CurrentWashington State Health Care AuthorityPolicy 62.40.70.AA-1

Multiple Sclerosis Agents: Ozanimod (Zeposia)

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 62.40.70.AA-1 alerts

Get alerted when Policy 62.40.70.AA-1 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

This policy governs Washington Apple Health fee-for-service prior authorization and medical-necessity review for ozanimod (Zeposia) in adults with qualifying multiple sclerosis or moderate-to-severe ulcerative colitis. It specifies clinical eligibility, preferred-drug trials, reauthorization, and quantity limits.

Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: Ozanimod (Zeposia)

Policy CodePolicy 62.40.70.AA-1

Change TypeAdministrative restructuring

Effective DateJul 1, 2025

Next Review DateN/A

Key ActionSubmit prior authorization documentation showing that two preferred MS Apple Health PDL medications were ineffective, contraindicated, or not tolerated before requesting ozanimod for multiple sclerosis.

SourceLink

POLICY UPDATE CHANGES

The policy was split from policy 66.27.00.AK to create a separate policy for Zeposia.

2Preferred MS PDL medications generally required before initial approval

18+Minimum patient age

6 monthsInitial ulcerative colitis authorization

12 monthsReauthorization duration

OpenPayer is powered by Trek Health's payer performance platform. Trek continuously ingests, validates, and normalizes Transparency in Coverage data alongside payer policies and other commercial payer data to create a structured payer intelligence foundation. OpenPayer uses this foundation to deliver personalized search results, dynamically generated policy pages, and tailored policy monitoring based on each user's payers, specialties, billing codes, and areas of interest. The same intelligence powers broader payer performance workflows, including reimbursement benchmarking, contract evaluation, payer negotiations, and financial decision-making.

CurrentWashington State Health Care AuthorityPolicy 62.40.70.AA-1

Multiple Sclerosis Agents: Ozanimod (Zeposia)

Customize your policy alerts

Sign up for Washington State Health Care Authority Policy 62.40.70.AA-1 alerts

Get alerted when Policy 62.40.70.AA-1 changes without checking for updates manually.

Monitor payer policy activity

Receive email alerts as soon as relevant payer policies are published or updated.

Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: Ozanimod (Zeposia)

Policy CodePolicy 62.40.70.AA-1

Change TypeAdministrative restructuring

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

POLICY UPDATE CHANGES

The policy was split from policy 66.27.00.AK to create a separate policy for Zeposia.

2Preferred MS PDL medications generally required before initial approval

18+Minimum patient age

6 monthsInitial ulcerative colitis authorization

12 monthsReauthorization duration

12 weeksMinimum ulcerative colitis therapy trial

30/30 days0.92 mg capsule quantity limit

Coverage Criteria

Multiple Sclerosis — Initial Therapy

Ozanimod (Zeposia) may be approved when all documented criteria are met.

ALL of the following

Patient is 18 years of age or older.
Prescribed by, or in consultation with a neurologist.
Not used in combination with other disease modifying therapies (DMTs) for multiple sclerosis.
ONE of the following diagnoses
- Relapsing remitting disease (RRMS).
- Active secondary progressive disease (SPMS).
- Clinically isolated syndrome (CIS).
Diagnosis is confirmed and documented by a laboratory report (e.g., MRI).
Documentation of baseline number of relapses per year or expanded disability status scale (EDSS) score.
Treatment with two preferred multiple sclerosis Apple Health Preferred Drug List (PDL) medications has been ineffective, unless all are contraindicated or not tolerated.

Ulcerative Colitis — Initial Therapy

If all criteria are met, the request will be authorized for 6 months.

ALL of the following

Patient is 18 years of age or older.
Prescribed by, or in consultation with a gastroenterologist.
Not used in combination with another Cytokine and CAM medication.
Diagnosis of moderate-to-severe Ulcerative Colitis (UC).
Baseline assessments are included (e.g., stool frequency, endoscopy results, presence of rectal bleeding, disease activity scoring tool).

