CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Alpha1‑Proteinase Inhibitor Augmentation Therapy (Aralast NP, Glassia, Prolastin‑C, Zemaira)

Covers criteria, documentation, and authorization rules for chronic augmentation therapy with alpha1‑proteinase inhibitors for members with emphysema due to severe congenital/hereditary alpha1‑antitrypsin (AAT) deficiency; affects providers requesting prior authorization for listed products.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAlpha1‑Proteinase Inhibitor Augmentation Therapy (Aralast NP, Glassia, Prolastin‑C, Zemaira)

Policy CodePolicy N/A

Change TypeNo material changes

Effective DateN/A

Next Review DateN/A

Key ActionSubmit pretreatment serum AAT level, pretreatment post‑bronchodilation FEV1, and AAT phenotype or genotype with prior authorization request.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4FDA‑approved products listed

12 monthsAuth duration (initial/cont)

<11 μmol/LSerum AAT threshold

25%–80% predictedFEV1 eligibility

Coverage Criteria

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Initial approval — Emphysema due to AAT deficiency

Authorization of 12 months may be granted when ALL of the following are met:

Initial approval criteria: 1. The member's pretreatment serum AAT level is less than 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry). 2. The member's pretreatment post-bronchodilation FEV1 is greater than or equal to 25% and less than or equal to 80% of predicted. 3. The member has a documented AAT deficiency phenotype/genotype consistent with severe deficiency (examples: PiZZ, PiZ (null), Pi (null, null) homozygous) or other phenotype/genotype associated with serum AAT < 11 micromol/L. 4. The member does not have the PiMZ or PiMS phenotype. 5. Required documentation submitted: pretreatment serum AAT level, pretreatment post-bronchodilation FEV1, and AAT protein phenotype or genotype.

Applies to listed products: Aralast NP, Glassia, Prolastin-C, Zemaira.

Continuation of therapy

Authorization of 12 months may be granted for continued treatment when the following is met:

Continuation criteria: Member is experiencing beneficial clinical response from therapy.

Continuation approvals are for 12 months.

All indications that are not among the product-specific FDA‑approved uses listed for Aralast NP, Glassia, Prolastin‑C, and Zemaira are considered experimental/investigational and not medically necessary.

Use of alpha1‑proteinase inhibitors (any product) for indications other than the FDA‑approved chronic augmentation/maintenance therapy for emphysema due to severe congenital or hereditary alpha1‑proteinase inhibitor (alpha1‑antitrypsin) deficiency is considered not medically necessary and may be denied.

Coding and Key Clinical Thresholds

Serum AAT level — eligibility threshold

Serum AAT thresholdPretreatment serum AAT level < 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry)

Alternate assay values80 mg/dL (radial immunodiffusion) or 50 mg/dL (nephelometry)

Clinical contextRequired as part of initial prior‑authorization criteria for augmentation therapy in emphysema due to AAT deficiency

Pretreatment post-bronchodilation FEV1 — eligibility window

FEV1 eligibility windowPretreatment post‑bronchodilation FEV1 ≥ 25% and ≤ 80% of predicted

Test conditionPost‑bronchodilation measurement required (pretreatment)

Use in prior authorizationMeasured FEV1 is required documentation to meet initial approval criteria for augmentation therapy

Severe AAT deficiency — definition

Definition — severe AAT deficiencyPretreatment serum AAT level < 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry)

Compatible phenotypes/genotypesDocumented PiZZ, PiZ (null), Pi (null,null) homozygous, or other phenotype/genotype associated with AAT < 11 micromol/L

ExclusionsPhenotypes PiMZ or PiMS do not meet criteria

Provider Actions and Authorization Requirements

Prior Authorization

Prior Authorization Required

Prior authorization is required for alpha1‑proteinase inhibitor therapy. Approval may be granted for up to 12 months when all clinical criteria and documentation requirements are met.

Authorization up to 12 months when criteria met

Documentation Required

Required Documentation for Prior Authorization

Submit the following documentation with the prior authorization request to support medical necessity: pretreatment serum AAT level, pretreatment post‑bronchodilation FEV1, and AAT protein phenotype or genotype. Incomplete documentation may delay review or lead to denial.

Pretreatment serum alpha1‑antitrypsin (AAT) level (report units and assay method if available)
Pretreatment post‑bronchodilation FEV1 (expressed as % predicted)
AAT protein phenotype or genotype (document PiZZ, PiZ (null), Pi (null,null) homozygous or other genotype associated with AAT < 11 micromol/L)

Denial Risk

Provider Action / Denial Risk

Provider action: ensure submitted clinical data meet numeric thresholds in the policy. Requests for members with PiMZ or PiMS phenotypes or without documented AAT < 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry) will not meet criteria.

Do not submit requests for PiMZ or PiMS phenotypes — these are excluded
Confirm and document serum AAT < 11 micromol/L (80 mg/dL RID or 50 mg/dL nephelometry)
Confirm pretreatment post‑bronchodilation FEV1 is ≥25% and ≤80% predicted

Note

Non‑approved Indications

Use FDA‑approved indications as the coverage boundary. Use for indications other than chronic augmentation/maintenance therapy for emphysema due to severe congenital AAT deficiency is considered experimental/investigational and is not medically necessary.

Covered only for FDA‑approved chronic augmentation/maintenance indications for Aralast NP, Glassia, Prolastin‑C, Zemaira
All other indications are experimental/investigational and not medically necessary