Cibinqo — Blue Cross Blue Shield of New Mexico

Initial criteria

• The requested agent is eligible for continuation of therapy AND prescriber states patient has been treated with the requested agent (not samples) within past 90 days AND is at risk if therapy is changed OR new start criteria apply
• Diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following:
• • ONE of the following: at least 10% body surface area involvement OR involvement of difficult-to-treat body sites (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR EASI score ≥ 16 OR Investigator Global Assessment (IGA) score ≥ 3
• • ONE of the following treatment history requirements: has tried and had inadequate response to ≥1 medium-potency topical corticosteroid ≥4-week course OR intolerance/hypersensitivity to ≥1 medium-potency topical corticosteroid OR FDA-labeled contraindication to all medium-, high-, and super-potency topical corticosteroids AND has tried and had inadequate response to ≥1 topical calcineurin inhibitor (e.g., Elidel [pimecrolimus], Protopic [tacrolimus]) ≥6-week course OR intolerance/hypersensitivity to ≥1 topical calcineurin inhibitor OR FDA-labeled contraindication to all topical calcineurin inhibitors
• OR patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or compendia-supported for AD
• OR patient has another FDA labeled or compendia-supported indication for the requested agent and route of administration
• AND if the patient has an FDA-labeled indication, age is within labeling OR supported by compendia
• AND if AD diagnosis present: patient is currently treated with topical emollients and practicing good skin care AND will continue same in combination with requested agent
• AND patient tested for latent tuberculosis (TB); if positive, has begun therapy for latent TB
• AND prescriber is a dermatologist, allergist, immunologist, or has consulted with such a specialist
• AND patient will NOT use Cibinqo concurrently with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL‑4 inhibitors) unless combination is not limited per labeling AND evidence supports use (clinical trials, phase III studies, or guidelines provided)
• AND patient has no FDA-labeled contraindications to the requested agent
• Length of Approval: BCBSIL, BCBSMT, BCBSTX = 12 months; all other plans = 6 months
• For Ohio residents with Fully Insured or HIM Shop plans: requested agent may be approved if no contraindications AND one of – FDA-labeled indication, compendia-supported indication, or two peer-reviewed journal articles supporting safe and effective off-label use (randomized, double‑blind, placebo-controlled preferred)

Reauthorization criteria

• Patient previously approved for the requested agent through plan’s PA process
• Patient has had clinical benefit with requested agent
• If AD diagnosis: patient will continue maintenance therapies (topical emollients, good skin care) with requested agent
• Prescriber is dermatologist, allergist, immunologist, or has consulted with such a specialist
• Patient will NOT use requested agent with another immunomodulatory agent (e.g., TNF, JAK, IL‑4 inhibitors) unless labeling allows and evidence supports combination (clinical trials, phase III, guidelines submitted)
• Patient has no FDA-labeled contraindications to requested agent

Approval duration

initial 6–12 months; renewal 12 months