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biologic immunomodulators (target agents per policy) — Blue Cross Blue Shield of Oklahoma

general policy use for biologic immunomodulators

Preferred products

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

Initial criteria

  • The patient does NOT have any FDA labeled contraindications to the requested agent
  • The patient has been tested for latent tuberculosis (TB) AND if positive has begun therapy for latent TB
  • The member resides in Ohio AND the plan is Fully Insured or HIM Shop (SG) AND BOTH:
  • • The patient does NOT have any FDA labeled contraindications to the requested agent
  • • ONE of the following:
  • – The patient has another FDA labeled indication for the requested agent and route of administration OR
  • – The patient has another indication that is supported in compendia for the requested agent and route of administration OR
  • – The prescriber has submitted TWO articles from peer-reviewed professional medical journals supporting the proposed use as generally safe and effective

Reauthorization criteria

  • The patient has been previously approved for the requested agent through the plan’s Prior Authorization process
  • The patient has had clinical benefit with the requested agent
  • ONE of the following (reference preferred agents table applies):
  • – The requested agent is a preferred agent OR (if not)
  • – BOTH of the following:
  • A. The patient has stage four advanced, metastatic cancer and the agent treats the cancer or related condition OR is consistent with evidence-based practice; OR
  • B. The patient is currently stable on the requested agent; OR
  • C. The patient has tried and had inadequate response to THREE preferred agents after ≥6-month trial per agent; OR
  • D. THREE preferred agents discontinued due to lack of efficacy/effectiveness/adverse event; OR
  • E. The patient has intolerance or hypersensitivity to THREE preferred agents; OR
  • F. The patient has FDA labeled contraindication to ALL preferred agents; OR
  • G. THREE preferred agents expected to be ineffective, barrier to adherence, worsen disease, or cause harm; OR
  • H. THREE preferred agents not in best interest of patient based on medical necessity; OR
  • I. The patient has tried another drug in same class as THREE preferred agents with discontinuation for ineffectiveness/adverse event
  • The prescriber is a specialist in or has consulted a specialist in the patient’s diagnosis
  • ONE of the following combination use conditions met: The patient will NOT use with another immunomodulatory agent OR use is clinically supported and permitted by labeling
  • The patient does NOT have any FDA labeled contraindications

Approval duration

12 months