Expert opinion on the use of cladribine tablets in clinical practice

Sørensen, Per Soelberg; Centonze, Diego; Giovannoni, Gavin; Montalbán, Xavier; Selchen, Daniel; Vermersch, Patrick; Wiendl, Heinz; Yamout, Bassem; Salloukh, Hashem; Rieckmann, Peter

doi:10.1177/1756286420935019

Cited by 27 publications

(31 citation statements)

References 31 publications

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“…Consequently, further research on both clinical and cost parameters is required to increase the robustness of the model. Better information will also serve to deal with structural and parameter uncertainties and to support recommendations made by clinicians [37], and last but not less, to provide local data.…”

Section: Discussionmentioning

confidence: 99%

A Model-Based Economic Evaluation of Cladribine Versus Alemtuzumab, Ocrelizumab and Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis with High Disease Activity in Chile

Espinoza

Rojas²,

Zaupa

et al. 2021

PharmacoEconomics Open

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The aim of this study was to evaluate the cost effectiveness of cladribine compared with alemtuzumab, natalizumab, and ocrelizumab for the treatment of highly active multiple sclerosis (HAD-MS) from the perspective of the Chilean health care public sector. Materials and Methods A Markov model was used to compare costs and quality-adjusted life-years (QALYs) over a 45-year time horizon using a 3% discount rate for costs and outcomes. Natural history of the disease was modeled in terms of progression of disability according to the Expanded Disability Status Scale (EDSS). A network meta-analysis was used as a source of comparative effectiveness for disability progression and annual relapse rates. Differences in costs and outcomes were modeled for only 10 years due to high temporal uncertainty. Ocrelizumab was assumed to have the same efficacy as cladribine due to lack of data. Direct costs were taken from national tariffs and expressed in 2019 US dollars. Utilities for EDSS health states were obtained from the literature. Second-order uncertainty was characterized through deterministic and probabilistic sensitivity analysis. Findings Compared with natalizumab (the current strategy covered in Chile), cladribine is associated with incremental costs and QALYs of US$70,989 and 1.875, respectively (incremental cost-effectiveness ratio [ICER] $37,861). Ocrelizumab was extendedly dominated by cladribine and natalizumab, and alemtuzumab was dominated by cladribine. A scenario analysis of a 10% discount did not modify the results substantially, but showed a decrease in the ICER of cladribine versus natalizumab (ICER $29,833/QALY). Implications Cladribine is a new oral alternative to treat patients with HAD-MS that is expected to produce higher QALYs than all evaluated alternatives. In the context of a conservative analysis, cladribine cannot be considered cost effective for the Chilean health care public sector using a 1 GDP per capita threshold. However, under reasonable discount scenarios, cladribine becomes an attractive alternative for the health system.

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Section: Discussionmentioning

confidence: 99%

A Model-Based Economic Evaluation of Cladribine Versus Alemtuzumab, Ocrelizumab and Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis with High Disease Activity in Chile

Espinoza

Rojas²,

Zaupa

et al. 2021

PharmacoEconomics Open

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“…The methodology was used previously for a consensus paper on the use of cladribine tablets in clinical practice. 18 Merck KGaA, Darmstadt, Germany, provided funding for the project; however, had no input into the development of clinical questions nor recommendations. No company representative voted on the recommendations.…”

Section: Methodsmentioning

confidence: 99%

“…Each statement/recommendation was assigned a strength score (i.e., the median score) and a level of consensus, defined as the percentage of votes with a score of 7-9. 18,[20][21][22][23][24]…”

Section: Methodsmentioning

confidence: 99%

Expert Opinion on COVID-19 Vaccination and the Use of Cladribine Tablets in Clinical Practice

