GIVLAARI (givosiran)

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