MHCP Enrolled Providers – Pharmacies

Fee-for-Service PA Criteria Sheet – Egrifta

(July 2011)

Drug

Egrifta (tesamorelin) [EMD Serono]

Available as 1 mg in a single use vial for reconstitution

Dose is 2 mg SubQ once daily

FDA approved indication

Tesamorelin (Egrifta™) is a growth hormone releasing factor (GRF) analog indicated for the reduction of excess abdominal fat* in HIV-infected patients with lipodystrophy.

Tesamorelin is not indicated for weight loss management; it has a weight neutral effect.

*Defined in clinical trials as 105 cm

Criteria

A.

Patient has been diagnosed with HIV associated-visceral adipose tissue (VAT) lipodystrophy with a waist circumference of at least 105 cm AND

B.

A baseline IGF-1 is logged AND

C.

An accurate baseline waist circumference is logged AND

D.

The first PA is limited to 3 fills And

E.

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

F.

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

G.

If neither (E) or (F), then 9 fills may be added

Exclusion 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
  • MHCP Provider Call Center (651) 431-2700 or 1-800-366-5411


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