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The Policy VaultThe Policy Vault

Mavenclad (cladribine)Blue Cross Blue Shield of New Mexico

Multiple sclerosis (off-label pediatric use)

Initial criteria

  • Request for BCBS MT Fully Insured or MT HIM member AND the patient is under age 18 years
  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • The patient has an indication that is supported in TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) as generally safe and effective. Accepted study designs include randomized, double blind, placebo controlled clinical trials; case studies are not acceptable
  • There is support for an age in the patient’s given age bracket in TWO articles from major peer-reviewed professional medical journals as generally safe and effective. Age brackets: infancy (birth to <2 years), childhood (2–11 years), adolescence (12–17 years)