HEREDITARY ANGIOEDEMA MEDICATION THERAPY

Transcription

1 HEREDITARY ANGIOEDEMA MEDICATION THERAPY Coverage for services, procedures, medical devices drugs are dependent upon benefit eligibility as outlined in the member's specific benefit plan. This Medical Coverage Guideline must be read in its entirety to determine coverage eligibility, if any. This Medical Coverage Guideline provides information related to coverage determinations only does not imply that a service or treatment is clinically appropriate or inappropriate. The provider the member are responsible for all decisions regarding the appropriateness of care. Providers should provide BCBSAZ complete medical rationale when requesting any exceptions to these guidelines. The section identified as Description defines or describes a service, procedure, medical device or drug is in no way intended as a statement of medical necessity /or coverage. The section identified as Criteria defines criteria to determine whether a service, procedure, medical device or drug is considered medically necessary or experimental or investigational. State or federal mates, e.g., FEP program, may dictate that any drug, device or biological product approved by the U.S. Food Drug Administration (FDA) may not be considered experimental or investigational thus the drug, device or biological product may be assessed only on the basis of medical necessity. Medical Coverage Guidelines are subject to change as new information becomes available. For purposes of this Medical Coverage Guideline, the terms "experimental" "investigational" are considered to be interchangeable. BLUE CROSS, BLUE SHIELD the Cross Shield Symbols are registered service marks of the Blue Cross Blue Shield Association, an association of independent Blue Cross Blue Shield Plans. All other trademarks service marks contained in this guideline are the property of their respective owners, which are not affiliated with BCBSAZ. Description: Injectable medications used for treating individuals with hereditary angioedema (HAE) include: Berinert (C1 esterase inhibitor, human) Cinryze (C1 esterase inhibitor, human) Firazyr (icatibant) Kalbitor (ecallantide) Ruconest (C1 esterase inhibitor, recombinant) O829.3.docx Page 1 of 5

2 Criteria: See Resources section for FDA-approved dosage. Berinert: FDA approved dosage of Berinert for treatment of acute abdominal, facial or laryngeal angioedema attacks in individuals 5 years of age or older with hereditary angioedema (HAE) is considered medically necessary with documentation of no previous life-threatening immediate hypersensitivity reactions, including anaphylaxis, to Berinert or its components. Berinert for all other indications not previously listed or if above criteria not met is considered 1. Lack of final approval from the Food Drug Administration, 3. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, These indications include, but are not limited to: Prophylaxis against angioedema attacks in individuals with HAE Cinryze: FDA approved dosage of Cinryze for routine prophylaxis against angioedema attacks in individuals 9 years of age or older with hereditary angioedema (HAE) is considered medically necessary with documentation of no previous life-threatening immediate hypersensitivity reactions, including anaphylaxis, to Cinryze or its components. Cinryze for all other indications not previously listed or if above criteria not met is considered 1. Lack of final approval from the Food Drug Administration, 3. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, O829.3.docx Page 2 of 5

3 Criteria: (cont.) Firazyr: FDA approved dosage of Firazyr for treatment of acute attacks of angioedema in individuals 18 years of age older with hereditary angioedema (HAE) is considered medically necessary. Firazyr for all other indications not previously listed or if above criteria not met is considered 1. Lack of final approval from the Food Drug Administration, 3. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, Kalbitor: FDA approved dosage of Kalbitor for treatment of acute attacks of angioedema in individuals 12 years of age older with hereditary angioedema (HAE) is considered medically necessary with documentation of no previous life-threatening immediate hypersensitivity reactions, including anaphylaxis, to Kalbitor or its components. Kalbitor for all other indications not previously listed or if above criteria not met is considered 1. Lack of final approval from the Food Drug Administration, 3. Insufficient evidence to support improvement of the net health outcome, than, established alternatives, O829.3.docx Page 3 of 5

4 Criteria: (cont.) Ruconest: FDA approved dosage of Ruconest for treatment of acute attacks in individuals 13 years of age or older with hereditary angioedema (HAE) is considered medically necessary with documentation of no previous life-threatening immediate hypersensitivity reactions, including anaphylaxis, to Ruconest or its components. Ruconest for all other indications not previously listed or if above criteria not met is considered 1. Lack of final approval from the Food Drug Administration, 3. sufficient evidence to support improvement of the net health outcome, than, established alternatives, These indications include, but are not limited to: The use in HAE individuals with laryngeal attacks Resources: Literature reviewed 09/27/16. We do not include marketing materials, poster boards nonpublished literature in our review. Berinert Package Insert: - FDA-approved indication dosage: Treatment of acute abdominal, facial or laryngeal attacks of hereditary angioedema (HAE) in adult pediatric individuals. The safety efficacy of Berinert for prophylactic therapy have not been established. For intravenous use only. Administer 20 International Units per kg body weight. Inject at a rate of approx. 4mL per minute. O829.3.docx Page 4 of 5

5 Resources: (cont.) Cinryze Package Insert: - FDA-approved indication dosage: Routine prophylaxis against angioedema attacks in individuals 13 years of age or older with hereditary angioedema (HAE). For intravenous use only. Administer 1,000 Units Intravenous every 3 or 4 days. Inject at a rate of approx 1 ml/min. Firazyr Package Insert: - FDA-approved indication dosage: Treatment of acute attacks of hereditary angioedema (HAE) in individuals 18 years of age older. Administer 30 mg injected subcutaneously in the abdominal area. If response is inadequate or symptoms recur, additional injections of 30 mg may be administered at intervals of at least 6 hours. Do not administer more than 3 injections in 24 hours. Kalbitor Package Insert: - FDA-approved indication dosage: Treatment of acute attacks of hereditary angioedema (HAE) in individuals 12 years of age older. Administer 30 mg injected subcutaneously in three 10 mg (1 ml) Injections. If an attack persists, an additional dose of 30 mg may be administered within a 24 hour period. Ruconest Package Insert: - FDA-approved indication dosage: Treatment of acute attacks in individuals 13 years of age or older with hereditary angioedema (HAE). Effectiveness has not been established in HAE patients with laryngeal attacks. For intravenous use only. Administer over approx. 5 minutes. If body weight < 84 kg, administer 50 IU per kg. If body weight > or = to 84 kg, administer 4200IU (2 vials). If the attack symptoms persist, an additional (second) dose can be administered at the recommended dose level. Do not exceed 4200 IU per dose. No more than two doses should be administered within a 24 hour period. O829.3.docx Page 5 of 5