Multiple Sclerosis — Reauthorization

Ozanimod (Zeposia) may be approved for reauthorization when all documented criteria are met. If all criteria are met, the request will be authorized for 12 months.

ALL of the following

Not used in combination with other disease modifying therapies (DMTs) for multiple sclerosis.
Documentation is submitted demonstrating disease stability or a positive clinical response (e.g., decreased frequency of relapses, delayed progression, stable disease, etc.).

Ulcerative Colitis — Reauthorization

Ozanimod (Zeposia) may be approved for reauthorization when all documented criteria are met.

ALL of the following

Not used in combination with another Cytokine and CAM medication.
Documentation is submitted demonstrating disease stability or a positive clinical response (e.g., decreased stool frequency, decreased rectal bleeding, improvement in endoscopic activity, tapering or discontinuation of corticosteroid therapy, or improvement on a disease activity scoring tool).

Ozanimod (Zeposia) must not be used in combination with other disease modifying therapies (DMTs) for multiple sclerosis or with another Cytokine and CAM medication.

Coding and Clinical Thresholds

Codingmixed

N/A

Active SPMS EDSS score

Minimum EDSS score≥ 3.0

Required disease progressionProgression for ≥ 3 months following an initial relapsing-remitting course

Progression measurementEDSS increase of 1.0 for EDSS ≤5.5, or 0.5 for EDSS ≥6

Active SPMS progression duration

Minimum progression duration≥ 3 months

Required disease courseProgression must follow an initial relapsing-remitting course

Objective progression measure

Provider Actions and Approval Risks

Prior Authorization

Preferred-Drug Requirement

Ozanimod (Zeposia) is subject to prior authorization when it is non-preferred on the current Apple Health Preferred Drug List (AHPDL). New-to-market agents in this class are non-preferred and require documentation of inadequate response or intolerance due to severe adverse reaction or contraindication to preferred agents.

For a non-preferred agent, document an inadequate response or documented intolerance to at least two preferred agents.
If only one preferred agent exists in the class, document an inadequate response to one preferred agent.
Review the current AHPDL at https://www.hca.wa.gov/assets/billers-and-providers/applehealth-preferred-drug-list.xlsx

Denial Risk

Ulcerative Colitis Requirements Not Met

Ozanimod requests for ulcerative colitis require documentation of every indication-specific clinical criterion. Requests that do not meet the age, specialist, medication-use, diagnosis, baseline-assessment, conventional-therapy, or preferred-therapy requirements may be denied.

Policy Background

Ozanimod (Zeposia) is a disease-modifying therapy used for qualifying relapsing forms of multiple sclerosis, including relapsing-remitting disease, active secondary progressive disease, and clinically isolated syndrome, as well as for moderate-to-severe ulcerative colitis. The Washington State Health Care Authority policy establishes prior authorization and medical-necessity requirements for adults, including specialist involvement, objective diagnostic or baseline disease-activity documentation, and required response to prior therapy before coverage is approved or continued.

Clinical Definitions

Relapsing-remitting multiple sclerosis (RRMS)

Disease courseRelapsing-remitting MS is based on dissemination of lesions in space and time

Clinical attacksQualifying evidence may include at least 2 clinical attacks, or 1 clinical attack with additional qualifying findings

Diagnostic findingsMRI evidence of lesions in distinct CNS locations or at different times, and/or CSF-specific oligoclonal bands

Secondary progressive multiple sclerosis (SPMS)

DefinitionA progressive MS course characterized by steadily increasing objectively documented neurologic disability independent of relapses

Course historyFollows an initial relapsing-remitting course

Initial Therapy Criteria

Multiple Sclerosis Initial Therapy

For multiple sclerosis, all documented criteria must be met.

Multiple sclerosis initial therapy

Patient is 18 years of age or older.Age ≥18
Prescribed by, or in consultation with, a neurologist.
Has a qualifying multiple sclerosis diagnosis: relapsing-remitting multiple sclerosis (RRMS), active secondary progressive multiple sclerosis (SPMS), or clinically isolated syndrome (CIS).
The qualifying diagnosis is an OR requirement.
Diagnosis is confirmed and documented by a laboratory report, such as MRI.

