RUCONEST — Blue Cross Blue Shield of Illinois

Preferred products

• icatibant (generic equivalent of Firazyr)

Initial criteria

• Diagnosis of HAE confirmed by laboratory or genetic testing (C1-INH protein level, function, C4 level, or mutation in C1-INH gene for Type 1 or Type 2; or mutation in listed genes or confirmation by HAE specialist for HAE-nI-C1INH)
• If FDA labeled indication: patient’s age is within FDA labeling for requested agent OR supported use for age range
• Medications known to cause angioedema (ACE inhibitors, estrogens, ARBs) have been evaluated and discontinued when appropriate
• Requested agent will be used to treat acute HAE attacks
• If request is for a brand with a generic equivalent (Firazyr/icatibant), then ONE of: (A) member of eligible BCBS groups; OR (B) currently stable on brand; OR (C) inadequate response to generic; OR (D) generic discontinued due to inefficacy or adverse event; OR (E) intolerance/hypersensitivity to generic; OR (F) labeled contraindication to generic not expected with brand; OR (G) generic expected ineffective or causes barrier to care; OR (H) not in best interest of patient; OR (I) tried other same class drug discontinued for ineffectiveness or adverse event; OR (J) support for use of brand over generic
• Prescriber is a specialist in allergy/immunology or has consulted with such a specialist
• Requested agent will NOT be used in combination with another acute HAE treatment (Berinert, Ekterly, Firazyr, icatibant, KALBITOR, RUCONEST)
• Patient does NOT have any FDA labeled contraindications to the requested agent
• For BCBS MT Fully Insured or HIM: patient <18 years, no labeled contraindications, indication supported by ≥2 peer-reviewed studies as safe and effective, and age bracket supported by ≥2 studies
• For BCBS NM Fully Insured or HIM: indication is a rare disease, no labeled contraindications, and (1) another FDA labeled indication OR (2) compendia-supported indication OR (3) two peer-reviewed articles support off-label use
• For BCBS OH Fully Insured or HIM: same as NM with additional requirements: member resides in Ohio, plan Fully Insured/HIM Shop, no labeled contraindications, and supportive compendia/peer-reviewed evidence

Reauthorization criteria

• Previously approved for requested agent through plan’s PA process
• Prescriber is a specialist or has consulted a specialist in allergy/immunology
• Patient has had clinical benefit from the requested agent
• For brand with generic equivalent (Firazyr/icatibant), then ONE of: (A) covered BCBS group; OR (B) currently stable; OR (C) inadequate response to generic; OR (D) discontinued generic for inefficacy/adverse event; OR (E) intolerance/hypersensitivity to generic; OR (F) labeled contraindication to generic not expected with brand; OR (G) generic expected ineffective or causes barrier to care; OR (H) not in best interest; OR (I) tried another class drug discontinued for effect/adverse event; OR (J) support for use of brand over generic
• Prescriber has communicated with patient regarding attack frequency/severity and verified no more than 1‑month supply (for 2 acute attacks) on hand
• Requested agent not used in combination with another acute HAE agent (Berinert, Ekterly, Firazyr, icatibant, KALBITOR, RUCONEST)
• Patient does NOT have any FDA labeled contraindications

Approval duration

6–12 months (plan dependent); renewals 12 months