Support for Your Patients
Every Step
of the Way

ZEPOSIA 360 SUPPORT™ CAN HELP APPROPRIATE PATIENTS START ON THERAPY

ZEPOSIA 360 Support™ Program—Services for Patients

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Pre-Initiation Support

  • Pre-Initiation Testing
    Assistance—

    includes comprehensive baseline testinga
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Access Support

  • Access Assistance—
    help with Benefits Investigation, Prior Authorization (PA), and Appeals
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Financial Support

  • Third-Party Referrals—
    suggestions for independent third‑party foundations that may be able to assist with treatment costs

Dedicated Nurse Navigators are available to support patients on every step of their treatment journey

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ZEPOSIA 24-Month Bridge Program

A free supply of ZEPOSIA for up to 24 months to qualified, commercially insured patients who are at risk of an interruption in therapyb

  • ▶︎Up to 24 months of ZEPOSIA for $0, as long as program eligibility rules are being met
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Co-Pay Assistance Program

Helps patients with co-pay costs, including prescription and medical assessment/initiation costsc

  • ▶︎Prescription Benefits—eligible patients may pay as little as $0 in out-of-pocket costs for their ZEPOSIA prescription
  • ▶︎Medical Benefits—commercially insured patients can be fully reimbursed for any out-of-pocket costs associated with medical assessments (required pre-initiation testing, such as blood tests and baseline heart tests)

CoverMyMeds offers access to multiple, integrated services — including electronic Prior Authorization (ePA) support for prescribers — that help simplify processes and access for patients prescribed ZEPOSIA. To begin the process online visit covermymeds®.

aFor patients with commercial coverage in all states except MA, MN, and RI.

bThe Bridge Program is available at no cost for eligible commercially insured, on-label diagnosed patients if there is a delay in determining whether commercial prescription coverage is available, and is not contingent on any purchase requirement. The Bridge Program is not available to patients who have prescription insurance coverage through Medicare, Medicaid, or any other federal or state program, or MI residents, and is available for no more than 12 months (365 days) to patients in MA, MN, and RI. Appeal of any prior authorization denial must be made within 90 days or as per payer guidelines, to remain in the Program. Eligibility will be re-verified in January for patients continuing into the following year, and may be at other times during Program participation. Up to 12 additional refills may be provided if needed. Offer is not health insurance, and may be modified or discontinued at any time without notice. Other limitations may apply.

cDepending on insurance coverage and where the full cost is not covered by patient’s insurance, eligible patients may receive a prescription benefit offer for out-of-pocket drug costs and pay as little as $0 per prescription, as well as a medical assessment benefit offer for out-of-pocket costs for the initial blood tests, ECG screening, and Macular Edema screening (if required) . Maximum savings limit applies; patient out-of-pocket expenses may vary. This program is not health insurance. Offer not valid for patients enrolled in Medicare, Medicaid, or other federal or state health care programs. Please visit ZEPOSIA.com/copayterms for Program Terms, Conditions, and Eligibility Criteria. Medical co-pay benefit not available for residents of MA, MN, and RI.

ICD Code: For reimbursement purposes, the ICD-10-CM code for patients with a multiple sclerosis diagnosis is G35.

nationwide, xx.xx% of patients with commercial coverage have access to zeposiaa

aBased on Weekly Field Intelligence Input and MMIT, as of November 2021.

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ADDITIONAL SERVICES FOR YOUR PATIENTS

ZEPOSIA 360 Support™ Program—Additional Services

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Ongoing Support

  • Payer Policy Research
  • Ongoing Reverification of Benefits
  • Shipment Coordination/Tracking
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Support Coordinators

  • Insurance Information and Support
  • Regionally Assigned Points of Contact

COVID-19 and MS

Access Resources

Getting Started

Start Form

Enrolls patients in ZEPOSIA 360 Support™ and helps them get started on treatment

Download the start form or get started online

BMS eSign

Available for your patients who forget to sign the ZEPOSIA Start Form. BMS eSign enables your patients to electronically sign through www.BMSesign.com

Initiation and Support Brochure

Provides important information on how to get patients started on ZEPOSIA and an overview of key benefits available through the ZEPOSIA 360 Support™

Tyramine and ZEPOSIA Food and Drug Interaction Information

A helpful list of foods and beverages that are high in tyramine (150 mg or more)—a compound that should be avoided if your patients are taking ZEPOSIA

Patient Decision Kit

Provides a comprehensive look at ZEPOSIA for patients and outlines steps to get them started on therapy

Patient Brochure

Provides a streamlined version of the Patient Decision Kit, including a quick overview of ZEPOSIA and ZEPOSIA 360 Support™

Access & Support

Access Resources for Healthcare Providers

Brochure highlighting tools for healthcare providers to assist in getting appropriate patients access to ZEPOSIA