Continuation and Reauthorization Criteria

Multiple Sclerosis Continuation

For multiple sclerosis reauthorization, all criteria must be met.

Multiple sclerosis continuation

Not used in combination with other disease-modifying therapies (DMTs) for multiple sclerosis.
Documentation demonstrates disease stability or a positive clinical response, such as decreased frequency of relapses, delayed progression, or stable disease.

Ulcerative Colitis Continuation

For ulcerative colitis reauthorization, all criteria must be met.

Ulcerative colitis continuation

Not used in combination with another Cytokine and CAM medication.

Required Prior Therapy

Step	Required trial	Duration	Outcome or exception
1	Two preferred multiple sclerosis Apple Health Preferred Drug List (PDL) medications	Not specified	Both treatments must have been ineffective, unless contraindicated or not tolerated

Step	Required trial	Duration	Outcome or exception
1	Conventional ulcerative colitis therapy, such as systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine	Minimum 12 weeks	Treatment must have been ineffective, unless contraindicated or not tolerated

Step	Required trial	Duration	Outcome or exception
2	Two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications	Minimum 12 weeks for each agent	Each treatment must have been ineffective, unless contraindicated or not tolerated

Quantity Limits

Zeposia 7-Day Starter Pack

PackageZeposia 7-Day Starter Pack containing 0.23 mg and 0.46 mg capsules

Quantity limit7 capsules

Duration limitPer 7 days

Zeposia Starter Kit with 0.92 mg 30-count bottle

PackageStarter Kit with a 7-day starter pack and a 0.92 mg 30-count bottle

Quantity limit37 capsules

Duration limitPer 37 days

Policy Summary

PayerWashington State Health Care Authority

PolicyMultiple Sclerosis Agents: Ozanimod (Zeposia)

Policy CodePolicy 62.40.70.AA-1

Change TypeAdministrative restructuring

Effective DateJul 1, 2025

Next Review DateN/A

SourceLink

On This Page

Treatment with conventional therapy (e.g., systemic corticosteroids, azathioprine, mesalamine, sulfasalazine) has been ineffective, unless all are contraindicated or not tolerated.

Minimum trial of 12 weeks.

Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications has each been ineffective, unless all are contraindicated or not tolerated.

Minimum trial of 12 weeks.

EDSS increase of 1.0 for EDSS ≤5.5, or 0.5 for EDSS ≥6

Active SPMS relapse activity

Required relapse activity≥ 1 relapse within the previous 2 years

Alternative disease activity evidenceGadolinium-enhancing activity or new or unequivocally enlarging T2 lesions on MRI

Activity requirementAt least one relapse or qualifying MRI activity is required

CIS neurologic symptom duration

Minimum neurologic symptom durationAt least 24 hours, with or without recovery

Clinical episodeMonophasic episode with patient-reported symptoms and objective focal or multifocal inflammatory demyelinating findings in the CNS

ExclusionsNo fever or infection, and the patient is not known to have multiple sclerosis

Ulcerative colitis therapy trials

Conventional therapy trialMinimum 12 weeks; therapy must have been ineffective unless contraindicated or not tolerated

Conventional therapy examplesSystemic corticosteroids, azathioprine, mesalamine, or sulfasalazine

Preferred therapy trialsTwo preferred Cytokine and CAM Apple Health PDL medications, each tried for a minimum of 12 weeks

The patient must be at least 18 years old and prescribed by, or in consultation with, a gastroenterologist.
The diagnosis must be moderate-to-severe ulcerative colitis, and baseline assessments must be submitted.
The patient must not use ozanimod with another Cytokine and CAM medication.
Required conventional and preferred-therapy trials must be ineffective, unless the applicable therapies are all contraindicated or not tolerated.

