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Radicava ORS starter kitBlue Cross Blue Shield of Alabama

amyotrophic lateral sclerosis (ALS)

Initial criteria

  • Diagnosis of amyotrophic lateral sclerosis (ALS)
  • Diagnosis duration ≤ 2 years
  • Baseline percent forced vital capacity (FVC%) or slow vital capacity (SVC) ≥ 80%
  • Patient able to perform most activities of daily living, defined as scores of 2 points or better on each individual item of ALS Functional Rating Scale – Revised (ALSFRS-R)
  • AND ONE of the following:
  • • Patient currently treated with riluzole AND will continue riluzole in combination with requested agent
  • • Patient has intolerance, hypersensitivity, or FDA-labeled contraindication to riluzole
  • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) OR has consulted with such specialist
  • Patient does NOT have any FDA-labeled contraindications to the requested agent
  • Continuation of therapy approval also requires patient has been treated with the requested agent within the past 90 days OR prescriber attests patient has been treated within past 90 days and is at risk if therapy is changed

Reauthorization criteria

  • Patient previously approved for the requested agent through plan’s prior authorization process
  • Patient has had clinical benefit with requested agent
  • Patient is NOT dependent on invasive ventilation or tracheostomy
  • Prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist) OR has consulted with such specialist
  • Patient does NOT have any FDA-labeled contraindications to the requested agent

Approval duration

6 months initial, 12 months renewal