FOR US HEALTHCARE PROFESSIONALS ONLY
INTRODUCTION
Provention Bio COMPASS™
Provention Bio COMPASS™ is a personalized patient assistance and support program with helpful resources. Our team will provide information about financial assistance options, reimbursement, educational tools and resources, and additional support from the day of enrollment.
A COMPASS Navigator will be there for your patient throughout their treatment with TZIELD.
As an important resource throughout your patient’s treatment with TZIELD, the COMPASS Navigator can:
Help navigate the steps to product access, including prior authorizations, medical exceptions, appeals and reauthorizations.
Identify where your patient can get TZIELD infusions depending on their insurance and other factors.
Offer education on product procurement through specialty pharmacy or Buy and Bill, as well as information about reimbursement.
Perform additional check-ins with your patient once treatment is completed.
Explain insurance coverage to your patient and provide information about financial assistance options that may be available to your patients.
Answer questions about the program and offerings.
Provention Bio COMPASS is a patient support program that helps patients gain access to TZIELD and provides patients with education and resources related to TZIELD. Provention Bio COMPASS is not a healthcare service or an insurance provider and does not provide care coordination. Provention Bio COMPASS and the COMPASS Navigator will not provide medical or treatment advice. Provention Bio COMPASS services are available only to those who have been prescribed TZIELD and are intended for US residents only.
COPAY & ENROLLMENT
Copay information and online enrollment
Your patients may be able to save on out-of-pocket costs for TZIELD
With the Provention Bio Copay Program,* commercially or privately insured individuals may pay as little as $0 for TZIELD. If your patient qualifies, their COMPASS Navigator can help enroll them into the copay program so they may be able to lower their out-of-pocket costs.
This program is intended to help with the cost of TZIELD and its infusion administration only. It does not help with the cost of other medicines your patients take at the same time as TZIELD or with other facility fees.
Enroll your patients online to get them started on TZIELD
The Patient START Form captures all necessary information to determine eligibility for TZIELD and initiates the enrollment process for Provention Bio COMPASS, the patient support program.
If your office prefers fax, please download a form here.
For more information about Provention Bio COMPASS, call 1-844-778-2246, Monday through Friday, 8 AM-8 PM ET.
ADDITIONAL RESOURCES
Additional resources for download
Provention Bio COMPASS Enrollment Support
Guidance for Completing the Provention Bio COMPASS™ Patient Start Form
A detailed version of the Patient START Form that provides directions for how to successfully complete the enrollment form.
Access
Prior Authorization (PA) Checklist
A checklist to help ensure you and your practice understand potential health plan prior authorization criteria to help prevent rejections and unnecessary delays.
Sample Letter of Medical Necessity Template
A resource that provides tips to help you draft a sample letter of necessity for your patients. A sample letter is provided for reference.
Sample Letter of Appeal Template
A resource that provides tips to help you draft a letter of appeal for your patients. A sample letter is provided for reference.
Financial Assistance
Provention Bio COMPASS™ Copay Assistance Guide
Detailed instructions on how to submit a patient copay claim and how patients can enroll in the copay program.
TZIELD Coding and Billing
Sample Coding
A quick reference sheet, including sample codes, related to coding and billing for TZIELD and its administration.
Coding and Billing Information for TZIELD® (teplizumab-mzwv)
A detailed guide with helpful information related to coding and billing for TZIELD and its administration.
Product Distribution and Ordering Information
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
- Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
- Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
- Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
- Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
- Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.
ADVERSE REACTIONS
Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm.
- Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.
Please see full Prescribing Information, including patient selection criteria, and Medication Guide.
View Important Safety Information page.
IMPORTANT SAFETY INFORMATION
WARNINGS AND PRECAUTIONS
- Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
- Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
- Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
Provention Bio, TZIELD, and the TZIELD logo are the registered trademarks of Provention Bio, a Sanofi Company.
The Provention Bio logo and Provention Bio COMPASS are the trademarks of Provention Bio, a Sanofi Company.
© 2023 Provention Bio, a Sanofi Company. All rights reserved. MAT-US-2400345-v1.0-01/2024
