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 FDA-approved label for use (e.g., use outside of studied population will be considered investigational); and
- Givosiran (Givlaari) must be prescribed by, or 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 (2) documented porphyria attacks within the past six (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: Six (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 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.
Givosiran (Givlaari) for all other indications not listed in this policy is considered experimental/investigational and therefore non-covered because the safety and/or effectiveness cannot be established by the available published peer-reviewed literature.
Procedure Codes
