biologic immunomodulator agents — Blue Cross Blue Shield of Oklahoma

Initial criteria

• All target agents EXCEPT Actemra are eligible for continuation of therapy
• ONE of the following:
• 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 been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat the cancer OR
• 2. The patient has been diagnosed with stage four advanced, metastatic cancer and the requested agent is being used to treat an associated condition related to stage four advanced metastatic cancer [chart notes required]
• AND
• B. The use of the requested agent is consistent with best practices for the treatment of stage four advanced metastatic cancer or associated condition, supported by peer-reviewed evidence and FDA approval OR
• 4. If the requested agent is a Step 1b agent for the requested indication, then ONE of the following:
• A. The patient has ONE of the following:
• 1. Tried and had an inadequate response to ONE TNF inhibitor for the requested indication after ≥3 months therapy OR
• 2. Has an intolerance or hypersensitivity to ONE TNF inhibitor for the requested indication OR
• B. The patient has an FDA-labeled contraindication to ALL TNF inhibitors OR
• C. BOTH of the following:
• 1. ALL TNF inhibitors are not clinically appropriate AND
• 2. The prescriber has provided a complete list of previously tried agents for the requested indication OR
• 5. If requested agent is a Step 2 agent, then ONE of the following:
• A. The patient has ONE of the following:
• 1. Tried and had an inadequate response to ONE Step 1 agent after ≥3 months therapy OR
• 2. Has an intolerance or hypersensitivity to ONE Step 1 agent OR
• B. FDA-labeled contraindication to ALL Step 1 agents OR
• C. ALL Step 1 agents not clinically appropriate and prescriber provided list of previously tried agents OR
• 6. If Step 3a agent, then ONE of the following (medical records required):
• A. The patient has ONE of the following:
• 1. Tried and had inadequate response to TWO Step 1 agents after ≥3 months each OR
• 2. Tried and had inadequate response to ONE Step 1 agent and intolerance/hypersensitivity to another Step 1 agent OR
• 3. Intolerance/hypersensitivity to TWO Step 1 agents OR
• B. FDA-labeled contraindication to ALL Step 1 agents OR
• C. ALL Step 1 agents not clinically appropriate and list of previously tried agents provided OR
• 7. If Step 3b agent, then ONE of the following (medical records required):
• A. Tried and had inadequate response to TWO agents from Step 1 and/or Step 2 after ≥3 months each OR
• B. Tried and had inadequate response to ONE agent from Step 1 or Step 2 after ≥3 months and intolerance/hypersensitivity to another OR
• C. Intolerance/hypersensitivity to TWO agents from Step 1/Step 2 OR
• B. FDA-labeled contraindication to ALL Step 1 AND Step 2 agents OR
• C. ALL Step 1 and Step 2 agents not clinically appropriate and prescriber provided list of previously tried agents OR
• 8. If Step 3c agent, one of the following (medical records required):
• A. Tried and had inadequate response to THREE Step 1 agents after ≥3 months each OR
• B. Tried and had inadequate response to TWO Step 1 agents after ≥3 months each and intolerance/hypersensitivity to one Step 1 agent OR
• C. Tried and had inadequate response to ONE Step 1 agent after ≥3 months and intolerance/hypersensitivity to TWO Step 1 agents OR
• D. Intolerance/hypersensitivity to THREE Step 1 agents OR
• B. FDA-labeled contraindication to ALL Step 1 agents OR
• C. ALL Step 1 agents not clinically appropriate and list of previously tried agents provided OR
• 9. The patient is currently stable on the requested agent (chart notes required) OR
• 10. Required prerequisite biologic immunomodulator agent(s) discontinued due to lack of efficacy, diminished effect, or adverse event (chart notes required) OR
• 11. Required prerequisite biologic immunomodulator agent(s) expected to be ineffective or unsafe based on clinical or patient-specific factors (chart notes required) OR
• 12. Required prerequisite biologic immunomodulator agent(s) not in best interest of patient due to medical necessity (chart notes required) OR
• 13. The patient has tried another agent in the same class/mechanism that was discontinued for lack of efficacy or adverse event (chart notes required)
• 7. If Cosentyx 300 mg is requested as maintenance dosing, then:
• A. For moderate to severe plaque psoriasis ± active psoriatic arthritis, requested dose is 300 mg every 4 weeks OR
• B. For hidradenitis suppurativa, requested dose is 300 mg every 4 weeks OR 300 mg every 2 weeks after inadequate response to every-4-week dosing for ≥3 months OR
• C. For active psoriatic arthritis or active ankylosing spondylitis, dose is 300 mg every 4 weeks AND inadequate response to 150 mg every 4 weeks after ≥3 months therapy
• 8. If Tremfya 200 mg is requested, patient has diagnosis of Crohn's disease or ulcerative colitis
• 9. If Omvoh 300 mg maintenance dosing requested, patient has diagnosis of Crohn’s disease
• 10. If Actemra requested for systemic sclerosis-associated interstitial lung disease, request must be for Actemra syringe (Actemra ACTpen not approvable)
• 11. The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Continuation of therapy allowed if patient remains stable on requested agent and no FDA labeled contraindications

Approval duration

12 months