Apo-Cladribine

18 years of age or older

Diagnosis of RRMS is in accordance with the McDonald 2017 criteria demonstrating dissemination of lesions in the central nervous system in space and time meeting the following:
i) 2 or more attacks¹ and clinical evidence of 2 or more lesions²;
OR
ii) 2 or more attacks¹ and clinical evidence of 1 lesion with clear historical evidence of prior attack involving lesion in different location;

¹If the patient has experienced only one attack, the patient must meet ONE of the additional criteria of dissemination in time in the list below:
• Additional clinical attack
• Simultaneous presence of both enhancing and non-enhancing, symptomatic or asymptomatic MS-typical MRI lesions; OR new T2 or enhancing MRI lesion compared to baseline scan (without regard to timing of baseline scan)
• Presence of cerebrospinal fluid (CSF)-specific oligoclonal bands

²If the patient has evidence of only one lesion the patient must meet ONE of the additional criteria of dissemination in space in the list below:
• Additional clinical attack implicating different CNS site
• 1 or more MS-typical T2 lesions in 2 or more areas of the Central Nervous System (CNS): periventricular, cortical, juxtacortical, infratentorial or spinal cord

AND

Failure or documented intolerance to at least one of an interferon OR glatiramer acetate OR dimethyl fumarate OR teriflunomide OR ocrelizumab; AND

Patient has experienced a clinical relapse and/or new MS lesions in the last 2 years; AND 

Patient has an EDSS score less than 6.0 before start of therapy; AND

Cladribine is used as monotherapy for the treatment of RRMS; AND