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ivabradine hcl oral soln — Blue Cross Blue Shield of Texas

other FDA labeled indication for the requested agent and route of administration

Initial criteria

  • Requested agent will be approved when ONE of the following:
  • A. Continuation of therapy: prescriber states patient has been treated with requested agent within past 90 days (samples not approvable) and is at risk if therapy is changed
  • OR
  • B. BOTH of the following:
  • 1. Diagnosis criteria:
  • A. Patient has diagnosis of stable symptomatic heart failure (NYHA Class II-IV) due to DCM AND patient is in sinus rhythm AND patient has an elevated heart rate
  • OR
  • B. Patient has diagnosis of stable symptomatic chronic heart failure (NYHA Class II-IV) AND (LVEF ≤ 35%) AND (in sinus rhythm) AND (resting HR ≥ 70 bpm) AND ONE of:
  • A. Currently treated with maximally tolerated beta blocker and will continue therapy OR
  • B. Intolerance or hypersensitivity to ONE beta blocker OR
  • C. FDA labeled contraindication to ALL beta blockers
  • OR
  • C. Patient has diagnosis of inappropriate sinus tachycardia (IST) or chronic nonparoxysmal sinus tachycardia AND IST is symptomatic
  • OR
  • D. Patient has another FDA labeled indication for requested agent and route of administration
  • 2. If patient has FDA labeled indication, then ONE of the following:
  • A. Patient age is within FDA labeling for requested indication
  • OR
  • B. Support exists for use at patient age for requested indication
  • OR
  • C. Patient has other indication supported in compendia (AHFS or DrugDex 1, 2a, or 2b)
  • 3. Prescriber is specialist in area of diagnosis (e.g., cardiologist) or has consulted with such specialist
  • 4. Patient does NOT have any FDA labeled contraindications to requested agent
  • Additional approval pathways:
  • • For BCBS NM Fully Insured or NM HIM members: no contraindications AND indication is a rare disease AND indication is FDA labeled or supported in compendia
  • • For Ohio residents (Fully Insured or HIM Shop): no contraindications AND indication is FDA labeled, compendia supported, or supported by TWO peer-reviewed journal articles (acceptable designs include randomized, double-blind, placebo-controlled clinical trials; case studies not acceptable)

Reauthorization criteria

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

Approval duration

12 months