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Drug - Mavenclad® (cladribine) [EMD Sorono, Inc.]

August 2019

Therapeutic area - Multiple Sclerosis

Initial approval criteria

  • Patient is ≥ 18 years old AND
  • Patient weighs ≥ 40 kg (88 lbs) AND
  • Patient has been diagnosed* with a relapsing form of multiple sclerosis (e.g., relapsing-remitting disease [RRMS] or active secondary progressive disease [SPMS]) as documented by laboratory report (e.g., magnetic resonance imaging [MRI]) AND
  • Patient does NOT have a diagnosis of clinically isolated syndrome (CIS) AND
  • If SPMS, patient has active/progressing disease defined as ≥ 1 of the following:
    • Patient has had ≥ 1 relapse within the previous 2 years OR
    • Patient has new and unequivocally enlarging T2 contrast-enhancing lesions as evidenced by MRI AND
  • Patient has had ≥ 1 relapse in the previous 12 months AND
  • Patient previously has had an inadequate response to, or is unable to tolerate, an alternate drug indicated for the treatment of MS AND
  • Patient does not have known hypersensitivity to cladribine AND
  • Patient does not have a current diagnosis of malignancy AND
  • Patient does not have human immunodeficiency virus (HIV) infection AND
  • Women of child-bearing age must have a negative pregnancy test prior to treatment AND
  • Patients of reproductive potential must use effective contraception during treatment with therapy and for at least 6 months after the last dose AND
  • Lactating women should discontinue breast feeding prior to and for 10 days after the last administered dose AND
  • Cladribine will NOT be used in combination with other antineoplastic, immunosuppressive or immunomodulating drugs (note: if there is a history of prior use of these drugs, consider possible unintended additive immunosuppressive effects) AND
  • Cladribine must NOT be administered concurrently with live vaccines; administer live vaccines 4 to 6 weeks prior to the start of therapy AND
  • Patient should be screened for the presence of tuberculosis according to local guidelines AND
  • Patient has been evaluated and screened for the presence of hepatitis B and hepatitis C virus (HBV/HCV) prior to initiating treatment AND
  • Patient has been tested for antibodies to the varicella zoster virus (VZV) or have received immunization for VZV 4 to 6 weeks prior to beginning therapy AND
  • Patient does not have an active infection, including clinically important localized infections AND
  • Patient has a baseline MRI before initiating the first treatment course (within 3 months prior to start of therapy) AND
  • Lymphocyte count is ≥ 800 cells/mL prior to start of therapy AND
  • Cladribine will be used as single agent therapy
  • Initial approval will be for first treatment course of 2 cycles

Renewal criteria

  • At least 43 weeks has or will have elapsed since the end of the first treatment course AND
  • Patient continues to meet approval criteria above AND
  • Patient is receiving ongoing monitoring for presence of TB or other active infections AND
  • Patient has demonstrated absence of unacceptable toxicity from the drug (e.g., lymphopenias; severe hepatic injury; active serious infection; progressive multifocal leukoencephalopathy [PML]; new onset malignancies; graft-versus-host-disease with blood transfusions; thrombocytopenia, neutropenia, pancytopenia, severe hypersensitivity reactions) AND
  • Continuous monitoring of response to therapy will be performed (manifestations of MS disease activity include, but are not limited to, an increase in annualized relapse rate [ARR], development of new/worsening T2 hyperintensities or enhancing lesions on brain/spinal MRI, and progression of sustained impairment as evidenced by expanded disability status scale [EDSS], timed 25-foot walk [T25-FW], 9-hole peg test [9-HPT])
  • Renewal approval will be for second treatment course of 2 cycles

*Diagnostic criteria for relapsing form of MS (diagnosis is based on both dissemination in time and space; unless contraindicated, MRI should be obtained even if criteria are met):

  • Dissemination in time (development/appearance of new CNS lesions over time):
    • ≥ 2 clinical attacks OR
    • 1 clinical attack AND 1 of the following:
      • MRI indicating simultaneous presence of gadolinium (Gd)-enhancing and non-enhancing lesions at any time or by a new T2- hyperintense or Gd-enhancing lesion on follow-up MRI compared to baseline scan OR
      • CSF-specific oligoclonal bands AND
  • Dissemination in space (development of lesions in distinct anatomical locations within the CNS; multifocal)
    • ≥ 2 lesions OR
    • 1 lesion AND 1 of the following:
      • Clear-cut historical evidence of a previous attack involving a lesion in a distinct anatomical location OR
      • MRI indicating ≥ 1 T2-hyperintense lesions characteristic of MS in ≥ 2 of 4 areas of the CNS (periventricular, cortical or juxtacortical, infratentorial, or spinal cord)

Denial criteria

  • Current malignancy
  • Pregnancy
  • HIV infection
  • Hepatitis B or C
  • Active TB
  • Hypersensitivity to cladribine
  • Concurrent immunosuppressive therapy

Quantity limits

Coverage will be provided for a maximum of 2 cycles per treatment course and may be renewed 1 time only after at least 43 weeks (total of 2 treatment courses or 4 cycles in a 2 year period).  

Cladribine 10 mg (4, 5, 6, 7, 8, 9 and 10 tablet blister card): 1 blister card per cycle

  • Initial (First Course = 28 days): 100 mg per cycle (2 cycles only); total 2 blister cards
  • Renewal (Second Course = 28 days): 100 mg per cycle (2 cycles only); total 2 blister cards

Background information

The safety and efficacy of reinitiating cladribine > 2 years after completing 2 treatment courses has not been studied.


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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