Rieckmann¹,

Centonze

Giovannoni

et al. 2021

Preprint

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BackgroundGaps in current evidence and guidance leave clinicians with unanswered questions on the use of cladribine tablets for the treatment of multiple sclerosis (MS) in theera of the COVID-19 pandemic, in particular relating to COVID-19 vaccination.ObjectiveWe describe a consensus-based programme led by international MS experts with the aim of supplementing current guidelines and treatment labels by providing timely recommendations relating to COVID-19 vaccination and the use of cladribine tablets inclinical practice.MethodsA steering committee (SC) of 10 international MS experts identified 7 clinical questions to answer concerning the use of cladribine tablets and COVID-19 vaccination, which addressed issues relating to patient selection, timing and efficacy, and safety. Clinicalrecommendations to address each question were drafted using available evidence combined with expert opinion from the SC. An extended faculty of 28 MS experts, representing 19 countries, in addition to the SC members, voted on the recommendations. Consensus on recommendations was achieved when ≥75% of respondents expressed an agreement score of 7–9, on a 9-point scale.ResultsConsensus was achieved on all 13 recommendations. Clinical recommendations are provided on whether all patients with MS receiving cladribine tablets should be vaccinated against COVID-19, and whether they should be prioritized; the timing of vaccination arounddosing of cladribine tablets (i.e., before and after a treatment course); and the safety of COVID-19 vaccination for these patients.ConclusionsThese expert recommendations provide timely guidance on COVID-19 vaccination in patients receiving cladribine tablets, which is relevant to everyday clinicalpractice.

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“…In the USA, the rate of switching from first DMT was 77%, second DMT was 17% and from third or higher DMT was 6% from 2015-2019 [31]. There are no RCTs investigating treatment switching from another DMT to cladribine tablets [32]. One reason for this is that there were few approved MS treatment options available during the time of cladribine tablets' development.…”

Section: Lack Of Data On the Effect Of Cladribine Tablets After Suboptimal Response To Another Dmtmentioning

confidence: 99%

CLICK-MS and MASTER-2 Phase IV Trial Design: Cladribine Tablets in Suboptimally Controlled Relapsing Multiple Sclerosis

Miravalle¹,

Katz

Robertson

et al. 2021

Neurodegener. Dis. Manag.

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Cladribine tablets 10 mg (3.5 mg/kg cumulative dose over 2 years) are approved for the treatment of relapsing forms of multiple sclerosis (MS), including relapsing-remitting MS and active secondary progressive MS. However, real-world data on cladribine tablets are limited. CLICK-MS and MASTER-2 are single arm, observational, 30-month, Phase IV studies in the US evaluating the effectiveness and safety of cladribine tablets 3.5 mg/kg in patients with relapsing-remitting MS or active secondary progressive MS who had suboptimal response to prior injectable (CLICK-MS), or infusion/oral (MASTER-2) disease-modifying therapy. The primary end point is 24-month annualized relapse rate. Key secondary end points include patient-reported outcomes on quality of life measures, treatment adherence and adverse events. Studies began in 2019 and are expected to be completed in 2023. Trial registration number • CLICK-MS: NCT03933215 (ClinicalTrials.gov) Full title; CLadribine tablets: observational evaluation of effectIveness and patient-reported outcomes in suboptimally Controlled patients previously taKing injectable disease-modifying drugs for relapsing forms of Multiple Sclerosis • MASTER-2: NCT03933202 (ClinicalTrials.gov) Full title; Cladribine tablets: observational evaluation of effectiveness and patient-reported outcomes in suboptiMAlly controlled patientS previously Taking oral or infusion disEase-modifying dRugs for relapsing forms of multiple sclerosis

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Expert opinion on the use of cladribine tablets in clinical practice

Cited by 27 publications

References 31 publications

A Model-Based Economic Evaluation of Cladribine Versus Alemtuzumab, Ocrelizumab and Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis with High Disease Activity in Chile

A Model-Based Economic Evaluation of Cladribine Versus Alemtuzumab, Ocrelizumab and Natalizumab for the Treatment of Relapsing-Remitting Multiple Sclerosis with High Disease Activity in Chile

Expert Opinion on COVID-19 Vaccination and the Use of Cladribine Tablets in Clinical Practice

CLICK-MS and MASTER-2 Phase IV Trial Design: Cladribine Tablets in Suboptimally Controlled Relapsing Multiple Sclerosis

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