Effective Date

Date of Origin 

01-01-2026            

Zeposia®

(ozanimod)

Capsule

Treatment of relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults

Moderately to severely active ulcerative colitis (UC) in adults

1

Multiple sclerosis

Multiple sclerosis (MS) is a disorder of the central nervous system (CNS) characterized by demyelination, inflammation, and degenerative changes. Most people with MS experience relapses and remissions of neurological symptoms, particularly early in the disease, and clinical events are usually associated with areas of CNS inflammation. Gradual worsening or progression, with or without subsequent acute attacks of inflammation or radiological activity, may take place early, but usually becomes more prominent over time. While traditionally viewed as a disease solely of CNS white matter, more advanced imaging techniques have demonstrated significant early and ongoing CNS gray matter damage as well.(2)

Those diagnosed with MS may have many fluctuating and disabling symptoms (including, but not limited to, fatigue, pain, bladder and bowel issues, sexual dysfunction, movement and coordination problems, visual disturbances, and cognition and emotional changes.(18) There are currently four major types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), primary progressive MS (PPMS), and secondary progressive MS (SPMS).(9)

Relapsing remitting multiple sclerosis

RRMS is characterized by clearly defined attacks (relapses) of new or increasing neurologic symptoms. These relapses are followed by periods of partial or complete recovery. There is no or minimal disease progression during the periods between disease relapses, though individual relapses may result in severe residual disability. The course of MS varies, however, about 85-90% of individuals with MS demonstrate a relapsing pattern at onset, which transitions over time in the majority of untreated patients to a pattern of progressive worsening with few or no relapses or MRI activity.(9)

Secondary progressive multiple sclerosis

SPMS begins as RRMS, but over time the disease enters a stage of steady deterioration in function, unrelated to acute attacks. Most people with RRMS will transition to SPMS. In SPMS there is no progressive worsening of symptoms over time with no definite periods of remission.(9)

2017 McDonald Criteria for the diagnosis of Multiple Sclerosis:

Diagnostic criteria for multiple sclerosis combining clinical, imaging, and laboratory evidence have evolved over time. The increasing incorporation of paraclinical assessments, especially imaging, to supplement clinical findings has allowed earlier, more sensitive, and more specific diagnosis.(7,8)

The diagnosis of MS requires elimination of more likely diagnoses and demonstration of dissemination of lesions in the CNS in space and time.(7)

Misdiagnosis of multiple sclerosis remains an issue in clinical practice, and several factors that potentially increase this risk have been identified. Multiple sclerosis has heterogeneous clinical and imaging manifestations, which differ between patients over time. There is no single pathognomonic clinical feature or diagnostic test; diagnosis of multiple sclerosis relies on the integration of clinical, imaging, and laboratory findings. MRI abnormalities associated with other diseases and non-specific MRI findings, which are common in the general population, can be mistaken for multiple sclerosis. The increasingly strong focus on timely diagnosis to alleviate uncertainty for patients and allow initiation of disease-modifying therapies might also increase the risk of misdiagnosis.(7)

With increasing availability and use of MRI, incidental T2 hyperintensities on brain imaging are common, the subset of individuals with MRI findings that are strongly suggestive of multiple sclerosis lesions but with no neurological manifestations or other clear-cut explanation are said to have radiologically isolated syndrome. There is no consensus on whether patients with radiologically isolated syndrome will develop MS. Some practitioners argue that these patients have a high likelihood of developing MS while others argue that up to two-thirds of these patients will not receive a diagnosis of MS in 5 years.  A consensus panel decided to require clinical manifestations to make the diagnosis of MS (2017 McDonald Criteria for the diagnosis of Multiple Sclerosis).(7)

The 2017 McDonald criteria to diagnose MS is shown in the chart below.(7,8)

* - Dissemination in space is defined as one or more T2-hyperintense lesions that are characteristic of multiple sclerosis in 2 or more of four areas of the CNS (periventricular, cortical or juxtacortical, and infratentorial brain regions, and the spinal cord) demonstrated by an additional clinical attack implicating a different CNS site or by MRI.(8)

** - Dissemination in time is defined as simultaneous presence of gadolinium-enhancing and non-enhancing lesions at any time or by a new T2-hyperintense or gadolinium-enhancing lesion on follow-up MRI, with reference to a baseline scan, irrespective of the timing of the baseline MRI. The presence of CSF-specific oligoclonal bands does not demonstrate dissemination in time per se but can substitute for the requirement for demonstration of this measure.(8)

