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THERA patient support® Program:
There for you and your patients every step of the way

97% of patients surveyed expressed very high satisfaction with the THERA patient support® program†‡

THERA patient support® is a personalized patient support Program for HCPs and patients.

  • By enrolling your patients in the THERA patient support® Program, your patients will receive the support they need throughout their TROGARZO® treatment journey.
  • By streamlining treatment access and removing barriers to care, THERA patient support® is here to support you, your staff, and your patients every step of the way.

For questions on enrolling your patients and getting them started on TROGARZO®, call the THERA patient support® line at 1-833-23-THERA/1-833-238-4372 and a THERA Patient Care Coordinator will assist you and your office staff.

Available Monday to Friday from 8:30 AM – 8:00 PM EST.

Benefits to Patients Enrolled in the THERA patient support® Program

Coverage and insurance support

Insurance coverage verification, help navigate prior authorizations, appeals and fulfillment process, educate on payer requirements and necessary documentation for personalized patient support.

Financial Assistance Program to help cover the cost of care

Commercial Insurance

THERA’s TROGARZO® Co‑Pay Program may help patients with private or commercial insurance lower their out‑of‑pocket cost.

Government Insurance

THERA patient support® can assist with alternative funding for patients with government insurance that may lower their out‑of‑pocket cost.

Patient Assistance Program

The THERA Patient Assistance Program offers qualifying patients THERA medications at no cost.

THERA Nurse Navigator Support

The THERA Nurse Navigators are your patient’s dedicated partner throughout their TROGARZO® treatment journey. They will answer any treatment‑related questions and set up bi‑weekly calls to help promote adherence.

Treatment Coordination

The THERA Patient Care Coordinator will arrange for your patient’s treatment to be given at a convenient location of their choice including:

  • Patient’s home
  • Your healthcare office
  • Hospital/IV Center

Meet the THERA patient support® Team

How we assist you and your patients

THERA Patient Care Coordinators

  • Provide patients a welcome call, sharps container, and patient resource kit
  • Verify specific insurance coverage and reimbursement solutions
  • Assist with prior authorization and claim denials/appeals
  • If eligible, will enroll patients in the TROGARZO® Co‑Pay Assistance Program
  • Explore financial assistance programs that may help cover the cost of care for your patients

Our goal is to secure access to treatment for your patients in a seamless single point of contact allowing you to focus on your patient’s care.

To request your THERA Patient Care Coordinator, contact 1-833-23-THERA/1-833-238-4372.

THERA Field Reimbursement Managers

  • Can answer questions about the THERA patient support® Program including the enrollment process and general reimbursement questions
  • Will educate on payer coverage criteria and policy updates
  • Assists with prior authorization and claim denials/appeals
  • Assist with billing and coding requirements
  • Assist with the treatment site coordination, dependent on payer coverage

Schedule a remote or live appointment with a THERA Field Reimbursement manager.

To request your THERA Field Reimbursement Manager, contact 1-833-23-THERA/1-833-238-4372.

THERA Nurse Navigators

Our professionally trained and experienced Nurse Navigators are there to provide your patients with personalized one‑on‑one nursing support.

THERA Nurse Navigators will:

  • Welcome patients into the THERA patient support® Program and coordinate calls and/or video meetings based on patient’s schedule and preference
  • Offer virtual step‑by‑step reconstitution and administration training
  • Facilitate patient adherence through scheduled touch points
  • Support answering any product‑related questions
  • THERA Nurse Navigators are a resource for your patients to call with any questions or concerns

Our Nurse Navigators will partner with you and your patients to ensure a successful treatment journey while on TROGARZO®.

For questions on enrolling your patients and getting them started on TROGARZO®, call the THERA patient support® line at 1-833-23-THERA/1-833-238-4372 and a THERA Patient Care Coordinator will assist you and your office staff.

Available Monday to Friday from 8:30 AM – 8:00 PM EST.

Download the THERA patient support® Program Enrollment Form

2 easy options to enroll your patients

Once you have identified an appropriate TROGARZO® patient, here are the 2 ways to enroll them in the THERA patient support® Program:

2

Online prescribing and registering through the Physician Portal

Access the Physician Portal

  • Click the "Login" button and enter your credentials; or if you have not yet registered, select the "Register" button to create an account
  • Upload the enrollment form including the signed patient consent section
  • Upload chart notes and track patient real‑time enrollment status
  • Obtain coverage information and view product shipment information

Important note: To ensure your patients can immediately get started on TROGARZO® therapy, it is important to get your patients’ signature/consent on the last page of the enrollment form.

