Criteria
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
Reauthorization Criteria
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.
Procedure Codes