Treatment of MS

Both the Multiple Sclerosis Coalition and the American Academy of Neurology recommend initiating treatment with a DMA FDA approved for the patient’s phenotype as soon as possible following the diagnosis of multiple sclerosis. There are several DMAs with at least 10 mechanisms of action available to people with MS. The factors affecting choice of therapy at any point in the disease course are complex and most appropriately analyzed and addressed through a shared decision-making process between the individual and the treating clinician.(2,5)

There is a subgroup of RRMS patients who have a more aggressive disease course marked by a rapid accumulation of physical and cognitive deficit, despite treatment with 1 or more DMTs. In the past, this disease phenotype was called aggressive MS; it is now called highly active MS. It is generally agreed that the severe nature of this phenotype requires different treatment decisions. There is no consensus on the definition of highly active MS or the treatment algorithm. The National Institute for Health and Care Excellence (NICE) defines rapidly evolving severe RRMS as two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared with a previous MRI.(4)

The Multiple Sclerosis Coalition recommends that clinicians should consider prescribing a high efficacy medication such as alemtuzumab, cladribine, fingolimod, natalizumab or ocrelizumab for newly diagnosed individuals with highly active MS. Clinicians should also consider prescribing a high efficacy medication for individuals who have breakthrough activity on another DMA regardless of the number of previously used agents.(2) The American Academy of Neurology has recommended alemtuzumab, fingolimod, and natalizumab as options for patients with MS with highly active MS. There lacks a consensus for what constitutes as highly active MS, however.(5) The National Institute for Health and Care Excellence (NICE) defines rapidly evolving severe RRMS as two or more disabling relapses in 1 year, and one or more gadolinium-enhancing lesions on brain MRI or a significant increase in T2 lesion load compared with a previous MRI.(19)

Lack of response to DMAs is hard to define, as most patients with MS are not free of all disease activity. Relapses or new MRI detected lesions may develop after initiation of a DMA and before the treatment becomes effective for patients. When determining efficacy, sufficient time for the DMA therapy to take full effect and patient adherence are important considerations. Evidence of one or more relapses, 2 or more unequivocally new MRI-detected lesions, or increased disability on examination while being treated with a DMA for a 1 year period suggests a sub-optimal response, an alternative regimen (e.g., different mechanism of action) should be considered to optimize therapeutic benefit.(5) A National MS Society consensus statement recommends changing from one disease modifying therapy to another only for medically appropriate reasons (e.g. lack of efficacy, adverse effects, or if better treatments options become available).(2)

Existing MS therapies are partly effective in halting ongoing inflammatory tissue damage and clinical progression. MS pathogenesis is complex and probably heterogeneous among patients, suggesting that combination therapy strategies that target a range of disease mechanisms might be more effective than medications used as monotherapy. Although preliminary studies have provided favorable results, however, several subsequent large, randomized, controlled trials have had negative or conflicting results. There also may be more adverse reactions associated with combination therapies due to the additive effect.(10)

In 2020 a Canadian MS working group published recommendations on optimal therapy in relapsing forms of MS. This group notes that there are few studies that have directly compared injectable and oral DMTs. A recent network meta-analysis suggested that pegylated interferon-β-1a and dimethyl fumarate have superior efficacy to other base therapies, however there is insufficient data to demonstrate that one base injectable or oral DMT is superior to another. As a result, the choice of initial treatment will need to be individualized according to disease activity, severity, and comorbidities.(11)

In addition to base therapies, the working group considers 5 DMTs to be of higher efficacy which although can be used as initial therapy, they are generally reserved for patients with a poor response or tolerability with a base therapy. Patients presenting with high disease activity or aggressive/rapidly evolving MS at onset could be considered to initiate therapy with one of these more effective therapies, but the most common treatment initiation is to start on a base therapy with the view of switching within 6-12 months. The 5 agents considered to be of higher efficacy are:(11)

• Oral agents
  • Fingolimod
  • Cladribine
• Monoclonal antibodies
  • Natalizumab
  • Ocrelizumab
  • Alemtuzumab

The MS working group discussed the criteria for switching therapies in RRMS and recommends a change in DMT is indicated for patients who meet any of the Major criteria below:(11)

The workgroup does note that on-treatment relapses should only be performed once the drug has achieved a full clinical effect (typically 2-6 months after drug initiation). Relapses that occur before the maximal efficacy of the drug has been reached should be given less weight, but major criteria should take precedence regardless of timing.(11)