Step Therapy

Multiple Sclerosis Preferred-Therapy Step

For multiple sclerosis, ozanimod requires an inadequate response to two preferred MS medications on the Apple Health PDL before approval. The requirement may be satisfied through documented contraindication or intolerance when all preferred agents are contraindicated or not tolerated.

Document ineffective treatment with two preferred MS PDL medications.
Document that all applicable preferred agents are contraindicated or not tolerated when relying on the exception.
If only one preferred agent is available in the class, the general policy requires documentation of an inadequate response to one preferred agent.

Step Therapy

Ulcerative Colitis Conventional and Preferred Therapy Steps

For ulcerative colitis, document failure of conventional therapy followed by failure of two preferred Cytokine and CAM Apple Health PDL medications before requesting ozanimod. The required trials may be waived only when all applicable therapies are contraindicated or not tolerated.

Conventional therapy may include systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine; document an ineffective trial of at least 12 weeks.
Document ineffective treatment with two preferred Cytokine and CAM PDL medications, with each trial lasting at least 12 weeks.
Document contraindication or intolerance to all applicable therapies when relying on the exception.

Documentation Required

Multiple Sclerosis Clinical Documentation

Submit documentation showing that the MS criteria are met before requesting ozanimod. The record must establish the qualifying diagnosis, objective confirmation, baseline disease status, and appropriate prescribing oversight.

Patient is at least 18 years old and ozanimod is prescribed by, or in consultation with, a neurologist.
Document relapsing-remitting MS, active secondary progressive MS, or clinically isolated syndrome.
Confirm and document the diagnosis with a laboratory report or imaging such as MRI.
Provide the baseline number of relapses per year or the Expanded Disability Status Scale (EDSS) score.
Confirm ozanimod is not used in combination with other MS disease-modifying therapies.

Documentation Required

Ulcerative Colitis Clinical Documentation

Submit the ulcerative-colitis clinical record needed to establish eligibility for ozanimod. Documentation must support the patient’s age, specialist involvement, diagnosis, baseline disease activity, medication-use restrictions, and required treatment history.

Patient is at least 18 years old and ozanimod is prescribed by, or in consultation with, a gastroenterologist.
Document moderate-to-severe ulcerative colitis and confirm ozanimod is not used with another Cytokine and CAM medication.
Include baseline assessments such as stool frequency, endoscopy results, rectal bleeding, or a disease-activity scoring tool.
Include documentation of the required conventional-therapy and two preferred Cytokine and CAM medication trials, including trial duration and outcome.

Documentation Required

Reauthorization Response Documentation

Reauthorization requires documentation that the disease remains stable or that the patient has had a positive clinical response. When the applicable reauthorization criteria are met, authorization is granted for the stated renewal period.

For MS, document disease stability or positive response, such as decreased relapse frequency, delayed progression, or stable disease; also confirm no combination use with other MS disease-modifying therapies.
For ulcerative colitis, document positive response such as decreased stool frequency, decreased rectal bleeding, improved endoscopic activity, corticosteroid tapering or discontinuation, or improvement on a disease-activity scoring tool; also confirm no combination use with another Cytokine and CAM medication.
MS reauthorization is authorized for 12 months when all criteria are met.
Ulcerative-colitis initial authorization is for 6 months; reauthorization requires the documented positive response criteria.

Denial Risk

Failure to Meet Clinical Criteria

Requests may be denied when indication-specific clinical criteria are not documented or when a required condition is not met. This includes failure to establish the qualifying diagnosis, required specialist involvement, medication-use restrictions, baseline assessment, or preferred-therapy step.

For MS, denial risk includes failure to document a qualifying diagnosis, laboratory or MRI confirmation, baseline relapses or EDSS, neurologist involvement, or the required preferred-agent trial.
For ulcerative colitis, denial risk includes failure to document moderate-to-severe disease, gastroenterologist involvement, baseline assessment, conventional therapy, or two preferred PDL medication trials.

