J0597 — Injection, c-1 esterase inhibitor (human), berinert, 10 units
HCPCS/CPT
Prior Authorization
No Prior Auth Required
Code is covered without prior authorization (high confidence)
Medicare Pricing
Work RVU
0.00
Facility
N/A
Non-Facility
N/A
Documentation Required
- Laboratory documentation of HAE diagnosis: either C1-INH antigenic level below the laboratory lower limit of normal OR C1-INH functional level below the laboratory lower limit of normal (for Type I/II HAE).
- If C1-INH levels are normal: genetic testing results confirming presence of variant(s) in one of the specified genes (factor XII, angiopoietin-1, plasminogen-1, kininogen-1, myoferlin, heparan sulfate-glucosamine 3-O-sulfotransferase 6).
- If applicable, documentation that angioedema attacks are recurring and refractory to high-dose antihistamines, with either (a) confirmed family history of angioedema or (b) unknown de-novo mutation(s) (HAE-unknown).
- Clinical documentation that the requested medication will be/were used for treatment of an acute HAE attack (i.e., indication of acute episode).
Key Coverage Criteria
- Treatment of an acute hereditary angioedema (HAE) attack with Berinert (C1 esterase inhibitor, human), Ruconest (C1 esterase inhibitor, recombinant), or Kalbitor (ecallantide) when: (a) used for treatment of an acute HAE attack; and (b) not used in combination with other approved treatments for acute HAE attacks (e.g., Berinert, Firazyr, Kalbitor, or Ruconest).
- Initial therapy medical necessity criteria for Berinert, Ruconest, and Kalbitor when all of the following are met: diagnosis of hereditary angioedema (HAE) confirmed by either (a) C1 inhibitor (C1-INH) deficiency or dysfunction (Type I or II HAE) documented by C1-INH antigenic level below the lower limit of normal OR C1-INH functional level below the lower limit of normal; OR (b) normal C1 inhibitor levels and either a confirmed pathogenic variant in one of the listed genes (factor XII, angiopoi [...]
- Berinert is FDA-labeled for treatment of acute abdominal, facial, or laryngeal HAE attacks in adult and pediatric patients (as noted in FDA section).
- Ruconest is FDA-labeled for treatment of acute attacks in adult and adolescent patients with HAE (effectiveness not established in HAE patients with laryngeal attacks).
- Kalbitor (ecallantide) is FDA-labeled for treatment of acute HAE attacks in patients 12 years of age and older.
- Cinryze (C1 esterase inhibitor, human) is indicated for routine prophylaxis against angioedema attacks in adults, adolescents, and pediatric patients 6 years of age and older (note: policy distinguishes coverage between Medical Necessity Plans and Non‑Medical Necessity Plans).
3 Active Policies
UHC-POL-hereditary-angioedema-treatment-prophylaxis — Hereditary Angioedema (HAE), Treatment and Prophylaxis
UMR-POL-UMR-hereditary-angioedema-treatment-prophylaxis — Hereditary Angioedema (HAE), Treatment and Prophylaxis
SUREST-POL-SUREST-hereditary-angioedema-treatment-prophylaxis — Hereditary Angioedema (HAE), Treatment and Prophylaxis
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