After enrollment in the program, a THERA Patient Care Coordinator will contact your patient to welcome them and start the process of coverage and reimbursement investigation. Once approved, THERA patient support® will then coordinate with specialty pharmacies in their insurance network, so that your patients can quickly get started on TROGARZO®.

Have questions? Connect with a THERA Patient Care Coordinator who can assist in enrolling your patients, verify insurance coverage, prior authorization support, and more.

Call THERA patient support® to enroll your patients 1‑833‑23THERA (1‑833‑238-4372), available Monday‑Friday 8:30AM-8:00PM EST

Download Helpful Patient Resources for your practice and patients.

† This single‑blinded study required patients (n=30) to complete a brief online survey regarding patient experience with TROGARZO®. Respondents had been taking TROGARZO® an average of 8.5 months and average duration of treatment ranged from 1 to 18 months. The survey included 20 questions of various types (i.e., Likert scale, dichotomous, multiple choice, open‑ended), which were analyzed in aggregate and by infusion setting (i.e., HCP clinic, infusion center, or at home). All surveys were completed from December 2020 – March 2021 (prior to the availability of the IV push administration method), and all participants were compensated for their time.
‡ Applies to 15/30 respondents. Information for the remaining 15 respondents was not available.



To report suspected adverse reactions, contact THERA patient support® toll‑free at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or visit www.fda.gov/medwatch.

Important Safety Information

Indication

TROGARZO® (ibalizumab‑uiyk), in combination with other antiretroviral(s), is indicated for the treatment of human immunodeficiency virus type 1 (HIV‑1) infection in heavily treatment‑experienced adults with multidrug resistant HIV‑1 infection failing their current antiretroviral regimen.

Contraindications

TROGARZO® is contraindicated in patients with a prior hypersensitivity reaction to TROGARZO® or any components of the product.

Use in Specific Populations

  • Pregnancy: No adequate human data are available to establish whether or not TROGARZO® poses a risk to pregnancy outcomes. Monoclonal antibodies, such as ibalizumab‑uiyk, are transported across the placenta as pregnancy progresses; therefore, ibalizumab‑uiyk has the potential to be transmitted from the mother to the developing fetus.
  • Lactation: No data are available regarding the presence of TROGARZO® in human milk, the effects on the breastfed child, or the effects on milk production. Because of the potential for HIV‑1 transmission, instruct mothers not to breastfeed if they are receiving TROGARZO®.

Warnings and Precautions

Hypersensitivity Including Infusion‑Related and Anaphylactic Reactions

  • Hypersensitivity reactions including infusion‑related reactions and anaphylactic reactions have been reported following infusion of TROGARZO® during post‑approval use. Symptoms may include dyspnea, angioedema, wheezing, chest pain, chest tightness, cough, hot flush, nausea, and vomiting. If signs and symptoms of an anaphylactic or other clinically significant hypersensitivity reaction occur, immediately discontinue administration of TROGARZO® and initiate appropriate treatment. The use of TROGARZO® is contraindicated in patients with known hypersensitivity with TROGARZO®.

Immune Reconstitution Inflammatory Syndrome

  • Immune Reconstitution Inflammatory Syndrome (IRIS) has been reported in one patient treated with TROGARZO® in combination with other antiretrovirals. During the initial phase of combination antiretroviral therapies, patients whose immune systems respond may develop an inflammatory response to indolent or residual opportunistic infections, which may necessitate further evaluation and treatment.

Embryo-Fetal Toxicity

  • Based on animal data, TROGARZO® may cause reversible immunosuppression (CD4+ T cell and B cell lymphocytopenia) in infants born to mothers exposed to TROGARZO® during pregnancy. Immune phenotyping of the peripheral blood and expert consultation are recommended to provide guidance regarding monitoring and management of exposed infants based on the degree of immunosuppression observed. The safety of administering live or live‑attenuated vaccines in exposed infants is unknown.

Adverse Reactions

  • The most common adverse reactions (all Grades) seen in clinical trial experience, reported in at least 5% of subjects receiving TROGARZO® were diarrhea (8%), dizziness (8%), nausea (5%) and rash (5%).
  • Most (90%) of the adverse reactions reported were mild or moderate in severity. Two subjects experienced severe adverse reactions: one subject had a severe rash and one subject developed IRIS manifested as an exacerbation of progressive multifocal leukoencephalopathy.

To report suspected adverse reactions, contact THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) or FDA at 1‑800‑FDA-1088 or www.fda.gov/medwatch.