Givosiran (GivlaariTM) is an aminolevulinate synthase 1-directed small interfering RNA that causes degradation of aminolevulinate synthase 1 (ALAS1) mRNA in hepatocytes through RNA interference, reducing the elevated levels of liver ALAS1 mRNA. This leads to reduced circulating levels of neurotoxic intermediates aminolevulinic acid (ALA) and porphobilinogen (PBG), factors associated with attacks and other disease manifestation of acute hepatic porphyria (AHP). Givosiran (Givlaari) is, therefore, indicated for the treatment of adults with AHP.
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:
Givosiran (Givlaari) for an additional reauthorization period of 12 months may be considered medically necessary when ALL of the following criteria are met:
Givosiran (Givlaari) for any other indication is considered not medically necessary and therefore, not covered.
Outpatient HCPCS (C Codes)
NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.