For patients with SPMS, the workgroup states that is generally advised to continue with the current DMT after onset of SPMS since many patients will have ongoing inflammatory disease and subclinical disease activity may worsen if treatment is withdrawn. A change in treatment may be warranted in patients with active SPMS who continue to have relapses or new MRI lesions, with the caveat that there is insufficient evidence to identify criteria for a suboptimal response in patients with SPMS.(11)

For patients with primary progressive MS, clinicians should offer ocrelizumab to patients with active disease provided the benefits outweigh the risks. Caution is recommended when considering treatment for PPMS subgroups that are less likely to benefit from treatment, such as older patients, those with long-standing stable disease, and/or significant neurological deficits, since the limited benefits may not justify the risk associated with treatment. Rituximab may be considered as an alternative therapy for PPMS in regions that permit off-label use in MS due to cost or other considerations.(11)

The Institute for Clinical and Economic Review (ICER) evaluated a new IV treatment, ublituximab against current FDA and accepted use DMT for adults with RRMS. Only in the case of ublituximab vs placebo/no DMT is ublituximab superior rated. The ratings are noted below.(3)

Adults with RRMS

A: Superior - High certainty of a substantial (moderate-large) net health benefit
B: Incremental -  High certainty of a small net health benefit
C++: Comparable or better - Moderate certainty of a comparable, small, or substantial net health benefit, with which certainty of at least a comparable net health benefit
I: Insufficient - Any situation where the level of certainty in the evidence is low

ICER does note that payers should consider the following:(3)

Payors should remove barriers to access to rituximab for RMS patients who are appropriate candidates for this therapy. This includes coverage of biosimilar rituximab with little or no prior authorization given the lack of concern regarding use in appropriate patients and how inexpensive it is compared with other monoclonal antibodies of equal effectiveness

Payers should not unilaterally implement policies to switch RMS patients who are stable on their chosen DMT over to lower-cost biosimilar rituximab

Ulcerative Colitis (UC)

Ulcerative colitis (UC) is a chronic inflammatory bowel disease affecting the large intestine. It typically starts with inflammation of the rectum, but often extends proximally to involve additional areas of the colon. The most common symptom is bloody diarrhea, but urgency, tenesmus, abdominal pain, malaise, weight loss, and fever can also be associated. UC commonly has a gradual onset and will present with periods of spontaneous remission and subsequent relapses.(17)

Disease severity is based on patient-reported outcomes (e.g., bleeding, bowel habits, bowel urgency), inflammatory burden (e.g., endoscopic assessment, inflammatory markers), disease course, and disease impact. Commonly assessed symptoms include frequency and timing of bowel movements, rectal bleeding, bowel urgency, abdominal pain, bowel cramping, and weight loss. Poor prognostic factors include less than 40 years of age at diagnosis, extensive colitis, severe endoscopic disease, hospitalization for colitis, elevated C-reactive protein (CRP), and low serum albumin. Therapeutic management in UC should be guided by the extent of bowel involvement, assessment of disease activity (i.e., quiescent, mild, moderate, or severe), and disease prognosis. Treatment response should be evaluated 12 weeks after initiation of therapy to confirm its efficacy and safety.(14)

The American College of Gastroenterology (ACG) published recommendations and guidance (2025) for the management of moderate-to-severe UC:(14)

