Nemluvio (nemolizumab-ilto) — Blue Cross Blue Shield of Kansas

Initial criteria

• For PN, ONE of the following: (1) has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of PN after at least a 2-week duration of therapy OR (2) has intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used in the treatment of PN OR (3) has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in the treatment of PN OR (4) medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of PN
• For AD, BOTH of the following: (1) ONE of the following: (A) patient has at least 10% body surface area involvement OR (B) involvement of difficult to treat body sites with prolonged topical corticosteroids (hands, feet, face, neck, scalp, genitals/groin, skin folds) OR (C) EASI ≥ 16 OR (D) IGA ≥ 3 AND (2) ONE of the following: (A) BOTH of the following: (1) ONE of the following: (A) has tried and had inadequate response to ONE at least medium-potency topical corticosteroid used in treatment of AD after at least 4-week duration OR (B) has intolerance or hypersensitivity to ONE at least medium-potency topical corticosteroid used for AD OR (C) has FDA-labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used for AD AND (2) ONE of the following: (A) has tried and had inadequate response to ONE topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in AD after at least 6-week duration OR (B) has intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in AD OR (C) has FDA-labeled contraindication to ALL topical calcineurin inhibitors used in AD) OR (B) medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for AD OR (C) patient has another FDA labeled indication for the requested agent and route of administration
• If the patient has an FDA labeled indication, then ONE of the following: (A) age is within FDA labeling for the requested indication OR (B) support exists for using requested agent for patient's age for that indication OR (C) patient has another indication supported in compendia for the requested agent and route
• If the patient has AD, ALL of the following: (A) BOTH of the following: (1) currently treated with topical emollients and practicing good skin care AND (2) will continue topical emollients and good skin care practices with the requested agent AND (B) ONE of the following: (1) BOTH of the following: (A) currently treated with at least a low-potency topical corticosteroid OR a topical calcineurin inhibitor (Elidel/pimecrolimus, Protopic/tacrolimus) AND (B) will continue topical corticosteroid OR topical calcineurin inhibitor therapy with the requested agent OR (2) has been treated with the requested agent for at least 16 consecutive weeks AND BOTH: (A) AD has sufficiently improved AND (B) concurrent topical therapies have been tapered and discontinued OR (3) has intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids AND topical calcineurin inhibitors AND (C) ONE of the following: (1) initiating therapy with the agent OR (2) has been treated with the agent for less than 16 consecutive weeks OR (3) has been treated for at least 16 consecutive weeks AND ONE of the following: (A) requested dose is 30 mg every 8 weeks OR (B) requested dose is 30 mg every 4 weeks AND ONE of the following: (1) patient has NOT achieved clear or almost clear skin OR (2) support exists for continued therapy at 30 mg every 4 weeks
• Prescriber is a specialist (e.g., allergist, dermatologist, immunologist), or has consulted a specialist for the diagnosis
• ONE of the following: (A) will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) will be using in combination AND BOTH of the following: (1) prescribing information does NOT limit such use AND (2) support for use of combination therapy (submitted copy of clinical trials, phase III studies, or guidelines)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

• Previously approved for the requested agent through prior authorization
• Has had clinical benefit with the requested agent
• If diagnosis is moderate-to-severe atopic dermatitis, then ALL of the following: (A) will continue standard maintenance therapies (topical emollients and good skin care) with the requested agent AND (B) ONE of the following: (1) will continue topical corticosteroid OR topical calcineurin inhibitor therapy with the requested agent OR (2) has been treated with requested agent for ≥16 consecutive weeks AND BOTH: (A) AD has sufficiently improved AND (B) concurrent topical therapies have been tapered and discontinued OR (3) has intolerance, hypersensitivity, or FDA labeled contraindication to ALL topical corticosteroids and topical calcineurin inhibitors AND (C) ONE of the following: (1) initiating therapy with requested agent OR (2) has been treated with requested agent for <16 consecutive weeks OR (3) has been treated for ≥16 consecutive weeks AND ONE of: (A) requested dose is 30 mg every 8 weeks OR (B) requested dose is 30 mg every 4 weeks AND ONE of: (1) patient has NOT achieved clear or almost clear skin OR (2) support exists for continued therapy at that dose)
• Prescriber is a specialist or has consulted a specialist in the patient's diagnosis area
• ONE of the following: (A) will NOT be using requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR (B) will be using in combination AND BOTH of the following: (1) prescribing information does NOT limit use with another immunomodulatory agent AND (2) support for combination therapy (submitted clinical evidence)
• Patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

6 months (AD, PN); 12 months (other indications); 12 months (renewal)