Ruconest — Medical Mutual

Initial criteria

• The requested medication will not be used for Hereditary Angioedema (HAE) prophylaxis
• The requested medication will not be used to treat Hereditary Angioedema (HAE) patients with laryngeal attacks
• Patient has low levels of functional C1-INH protein (< 50% of normal) OR patient has lower than normal serum C4 levels (< 14 mg/dL) AND lower than normal C1-INH level (< 19.9 mg/dL) [documentation required]
• The medication is prescribed by or in consultation with an allergist, immunologist, hematologist or a physician that specializes in the treatment of HAE or related disorders
• Provider has determined that patient does not have a known or suspected allergy to rabbits and rabbit-derived products
• All other causes of acquired angioedema (e.g., medications, auto-immune diseases) have been excluded
• Patient has at least ONE of the following: history of self-limiting, non-inflammatory subcutaneous angioedema, without urticaria, recurrent and lasting >12 hours OR self-limiting, recurrent abdominal pain without a clear organic cause lasting >6 hours
• Patient must NOT have HAE with laryngeal attacks
• Ruconest is not used in combination with other approved treatments for acute HAE attacks (e.g. Berinert, Firazyr, Kalbitor)
• Site of care medical necessity is met

Reauthorization criteria

• Patient has low levels of functional C1-INH protein (< 50% of normal) OR patient has lower than normal serum C4 levels (< 14 mg/dL) AND lower than normal C1-INH level (< 19.9 mg/dL) [documentation required]
• The medication is prescribed by or in consultation with an allergist, immunologist, hematologist or a physician that specializes in the treatment of HAE or related disorders
• Provider has determined that patient does not have a known or suspected allergy to rabbits and rabbit-derived products
• All other causes of acquired angioedema (e.g., medications, auto-immune diseases) have been excluded
• Patient has at least ONE of the following: history of self-limiting, non-inflammatory subcutaneous angioedema, without urticaria, recurrent and lasting >12 hours OR self-limiting, recurrent abdominal pain without a clear organic cause lasting >6 hours
• Patient must NOT have HAE with laryngeal attacks
• Ruconest is not used in combination with other approved treatments for acute HAE attacks (e.g. Berinert, Firazyr, Kalbitor)
• Patient has at least 1 annual assessment by an HAE specialist
• The patient has had a favorable clinical response to treatment with Ruconest (e.g. decrease in the duration of HAE attacks, quick onset of symptom relief, complete resolution of symptoms, decrease in HAE acute attack frequency or severity)
• Site of care medical necessity is met

Approval duration

1 year initial, 1 year reauth