THE ZEPOSIA 360 SUPPORT™ PROGRAM

Support for Your Patients Every Step of the Way

Pre-initiation icon

Initiation Support

  • Preinitiation Assessment Assistancea
    Provided at the homes of eligible patients:
    • Blood work
    • ECG with cardiologist overread
    • Macular edema screening with
      licensed eye clinician overread
    • VZV antibody testing
  • ZEPOSIA Starter Kit
    A 7-day Starter Pack along with a 30-day supply of ZEPOSIA
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Access Support

  • Access Assistance
    Help with Benefits Investigation, Prior Authorization (PA), and Appeals
  • ZEPOSIA Bridge Programb
    A free supply of ZEPOSIA for up to 24 months to qualified, commercially insured patients who are at risk of an interruption in therapy
    • Up to 24 months of ZEPOSIA for $0, as long as program eligibility rules are met
    • Dispensed in 30-day increments
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Financial Support

  • Co-pay Assistance Programc
    For eligible, commercially insured patients, helps with:
    • Prescription Benefits
      Eligible patients 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 preinitiation testing
  • Third-Party Referrals
    Suggestions for independent third-party foundations that may be able to assist with treatment costs

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

*Nurse Navigators do not provide medical advice.

aHome visits for initial routine medical tests are not available to people enrolled in Medicare, Medicaid, or other federal or state healthcare programs, or to people living in Rhode Island.

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, for up to 24 months (dispensed in 30-day increments). 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 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. Offer is not health insurance, and may be modified or discontinued at any time without notice. Once coverage is approved by the patient’s commercial insurance plan, the patient will no longer be eligible. 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 eye exam. 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 healthcare programs. Please click here for Program Terms, Conditions, and Eligibility Criteria.

 ECG=electrocardiogram; VZV=varicella-zoster virus.

Additional Support for Your Patients

Assistance designed to meet the needs of your patients

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Ongoing Support

  • Payer Policy Research
  • Ongoing Reverification
  • Shipment Coordination/Tracking
  • Access and Reimbursement Guide
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Support Coordinators

  • Dedicated Point of Contact for HCPs
  • Insurance Information and Support
  • Regionally Assigned Points of Contact
CoverMyMeds logo

CoverMyMeds offers access to multiple, integrated services—helping to simplify processes and access for patients prescribed ZEPOSIA.

Resources

Resources to help you learn more about ZEPOSIA for the treatment of ulcerative colitis and to get your patients started

GETTING STARTED

ZEPOSIA Gastroenterology Start Form

ZEPOSIA Gastroenterology Start Form

Enrolls patients in the ZEPOSIA 360 Support™ Program and helps them get started on treatment. Sign in or register to submit the Start Form to the ZEPOSIA Portal

Download (English)
Download (Español)

ZEPOSIA Start Form Instructions & Support

A step-by-step guide that outlines how to enroll patients in the ZEPOSIA 360 Support™ Program and get them started on treatment

Download
ZEPOSIA Dosing, Initiation, and Patient Brochure

Dosing, Initiation, and Patient Support Guide

Provides information on how to initiate treatment with ZEPOSIA, and education on the patient support offered to assist with the process

Download
BMS eSign PDF

BMS eSign

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

Download
ZEPOSIA Baseline Testing Clearance Form

Baseline Testing Clearance Form

Used by 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

Download

ACCESS

ZEPOSIA Access Resources for HCPs

Access Resources for HCPs

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

Download
ZEPOSIA Access and Reimbursement Guide

Access and Reimbursement Guide

Provides information on the process for accessing ZEPOSIA from initiation to delivery, coverage authorizations and appeals, and patient support offered by the ZEPOSIA 360 Support™ Program

Download
ZEPOSIA Specialty Pharmacies (SPs) Resource

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

Download
Patient Access Letters to get started with ZEPOSIA

Patient Access Letters

Template letters (Formulary Exception, Medical Necessity, Appeals) to assist in getting appropriate patients access for ZEPOSIA

Download

SUPPORT

ZEPOSIA Portal Assist

ZEPOSIA Portal Assist

Provides an outline of how to enroll and manage patients using the ZEPOSIA portal

Download
ZEPOSIA In-Home Support Overview

ZEPOSIA In-Home Support Overview

Provides a brief overview of in-home support available to patients with ZEPOSIA

Download
CoverMyMeds support overview

CoverMyMeds Overview

Overview of support available through CoverMyMeds® to enroll patients in the ZEPOSIA 360 Support™ Program and assist with access

Download

FOR YOUR PATIENTS

ZEPOSIA Patient Brochure

Patient Brochure

Provides your patients with an overview of clinical study results, safety, and support information for ZEPOSIA

Download
ZEPOSIA Patient Getting Started Brochure

Patient Getting Started Brochure

Provides a comprehensive guide to your patients about getting started on ZEPOSIA

Download

ADDITIONAL CLINICAL RESOURCES

ZEPOSIA UC Patient Profiles

ZEPOSIA UC Patient Profiles

Helps identify which of your patients are potentially appropriate for ZEPOSIA

Download
Tyramine and ZEPOSIA Food and Drug Information

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

Download

Learn more about ZEPOSIA efficacy, safety, and support

SPEAK TO A REP

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.

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

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Are You a Healthcare Professional?

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

Indications:

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