for the models' adaptation were retrieved from the literature and validated by Lebanese experts. The comparators considered in the cost-utility model were alemtuzumab, fingolimod, and natalizumab while budget impact analysis additionally considered dimethyl fumarate. A sensitivity analysis was also performed to assess the uncertainty in the analysis. RESULTS: The cost-utility results showed that cladribine tablets are an economically dominant therapeutic strategy (i.e., less costly and better quality-adjusted life year [QALY]) compared to all comparators. The cost saving was driven by drug acquisition, administration, and monitoring costs; while incremental QALY gain was driven by differences in delayed Expanded Disability Status Scale progression. Sensitivity analysis showed that cladribine tablets have a high probability (99.3-100%) of being dominant at a threshold of 22,000 United States Dollars (approximately three times of gross domestic product) per QALY gained against different comparators. The budget impact analysis showed that the introduction of cladribine tablets would result in 5.0% to 21.5% savings in the overall budget over a period of five years. CONCLUSIONS: Cladribine tablets are a cost-effective and a budget-saving treatment option for the treatment of HDA-RMS patients in Lebanon from the NSSF perspective.

Cladribine tablets are a cost-effective strategy in high-disease activity relapsing multiple sclerosis patients in Iran.

Background: Cladribine tablets are the foremost oral immune-reconstitution therapy for high disease activity relapsing multiple sclerosis (HDA-RMS). We aimed to assess the cost-effectiveness of cladribine tablets compared to natalizumab in patients with HDA-RMS in Iran. Methods: A 5-year cohort-based Markov model was developed with 11 expanded disability status score (EDSS) health states, including patients with HDA-RMS as on and off-treatment. All costs were identified from the literature and expert opinion and were measured in Iranian Rial rates, changed to the 2020 USD rate and were discounted by 7.2%. Quality adjusted life years (QALY), discounted by 3.5%, and life years gained (LYG) were adopted to measure efficacy. The final results were presented as incremental cost-effectiveness ratio that was compared to a national willingness to pay (WTP) threshold of 1 to 3 gross domestic product (GDP) per capita. Deterministic and probabilistic sensitivity analyses (D/PSA) were employed to evaluate uncertainty. Results: Cladribine tablets dominated natalizumab and yielded 6,607 USD cost-saving and 0.003 additional QALYs per patient. LYG was comparable. The main cost component was drug acquisition cost in both arms. DSA indicated the sensitivity of the results to the cost discount rates and also the patients' body weight; while they were less sensitive to the main clinical variables. PSA indicated that cladribine tablets were cost-effective in Iran, with a probability of 57.5% and 58.6% at lower and higher limits of threshold, respectively. Conclusion: Cladribine tablets yielded higher QALYs and lower costs compared to natalizumab, in patients with HDA-RMS in Iran.