Denial Risk

Ulcerative Colitis Denial Conditions

An ulcerative-colitis request may be denied when the required ulcerative-colitis-specific conditions are not met or adequately supported in the submitted record.

The patient is younger than 18, or the request is not prescribed by or in consultation with a gastroenterologist.
The diagnosis is not moderate-to-severe ulcerative colitis, baseline assessments are missing, or ozanimod is used with another Cytokine and CAM medication.
Conventional therapy or two preferred Cytokine and CAM medication trials were not ineffective for at least 12 weeks, and no applicable contraindication or intolerance exception is documented.
Reauthorization lacks evidence of disease stability or positive clinical response, such as improved stool frequency, rectal bleeding, endoscopic activity, corticosteroid use, or disease-activity score.

Billing Rule

Quantity Limit Exceeded

Ozanimod must be dispensed within the policy’s dosage and quantity limits. Requests exceeding the applicable limit may be denied or adjusted to the covered quantity and days’ supply.

7-day starter pack: 7 capsules per 7 days.
Starter Kit with a 7-day starter pack and 0.92 mg 30-count bottle: 37 capsules per 37 days.
Starter Kit with a 7-day starter pack and 0.92 mg 21-count bottle: 28 capsules per 28 days.
0.92 mg capsules: 30 capsules per 30 days.

Clinical patternFluctuations, periods of stability, and superimposed relapses might occur

DiagnosisDiagnosed retrospectively based on the previous year's history

Active secondary progressive multiple sclerosis

EDSS requirementEDSS score ≥ 3.0

Progression requirementDisease progression for ≥ 3 months following an initial relapsing-remitting course

Progression measureEDSS increase of 1.0 for EDSS ≤5.5 or 0.5 for EDSS ≥6

Disease activityAt least 1 relapse within the previous 2 years, or qualifying gadolinium-enhancing or new or unequivocally enlarging T2 lesions on MRI

Clinically isolated syndrome (CIS)

DefinitionA monophasic clinical episode with patient-reported symptoms and objective focal or multifocal inflammatory demyelinating findings in the CNS

Symptom durationNeurologic symptoms last at least 24 hours, with or without recovery

Required absenceNo fever or infection

Prior diagnosisThe patient is not known to have multiple sclerosis

Baseline number of relapses per year or Expanded Disability Status Scale (EDSS) score is documented.

Not used in combination with other disease-modifying therapies (DMTs) for multiple sclerosis.

Treatment with two preferred multiple sclerosis Apple Health Preferred Drug List (PDL) medications has been ineffective, unless all are contraindicated or not tolerated.

Ulcerative Colitis Initial Therapy

For ulcerative colitis, all documented criteria must be met.

Ulcerative colitis initial therapy

Patient is 18 years of age or older.Age ≥18
Prescribed by, or in consultation with, a gastroenterologist.
Not used in combination with another Cytokine and CAM medication.
Has moderate-to-severe ulcerative colitis.
Baseline assessments are included, such as stool frequency, endoscopy results, presence of rectal bleeding, or a disease-activity scoring tool.
Treatment with conventional therapy, such as systemic corticosteroids, azathioprine, mesalamine, or sulfasalazine, has been ineffective, unless all are contraindicated or not tolerated.Minimum trial of 12 weeks
Treatment with two preferred Cytokine and CAM Apple Health Preferred Drug List (PDL) medications has each been ineffective, unless all are contraindicated or not tolerated.Minimum trial of 12 weeks for each agent

Documentation demonstrates disease stability or a positive clinical response, such as decreased stool frequency, decreased rectal bleeding, improved endoscopic activity, tapering or discontinuation of corticosteroid therapy, or improvement on a disease-activity scoring tool.

Zeposia Starter Kit with 0.92 mg 21-count bottle

PackageStarter Kit with a 7-day starter pack and a 0.92 mg 21-count bottle

Quantity limit28 capsules

Duration limitPer 28 days

Zeposia 0.92 mg capsules

Dosage formZeposia 0.92 mg capsules

Quantity limit30 capsules

Duration limitPer 30 days