Egrifta- NC Standard

• Egrifta® (tesamorelin acetate)

• For the reduction of excess abdominal fat in HIV-infected patients with lipodystrophy
• Limitations of use: 
  • Long-term cardiovascular benefit and safety of Egrifta have not been studied. 
  • 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.

Initial Coverage Criteria  

1. The patient has a diagnosis of HIV infection; AND 
2. The patient has abdominal lipodystrophy, defined as:
   1. Waist circumference of ≥95 cm [37.4 inches] and a waist-to-hip ratio of ≥0.94 for men; OR 
   2. Waist circumference of ≥94 cm [37.0 inches] and ≥0.88 for women respectively; AND 
3. The patient has a CD4 cell count >100 cells/mm³ and a viral load <10,000 copies/mL; AND
4. The patient is between 18 and 65 years of age; AND
5. The patient is currently on anti-retroviral therapy (ART); AND 
6. The patient has a BMI> 20 kg/m² ; AND
7. The patient does not have a disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism, or pituitary tumor/surgery, head irradiation or head trauma; AND
8. The patient does not have an active malignancy; AND 
9. The patient is not currently pregnant, planning to become pregnant or breastfeeding; AND
10. The patient does not have a diagnosis of diabetes mellitus or a fasting blood glucose of >150 mg/dL; AND 
11. The patient is not currently being treated with growth hormone (GH), GH secretagogues, GH-releasing hormone/GH-releasing factor products, insulin-like growth factor (IGF)-1, or IGF-binding protein-3; AND
12. The prescribed dosage is 2 mg injected subcutaneously once daily; AND 
13. For formularies that exclude (non-formulary) the requested medication, Non-formulary Exception Criteria applies.

Duration of Approval: 180 days (6 months)

Continuation Coverage Criteria 

1. The patient was previously approved through BlueCross NC criteria or would have met initial criteria for approval upon the start of therapy; AND 
2. The patient has experienced a positive clinical response (e.g. improvement in visceral adipose tissue (VAT), decrease in waist circumference, belly appearance) while on Egrifta therapy (medical record documentation required).

Duration of Approval: 365 days (12 months)

All information referenced is from FDA package insert unless otherwise noted below

June 2023: Criteria update: Criteria review and formatting changes. Decreased duration of approval to 365 days for continuation criteria.

April 2021: Criteria change: Annual criteria review. Changed initial approval duration to 6 months. Added continuation coverage section.

June 2017: Annual Policy Review; formatting change; no change to criteria

August 2014: Policy Originated