Mavenclad (cladribine tablets – EMD Serono) — Cigna
Relapsing forms of multiple sclerosis (including relapsing remitting disease and active secondary progressive disease)
Initial criteria
- Patient has a relapsing form of multiple sclerosis; 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 subcutaneous injection), a natalizumab intravenous product (Tysabri, biosimilar), Briumvi (ublituximab-xiiy intravenous infusion), Lemtrada (alemtuzumab intravenous infusion), Ocrevus (ocrelizumab intravenous infusion) or Ocrevus Zunovo (ocrelizumab and hyaluronidase-ocsq subcutaneous injection); 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) Patient has demonstrated rapidly advancing deterioration(s) in physical functioning [documentation required]; OR (2) Disabling relapse(s) with suboptimal response to systemic corticosteroids [documentation required]; OR (3) Magnetic resonance imaging (MRI) findings suggest highly active or aggressive multiple sclerosis [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; 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; 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