MHCP Enrolled Providers – Pharmacies

Fee-for-Service PA Criteria Sheet – Egrifta™

(June 2016)

Drug

Egrifta (tesamorelin) [Theratechnologies, Inc.]

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

    a) At 3 months of therapy, if the IGF-1 level is > 3 SD, then no more refills will be added AND

    b) At 3 months of therapy, if waist circumference has not been reduced, then no more refills will be added AND

    c) 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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