GIVLAARI (givosiran) 

OFFICE ADMINISTRATION – Subcutaneous

Indications for Prior Authorization:
  • Indicated for the treatment of adults with acute hepatic porphyria (AHP)
Patients must meet the following criteria for the indication(s) above:
  • Patient is 18 years of age or older, AND
  • Prescribed by or in consultation with a gastroenterologist or specialist in acute hepatic porphyria, AND
  • Diagnosis of acute hepatic porphyria (AHP) (i.e., acute intermittent porphyria, hereditary coproporphyria, variegate porphyria, ALA dehydrase deficient porphyria), AND
  • Lifestyle factors that could trigger acute attacks have been addressed and modified (e.g., CYP450 inducing drugs, diet changes, hormonal fluctuations, etc.), AND
  • Patient has active disease with at least two documented porphyria attacks within the past 6 months, AND
  • Patient has elevated urinary or plasma levels of one of the following within the past 12 months:
    • Porphobilinogen (PBG)
    • Delta-aminolevulinic acid (ALA), AND
  • Patient has not had a liver transplant
Reauthorization criteria:
  • Prescribed by or in consultation with a gastroenterologist or specialist in acute hepatic porphyria, AND
  • Patient is responding positively to Givlaari™ (reduction in number of hemin administration requirements AND reduction in number of porphyria attacks), AND
  • Patient has not had a liver transplant
Dosing:
  • 2.5 mg/kg once monthly by subcutaneous injection
  • Givlaari™ is intended for subcutaneous use by a healthcare professional only.
  • Ensure medical support is available to appropriately manage anaphylactic reactions when administering Givlaari™.
  • Concomitant use of Givlaari™ with CYP1A2 or CYP2D6 substrates should be avoided when possible
Approval:
  • Initial: 6 months
  • Renewal: 12 months

Last review date: May 19, 2020

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