• General treatment information:
  • Patients with mildly to moderately active UC and a number of prognostic factors associated with an increased risk of hospitalization or surgery should be treated with therapies for moderate-to-severe disease
  • Patients with mildly to moderately active UC who are not responsive (or are intolerant) to 5-ASA therapies should be treated as patients with moderate-to-severe disease
• Corticosteroid therapy:
  • In patients with moderately active UC, recommend oral budesonide MMX for induction of remission
    • In patients with moderately active UC, consider nonsystemic corticosteroids such as budesonide MMX before the use of systemic therapy
  • Recommend oral systemic corticosteroids to induce remission in UC of any extent
    • In patients with severely active UC, consider systemic corticosteroids rather than topical corticosteroids
  • Recommend against systemic, budesonide MMX, or topical corticosteroids for maintenance of remission
• Disease modifying antirheumatic drug (DMARD) therapy:
  • Recommend against monotherapy with thiopurines or methotrexate for induction of remission
  • 5-ASA therapy could be used as monotherapy for induction of moderately but not severely active UC
  • 5-ASA therapy for maintenance of remission is likely not as effective in prior severely active UC as compared with prior moderately active UC
  • Suggest thiopurines for maintenance of remission in patients now in remission due to corticosteroid induction
  • Suggest against using methotrexate for maintenance of remission
• Biologic/advanced therapy:
  • Recommend the following drugs for induction of remission and continuing the same drug for maintenance of remission:
    • Anti-tumor necrosis factor (TNF) agents (e.g., infliximab, adalimumab, golimumab), ustekinumab, guselkumab, mirikizumab, risankizumab, vedolizumab, tofacitinib, upadacitinib, sphingosine-1-phosphate (S1P) receptor modulators (e.g., ozanimod, etrasimod)
    • Most clinical trials and available data demonstrate a benefit of using the steroid-sparing therapy that induces remission to maintain that remission
  • When infliximab is used as induction therapy, recommend combination therapy with a thiopurine
    • Data on combination anti-TNF and immunomodulators in moderately to severely active UC only exist for infliximab and thiopurines
  • Infliximab is the preferred anti-TNF therapy for patients with moderately to severely active UC
  • Recommend vedolizumab as compared to adalimumab for induction and maintenance of remission
  • Patients who are primary nonresponders to an anti-TNF (defined as lack of therapeutic benefit after induction and despite sufficient serum drug concentrations) should be evaluated and considered for alternative mechanisms of disease control (e.g., in a different class of therapy) rather than cycling to another drug within the anti-TNF class
  • Biosimilars to anti-TNF therapies and to ustekinumab are acceptable substitutes for originator therapies. Delays in switching should not occur and patients and clinicians should be notified about such changes

The American Gastroenterology Association (AGA) published recommendations and guidance (2018) for the management of mild-to-moderate UC:(15)

• In patients with moderate disease activity, suggest using high dose mesalamine (greater than 3 g/day) with rectal mesalamine for induction of remission and maintenance of remission
• Add either oral prednisone or budesonide MMX in patients that are refractory to optimized oral and rectal 5-ASA, regardless of disease extent
• If progression to moderate-to-severe disease activity occurs, or if the patient is at high risk for colectomy despite therapy, consider escalating to treatment for moderate-to-severe disease with immunomodulators and/or biologics

The American Gastroenterology Association (AGA) published recommendations and guidance (2024) for the management of moderate-to-severe UC:(16) 

• General treatment information:
  • Suggest early use of advanced therapy (e.g., biologics, ozanimod, etrasimod), with or without immunomodulator therapy (e.g., thiopurines), rather than treatment with 5-ASA and a gradual step up to biologic/immunomodulator therapy after 5-ASA treatment failure (conditional recommendation, very low certainty of evidence)
    • Patients with less severe disease or those who place a higher value on the safety of 5-ASA therapy over the efficacy of immunosuppressives may reasonably choose gradual step therapy with 5-ASA therapy
• Disease modifying antirheumatic drug (DMARD) therapy:
  • Suggest against using thiopurine monotherapy for inducing remission
  • Suggest thiopurine monotherapy may be used for maintaining remission typically induced with corticosteroids
  • Suggest against using methotrexate monotherapy for inducing or maintaining remission 
• Advanced therapy:
  • Recommend using one of the following advanced therapies over no treatment:
    • Infliximab, golimumab, vedolizumab, tofacitinib, upadacitinib, ustekinumab, ozanimod, etrasimod, risankizumab, guselkumab
  • Suggest using one of the following advanced therapies over no treatment:
    • Adalimumab, filgotinib*, mirikizumab (*not currently approved by the Food and Drug Administration)
  • Biosimilars of infliximab, adalimumab, and ustekinumab can be considered equivalent to their originator drug in their efficacy
  • Suggest the use of infliximab in combination with an immunomodulator over infliximab or an immunomodulator alone
  • Suggest the use of adalimumab or golimumab in combination with an immunomodulator over adalimumab, golimumab or immunomodulator monotherapy
• Advanced therapy-naïve patients (first-line therapy):
  • Suggest that a higher or intermediate efficacy medication be used rather than a lower efficacy medication
    • Higher efficacy: infliximab, vedolizumab, ozanimod, etrasimod, upadacitinib, risankizumab, guselkumab
    • Intermediate efficacy: golimumab, ustekinumab, tofacitinib, filgotinib, mirikizumab
    • Lower efficacy: adalimumab
• Prior exposure to one or more advanced therapies, particularly TNF antagonists:
  • Suggest that a higher or intermediate efficacy medication be used rather than a lower efficacy medication
    • Higher efficacy: tofacitinib, upadacitinib, ustekinumab
    • Intermediate efficacy: filgotinib, mirikizumab, risankizumab, guselkumab
    • Lower efficacy: adalimumab, vedolizumab, ozanimod, etrasimod

