Prognostic factors for first relapse in Thai patients with neuromyelitis optica spectrum disorder

Suksuchano, K.; Aungsumart, Saharat; Apiwattanakul, Metha

doi:10.1016/j.jns.2017.08.3005

Cited by 2 publications

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“…The budget impact analysis was based on an estimated population of 69 million [22] and on the prevalence rate of NMOSD [23]. The following criteria were used for the analysis: (i) Cost effectiveness of high-efficacy drugs for neuromyelitis optica spectrum disorder patients resistant to the first-line treatment (azathioprine) who were previously studied at the Prasat Neurological Institute, Thailand [24]; (ii) a treatment coverage rate of 30% for each year; (iii) a treatment coverage rate of 100% in three years (iv); a closed cohort model, and (v) a no cost discount.…”

Section: Budget Impact Analysismentioning

confidence: 99%

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Cost effectiveness of rituximab and mycophenolate mofetil for neuromyelitis optica spectrum disorder in Thailand: Economic evaluation and budget impact analysis

Aungsumart

Apiwattanakul

2020

PLoS ONE

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Neuromyelitis optica spectrum disorder (NMOSD) is an inflammatory condition of the central nervous system. The extent of disability depends on the severity of the disease and the number of relapses. Although azathioprine is currently the main treatment for patients with NMOSD in Thailand, patients often relapse during its use. Hence, it is argued that there are other drugs that would be more effective. The purpose of this study is to evaluate, from a societal perspective and from the economic impact on Thailand's healthcare system, the cost utility of treatment with mycophenolate mofetil (MMF) and rituximab in patients resistant to azathioprine. The Markov model with a one-year cycle length was applied to predict the health and cost outcomes in patients with NMOSD over a lifetime. The results showed that rituximab exhibited the highest quality-adjusted life year (QALY) gains among all the options. Among the rituximab-based treatments, the administration of a rituximab biosimilar with CD27 + memory B cell monitoring proved to be the most cost-effective option. At the willingness-to-pay threshold of 160,000 Thai baht (THB), or 5,289 US dollar (USD), per QALY gained, the treatment exhibited the highest probability of being cost effective (48%). A sensitivity analysis based on the adjusted price of a generic MMF determined that the treatment was cost effective, exhibiting an incremental cost-effectiveness ratio of -164,653 THB (-5,443 USD) and a 32% probability of being cost effective. The calculated budget impact of treating patients resistant to conventional therapy was 1-6 million THB (33,000-198,000 USD) for the first three years, while after the third year, the budget impact stabilized at 3-4 million THB (99,000-132,000 USD). These data indicate that, in Thailand, treatment of drug resistant NMOSD with a rituximab biosimilar with CD27 + memory B cell monitoring or treatment with a generic MMF would be cost effective and would result in a low budget impact.

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Section: Budget Impact Analysismentioning

confidence: 99%

“…The budget impact (Table 3) was based on an NMOSD prevalence rate of 0.403 per 100,000 [23], which corresponds to approximately 280 NMOSD patients in a population of 69 million [22]. Azathioprine resistance was found in 30% of the Thai cohorts [24]. Eighty-four patients were identified as resistant to conventional NMOSD drugs.…”

Section: Budget Impact Analysismentioning

confidence: 99%

Cost effectiveness of rituximab and mycophenolate mofetil for neuromyelitis optica spectrum disorder in Thailand: Economic evaluation and budget impact analysis

Aungsumart

Apiwattanakul

2020

PLoS ONE

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“…Standard immunosuppressive medication considered initial treatments for relapse prevention especially poor resource countries include prednisolone, azathioprine, and mycophenolate mofetil. However, many patients still relapse because of low efficacy and low adherence related to severe side effects ( 3 ). Monoclonal antibodies [mAbs: i.e., eculizumab, ( 4 ) satralizumab ( 5 , 6 ), inebilizumab ( 7 )] have more recently been approved by the Food and Drug Administration (FDA) for NMOSD, and are claimed to have higher efficacy and lower side effects, but at much higher cost than the standard immunosuppressive drugs, making them less accessible.…”

Section: Introductionmentioning

confidence: 99%

Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis

et al. 2023

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IntroductionNeuromyelitis optica spectrum disorder (NMOSD) is a devastating inflammatory CNS demyelinating disease. Two groups of monoclonal antibodies (mAbs) are used to prevent disease relapse, i.e., Food and Drug Administration (FDA)-approved mAbs (e.g., eculizumab satralizumab, inebilizumab), and off-label mAb drugs (e.g., rituximab and tocilizumab). The FDA-approved mAbs have high efficacy but more expensive compared to the off-labels, and thus are less accessible. This systematic review and network meta-analysis (NMA) was to assess the efficacy and safety of both classes of mAbs compared to the current standard treatments.MethodsSystematically searches were conducted in MEDLINE and SCOPUS from inception until July 2021. Randomized-controlled trials (RCTs) were eligible if they compared any pair of treatments (mAbs, immunosuppressive drugs, or placebo) in adult patients with NMOSD. Studies with AQP4-IgG positive or negative were used in the analysis. Probability of relapse and time to event were extracted from the Kaplan-Meier curves using Digitizer. These data were then converted into individual patient time-to-event data. A one-stage mixed-effect survival model was applied to estimate the median time to relapse and relative treatment effects using hazard ratios (HR). Two-stage NMA was used to determine post-treatment annualized relapse rate (ARR), expanded disability status score (EDSS) change, and serious adverse events (SAE). Risk of bias was assessed using the revised cochrane risk of bias tool.ResultsA total of 7 RCTs with 776 patients were eligible in the NMA. Five of the seven studies were rated low risk of bias. Both FDA-approved and off-label mAbs showed significantly lower risk of relapse than standard treatments, with HR (95% CI) of 0.13 (0.07, 0.24) and 0.16 (0.07, 0.37) respectively. In addition, the FDA-approved mAbs had 20% lower risk of relapse than the off-label mAbs, but this did not reach statistical significance. The ARRs were also lower in FDA-approved and off-label mAbs than the standard treatments with the mean-difference of−0.27 (-0.37,−0.16) and−0.31(-0.46,−0.16), respectively.ConclusionThe off-label mAbs may be used as the first-line treatment for improving clinical outcomes including disease relapse, ARR, and SAEs for NMOSD in countries where resources and accessibility of the FDA-approved mAbs are limited.Systematic review registrationhttps://www.crd.york.ac.uk/prospero/display_record.php?RecordID=283424, identifier: CRD42021283424.

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Prognostic factors for first relapse in Thai patients with neuromyelitis optica spectrum disorder

Cited by 2 publications

References 0 publications

Cost effectiveness of rituximab and mycophenolate mofetil for neuromyelitis optica spectrum disorder in Thailand: Economic evaluation and budget impact analysis

Cost effectiveness of rituximab and mycophenolate mofetil for neuromyelitis optica spectrum disorder in Thailand: Economic evaluation and budget impact analysis

Efficacy and safety of monoclonal antibody therapy in patients with neuromyelitis optica spectrum disorder: A systematic review and network meta-analysis

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