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The Policy VaultThe Policy Vault

other biologic immunomodulator agents — Blue Cross Blue Shield of Alabama

psoriatic arthritis (PsA)

Preferred products

  • adalimumab-aaty
  • adalimumab-adaz
  • Hadlima
  • Humira (preferred for current utilizers only)
  • Simlandi
  • Selarsdi
  • Steqeyma
  • Stelara
  • Yesintek

Initial criteria

  • Request is not for use of Olumiant or Actemra in the treatment of COVID-19 in hospitalized adults requiring supplemental oxygen, non-invasive or invasive mechanical ventilation, or ECMO
  • If the request is for alopecia areata, condition is not restricted from coverage under the patient's benefit
  • EITHER continuation of therapy requirements are met OR all the following for new starts:
  • The patient has an FDA labeled indication or compendia-supported indication for the requested agent and route of administration
  • For psoriasis (PS): patient has an FDA labeled contraindication to ALL conventional agents used in the treatment of PS OR severe active PS (≥10% body surface area or select locations or with intractable pruritus or serious emotional consequences) OR concomitant severe PsA OR patient’s medication history indicates use of another biologic immunomodulator agent or Otezla that is FDA labeled or supported in compendia for PS
  • For Crohn’s disease (CD): patient has diagnosis of moderately to severely active CD AND ONE of the following: tried and had inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, corticosteroids, methotrexate) for ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR FDA labeled contraindication to ALL conventional agents OR medication history indicates use of another biologic immunomodulator agent FDA labeled or supported in compendia for CD
  • For ulcerative colitis (UC): patient has diagnosis of moderately to severely active UC AND ONE of the following: tried and had inadequate response to ONE conventional agent (6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity to ONE conventional agent OR FDA labeled contraindication to ALL conventional agents OR severely active UC OR medication history indicates use of another biologic immunomodulator agent FDA labeled or supported in compendia for UC
  • If client has preferred agents, then ONE of the following: (1) requested agent is preferred OR (2) Has tried and had inadequate response to THREE preferred agents (≥6 months each) OR (3) Has tried and had inadequate response to TWO preferred agents (≥6 months each) and intolerance/hypersensitivity to ONE preferred agent OR (4) Has tried and had inadequate response to ONE preferred agent (≥6 months) and intolerance/hypersensitivity to TWO preferred agents OR (5) Intolerance/hypersensitivity to THREE preferred agents OR (6) FDA labeled contraindication to ALL preferred agents
  • If an ustekinumab product is requested for CD or UC: patient received an ustekinumab IV product for induction therapy OR is new to therapy and will receive ustekinumab IV for induction
  • If patient has an FDA labeled indication, then patient age is within FDA labeling or there is support for use at given age
  • If ustekinumab 90 mg product is requested: diagnosis PS with weight >100kg OR dual PS and PsA with weight >100kg OR diagnosis of CD or UC
  • Prescriber is a relevant specialist or has consulted with one
  • NOT used in combination with another immunomodulatory agent (TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR if used in combination, prescribing information does not limit and there is supporting evidence
  • Patient does not have an FDA labeled contraindication to the requested agent
  • Patient has been tested for latent tuberculosis; if positive, has begun therapy for latent TB

Reauthorization criteria

  • Patient previously approved through plan’s prior authorization process
  • Patient had clinical benefit with requested agent
  • If client has preferred agents, criteria same as initial: either requested agent is preferred or meets trial/intolerance/contraindication criteria for preferred agents with medical records
  • Prescriber is a specialist or consulted with one
  • Not used concomitantly with another immunomodulatory agent unless prescribing information allows and supportive evidence submitted
  • Patient does not have FDA labeled contraindications

Approval duration

12 months