Safety

Zeposia (ozanimod) is contraindicated in:(1)

• In patients who in, the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, or Class III or IV heart failure
• 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
• Severe untreated sleep apnea
• Concomitant use with a monoamine oxidase inhibitor

1

Zeposia prescribing information. Celgene Corporation. August 2024.

2

National Institute for Health and Care Excellence (NICE) Guideline. Multiple Sclerosis in Adults: Management (NG220). Published: 22 June 2022. Available at: https://www.nice.org.uk/guidance/ng220

3

McKenna A, Lin GA, Whittington MD, et al. Oral and Monoclonal Antibody Treatments for Relapsing Forms of Multiple Sclerosis: Effectiveness and Value. A Summary from the Institute for Clinical and Economic Review's (ICER) New England Comparative Effectiveness Public Advisory Council. J Manag Care Spec Pharm. 2023 Jul;29(7):10.18553.

4

Rae-Grant A, Day GS, Marrie RA, et al. Practice Guideline Recommendations Summary: Disease-Modifying Therapies for Adults with Multiple Sclerosis. Neurology. 2018 Apr;90(17):777-788.

5

Corboy JR, Weinshenker BG, Wingerchuk DM. Comment on 2018 American Academy of Neurology Guidelines on Disease-Modifying Therapies in MS. Neurol. 2018 Apr;90(24):1106-1112.

6

Reference no longer used.

7

Thompson AJ, Banwell BL, Barkhof F, et al. Diagnosis of Multiple Sclerosis: 2017 Revisions of the McDonald Criteria. Lancet Neurol. 2018 Feb;17(2):162-173.

8

National Multiple Sclerosis Society 2017 McDonald MS Diagnostic Criteria. Available at: https://www.nationalmssociety.org/for-professionals/for-healthcare-professionals/diagnosing-ms/diagnostic-criteria-workup

9

MS International Federation. Types of MS. Last updated: 12th March 2022. Available at: https://www.msif.org/about-ms/types-of-ms/

10

Conway D, Cohen JA. Combination Therapy in Multiple Sclerosis. Lancet Neurol. 2010 Mar;9(3):299-308.

11

Freedman MS, Devonshire V, Duquette P, et al. Treatment Optimization in Multiple Sclerosis: Canadian MS Working Group Recommendations. Can J Neurol Sci. 2020 Jul;47(4):437-455.

12

Reference no longer used.

13

Reference no longer used.

14

Rubin DT, Ananthakrishnan AN, Siegel CA, Barnes EL, Long MD. American College of Gastroenterology (ACG) clinical guideline update: Ulcerative colitis in adults. Am J Gastroenterol. 2025;120(6):1187-1224. doi: 10.14309/ajg.0000000000003463

15

Ko CW, Singh S, Feuerstein JD, et al. American Gastroenterological Association (AGA) clinical practice guidelines on the management of mild-to-moderate ulcerative colitis. Gastroenterol. 2018;156(3):748-764. doi: 10.1053/j.gastro.2018.12.009

16

Singh S, Loftus EV, Limketkai BN, et al. American Gastroenterological Association (AGA) living clinical practice guideline on pharmacological management of moderate-to-severe ulcerative colitis. Gastroenterol. 2024;167(7):1307-1343. doi: 10.1053/j.gastro.2024.10.001

17

Lynch WD, Hsu R. Ulcerative colitis. Last updated June 2023. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available at https://www.ncbi.nlm.nih.gov/books/NBK459282/

18

MS International Federation. Symptoms. Last updated: 25th October 2021. Available at: https://www.msif.org/about-ms/symptoms-of-ms/

19

National Institute for Health and Care Excellence (NICE). Ofatumumab for Treating Relapsing Multiple Sclerosis: Technology Appraisal Guidance (TA699). 2021 May. Available at: https://www.nice.org.uk/guidance/ta699

