Egrifta
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™
Questions?
MHCP Provider Call Center 651-431-2700 or 800-366-5411
