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all target agents except Actemra — Blue Cross Blue Shield of Texas

as specified by requested indication per Step 1a, 1b, 2, 3a, 3b, 3c classification

Initial criteria

  • ONE of the following applies:
  • 1. The requested indication does NOT require any prerequisite biologic immunomodulator agents OR
  • 2. The requested agent is a Step 1a agent for the requested indication OR
  • 3. BOTH of the following:
  • A. ONE of the following:
  • 1. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
  • 2. The patient has stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four metastatic cancer [chart notes required]
  • AND
  • B. The use is consistent with best practices for stage four advanced metastatic cancer, supported by evidence-based literature, and FDA approved OR
  • 4. If the requested agent is a Step 1b agent for the requested indication, then ONE of the following:
  • A. The patient has tried and had an inadequate response to ONE TNF inhibitor for at least 3 months OR
  • B. Has intolerance or hypersensitivity to ONE TNF inhibitor OR
  • C. Has an FDA labeled contraindication to ALL TNF inhibitors OR
  • D. ALL TNF inhibitors are not clinically appropriate and prescriber has provided a complete list of previously tried agents OR
  • 5. If the requested agent is a Step 2 agent for the requested indication, then ONE of the following:
  • A. Has tried and had an inadequate response to ONE Step 1 agent for at least 3 months OR
  • B. Has intolerance or hypersensitivity to ONE required Step 1 agent OR
  • C. Has an FDA labeled contraindication to ALL Step 1 agents OR
  • D. ALL required Step 1 agents are not clinically appropriate and prescriber has provided list of previously tried agents OR
  • 6. For Step 3a agents: ONE of the following (medical records required): inadequate response to TWO Step 1 agents for at least 3 months each; or inadequate response to ONE Step 1 plus intolerance/hypersensitivity to one; or intolerance/hypersensitivity to TWO; or FDA labeled contraindication to ALL Step 1s; or ALL Step 1s not clinically appropriate with list provided OR
  • 7. For Step 3b agents: ONE of the following (medical records required): inadequate response to TWO agents from Step 1 and/or Step 2 for at least 3 months each; or inadequate response to ONE with intolerance/hypersensitivity to another; or intolerance/hypersensitivity to TWO; or FDA contraindication to ALL Step 1 and 2 agents; or ALL those agents not clinically appropriate with list provided OR
  • 8. For Step 3c agents: ONE of the following (medical records required): inadequate response to THREE Step 1 agents for at least 3 months each; or inadequate response to TWO plus intolerance to one; or inadequate response to ONE plus intolerance to two; or intolerance/hypersensitivity to THREE; or FDA contraindication to ALL Step 1 agents; or ALL Step 1s not clinically appropriate with list provided OR
  • 9. Patient is currently stable on requested agent [chart notes required] OR
  • 10. Required prerequisite biologic agent(s) discontinued due to lack of efficacy, diminished effect, or adverse event [chart notes required] OR
  • 11. Required prerequisite biologic agent(s) expected to be ineffective, cause adherence barrier, worsen comorbid condition, reduce function, or cause harm [chart notes required] OR
  • 12. Required prerequisite agent(s) not in patient’s best interest based on medical necessity [chart notes required] OR
  • 13. Patient has tried another drug in same class or mechanism discontinued due to lack of efficacy or adverse event [chart notes required] OR
  • 14. If Cosentyx 300 mg requested as maintenance:
  • A. Moderate to severe plaque psoriasis ± active psoriatic arthritis, requested dose 300 mg every 4 weeks OR
  • B. Hidradenitis suppurativa, requested dose 300 mg every 4 weeks OR 300 mg every 2 weeks after inadequate response to every 4 weeks for ≥3 months OR
  • C. Active psoriatic arthritis or active ankylosing spondylitis, dose 300 mg every 4 weeks AND inadequate response to Cosentyx 150 mg every 4 weeks ≥3 months OR
  • 15. If Tremfya 200 mg requested, diagnosis of Crohn’s disease or ulcerative colitis OR
  • 16. If Omvoh 300 mg as maintenance, diagnosis of Crohn’s disease OR
  • 17. If Actemra requested for systemic sclerosis associated interstitial lung disease, request is for Actemra syringe (not ACTpen) OR
  • 18. The patient does NOT have any FDA labeled contraindications to the requested agent.

Approval duration

12 months