Zeposia – NC Standard

Restricted Product(s)

• Zeposia® (ozanimod)

FDA Approved Use

• For the treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults 
• For the treatment of moderately to severely active ulcerative colitis (UC) in adults

Criteria for Approval of Restricted Product(s)

1. The patient has a diagnosis of multiple sclerosis (MS); AND 
   1. The patient has a diagnosis of relapsing-remitting disease (RRMS) or secondary progressive multiple sclerosis (SPMS); OR 
      1. The patient will be using for treatment at time of first demyelinating event to delay development or progression to multiple sclerosis; AND 
   2. The patient must still either be able to walk at least a few steps with or without aid, or alternatively must have some functional arm/hand use consistent with performing activities of daily living; AND 
   3. ONE of the following: 
      1. The patient has tried and had an inadequate response, intolerance, or hypersensitivity to ONE of the following: dimethyl fumarate (generic Tecfidera) or glatiramer acetate (generic Copaxone or Glatopa) or fingolimod (generic Gilenya) or teriflunomide (generic Aubagio) (medical record documentation required); OR  
         1. The patient has an FDA labeled contraindication to ALL of the following: dimethyl fumarate (generic Tecfidera), glatiramer acetate (generic Copaxone or Glatopa), fingolimod (generic Gilenya), teriflunomide (generic Aubagio) (medical record documentation required); OR
      2. The patient has highly active MS disease activity (medical record documentation required); AND 
         1. The patient has ≥ 2 relapses in the previous year; AND 
            1. The patient has ≥ 1 gadolinium enhancing lesion on MRI; OR 
            2. The patient has significant increase in T2 lesion load compared with previous MRI; OR 
      3. The patient has been treated with at least 3 MS agents from different drug classes (medical record documentation required); OR 
2. The patient has a diagnosis of moderate to severely active ulcerative colitis (UC); AND 
   1. ONE of the following:
      1. The patient has tried and had an inadequate response to ONE conventional agent (i.e., 6-mercaptopurine, azathioprine, balsalazide, corticosteroids, cyclosporine, mesalamine, steroid suppositories, sulfasalazine) used in the treatment of UC for at least 3-months (medical record documentation required); OR
      2. The patient has severely active ulcerative colitis; OR 
      3. The patient has an intolerance or hypersensitivity to ONE of the conventional agents used in the treatment of UC (medical record documentation required); OR
      4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC (medical record documentation required); AND
   2. ONE of the following: 
      1. The patient has tried and had an inadequate response to at least TWO of the following for at least 3-months: preferred adalimumab product, Entyvio, Rinvoq, Skyrizi, Stelara, Xeljanz/Xeljanz XR, Tremfya (medical record documentation required); OR
      2. The patient has an intolerance or hypersensitivity to at least TWO of the following: preferred adalimumab product, Rinvoq, Entyvio, Skyrizi, Stelara, Xeljanz/Xeljanz XR, Tremfya (medical record documentation required); OR
      3. The patient has an FDA labeled contraindication to ALL of the following: preferred adalimumab product, Entyvio, Rinvoq, Skyrizi, Stelara, Xeljanz/Xeljanz XR, Tremfya (medical record documentation required); AND
3. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., neurologist for the diagnosis of multiple sclerosis, gastroenterologist for the diagnosis of ulcerative colitis) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis; AND
4. ONE of the following: 
   1. The patient will not be using the requested medication in combination with any of the following for the requested indication:
      1. An additional disease modifying agent (DMA) 
      2. A biologic immunomodulator 
      3. Otezla (apremilast); OR 
   2. The patient has a diagnosis of a relapsing form of MS; AND 
      1. The requested agent will be used in combination with Mavenclad (cladribine); AND 
      2. . Information has been provided supporting the use of the requested agent in combination with Mavenclad (e.g., relapse between cycles of Mavenclad) (medical record documentation required); AND
5. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.
   

Duration of Approval: 365 days (1 year)

Quantity Limit Exception Criteria

1. The quantity (dose) requested is for documented titration purposes at the initiation of therapy (authorization for a 90 day titration period); AND 
2. The prescribed dose cannot be achieved using a lesser quantity of a higher strength; AND 
3. The quantity (dose) requested does not exceed the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert; OR 
4. If the quantity (dose) requested exceeds the maximum FDA labeled dose, when specified, or to the safest studied dose per the manufacturer’s product insert, then the prescriber must submit documentation in support of therapy with a higher dose for the intended diagnosis (submitted documentation may include medical records OR fax form which reflects medical record documentation that shows the length of time the requested dose has been used, and what other medications and doses have been tried and failed).

Duration of Approval: 365 days (1 year)

References

All information referenced is from FDA package insert unless otherwise noted below.

Policy Implementation/Update Information

Criteria and treatment protocols are reviewed annually by the Blue Cross NC P&T Committee, regardless of change. This policy is reviewed in Q2 annually.

March 2025: Criteria update: Corrected grammatical error in policy. No changes in intent.
January 2025: Criteria change: Updated ulcerative colitis section to include Entyvio as trial/fail option.
October 2024: Criteria change: Updated ulcerative colitis section to include Tremfya as trial/fail option.
July 2024 v2: Criteria update: Updated requirement of trial and failure for Ulcerative colitis to include Skyrizi.
July 2024: Criteria update: Update policy to remove the requirement for clinically isolated syndrome as part of the diagnosis requirement.
July 2023: Criteria change: Updated Humira to preferred adalimumab product. Added teriflunomide (generic Aubagio), fingolimod (generic Gilenya) and glatiramer acetate (Glatopa) to preferred products.
June 2023: Criteria update: Added new Zeposia 28-day starter pack to the policy.
April 2022: Criteria update: Added Rinvoq as tried/failed agent for ulcerative colitis indication.
June 2021: Original utilization management criteria issued.