EGRIFTA, Tesamorelin Acetate Form

Tesamorelin (Egrifta SV™) is a growth hormone releasing factor analog. FDA Approved Indication(s) Egrifta SV is indicated for the reduction of excess abdominal fat in human immunodeficiency virus (HIV)-infected patients with lipodystrophy.
Limitation(s) of use:
• Since the long-term cardiovascular safety and potential long-term cardiovascular benefit of Egrifta SV treatment have not been studied and are not known, careful consideration should be given whether to continue Egrifta SV treatment in patients who do not show a clear efficacy response as judged by the degree of reduction in visceral adipose tissue measured by waist circumference or CT scan. • Egrifta SV is not indicated for weight loss management (weight neutral effect). • There are no data to support improved compliance with anti-retroviral therapies in HIV- positive patients taking Egrifta SV. Policy/Criteria Provider must submit documentation (such as office chart notes, lab results or other clinical information) supporting that member has met all approval criteria.
It is the policy of health plans affiliated with Centene Corporation® that Egrifta SV is medically necessary when the following criteria are met:
I. Initial Approval Criteria
A. Human Immunodeficiency Virus Infection with Lipodystrophy (must meet all):

1. Diagnosis of HIV infection with lipodystropy;
   2. Age ≥ 18 years or documentation of closed epiphyses;
   3. Member meets clinical indicators for abdominal lipodystrophy (a or b):
      a. If female, waist circumference ≥ 88 cm; b. If male, waist circumference ≥ 102 cm;

2. Member is currently receiving and adherent to antiretroviral therapy;

   5. Dose does not exceed 1.4 mg (1 vial) per day. Approval duration:
      Medicaid/HIM – 6 months Commercial – 6 months or to member’s renewal date, whichever is longer Page 1 of 6

   CLINICAL POLICY Tesamorelin B. Other diagnoses/indications (must meet 1 or 2):

3. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or
4. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   II. Continued Therapy A. Human Immunodeficiency Virus Infection with Lipodystrophy (must meet all):
5. Member meets one of the following (a or b): a. Currently receiving medication via Centene benefit or member has previously met initial approval criteria; b. Member is currently receiving medication and is enrolled in a state and product with continuity of care regulations (refer to state specific addendums for CC.PHARM.03A and CC.PHARM.03B);
   2. Member is responding positively to therapy;
   3. If request is for a dose increase, new dose does not exceed 1.4 mg (1 vial) per day. Approval duration:
      Medicaid/HIM – 12 months Commercial – 6 months or to member’s renewal date, whichever is longer B. Other diagnoses/indications (must meet 1 or 2):
6. If this drug has recently (within the last 6 months) undergone a label change (e.g., newly approved indication, age expansion, new dosing regimen) that is not yet reflected in this policy, refer to one of the following policies (a or b): a. For drugs on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the no coverage criteria policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.33 for health insurance marketplace, and CP.PMN.255 for Medicaid; or b. For drugs NOT on the formulary (commercial, health insurance marketplace) or PDL (Medicaid), the non-formulary policy for the relevant line of business: CP.CPA.190 for commercial, HIM.PA.103 for health insurance marketplace, and CP.PMN.16 for Medicaid; or

7. If the requested use (e.g., diagnosis, age, dosing regimen) is NOT specifically listed under section III (Diagnoses/Indications for which coverage is NOT authorized) AND Page 2 of 6

   CLINICAL POLICY Tesamorelin criterion 1 above does not apply, refer to the off-label use policy for the relevant line of business: CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid.
   III. Diagnoses/Indications for which coverage is NOT authorized:
   A. Non-FDA approved indications, which are not addressed in this policy, unless there is sufficient documentation of efficacy and safety according to the off label use policies – CP.CPA.09 for commercial, HIM.PA.154 for health insurance marketplace, and CP.PMN.53 for Medicaid or evidence of coverage documents.
   IV. Appendices/General Information Appendix A: Abbreviation/Acronym Key FDA: Food and Drug Administration HIV: human immunodeficiency virus Appendix B: Therapeutic Alternatives
   Not applicable Appendix C: Contraindications/Boxed Warnings • Contraindication(s): o Disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, pituitary tumor/surgery, head irradiation or head trauma. o Active malignancy (either newly diagnosed or recurrent): any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with Egrifta SV. o Pregnancy: During pregnancy, visceral adipose tissue increases due to normal metabolic and hormonal changes. Modifying this physiologic change of pregnancy with Egrifta SV offers no known benefit and could result in fetal harm. If pregnancy occurs, discontinue Egrifta SV therapy. o Known hypersensitivity to tesamorelin and/or mannitol. • Boxed warning(s): none reported Appendix D: General Information • On June 15, 2020, Theratechnologies discontinued Egrifta and permanently replaced it with Egrifta SV, a smaller volume injection able to be stored at room temperature. V. Dosage and Administration
   Indication HIV infection with lipodystrophy Dosing Regimen 1.4 mg (0.35 mL) SC QD Maximum Dose 1.4 mg/day After reconstitution and administration, any unused solution should be thrown away VI. Product Availability Single-use vial with powder for reconstitution: 2 mg
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   CLINICAL POLICY Tesamorelin VII.