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The Policy VaultThe Policy Vault

Biologic Immunomodulator agentsBlue Cross Blue Shield of Kansas

Crohn’s disease

Preferred products

  • Adalimumab-aaty
  • Adalimumab-adaz
  • Hadlima
  • Simlandi
  • Selarsdi
  • Steqeyma
  • Yesintek

Initial criteria

  • Request is NOT for use of Olumiant or Actemra in treatment of COVID-19 in hospitalized adults requiring oxygen, ventilation, or ECMO
  • If request is for alopecia areata, coverage is not restricted under patient’s benefit
  • Requested agent is eligible for continuation of therapy OR patient meets labeled or compendia-supported indication
  • If continuation of therapy: patient has been treated with requested agent (not samples) within past 90 days OR prescriber attests patient treated within 90 days and at risk if therapy changed
  • If new start and has indication: patient has FDA-labeled or compendia-supported indication for requested agent and route
  • For ulcerative colitis: trial of at least ONE conventional agent (e.g., cyclosporine, mesalamine, sulfasalazine) for ≥3 months OR intolerance/hypersensitivity to one conventional agent OR contraindication to all conventional agents OR severely active UC OR prior biologic/immunomodulator use labeled/supported for UC
  • If diagnosis not mentioned previously: requested agent is preferred OR patient meets one of following (medical records required): tried and inadequate response to 3 preferred agents (≥6-month duration each), OR 2 preferred with 1 intolerance to another preferred, OR 1 preferred with 2 intolerances, OR intolerance to 3 preferred, OR contraindication to all preferred agents not expected with requested agent
  • If ustekinumab requested for Crohn’s disease or ulcerative colitis: patient received IV ustekinumab for induction OR new to therapy and will receive ustekinumab IV for induction
  • If ustekinumab 90 mg product requested: (a) psoriasis and weight >100 kg OR (b) psoriasis + psoriatic arthritis and weight >100 kg OR (c) Crohn’s disease or ulcerative colitis
  • Prescriber is or consulted with specialist in relevant area (rheumatologist for PsA/RA, gastroenterologist for CD/UC, dermatologist for PS)
  • Requested agent not used with another immunomodulatory agent OR used with one with BOTH (1) prescribing information does not limit use and (2) support for combination therapy (clinical trials, guidelines provided)
  • No FDA‑labeled contraindications to requested agent
  • Patient tested for latent tuberculosis and, if positive, has begun therapy

Reauthorization criteria

  • Patient previously approved for requested agent through plan’s PA process
  • Patient has had clinical benefit with requested agent
  • Requested agent is preferred OR patient meets one of following (medical records required): inadequate response to 3 preferred (≥6-month duration each), OR 2 preferred + intolerance to 1, OR 1 preferred + intolerance to 2, OR intolerance to 3 preferred, OR contraindication to all preferred agents not expected with requested agent
  • Prescriber is or has consulted with appropriate specialist
  • Requested agent not used with another immunomodulatory OR if used, both (1) prescribing info allows and (2) support for combination therapy provided
  • No FDA‑labeled contraindications to requested agent

Approval duration

12 months