Ebglyss — Blue Cross Blue Shield of Alabama

Initial criteria

• Prescriber states the patient has been treated with the requested agent within the past 90 days (starting on samples is not approvable) AND is at risk if therapy is changed OR BOTH of the following:
• ONE of the following: patient has a 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 body sites difficult to treat with prolonged topical corticosteroid use (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR EASI score ≥ 16 OR IGA score ≥ 3
• AND ONE of the following: patient has tried and had inadequate response to at least one medium-potency topical corticosteroid after ≥ 4 weeks OR intolerance/hypersensitivity OR FDA labeled contraindication to all medium-, high-, and super-potency topical corticosteroids
• AND ONE of the following: patient has tried and had inadequate response to one topical calcineurin inhibitor (e.g., pimecrolimus, tacrolimus) after ≥ 6 weeks OR intolerance/hypersensitivity OR FDA labeled contraindication to all topical calcineurin inhibitors
• OR the medication history indicates use of another biologic immunomodulator agent FDA labeled or compendia-supported for AD
• OR patient has another FDA labeled indication for the requested agent and route
• AND if patient has an FDA labeled indication, then ONE of the following: patient’s age is within FDA labeling for indication OR support for use in patient’s age OR indication supported in compendia
• AND if patient has moderate-to-severe AD: patient is currently treated with topical emollients and good skin care AND will continue these with requested agent
• AND if requested agent is Adbry for AD: ONE of the following: patient < 18 years OR initiating therapy OR treated <16 consecutive weeks OR treated ≥16 consecutive weeks AND ONE of the following based on weight (<100 kg or ≥100 kg) and skin clearance outcome per protocol for dose adjustment described (300 mg every 4 weeks or every 2 weeks as applicable)
• AND if requested agent is Ebglyss for AD, patient weighs ≥40 kg
• AND prescriber is a specialist in the area (e.g., dermatologist, allergist, immunologist) or consults with such specialist
• AND ONE of the following regarding concomitant therapy: patient will NOT use requested agent with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR use is supported by prescribing information and clinical evidence for combination therapy
• AND patient does NOT have any FDA labeled contraindications
• Compendia allowed: AHFS, DrugDex 1 or 2a, or NCCN 1 or 2a recommended use

Reauthorization criteria

• Patient previously approved for requested agent through plan’s PA process AND has had clinical benefit
• AND if patient has moderate-to-severe AD, will continue standard maintenance therapies (topical emollients, good skin care) with requested agent
• AND if requested agent is Adbry for AD, same age/weight/dose adjustment criteria as initial evaluation apply
• AND prescriber is a specialist or has consulted with a specialist
• AND ONE of the following regarding combination therapy: patient will NOT use requested agent with another immunomodulatory agent OR use is supported by prescribing information and submitted evidence
• AND patient lacks any FDA labeled contraindications

Approval duration

initial 6 months, renewal 12 months