Omvoh 300 mg — Blue Cross Blue Shield of New Mexico

Initial criteria

• The requested indication does NOT require any prerequisite biologic immunomodulator agents OR the requested agent is a Step 1a agent for the requested indication.
• OR The patient has stage four advanced metastatic cancer and the requested agent is used to treat the cancer or an associated condition related to stage four advanced metastatic cancer, AND the use of the agent is consistent with best practices, supported by evidence-based literature, and FDA approved.
• If Step 1b agent requested, patient must have inadequate response after ≥3 months to ONE TNF inhibitor OR intolerance/hypersensitivity to ONE TNF inhibitor OR FDA labeled contraindication to ALL TNF inhibitors OR ALL TNF inhibitors not clinically appropriate and prescriber provided list of previously tried agents.
• If Step 2 agent requested, patient must have inadequate response after ≥3 months to ONE required Step 1 agent OR intolerance/hypersensitivity to ONE required Step 1 agent OR FDA labeled contraindication to ALL required Step 1 agents OR ALL required Step 1 agents not clinically appropriate and prescriber provided list of previously tried agents.
• If Step 3a agent requested, patient must have inadequate response after ≥3 months to TWO Step 1 agents OR inadequate response to ONE Step 1 agent and intolerance/hypersensitivity to ONE Step 1 agent OR intolerance/hypersensitivity to TWO Step 1 agents OR FDA labeled contraindication to ALL Step 1 agents OR ALL Step 1 agents not clinically appropriate and prescriber provided list.
• If Step 3b agent requested, patient must have inadequate response after ≥3 months to TWO agents from Step 1 and/or Step 2 OR inadequate response to ONE agent from Step 1 or Step 2 and intolerance/hypersensitivity to ONE agent from Step 1 or Step 2 OR intolerance/hypersensitivity to TWO agents from Step 1/2 OR FDA labeled contraindication to ALL Step 1 and Step 2 agents OR ALL Step 1/2 agents not clinically appropriate and prescriber provided list.
• If Step 3c agent requested, patient must have inadequate response after ≥3 months to THREE Step 1 agents OR inadequate response to TWO Step 1 agents and intolerance/hypersensitivity to ONE Step 1 agent OR inadequate response to ONE Step 1 agent and intolerance/hypersensitivity to TWO Step 1 agents OR intolerance/hypersensitivity to THREE Step 1 agents OR FDA labeled contraindication to ALL Step 1 agents OR ALL Step 1 agents not clinically appropriate and prescriber provided list.
• Patient currently stable on the requested agent OR prior biologic immunomodulator discontinued due to lack of efficacy, diminished effect, or adverse event OR expected to be ineffective, cause barrier/adverse reaction/harm, or not in best interest of patient based on medical necessity OR patient has tried other drug with same mechanism that was discontinued due to lack of efficacy or adverse event.
• Cosentyx 300 mg maintenance dosing: diagnosis of moderate to severe plaque psoriasis with or without active psoriatic arthritis and requested dose 300 mg every 4 weeks OR diagnosis of hidradenitis suppurativa with dose 300 mg every 4 weeks OR with dose 300 mg every 2 weeks after inadequate response to 300 mg every 4 weeks for ≥3 months OR diagnosis of active psoriatic arthritis or active ankylosing spondylitis with dose 300 mg every 4 weeks and inadequate response after ≥3 months to Cosentyx 150 mg every 4 weeks.
• Tremfya 200 mg request requires diagnosis of Crohn’s disease or ulcerative colitis.
• Omvoh 300 mg maintenance dosing requires diagnosis of Crohn’s disease.
• Actemra for systemic sclerosis associated interstitial lung disease must be for Actemra syringe; Actemra ACTpen not approvable.
• Patient must NOT have any FDA labeled contraindications to the requested agent.

Approval duration

12 months