Coverage is subject to the specific terms of the member’s benefit plan.
The use of givosiran (Givlaari) may be considered medically necessary when ALL of the following criteria are met:
- The individual must meet criteria as outlined in prescribing information (PI) including recommendations for diagnosis and age; and
- The prescriber is, or is in consult with, a geneticist, hepatologist, hematologist, gastroenterologist, or specialist in acute hepatic porphyria (AHP); and
- The individual must have a diagnosis of AHP (i.e., acute intermittent porphyria (AIP), variegate porphyria (VP), hereditary coproporphyria (HCP), delta-aminolevulinic acid dehydratase deficient porphyria (ADP)) with the following as defined by laboratory reference range (evidenced with submitted documentation):
- Elevated urine porphobilinogen (PBG); and
- Increased aminolevulinic acid (ALA); and
- Genetic testing confirming a mutation; and
- The individual has addressed identifiable lifestyle triggers (e.g. certain drugs, smoking, stress); and
- The individual has had two documented porphyria attacks within the past 6 months requiring hospitalization, urgent healthcare visit, or intravenous hemin administration (number of attacks and days of hemin are documented); and
- The individual has not had a liver transplant.
Initial Authorization: 6 months
Continuation of therapy with givosiran (Givlaari) may be considered medically necessary when ALL of the following criteria is met:
- The individual has not had a liver transplant; and
- The individual has had a meaningful reduction (e.g., 30%) in each of the following:
- Number of porphyria attacks; and
- Days of Hemin Use; and
- Reduction in urinary ALA.
Continuation Authorization: 12 months
Givosiran (Givlaari) for any other indication is considered not medically necessary and therefore, not covered.