ozanimod — Blue Cross Blue Shield of Illinois
relapsing forms of multiple sclerosis
Preferred products
- adalimumab-aaty
- adalimumab-adaz
- Hadlima
- Humira
- Simlandi
- Omvoh
- Selarsdi
- Simponi
- Steqeym
- Skyrizi
- Stelara
- Tremfya
- Velsipity
- Xeljanz
- Xeljanz XR
Initial criteria
- ONE of the following:
- A. The requested agent is eligible for continuation of therapy AND the following: 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
- 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 use of the requested agent in combination with Mavenclad (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:
- A. The patient has tried and had an inadequate response to ONE conventional agent (e.g., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, sulfasalazine) for at least 3 months OR
- B. The patient has severely active ulcerative colitis OR
- C. The patient has an intolerance or hypersensitivity to ONE conventional agent used in the treatment of UC OR
- D. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC OR
- E. The patient’s medication history indicates use of another biologic immunomodulator agent FDA labeled or compendia supported for treatment of UC AND
- 2. ONE of the following:
- A. The patient is currently being treated with the requested agent and is currently stable on the requested agent [chart notes required] OR
- B. The patient has tried and had an inadequate response to at least TWO Step 1 immunomodulatory agents (see Immunomodulatory Agent Step table) [chart notes required] OR
- C. TWO Step 1 immunomodulatory agents were discontinued due to lack of efficacy or effectiveness, diminished effect, or an adverse event [chart notes required] OR
- D. The patient has an intolerance or hypersensitivity to at least TWO Step 1 immunomodulatory agents [chart notes required] OR
- E. The patient has an FDA labeled contraindication to ALL Step 1 immunomodulatory agents [chart notes required] OR
- F. TWO Step 1 immunomodulatory agents are expected to be ineffective based on patient characteristics or would cause significant barrier to adherence or worsen comorbidity or decrease functional ability or cause harm [chart notes required] OR
- G. TWO Step 1 immunomodulatory agents are not in the best interest of the patient based on medical necessity [chart notes required] OR
- H. The patient has tried another prescription drug in the same pharmacologic class or with the same mechanism of action as TWO Step 1 immunomodulatory agents and discontinued due to lack of efficacy or adverse event [chart notes required]
- AND
- 3. ONE of the following:
- A. The patient will NOT be using the requested agent in combination with an immunomodulatory (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors) OR
- B. The patient will be using the requested agent in combination with an immunomodulatory agent AND BOTH of the following:
- 1. The prescribing information for the requested agent does NOT limit the use with another immunomodulatory agent AND
- 2. There is support for the use of combination therapy [copy of support required, i.e., clinical trials, phase III studies, guidelines required]
- AND
- 2. If the patient has an FDA approved indication, then ONE of the following:
- A. The patient’s age is within FDA labeling for the requested indication OR
- B. There is support for using the requested agent for the patient’s age for the requested indication
- AND the prescriber has performed an electrocardiogram within 6 months prior to initiating treatment
- AND the prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist for MS, gastroenterologist for UC) or has consulted with one
- AND the patient does NOT have any FDA labeled contraindications to the requested agent
Approval duration
12 months