CurrentCommunity-CarePolicy N/A

Alpha1‑antitrypsin (AAT) augmentation therapy — Medical Benefit Medication Utilization Policy

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Medical benefit coverage policy for alpha1 proteinase inhibitor products (Aralast‑NP, Glassia, Prolastin‑C, Zemaira) for members with congenital alpha1‑antitrypsin deficiency, governing initial approval, quantity limits, and coding for Community‑Care.

Policy Summary

PayerCommunity-Care

PolicyAlpha1‑antitrypsin (AAT) augmentation therapy — Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewDec 1, 2023

Next Review DateDec 1, 2023

Key ActionObtain prior authorization with documentation including pulmonologist involvement, AAT level below protective threshold, high‑risk genotype, FEV1 ≤ 65% predicted, non‑smoker status, IgA and transplant history, and patient weight.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤65%FEV1 threshold

<11 μM/LProtective AAT level

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CurrentCommunity-CarePolicy N/A

Alpha1‑antitrypsin (AAT) augmentation therapy — Medical Benefit Medication Utilization Policy

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Policy Summary

PayerCommunity-Care

PolicyAlpha1‑antitrypsin (AAT) augmentation therapy — Medical Benefit Medication Utilization Policy

Policy CodePolicy N/A

Change TypeNo material change

Effective DateN/A

Last ReviewDec 1, 2023

Next Review DateDec 1, 2023

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

≤65%FEV1 threshold

<11 μM/LProtective AAT level

Coverage Criteria for Alpha1‑Antitrypsin Augmentation Therapy

Initial Approval

Covered when ALL of the following are met:

Initial approval criteria: (1) Prescribed by, or in consultation with, a pulmonologist; (2) Confirmed diagnosis of congenital alpha1‑antitrypsin deficiency with BOTH: circulating AAT level below the standard protective threshold (method‑specific) AND a high‑risk AATD genotype (SS, SZ, ZZ, or null/null); (3) Diagnosis of emphysema with FEV1 ≤ 65% of predicted; (4) Currently a non‑smoker; (5) Not IgA deficient with anti‑IgA antibodies; (6) No prior liver transplantationCirculating AAT level below protective threshold: < 11 μM/L by rocket immunoelectrophoresis OR < 80 mg/dL by radial immunodiffusion OR < 50 mg/dL by nephelometry

Members with a history of liver transplantation are excluded from coverage. Additionally, members who are IgA deficient with anti‑IgA antibodies are not eligible for augmentation therapy under this policy.

Augmentation therapy is not supported when the member does not meet the policy’s required criteria. Examples include: circulating AAT levels at or above the protective thresholds (not < 11 μM/L by rocket immunoelectrophoresis, not < 80 mg/dL by radial immunodiffusion, or not < 50 mg/dL by nephelometry), absence of a qualifying high‑risk genotype (SS, SZ, ZZ, or null/null), FEV1 > 65% predicted, or continued active smoking. Therapy is also not supported for members who are IgA deficient with anti‑IgA antibodies or who have had a liver transplant.

Coding and Dosing Information

Applicable HCPCS CodesHCPCS

J0256	Injection, alpha 1 proteinase inhibitor (human), not otherwise specified, 10 mg.
J0257	Injection, alpha 1 proteinase inhibitor (human), (glassia), 10 mg.

AAT level and dosing — protective thresholds and dosing limits

Protective thresholds (by assay)< 11 μM/L by rocket immunoelectrophoresis OR < 80 mg/dL by radial immunodiffusion OR < 50 mg/dL by nephelometry

Maximum authorized doseUp to 60 mg/kg per week

Days per fill28 days per fill

Weight requirementMember weight required for approval to calculate dose

Prior Authorization, Documentation, and Denial Triggers

Prior Authorization

Prior Authorization Required

Prior authorization is required for alpha1‑proteinase inhibitor therapy. Requests must meet clinical criteria including documentation that therapy is prescribed by or in consultation with a pulmonologist, confirmed alpha1‑antitrypsin deficiency with qualifying genotype and protective-threshold AAT level, and other medical-necessity criteria.

Prescribing provider: pulmonologist or documented pulmonology consultation
Confirmed diagnosis: circulating AAT below protective threshold (e.g., <11 μM/L by rocket immunoelectrophoresis; <80 mg/dL by radial immunodiffusion; or <50 mg/dL by nephelometry)
Qualifying genotype: SS, SZ, ZZ, or null/null
FEV1 ≤ 65% predicted (diagnosis of emphysema)
Patient is a current non-smoker
Not IgA deficient with anti‑IgA antibodies
No prior liver transplantation

Note

Key Definitions

Protective AAT level — definition and assay-specific thresholds

DefinitionProtective AAT level: circulating alpha1‑antitrypsin level below which patients are considered deficient; specified by assay method

Rocket immunoelectrophoresis threshold< 11 μM/L

Radial immunodiffusion threshold< 80 mg/dL

Nephelometry threshold< 50 mg/dL

High‑risk AATD genotypes

High‑risk genotypes listedSS

High‑risk genotypes listedSZ

Background

Alpha1‑antitrypsin deficiency (AATD) is a congenital, genetic disorder characterized by reduced circulating levels of alpha1‑antitrypsin, which increases the risk of panacinar emphysema. Intravenous augmentation with human alpha1 proteinase inhibitor is used to raise circulating AAT levels and, in appropriately selected patients with AATD‑related emphysema, to slow progression. This policy limits augmentation therapy to members who meet strict diagnostic and clinical criteria—including a circulating AAT level below the method‑specific protective thresholds, a qualifying high‑risk genotype (SS, SZ, ZZ, or null/null), documentation of emphysema with FEV1 ≤ 65% predicted, pulmonologist involvement, and absence of active smoking, IgA antibodies, or prior liver transplant.