Zeposia ; Zeposia 7-day starter pac ; Zeposia starter kit

ozanimod cap pack  ; ozanimod hcl cap

0.23MG &0.46MG 0.92MG(21) ; 0.92 MG ; 4 x 0.23MG & 3 x 0.46MG

M ; N ; O ; Y

N

37

Capsules

180

DAYS

Zeposia

ozanimod hcl cap

0.92 MG

30

Capsules

30

DAYS

Zeposia 7-day starter pac

Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG

4 x 0.23MG & 3 x 0.46MG

1

Pack

180

DAYS

Zeposia starter kit

ozanimod cap pack

0.23MG &0.46MG 0.92MG(21)

28

Capsules

180

DAYS

Zeposia ; Zeposia 7-day starter pac ; Zeposia starter kit

ozanimod cap pack  ; ozanimod hcl cap

0.23MG &0.46MG 0.92MG(21) ; 0.92 MG ; 4 x 0.23MG & 3 x 0.46MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zeposia

ozanimod hcl cap

0.92 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zeposia 7-day starter pac

Ozanimod Cap Pack 4 x 0.23 MG & 3 x 0.46 MG

4 x 0.23MG & 3 x 0.46MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zeposia starter kit

ozanimod cap pack

0.23MG &0.46MG 0.92MG(21)

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx ; SourceRx-Performance

Zeposia PA with MS Step

Immunomodulatory Agent Step Table

* A trial of either or both Xeljanz products (Xeljanz and Xeljanz XR) collectively counts as ONE product
** Allowable preferred adalimumab product(s): Adalimumab-aaty, Adalimumab-adaz, Hadlima, Simlandi
*** Allowable preferred adalimumab product(s): Adalimumab-aaty, Adalimumab-adaz, Hadlima, Humira, Simlandi
^^ Allowable preferred ustekinumab product(s): Selarsdi, Stelara, Steqeyma, Yesintek

Initial Evaluation

Target Agent(s) will be approved when ONE of the following is met:

1. The requested agent is eligible for continuation of therapy AND ONE of following:

1. 1. The patient has been treated with the requested agent within the past 90 days OR
   2. 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
2. BOTH of the following:
   1. The patient has a diagnosis of multiple sclerosis (MS) AND
   2. The patient will NOT be using the requested agent in combination with another MS disease modifying agent (DMA) (Please refer to "MS Disease Modifying Agents" list in the"Contraindicated for Concomitant Therapy" table) OR  
3. The patient has a diagnosis of moderately to severely active ulcerative colitis (UC) AND ALL of the following:
   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, sulfasalazine) used in the treatment of UC for at least 3-months 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 OR
      4. The patient has an FDA labeled contraindication to ALL of the conventional agents used in the treatment of UC OR
      5. The patient’s medication history indicates use of a biologic immunomodulator agent that is FDA labeled or supported in compendia for the treatment of UC AND
   2. ONE of the following:
      1. The patient has tried and had an inadequate response to TWO Step 1 immunomodulatory agents (see Immunomodulatory Agent Step table) OR
      2. The patient has an intolerance (defined as an intolerance to the drug or its excipients, not to the route of administration) or hypersensitivity to at least TWO Step 1 immunomodulatory agents OR
      3. The patient has an FDA labeled contraindication to ALL Step 1 immunomodulatory agents AND
   3. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; please refer to "Immunomodulatory Agents NOT to be used Concomitantly" list in the "Contraindicated as Concomitant Therapy" table) AND
   4. If the patient has an FDA labeled indication, then ONE of the following:
      1. The patient’s age is within FDA labeling for the requested indication for the requested agent OR
      2. There is support for using the requested agent for the patient’s age for the requested indication AND   
   5. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
   6. The patient does NOT have any FDA labeled contraindications to the requested agent

Compendia Allowed: AHFS, or DrugDex 1 or 2a level of evidence

Length of Approval: 12 months. NOTE: The starter dose can be approved for the FDA labeled starting dose and the maintenance dose can be approved for the remainder of 12 months

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Renewal Evaluation

Target Agent(s) will be approved when BOTH of the following are met:

