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Radicava ors starter kit — Blue Cross Blue Shield of Montana

other FDA labeled indications for requested agent and route of administration

Initial criteria

  • ONE of the following:
  • A. Patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR
  • B. ALL of the following:
  • 1. Diagnosis of amyotrophic lateral sclerosis (ALS)
  • 2. Diagnosis duration ≤ 2 years
  • 3. Baseline forced vital capacity (FVC%) or slow vital capacity (SVC) ≥ 80%
  • 4. Able to perform most activities of daily living (scores ≥ 2 on each ALSFRS-R item)
  • 5. ONE of the following:
  • A. BOTH of the following:
  • 1. Currently being treated with riluzole AND
  • 2. Will continue riluzole in combination with requested agent OR
  • B. Has intolerance, hypersensitivity, or FDA labeled contraindication to riluzole
  • Prescriber is a specialist in the area of diagnosis (e.g., neurologist) or has consulted with a specialist
  • Patient does NOT have any FDA labeled contraindications to the requested agent
  • Length of Approval: BCBSIL: 12 months; All other plans: 6 months
  • Alternate pathway for Ohio members (Fully Insured or HIM Shop [SG]):
  • 1. Member resides in Ohio AND plan is Fully Insured or HIM Shop (SG)
  • 2. Patient does NOT have FDA labeled contraindications to the requested agent
  • 3. ONE of the following:
  • A. Has another FDA labeled indication for requested agent and route of administration OR
  • B. Has another indication supported in compendia for requested agent and route of administration OR
  • C. Prescriber has submitted TWO articles from major peer-reviewed medical journals supporting proposed use as generally safe and effective

Reauthorization criteria

  • 1. Patient has been previously approved for the requested agent through the plan's Prior Authorization process
  • 2. Patient has had clinical benefit with the requested agent
  • 3. Prescriber is a specialist in the area of diagnosis (e.g., neurologist) or has consulted with a specialist
  • 4. Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

Initial 6–12 months; Renewal 12 months (plan dependent)