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Drug - Egrifta™ (tesamorelin) [Theratechnologies, Inc.]

June 2016

Therapeutic area - Growth Hormone Releasing Factor

Approval criteria

  • Patient has been diagnosed with HIV associated-visceral adipose tissue (VAT) lipodystrophy with a waist circumference of at least 105 cm AND
  • The following information must be provided at the time of prior authorization request:
    • A baseline IGF-1
    • A baseline waist circumference

Initial approvals will be limited to 3 fills.

Renewal criteria

  • At 3 months of therapy, if the IGF-1 level is > 3 SD, then no more refills will be added AND
  • At 3 months of therapy, if waist circumference has not been reduced, then no more refills will be added AND
  • If neither (a) or (b), then 9 fills may be added

Denial criteria

  • Active malignancy 
  • Pregnancy (pregnancy category X)
  • Patients with a disruption of the hypothalamic-pituitary axis due to hypophysectomy, hypopituitarism or pituitary tumor/surgery, head irradiation or head trauma
  • Known hypersensitivity to tesamorelin or mannitol

Quantity limits

60 vials of 1 mg each of Egrifta™ = 30 day supply

Background information

Tesamorelin (Egrifta™) is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat (defined in clinical trials as 105 cm) in HIV-infected patients with lipodystrophy. Tesamorelin is not indicated for weight loss management; it has a weight neutral effect. Long-term cardiovascular benefit and safety of Egrifta™ have not been studied.  There are no data to support improved compliance with anti-retroviral therapies in HIV-positive patients taking Egrifta™


MHCP Provider Call Center 651-431-2700 or 800-366-5411

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