1. The patient has been previously approved for the requested agent through the plan’s Prior Authorization process [Note: patients not previously approved for the requested agent will require initial evaluation review] AND
2. ONE of the following:
   1. BOTH of the following:
      1. The patient has a diagnosis of multiple sclerosis (MS) AND 
      2. The patient will not be using the requested agent in combination with another MS disease modifying agent (DMA) (Please refer to "MS Disease Modifying Agents" list in the"Contraindicated for Concomitant Therapy" table) OR
   2. The patient has a diagnosis of ulcerative colitis AND ALL of the following:
      1. The patient has had clinical benefit with the requested agent AND
      2. The prescriber is a specialist in the area of the patient’s diagnosis (e.g., gastroenterologist) or the prescriber has consulted with a specialist in the area of the patient’s diagnosis AND
      3. The patient does NOT have any FDA labeled contraindications to the requested agent AND
      4. The patient will NOT be using the requested agent in combination with another immunomodulatory agent (e.g., TNF inhibitors, JAK inhibitors, IL-4 inhibitors; please refer to "Immunomodulatory Agents NOT to be used Concomitantly" list in the "Contraindicated as Concomitant Therapy" table)

Length of Approval: 12 months 

NOTE: If Quantity Limit applies, please refer to Quantity Limit Criteria.

Quantity limit for the Target Agent(s) will be approved when ONE of the following is met:

1. The requested quantity (dose) does NOT exceed the program quantity limit OR
2. The requested quantity (dose) exceeds the program quantity limit AND ONE of the following:
   1. BOTH of the following:
      1. The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication OR
   2. BOTH of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND
      2. There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR
   3. BOTH of the following:
      1. The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND
      2. There is support for therapy with a higher dose for the requested indication

Length of Approval: up to 12 months

Class Ia antiarrhythmics

Class Ia antiarrhythmics

NORPACE*Disopyramide Phosphate Cap

Class Ia antiarrhythmics

PROCAINAMIDE*Procainamide HCl Inj

Class Ia antiarrhythmics

QUINIDINE*Quinidine

Class III antiarrhythmics

Class III antiarrhythmics

BETAPACE*Sotalol HCl Tab

Class III antiarrhythmics

Cordarone, Pacerone (amiodarone)

Class III antiarrhythmics

CORVERT*Ibutilide Fumarate Inj

Class III antiarrhythmics

MULTAQ*Dronedarone HCl Tab

Class III antiarrhythmics

TIKOSYN*Dofetilide Cap

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

MS Disease Modifying Agents drug class: CD20 monoclonal antibody

BRIUMVI*ublituximab-xiiy soln for iv infusion

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

KESIMPTA*Ofatumumab Soln Auto-Injector

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

OCREVUS*Ocrelizumab Soln For IV Infusion

MS Disease Modifying Agents drug classes: CD20 monoclonal antibody

OCREVUS*ZUNOVO*ocrelizumab-hyaluronidase-ocsq inj

MS Disease Modifying Agents drug classes: CD52 monoclonal antibody

MS Disease Modifying Agents drug classes: CD52 monoclonal antibody

LEMTRADA*Alemtuzumab IV Inj

MS Disease Modifying Agents drug classes: Fumarates

MS Disease Modifying Agents drug classes: Fumarates

BAFIERTAM*Monomethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Fumarates

TECFIDERA*Dimethyl Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Fumarates

VUMERITY*Diroximel Fumarate Capsule Delayed Release

MS Disease Modifying Agents drug classes: Glatiramer

MS Disease Modifying Agents drug classes: Glatiramer

COPAXONE*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug classes: Glatiramer

GLATOPA*Glatiramer Acetate Soln Prefilled Syringe

MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody

MS Disease Modifying Agents drug classes: IgG4k monoclonal antibody

TYSABRI*Natalizumab for IV Inj Conc

MS Disease Modifying Agents drug classes: Interferons

MS Disease Modifying Agents drug classes: Interferons

AVONEX*Interferon beta-1a injection

MS Disease Modifying Agents drug classes: Interferons

BETASERON*Interferon beta-1b injection

MS Disease Modifying Agents drug classes: Interferons

EXTAVIA*Interferon beta-1b injection

MS Disease Modifying Agents drug classes: Interferons

PLEGRIDY*Peginterferon beta-1a injection

MS Disease Modifying Agents drug classes: Interferons

REBIF*Interferon beta-1a injection

MS Disease Modifying Agents drug classes: Purine antimetabolite

MS Disease Modifying Agents drug classes: Purine antimetabolite

MAVENCLAD*Cladribine Tab Therapy Pack

MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor

MS Disease Modifying Agents drug classes: Pyrimidine synthesis inhibitor

AUBAGIO*Teriflunomide Tab

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

GILENYA*Fingolimod HCl Cap

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

MAYZENT*Siponimod Fumarate Tab

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

PONVORY*Ponesimod Tab

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

TASCENSO*fingolimod lauryl sulfate tablet disintegrating

MS Disease Modifying Agents drug classes: Sphingosine 1-phosphate (SIP) receptor modulator

