ZEPOSIA (ozanimod)

ZEPOSIA (ozanimod)

Self-Administration – oral capsule

Indications for Prior Authorization:

Relapsing forms of multiple sclerosis (MS): Indicated 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. 

Ulcerative Colitis (UC): Indicated for the treatment of moderately to severely active ulcerative colitis in adults.

Coverage Criteria:

For diagnosis of Multiple Sclerosis (MS):

• Patient has a documented diagnosis of relapsing forms of multiple sclerosis (MS) (e.g., clinically isolated syndrome, relapsing-remitting disease, secondary progressive disease, including active disease with new brain lesions), AND
• Prescribed by or in consultation with a neurologist, AND
• One of the following: 
  • Patient has experienced an inadequate response, contraindication, or intolerable side effect to TWO different preferred agents from the following list:
    • interferon beta-1a injections (e.g., Avonex, Rebif) 
    • interferon beta-1b injections (e.g., Betaseron) 
    • glatiramer acetate injections (e.g., Copaxone, Glatopa, generic glatiramer acetate) 
    • oral fumarates (e.g., dimethyl fumarate [Tecfidera]; diroximel fumarate [Vumerity])
    • sphingosine 1-phosphate (S1P) receptor modulators (e.g., Gilenya) 
    • Plegridy (peginterferon beta-1a)
    • Kesimpta (ofatumumab)
  • For continuation of therapy, defined as no more than a 45-day gap in therapy

For diagnosis of Ulcerative Colitis (UC):

• Patient has a diagnosis of moderately to severely active ulcerative colitis AND
• Prescribed by or in consultation with a gastroenterologist; AND
• One of the following:
  • Greater than 6 stools per day 
  • Frequent blood in the stools 
  • Frequent urgency 
  • Presence of ulcers 
  • Abnormal lab values (e.g., hemoglobin, ESR, CRP) 
  • Dependent on, or refractory to, corticosteroids; AND 
• Trial and failure, contraindication, or intolerance to ONE of the following conventional therapies: 
  • 6-mercaptopurine (Purinethol)
  • aminosalicylates (e.g., mesalamine [Asacol, Pentasa, Rowasa], olsalazine [Dipentum], sulfasalazine [Azulfidine, Sulfazine])
  • azathioprine (Imuran)
  • corticosteroids (e.g., budesonide, prednisone, methylprednisolone); AND
• One of the following:
  • Trial and failure, contraindication, or intolerance to TWO of the following, or attestation demonstrating a trial may be inappropriate*: 
    • Humira (adalimumab), Amjevita, Cyltezo, Hyrimoz (Sandoz manufacturer), or Brand Adalimumab-adaz
    • Simponi (golimumab)
    • Skyrizi (risankizumab-rzaa) 
    • Stelara (ustekinumab)
    • Rinvoq (upadacitinib)
    • Xeljanz/XR (tofacitinib/ER)
  • For continuation of prior therapy, defined as no more than a 45-day gap in therapy.

* Includes attestation that the patient has failed to respond to the TNF inhibitor mechanism of action in the past and should not be made to try a second TNF inhibitor. In this case, only a single step through a preferred agent is required.

Reauthorization Criteria:

For diagnosis of MS:

• Patient demonstrates positive clinical response to therapy (e.g., stability in radiologic disease activity, clinical relapses, disease progression) AND
• Not used in combination with another disease-modifying therapy for MS; AND
• Prescribed by or in consultation with a neurologist.

For diagnosis of UC:

• Patient demonstrates a positive clinical response to therapy as evidenced by at least one of the following:
  • Improvement in intestinal inflammation (e.g., mucosal healing, improvement of lab values [platelet counts, erythrocyte sedimentation rate, C-reactive protein level]) from baseline 
  • Reversal of high fecal output state.

Dosing:

For diagnosis MS, UC:

• Recommended adult maintenance dose:  0.92mg once daily
• Dose Titration Regimen: 

Coverage Duration:

For diagnosis MS:

• Initial: 1 year
• Reauthorization: 1 year

For diagnosis UC:

• Initial: 6 months
• Reauthorization: 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• Co-administration of Zeposia with monoamine oxidase (MAO) inhibitors (e.g., selegiline, phenelzine, linezolid) is contraindicated, and co-administration with strong CYP2C8 inducers (e.g., rifampin) should be avoided. 
• Zeposia is contraindicated in patients who have experienced a myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III or IV heart failure in the last 6 months; have the presence of Mobitz type II second-degree or third degree atrioventricular (AV) block, sick sinus syndrome, or sino-atrial block, unless the patient has a functioning pacemaker; have severe untreated sleep apnea; are taking a MAO inhibitor.

Policy Changes:

• 11/17/2020 – Class review, new policy
• 05/17/2022 – Modified coverage criteria for MS to include dosing and patient age.  Added reauthorization criteria for MS. Criteria/reauthorization criteria added for ulcerative colitis.
• 01/01/2023 – Add symptom requirements for UC; update formatting. (P&T 11/15/2022)
• 09/01/2023 – Addition of Amjevita, Cyltezo, Hyrimoz, and brand Adalimumab-adaz as preferred options for UC (P&T 08/15/2023).
• 11/14/2023 – Update Hyrimoz preferred agent to Sandoz manufacturer only.
• 6/1/2024 (policy effective date)- RRT MS update, added Kesimpta as ST option (P&T 5/20/2024) (P&T Meeting May)
• 10/01/2024 – Addition of Skyrizi as an additional trial option for UC indication.

References:

1. Rae-Grant A, Day GS, Marrie RA, et al. Practice guideline: Disease-modifying therapies for adults with multiple sclerosis. Neurology 2018;90:777-788. 
2. National Multiple Sclerosis Society. Types of MS. Available at: https://www.nationalmssociety.org/What-is-MS/Types-of-MS. Accessed March 29, 2019. 
3. Zeposia Prescribing Information. Celgene Corporation. Summit, NJ. June 2023. 
4. Per clinical consultation with gastroenterologist, July 9, 2021. 
5. Rubin DT, Ananthakrishnan AN, Siegel CA, et al. ACG clinical guideline: ulcerative colitis in adults. Am J Gastroenterol. 2019;114:384-413. 
6. Feuerstein JD, Isaacs KL, Schneider Y, et al. AGA clinical practice guidelines on the management of moderate to severe ulcerative colitis. Gastroenterol. 2020;158:1450-1461.