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The Policy VaultThe Policy Vault

Cibinqo — Blue Cross Blue Shield of Alabama

moderate-to-severe atopic dermatitis (AD)

Initial criteria

  • ONE of the following: • The requested agent is eligible for continuation of therapy AND ONE of the following: – The patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days OR – The prescriber states the patient has been treated with the requested agent (starting on samples is not approvable) within the past 90 days AND is at risk if therapy is changed OR BOTH of the following:
  • ONE of the following: • The patient has a diagnosis of moderate-to-severe atopic dermatitis (AD) AND BOTH of the following: – ONE of the following: ○ The patient has at least 10% body surface area involvement OR ○ The patient has involvement of body sites difficult to treat with prolonged topical corticosteroid therapy (e.g., hands, feet, face, neck, scalp, genitals/groin, skin folds) OR ○ The patient has an EASI score ≥ 16 OR ○ The patient has an IGA score ≥ 3 – ONE of the following: ○ The patient has tried and had an inadequate response to ONE at least medium-potency topical corticosteroid used in the treatment of AD after ≥ 4 weeks OR ○ The patient has an intolerance or hypersensitivity to ONE medium-potency topical corticosteroid used in AD OR ○ The patient has an FDA labeled contraindication to ALL medium-, high-, and super-potency topical corticosteroids used in AD – AND ONE of the following: ○ The patient has tried and had an inadequate response to ONE topical calcineurin inhibitor (e.g., Elidel/pimecrolimus, Protopic/tacrolimus) used in AD after ≥ 6 weeks OR ○ The patient has an intolerance or hypersensitivity to ONE topical calcineurin inhibitor used in AD OR ○ The patient has an FDA labeled contraindication to ALL topical calcineurin inhibitors used in AD
  • OR The patient’s medication history indicates use of another biologic immunomodulator agent that is FDA labeled or supported in compendia for AD
  • OR The patient has another FDA labeled indication for the requested agent and route of administration
  • AND If the patient has an FDA labeled indication, ONE of the following: • The patient’s age is within FDA labeling for the requested indication and agent OR • There is compendia support for use in the patient’s age OR • The patient has another indication supported in compendia
  • AND If AD diagnosis present, BOTH of the following: • The patient is currently treated with topical emollients and practicing good skin care AND • The patient will continue emollients and good skin care in combination with the requested agent
  • AND The patient has been tested for latent tuberculosis (TB) AND if positive has begun therapy for latent TB
  • AND The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, allergist, immunologist) or has consulted with one
  • AND ONE of the following concerning concomitant use: • The patient will NOT use the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR • The patient will use in combination AND BOTH of the following: – The prescribing information for the requested agent does NOT limit combination use – There is support for combination therapy (copies of clinical trials or guidelines required)
  • AND The patient does NOT have any FDA labeled contraindications to the requested agent

Reauthorization criteria

  • • The patient has been previously approved for the requested agent through the plan’s PA process • The patient has had clinical benefit with the requested agent • If diagnosis is moderate-to-severe AD, the patient will continue standard maintenance therapies (e.g., topical emollients, good skin care practices) in combination with the requested agent • The prescriber is a specialist in the area of the patient’s diagnosis (e.g., dermatologist, allergist, immunologist) or has consulted with one • ONE of the following: – The patient will NOT use the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) – OR The patient will use in combination AND BOTH of the following: ○ The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent ○ There is support for combination therapy (submitted trials or guidelines) • The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

initial 6 months; renewal 12 months