ZEPOSIA*Ozanimod capsule

MS Disease Modifying Agents (DMAs)

Aubagio (teriflunomide)

Avonex (interferon b-1a)

Bafiertam (monomethyl fumarate)

Betaseron (interferon b-1b)

Briumvi (ublituximab-xiiy)

Copaxone (glatiramer)

dimethyl fumarate

Extavia (interferon b-1b)

fingolimod

Gilenya (fingolimod)

glatiramer

Glatopa (glatiramer)

Kesimpta (ofatumumab)

Lemtrada (alemtuzumab)

Mavenclad (cladribine)

Mayzent (siponimod)

Ocrevus (ocrelizumab)

Ocrevus Zunovo (ocrelizumab-hyaluronidase)

Plegridy (peginterferon b-1a)

Ponvory (ponesimod)

Rebif (interferon b-1a)

Tascenso ODT (fingolimod)

Tecfidera (dimethyl fumarate)

teriflunomide

Tysabri (natalizumab

Vumerity (diroximel fumarate)

Zeposia (ozanimod)

Immunomodulatory Agents NOT to be used Concomitantly

Abrilada (adalimumab-afzb)

Actemra (tocilizumab)

Adalimumab

Adbry (tralokinumab-ldrm)

Amjevita (adalimumab-atto)

Arcalyst (rilonacept)

Avsola (infliximab-axxq)

Avtozma (tocilizumab-anoh)

Benlysta (belimumab)

Bimzelx (bimekizumab-bkzx)

Cibinqo (abrocitinib)

Cimzia (certolizumab)

Cinqair (reslizumab)

Cosentyx (secukinumab)

Cyltezo (adalimumab-adbm)

Dupixent (dupilumab)

Ebglyss (lebrikizumab-lbkz)

Enbrel (etanercept)

Entyvio (vedolizumab)

Fasenra (benralizumab)

Hadlima (adalimumab-bwwd)

Hulio (adalimumab-fkjp)

Humira (adalimumab)

Hyrimoz (adalimumab-adaz)

Idacio (adalimumab-aacf)

Ilaris (canakinumab)

Ilumya (tildrakizumab-asmn)

Imuldosa (ustekinumab-srlf)

Inflectra (infliximab-dyyb)

Infliximab

Kevzara (sarilumab)

Kineret (anakinra)

Leqselvi (deuruxolitinib)

Litfulo (ritlecitinib)

Nemluvio (nemolizumab-ilto)

Nucala (mepolizumab)

Olumiant (baricitinib)

Omlyclo (omalizumab-igec)

Omvoh (mirikizumab-mrkz)

Opzelura (ruxolitinib)

Orencia (abatacept)

Otezla (apremilast)

Otulfi (ustekinumab-aauz)

Pyzchiva (ustekinumab-ttwe)

Remicade (infliximab)

Renflexis (infliximab-abda)

Riabni (rituximab-arrx)

Rinvoq (upadacitinib)

Rituxan (rituximab)

Rituxan Hycela (rituximab/hyaluronidase human)

Ruxience (rituximab-pvvr)

Saphnelo (anifrolumab-fnia)

Selarsdi (ustekinumab-aekn)

Siliq (brodalumab)

Simlandi (adalimumab-ryvk)

Simponi (golimumab)

Simponi ARIA (golimumab)

Skyrizi (risankizumab-rzaa)

Sotyktu (deucravacitinib) 

Spevigo (spesolimab-sbzo) subcutaneous injection

Starjemza (ustekinumab-hmny)

Stelara (ustekinumab)

Steqeyma (ustekinumab-stba)

Taltz (ixekizumab)

Tezspire (tezepelumab-ekko)

Tofidence (tocilizumab-bavi)

Tremfya (guselkumab)

Truxima (rituximab-abbs)

Tyenne (tocilizumab-aazg)

Tysabri (natalizumab)

Ustekinumab

Velsipity (etrasimod)

Wezlana (ustekinumab-auub)

Xeljanz (tofacitinib)

Xeljanz XR (tofacitinib extended release)

Xolair (omalizumab)

Yesintek (ustekinumab-kfce)

Yuflyma (adalimumab-aaty)

Yusimry (adalimumab-aqvh)

Zeposia (ozanimod)

Zymfentra (infliximab-dyyb)