Mavenclad (cladribine) — Blue Cross Blue Shield of Montana

Initial criteria

• Requested agent is eligible for continuation of therapy AND prescriber states patient has been treated with the requested agent within the past 90 days AND patient is at risk if therapy is changed OR BOTH of the following:
• Patient has ONE of the following relapsing forms of MS: relapsing-remitting disease (RRMS) OR active secondary progressive disease (SPMS)
• If patient has an FDA labeled indication, THEN ONE of the following: patient’s age is within FDA labeling for the requested indication OR there is support for use in the patient’s age for the requested indication
• If patient was previously treated with requested agent, BOTH of the following: prescriber provided number of courses patient has completed (one course = 2 cycles of 4–5 days each) AND patient has NOT completed 2 courses
• A complete CBC with differential including lymphocyte count has been performed AND lymphocyte count is within normal limits
• Prescriber is a specialist in the area of the patient’s diagnosis (neurologist) OR has consulted with one
• ONE of the following: patient will NOT be using requested agent with an additional disease modifying agent (DMA) for this indication OR BOTH of the following: patient is currently using requested agent AND information supports use of the additional DMA (e.g., relapse between cycles)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• Requested quantity (dose) does NOT exceed FDA labeled maximum based on patient weight
• Additional BCBSMT child coverage exception: for MT Fully Insured or MT HIM member under age 18 years AND no FDA-labeled contraindications AND indication supported in TWO major peer-reviewed journal articles as generally safe and effective AND age support shown in TWO such articles within bracket (infancy, childhood, adolescence)
• Additional OH coverage exception: member resides in Ohio AND plan is Fully Insured or HIM Shop (SG) AND no FDA labeled contraindications AND ONE of the following (criteria continues beyond visible section)

Approval duration

12 months (2 courses) for BCBSIL/BCBSMT/BCBSTX; 36 weeks for others or remainder of annual course