Authorization and Appeals Kit

Offers information on potential coverage scenarios for ZEPOSIA, explains how to navigate authorizations and appeals (including template letters), and outlines services offered by ZEPOSIA 360 Support™

Formulary Exception Letter

Helps you advocate for your patients, so they can gain approval to start therapy with ZEPOSIA

Letter of Medical Necessity for Patients Currently Receiving MS Treatment

Enables you to help patients continue receiving therapy

Letter of Medical Necessity for Patients Not Currently Receiving MS Treatment

Helps your patients not currently receiving any therapy get started on ZEPOSIA

Letter of Appeal for Patients Currently Receiving MS Treatment

Enables you to advocate for patients who are currently receiving therapy, if they receive an unfavorable coverage decision

Letter of Appeal for Patients Not Currently Receiving MS Treatment

Enables you to advocate for patients who are not currently receiving therapy, if they receive an unfavorable coverage decision

Additional Resources

Specialty Pharmacy Resource

Provides a quick overview of the benefits of using Specialty Pharmacies (SPs) and a list of SPs ready to handle ZEPOSIA prescriptions

Baseline Testing Clearance Form

This form is used by the ZEPOSIA 360 Support™ clinical partners to verify that a patient’s baseline tests have been reviewed by their prescriber and that they are able to start therapy. If this form is not submitted online or via fax, the ZEPOISA 360 Support™ program will call you and/or your office for verbal confirmation of baseline test completion.

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IMPORTANT SAFETY INFORMATION

INDICATIONS

ZEPOSIA® (ozanimod) is indicated for the treatment of:

  1. Relapsing forms of multiple sclerosis (MS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults.
  2. Moderately to severely active ulcerative colitis (UC) in adults.

IMPORTANT SAFETY INFORMATION

Contraindications:

  • Patients who in the last 6 months, experienced myocardial infarction, unstable angina, stroke, transient ischemic attack (TIA), decompensated heart failure requiring hospitalization, or Class III/IV heart failure or have a 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
  • Patients with severe untreated sleep apnea
  • Patients taking a monoamine oxidase (MAO) inhibitor

Infections: ZEPOSIA may increase the susceptibility to infections. Life-threatening and rare fatal infections have occurred in patients receiving ZEPOSIA. Obtain a recent (i.e., within 6 months or after discontinuation of prior MS or UC therapy) complete blood count (CBC) including lymphocyte count before initiation of ZEPOSIA. Delay initiation of ZEPOSIA in patients with an active infection until the infection is resolved. Consider interruption of treatment with ZEPOSIA if a patient develops a serious infection. Continue monitoring for infections up to 3 months after discontinuing ZEPOSIA.

  • Herpes zoster was reported as an adverse reaction in ZEPOSIA-treated patients. Herpes simplex encephalitis and varicella zoster meningitis have been reported with sphingosine 1-phosphate (S1P) receptor modulators. Patients without a healthcare professional-confirmed history of varicella (chickenpox), or without documentation of a full course of vaccination against varicella zoster virus (VZV), should be tested for antibodies to VZV before initiating ZEPOSIA. A full course of vaccination for antibody-negative patients with varicella vaccine is recommended prior to commencing treatment with ZEPOSIA.
  • Cases of fatal cryptococcal meningitis (CM) were reported in patients treated with another S1P receptor modulator. If CM is suspected, ZEPOSIA should be suspended until cryptococcal infection has been excluded. If CM is diagnosed, appropriate treatment should be initiated.
  • In the MS and UC clinical studies, patients who received ZEPOSIA were not to receive concomitant treatment with antineoplastic, non-corticosteroid immunosuppressive, or immune-modulating therapies used for treatment of MS and UC. Concomitant use of ZEPOSIA with any of these therapies would be expected to increase the risk of immunosuppression. When switching to ZEPOSIA from immunosuppressive medications, consider the duration of their effects and their mode of action to avoid unintended additive immunosuppressive effects.
  • Use of live attenuated vaccines should be avoided during and for 3 months after treatment with ZEPOSIA. If live attenuated vaccine immunizations are required, administer at least 1 month prior to initiation of ZEPOSIA.

Progressive Multifocal Leukoencephalopathy (PML): PML is an opportunistic viral infection of the brain that typically occurs in patients who are immunocompromised, and that usually leads to death or severe disability.

PML has been reported in patients treated with S1P receptor modulators, including ZEPOSIA, and other MS and UC therapies and has been associated with some risk factors. If PML is suspected, withhold ZEPOSIA and perform an appropriate diagnostic evaluation.

If confirmed, treatment with ZEPOSIA should be discontinued.

