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Zeposia (ozanimod) — Blue Cross Blue Shield of Texas

other FDA labeled indications

Initial criteria

  • The member resides in Ohio AND
  • The plan is Fully Insured or HIM Shop (SG) AND BOTH of the following:
  • 1. The patient does NOT have any FDA labeled contraindications to the requested agent AND
  • 2. ONE of the following:
  • A. The patient has another FDA labeled indication for the requested agent and route of administration OR
  • B. The patient has another indication that is supported in compendia for the requested agent and route of administration OR
  • C. The prescriber has submitted TWO articles from major peer-reviewed professional medical journals (e.g., JAMA, NEJM, Lancet) supporting the proposed use(s) as generally safe and effective. Accepted study designs may include randomized, double-blind, placebo-controlled clinical trials. Case studies are not acceptable.
  • Non-oncology compendia allowed: DrugDex level 1, 2A or 2B, AHFS-DI (narrative text must be supportive)
  • Oncology compendia allowed: NCCN 1 or 2A, AHFS-DI (narrative text must be supportive), DrugDex level 1, 2A, or 2B, or Clinical Pharmacology (narrative text must be supportive), LexiDrugs evidence level A, peer-reviewed medical literature

Reauthorization criteria

  • 1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process AND
  • 2. The patient has had clinical benefit with the requested agent AND
  • 3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist for multiple sclerosis, gastroenterologist for ulcerative colitis) OR the prescriber has consulted with such a specialist AND
  • 4. ONE of the following:
  • A. The patient has a diagnosis of multiple sclerosis AND ONE of the following:
  • 1. The patient will NOT be using the requested agent in combination with another disease modifying agent (DMA) for the requested indication OR
  • 2. The patient will be using the requested agent in combination with another DMA (Mavenclad/cladribine) AND there is support for such use (e.g., relapse between cycles of Mavenclad) OR
  • B. The patient has a diagnosis of ulcerative colitis AND ONE of the following:
  • 1. The patient will NOT be using the requested agent in combination with an immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
  • 2. The patient will be using the requested agent in combination with another immunomodulatory agent AND BOTH of the following:
  • A. The prescribing information for the requested agent does NOT limit use with another immunomodulatory agent AND
  • B. There is support for the use of the combination therapy (copy of clinical trials, phase III studies, or guidelines required) AND
  • 5. The patient does NOT have any FDA labeled contraindications to the requested agent

Approval duration

12 months