Zeposia starter kit — Blue Cross Blue Shield of Montana
Moderately to severely active ulcerative colitis
Preferred products
- Adalimumab-aaty
- Adalimumab-adaz
- Hadlima
- Humira
- Simlandi
- Xeljanz
- Xeljanz XR
- Omvoh
- Selarsdi
- Simponi
- Steqeym
- Skyrizi
- Stelara
- Tremfya
- Velsipity
Initial criteria
- ONE of the following: (A) The requested agent is eligible for continuation of therapy AND the prescriber states the patient has been treated with the requested agent within the past 90 days AND is at risk if therapy is changed; OR (B) BOTH of the following:
- 1. ONE of the following:
- A. The patient has a relapsing form of multiple sclerosis (MS) AND ONE of the following: (1) The patient will NOT be using the requested agent in combination with another disease modifying agent (DMA) used for the requested indication OR (2) The patient will be using the requested agent in combination with Mavenclad (cladribine) AND there is support for the combination (e.g., relapse between cycles of Mavenclad), OR
- B. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC) AND ALL of the following:
- 1. ONE of the following regarding conventional therapy: (A) Tried and had inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for at least 3 months; OR (B) Has severely active UC; OR (C) Has intolerance or hypersensitivity to ONE conventional agent; OR (D) Has FDA-labeled contraindication to ALL conventional agents; OR (E) Medication history indicates use of another biologic immunomodulator for UC.
- 2. ONE of the following Step 1 immunomodulatory agent conditions (chart notes required): (A) Currently being treated with requested agent and stable; OR (B) Tried and had inadequate response to at least TWO Step 1 immunomodulatory agents; OR (C) TWO Step 1 agents discontinued due to lack of efficacy, diminished effect, or adverse event; OR (D) Intolerance or hypersensitivity to TWO Step 1 agents; OR (E) Contraindication to ALL Step 1 agents; OR (F) TWO Step 1 agents expected ineffective or inappropriate due to medical reasons; OR (G) TWO Step 1 agents not in the patient’s best interest based on medical necessity; OR (H) Tried another prescription drug in the same pharmacologic class or mechanism as TWO Step 1 immunomodulatory agents and discontinued due to lack of efficacy or adverse event.
- 3. ONE of the following regarding immunomodulator combinations: (A) Will NOT be used with another immunomodulatory (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors); OR (B) Will be used with another immunomodulator AND BOTH of the following: (1) The prescribing information does NOT limit the combination; AND (2) There is support for combination therapy (e.g., clinical trials, phase III studies, guidelines).
- 4. If the patient has an FDA approved indication, ONE of the following: (A) Age is within FDA labeling for the intended indication; OR (B) There is supporting evidence for off-label age use.
- 5. Prescriber has performed an electrocardiogram within 6 months prior to initiating treatment.
- 6. Prescriber is a specialist (neurologist for MS; gastroenterologist for UC) or has consulted with a specialist in the relevant field.
- 7. Patient does NOT have any FDA-labeled contraindications to the requested agent.
Approval duration
12 months