Step 3a agents — Blue Cross Blue Shield of Montana

Initial criteria

• If the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer, chart notes are required AND use must be consistent with best practices, supported by peer-reviewed evidence, and FDA approved.
• If the requested agent is a Step 1b agent, ONE of the following: (A) the patient has tried and had an inadequate response to ONE TNF inhibitor after at least 3 months OR has intolerance/hypersensitivity to ONE TNF inhibitor; (B) the patient has an FDA labeled contraindication to ALL TNF inhibitors; (C) ALL TNF inhibitors are not clinically appropriate and prescriber provides list of previously tried agents.
• If the requested agent is a Step 2 agent, ONE of the following: (A) the patient has tried and had an inadequate response to ONE Step 1 agent after at least 3 months OR has intolerance/hypersensitivity to ONE Step 1 agent; (B) FDA labeled contraindication to ALL Step 1 agents; (C) ALL required Step 1 agents not clinically appropriate and list of previously tried agents provided.
• If the requested agent is a Step 3a agent, ONE of the following: (A) the patient has tried and had an inadequate response to TWO Step 1 agents (≥3 months each) OR inadequate response to ONE Step 1 agent plus intolerance/hypersensitivity to another OR intolerance/hypersensitivity to TWO Step 1 agents; (B) contraindication to ALL Step 1 agents; (C) ALL Step 1 agents not clinically appropriate and list of tried agents provided.
• If the requested agent is a Step 3b agent, ONE of the following: (A) inadequate response to TWO agents from Step 1 and/or 2 (≥3 months each) OR to ONE agent plus intolerance/hypersensitivity to another OR intolerance/hypersensitivity to TWO agents from Step 1 and/or 2; (B) contraindication to ALL Step 1 and Step 2 agents; (C) ALL Step 1 and Step 2 agents not clinically appropriate and list of tried agents provided.
• If the requested agent is a Step 3c agent, ONE of the following: (A) inadequate response to THREE Step 1 agents (≥3 months each) OR to TWO Step 1 agents plus intolerance/hypersensitivity to one OR to ONE Step 1 agent plus intolerance/hypersensitivity to two OR intolerance/hypersensitivity to THREE Step 1 agents; (B) contraindication to ALL Step 1 agents; (C) ALL Step 1 agents not clinically appropriate and list of tried agents provided.
• The patient is currently being treated with and stable on the requested agent (chart notes required).
• Required prerequisite biologic immunomodulator agent(s) discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required).
• Required prerequisite biologic immunomodulator agent(s) expected to be ineffective, cause adherence barrier, worsen comorbidity, decrease functional ability, or cause harm (chart notes required).
• Required prerequisite biologic immunomodulator agent(s) not in patient’s best interest based on medical necessity (chart notes required).
• Patient has tried another prescription drug in same pharmacologic class or mechanism as prerequisite agent and it was discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required).
• For Cosentyx 300 mg maintenance dosing: (A) for moderate to severe plaque psoriasis ± psoriatic arthritis and dose is 300 mg q4wk OR (B) for hidradenitis suppurativa with dose 300 mg q4wk OR 300 mg q2wk after failure of 300 mg q4wk for ≥3 months OR (C) for active psoriatic arthritis or ankylosing spondylitis, dose 300 mg q4wk and prior inadequate response to Cosentyx 150 mg q4wk for ≥3 months.
• For Tremfya 200 mg: patient has Crohn’s disease or ulcerative colitis.
• For Omvoh 300 mg maintenance dosing: patient has Crohn’s disease.
• For Actemra for systemic sclerosis associated interstitial lung disease: must request Actemra syringe, not ACTpen.
• Patient must NOT have any FDA labeled contraindications to requested agent.

Approval duration

12 months