Bradyarrhythmia and Atrioventricular Conduction Delays: Since initiation of ZEPOSIA may result in a transient decrease in heart rate and atrioventricular conduction delays, dose titration is recommended to help reduce cardiac effects. Initiation of ZEPOSIA without dose escalation may result in greater decreases in heart rate. If treatment with ZEPOSIA is considered, advice from a cardiologist should be sought for those individuals:

  • with significant QT prolongation
  • with arrhythmias requiring treatment with Class 1a or III anti-arrhythmic drugs
  • with ischemic heart disease, heart failure, history of cardiac arrest or myocardial infarction, cerebrovascular disease, and uncontrolled hypertension
  • with a history of Mobitz type II second-degree or higher AV block, sick sinus syndrome, or sino-atrial heart block

Liver Injury: Elevations of aminotransferases may occur in patients receiving ZEPOSIA. Obtain liver function tests, if not recently available (i.e., within 6 months), before initiation of ZEPOSIA. Patients who develop symptoms suggestive of hepatic dysfunction should have hepatic enzymes checked and ZEPOSIA should be discontinued if significant liver injury is confirmed. Caution should be exercised when using ZEPOSIA in patients with history of significant liver disease.

Fetal Risk: There are no adequate and well-controlled studies in pregnant women. Based on animal studies, ZEPOSIA may cause fetal harm. Women of childbearing potential should use effective contraception to avoid pregnancy during treatment and for 3 months after stopping ZEPOSIA. Women who become pregnant while taking ZEPOSIA for MS may enroll in the ZEPOSIA pregnancy registry by calling 1-877-301-9314 or visiting www.zeposiapregnancyregistry.com.

Increased Blood Pressure: Increase in systolic pressure was observed after about 3 months of treatment and persisted throughout treatment. Blood pressure should be monitored during treatment and managed appropriately. Certain foods that may contain very high amounts of tyramine could cause severe hypertension in patients taking ZEPOSIA. Patients should be advised to avoid foods containing a very large amount of tyramine while taking ZEPOSIA.

Respiratory Effects: ZEPOSIA may cause a decline in pulmonary function. Spirometric evaluation of respiratory function should be performed during therapy, if clinically indicated.

Macular Edema: S1P modulators have been associated with an increased risk of macular edema. Patients with a history of uveitis or diabetes mellitus are at increased risk. Patients with a history of these conditions should have an ophthalmic evaluation of the fundus, including the macula, prior to treatment initiation and regular follow-up examinations. An ophthalmic evaluation is recommended in all patients at any time if there is a change in vision. Continued use of ZEPOSIA in patients with macular edema has not been evaluated; potential benefits and risks for the individual patient should be considered if deciding whether ZEPOSIA should be discontinued.

Posterior Reversible Encephalopathy Syndrome (PRES): Rare cases of PRES have been reported in patients receiving a S1P receptor modulator. If a ZEPOSIA-treated patient develops unexpected neurological or psychiatric symptoms or any symptom/sign suggestive of an increase in intracranial pressure, a complete physical and neurological examination should be conducted. Symptoms of PRES are usually reversible but may evolve into ischemic stroke or cerebral hemorrhage. Delay in diagnosis and treatment may lead to permanent neurological sequelae. If PRES is suspected, treatment with ZEPOSIA should be discontinued.

Unintended Additive Immunosuppressive Effects From Prior Immunosuppressive or Immune-Modulating Drugs: When switching from drugs with prolonged immune effects, the half-life and mode of action of these drugs must be considered to avoid unintended additive immunosuppressive effects while at the same time minimizing risk of disease reactivation. Initiating treatment with ZEPOSIA after treatment with alemtuzumab is not recommended.

Severe Increase in Multiple Sclerosis (MS) Disability After Stopping ZEPOSIA: In MS, severe exacerbation of disease, including disease rebound, has been rarely reported after discontinuation of a S1P receptor modulator. The possibility of severe exacerbation of disease should be considered after stopping ZEPOSIA treatment so patients should be monitored upon discontinuation.

Immune System Effects After Stopping ZEPOSIA: After discontinuing ZEPOSIA, the median time for lymphocyte counts to return to the normal range was 30 days with approximately 90% of patients in the normal range within 3 months. Use of immunosuppressants within this period may lead to an additive effect on the immune system, therefore caution should be applied when initiating other drugs 4 weeks after the last dose of ZEPOSIA.

Most Common Adverse Reactions that occurred in the MS clinical trials of ZEPOSIA-treated patients (≥ 4%): upper respiratory infection, hepatic transaminase elevation, orthostatic hypotension, urinary tract infection, back pain, and hypertension.

In the UC clinical trials, the most common adverse reactions that occurred in ≥4% of ZEPOSIA-treated patients and greater than in patients who received placebo were upper respiratory infection, liver test increased, and headache.

Use in Specific Populations: Hepatic Impairment: Use is not recommended.

For additional safety information, please see the full Prescribing Information and Medication Guide

Are You a Healthcare Professional?

This information is intended for U.S. Healthcare Professionals.