How does the THERA patient support® program work?

Explore the key steps involved in the THERA patient support® journey.

Enrollment and patient consent

1 Identify Your Patient as Appropriate for EGRIFTA WRTM

Consider the patient meets important criteria such as:

  • HIV (B20)* and HIV-associated lipodystrophy (E88.1)*
  • Risk for medical complications due to excess abdominal fat
  • Baseline waist circumference (>37.4 inches for males and >37 inches for females) and waist-to-hip ratio (>0.94 for males and >0.88 for females)
  • BMI >20 kg/m²
  • Fasting blood glucose <150 mg/dL (8.33 mmol/L)
  • Symptoms associated with lipodystrophy, such as shortness of breath and abdominal pain

* ICD-10-CM

2 Enroll Your Patient into the THERA patient support® Program

You can do this in 2 ways:

  • Fax: Download the enrollment form, fill it out, scan it, and fax it to 1-855-836-3069
    OR
  • Online: Prescribe and enroll your patients through the Physician Portal. You will need to register if you do not already have an account.

You can learn more about how to enroll your patients here.

Please ensure that all relevant fields in the enrollment form are filled out.

3 Capture Your Patient’s Consent

Ensure your patients have provided consent. Patients can provide consent by signing the last page of the enrollment form.

If your patient is unable to sign the back of the enrollment form, they can also provide their consent digitally by:

  • Visiting here OR
  • Calling THERA patient support® at 1‑833‑23THERA (1‑833‑238-4372) and requesting a consent link via SMS

If patient consent is not on file, a THERA patient support® Patient Care Coordinator will reach out to your patient and request consent via SMS.

You can learn more about enrollment and patient consent capture here.

4 Welcome Call to Patient from THERA patient support®
  • Once THERA patient support® receives the enrollment form, a THERA patient support® Patient Care Coordinator calls your patient to welcome them into the program.
  • The THERA patient support® Patient Care Coordinator offers patients a free sharps container and EGRIFTA WRTM Patient Resource Kit.

Reimbursement navigation

5 THERA Patient Support® Drives Benefits Investigation

THERA patient support® investigates patient’s coverage and reimbursement options for EGRIFTA WRTM.

Prior Authorization Initiation
If required, the THERA patient support® Patient Care Coordinator will initiate prior authorization, making it easy for your office to complete the submission.

  • If it’s denied, THERA patient support® will work with your office to appeal the denial

You can find coverage access forms like a Prior Authorization Checklist, Letter of Medical Necessity template, and Appeal Letter template here.

6 Patient Is Set Up for Their First EGRIFTA WRTM Injection Training with a THERA patient support® Nurse Navigator
  • Once approved, THERA patient support® triages to an in-network specialty pharmacy so your patient can quickly receive and start their treatment
  • A THERA patient support® Nurse Navigator reaches out to the patient to schedule their one-on-one EGRIFTA WRTM injection training sessions

Continued support for you and your patients

7 Individualized Support for Your Patients with a THERA Nurse Navigator

THERA patient support® Nurse Navigators provide ongoing support throughout the patient's treatment journey, assisting with training and onboarding based on the patient's schedule and availability. They remain a resource for patients to contact with any questions or concerns at any stage of treatment.

8 Individualized Support for You

THERA patient support® remains available as the primary point of contact to support you and your staff with any questions on EGRIFTA WRTM or Thera patient support®.

Need more information?

Get answers to frequently asked questions about enrollment, coverage, and support.

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IMPORTANT SAFETY INFORMATION ABOUT EGRIFTA WRTM (TESAMORELIN) FOR INJECTION

Indication

EGRIFTA WRTM is indicated for the reduction of excess abdominal fat in HIV-infected adult patients with lipodystrophy.

Limitations of Use:

  • The impact and safety of EGRIFTA WRTM on cardiovascular health has not been studied.
  • EGRIFTA WRTM is not indicated for weight loss management.
  • It is not known whether taking EGRIFTA WRTM helps improve compliance with anti-retroviral medications.

Contraindications:

Do not use EGRIFTA WRTM if patient:

  • Has a pituitary gland tumor, has had pituitary gland surgery, has other problems related to their pituitary gland, or has had radiation treatment to their head or a head injury.
  • Has active cancer.
  • Is allergic to tesamorelin or any of the ingredients in EGRIFTA WRTM.
  • Is pregnant or planning to become pregnant.

Warnings and Precautions

  • Increased risk of neoplasms: Preexisting malignancy should be inactive and its treatment complete prior to starting EGRIFTA WRTM. EGRIFTA WRTM should be discontinued if the patient has evidence of recurrent malignancy.
  • Elevated IGF-1: Regularly monitor IGF-1 levels in all patients during EGRIFTA WRTM therapy. Consider discontinuing in patients with persistent elevations (e.g., >3 SDS).
  • Fluid retention: May include edema, arthralgia, and carpal tunnel syndrome.
  • Glucose intolerance or diabetes mellitus: May develop with EGRIFTA WRTM treatment. Evaluate glucose status prior to and during therapy with EGRIFTA WRTM.
  • Hypersensitivity reactions: Advise patients to seek immediate medical attention if suspected.
  • Injection site reactions: Advise patients to rotate sites to different areas of the abdomen to decrease injection site reactions.
  • Increased mortality in patients with acute critical illness: Consider discontinuation in critically ill patients.

Drug Interactions

  • EGRIFTA WRTM had no significant impact on the pharmacokinetic profiles of simvastatin in healthy subjects.
  • Monitor patients for potential interactions when administering EGRIFTA WRTM in combination with other drugs known to be metabolized by CYP450 liver enzyme.
  • Patients on glucocorticoids may require dosage adjustment upon initiation of EGRIFTA WRTM.

Use in Specific Populations

  • Lactation: Mothers should not breastfeed if they receive EGRIFTA WRTM.
  • Pediatric use: Safety and effectiveness in pediatric patients have not been established.
  • Geriatric use: There is no information on the use of EGRIFTA WRTM in patients greater than 65 years of age.

Adverse Reactions

The most commonly reported adverse reactions include injection site reactions, arthralgia, pain in extremity, myalgia, and peripheral edema.

For complete disclosure of EGRIFTA WRTM product information, please read the Full Prescribing Information, Patient Information, and Patient Instructions for Use.

For more information about EGRIFTA WRTM, contact THERA patient support® program toll-free at 1-833-23THERA (1-833-238-4372). To report suspected adverse reactions, contact THERA patient support® program or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.