Coverage is subject to the specific terms of the member’s benefit plan.
Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.
Givosiran (Givlaari) for an initial six (6) month authorization may be considered medically necessary when ALL of the following criteria are met:
- Individual is 18 years of age or older; and
- Individual is diagnosed with AHP [acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP), delta-aminolevulinic acid dehydratase deficient porphyria (ADP), or no identified mutation] by at least ONE of the following:
- Elevated urine porphobilinogen (PBG); or
- Increased aminolevulinic acid (ALA); or
- Genetic testing confirming a mutation; and
- Individual has a history of symptoms of AHP chronically or during previous acute attack(s) (e.g., abdominal, back, and/or chest pain, weakness, paralysis, respiratory failure, confusion, anxiety, depression, memory loss, fatigue, hallucinations, seizures, skin lesions, hypertension, tachycardia, nausea, vomiting, constipation, hyponatremia, neuropathic pain, sensory loss); and
- Individual has not had a prior liver transplantation; and
- Prescribed by or in consultation with a geneticist, hepatologist, hematologist, gastroenterologist, neurologist, or any healthcare provider with experience managing AHP.
Givosiran (Givlaari) for an additional reauthorization period of 12 months may be considered medically necessary when ALL of the following criteria are met:
- Individual has experienced a positive clinical response indicated by an improvement of the previously reported laboratory value(s) and symptoms; and
- Prescribed by or in consultation with a geneticist, hepatologist, hematologist, gastroenterologist, neurologist, or any healthcare provider with experience managing AHP; and
- Individual has not had a prior liver transplantation.
Givosiran (Givlaari) not meeting the criteria as indicated in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness of this service cannot be established by the available published peer-reviewed literature.