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Mavenclad (cladribine tablets) — Medica

Relapsing forms of multiple sclerosis (including relapsing remitting and active secondary progressive disease)

Preferred products

  • Kesimpta (ofatumumab)
  • Tysabri (natalizumab)
  • Briumvi (ublituximab-xiiy)
  • Lemtrada (alemtuzumab)
  • Ocrevus (ocrelizumab)
  • Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq)

Initial criteria

  • Patient has a relapsing form of multiple sclerosis (examples include relapsing remitting disease and active secondary progressive disease); AND
  • Patient meets ONE of the following (a, b, c, or d):
  • a) According to the prescriber, the patient has experienced inadequate efficacy or significant intolerance to two disease-modifying agents used for multiple sclerosis; OR
  • b) According to the prescriber, patient has experienced inadequate efficacy or significant intolerance to one of Kesimpta (ofatumumab), a natalizumab intravenous product (Tysabri, biosimilar), Briumvi (ublituximab-xiiy), Lemtrada (alemtuzumab), Ocrevus (ocrelizumab), or Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq); OR
  • c) Patient has received Mavenclad in the past; OR
  • d) According to the prescriber, the patient has highly-active or aggressive multiple sclerosis by meeting ONE of the following [(1), (2), (3), or (4)]:
  • (1) Rapidly advancing deterioration(s) in physical functioning (documentation required); OR
  • (2) Disabling relapse(s) with suboptimal response to systemic corticosteroids (documentation required); OR
  • (3) MRI findings suggest highly active or aggressive multiple sclerosis (e.g., new, enlarging, or a high burden of T2 lesions or gadolinium-enhancing lesions) (documentation required); OR
  • (4) Manifestations of multiple sclerosis-related cognitive impairment (documentation required); AND
  • Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Reauthorization criteria

  • Patient has a relapsing form of multiple sclerosis (examples include relapsing remitting disease and active secondary progressive disease); AND
  • Patient meets ONE of the following (a or b):
  • a) Patient experienced a beneficial clinical response when assessed by at least one objective measure (e.g., stabilization or reduced worsening in disease activity by MRI, EDSS score, NEDA-3/NEDA-4 criteria, fatigue scale, relapse rate, walking test, MSFC score, or brain volume loss); OR
  • b) Patient experienced stabilization, slowed progression, or improvement in at least one symptom such as motor function, fatigue, vision, bowel/bladder function, spasticity, walking/gait, or pain/numbness/tingling sensation; AND
  • Medication is prescribed by or in consultation with a neurologist or a physician who specializes in the treatment of multiple sclerosis.

Approval duration

1 year