ONPATTRO (patisiran for intravenous infusion)

Patisiran for intravenous infusion (Onpattro™)

OFFICE ADMINISTRATION

Indications for Prior Authorization:

• Treatment of the polyneuropathy of hereditary transthyretin-mediated amyloidosis in adults

Patients must meet the following criteria for the indication(s) above:

• Diagnosis of polyneuropathy of hereditary amyloid transthyretin-mediated amyloidosis (hATTR), AND
• Is prescribed by or in consultation with a neruologist, geneticist, or a physician who specializes in the treatment of amyloidosis, AND
• The patient is 18 years of age or older, AND
• The patient has a documented transthyretin (TTR) mutation verified by genetic testing, AND
• The patient has symptomatic peripheral neuropathy (e.g., reduced motor strength/coordination, impaired sensation [e.g., pain, temperature, vibration, touch])

Dosing:

• For patients weighing < 100 kg: the recommended dosage is 0.3 mg/kg intravenously (IV) once every 3 weeks
• For patients weighing ≥ 100 kg: the recommended dosage is 30 mg IV once every 3 weeks 
• Onpattro should be administered by a healthcare professional along with premedications to reduce risk of infusion-related reactions

Approval:

• One year