GUIDING YOUR PATIENTS THROUGH TREATMENT WITH TZIELD
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 is here for your patient throughout their treatment journey. Learn more.
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.
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.
*Eligibility requirements and terms and conditions apply. Click here for more information.
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 to get them started with TZIELD
The Patient START Form captures all necessary information for the TZIELD prescription and initiates the enrollment process for Provention Bio COMPASS.
For more information about Provention Bio COMPASS, call 1-844-778-2246, Monday through Friday, 8 AM-8 PM ET.
ADDITIONAL RESOURCES FOR DOWNLOAD
PROVENTION BIO COMPASS ENROLLMENT SUPPORT
Annotated Patient START Form
A detailed version of the Patient START Form that provides direction to guide offices through how to successfully complete the enrollment form.
ACCESS
Prior Authorization Guide
A guide for provider offices and sites of care to provide information about potential PA requirements and criteria for TZIELD.
Letters of Medical Necessity
A resource that provides tips to help you draft a sample letter of necessity for your patients. A sample letter is provided for reference.
Letters of Appeal
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 Copay Assistance Program Guide
Detailed instructions on how to submit a patient copay claim and how patients can enroll in the copay program.
TZIELD CODING AND BILLING
Product Distribution and Ordering Information
Product Distribution and Ordering Information
A document that includes information about distribution of TZIELD and how to order it.
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 in 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.
Before prescribing TZIELD, please see full Prescribing Information, including patient selection criteria, and Medication Guide.