Alpha-1 Proteinase Inhibitors
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Medical necessity policy for use, precertification, and continuation of alpha-1 proteinase inhibitors (Aralast NP, Glassia, Prolastin-C, Zemaira) for treatment of emphysema due to alpha1-antitrypsin deficiency; applies to Medical and Pharmacy Utilization Management departments and participating providers/members.
No material clinical or coverage changes in this revision.
Coverage Criteria
Initial Approval — Covered when ALL of the following are met:
Covered when ALL of the following are met:
All conditions required
Continuation of Therapy — Covered when:
Covered when:
Clinical benefit must be documented
Brand Selection / Step Therapy — Coverage preference:
Coverage preference:
Precertification required
Replacement therapy with alpha‑1 proteinase inhibitor (AAT inhibitor) is considered experimental and investigational for individuals who have AAT deficiency but do not have clinical evidence of emphysema, because there is no proven value for augmentation therapy in this population.
Aralast NP, Glassia, and Zemaira are medically necessary only when Prolastin‑C is contraindicated, not tolerated, or has been tried and found ineffective. These products are considered more costly than Prolastin‑C and there is insufficient evidence of superiority over the lower‑cost alternative.
Coding and Clinical Thresholds
Provider Actions and Prior Authorization
Precertification required
Precertification (prior authorization) is required for all alpha‑1 proteinase inhibitor products (Aralast NP, Glassia, Prolastin‑C, and Zemaira) for Curative participating providers and members in applicable plan designs.
Preferred product / step therapy
Curative requires a trial of the lower‑cost product Prolastin‑C before authorizing Aralast NP, Glassia, or Zemaira unless there is a documented contraindication, intolerance, or ineffective trial to Prolastin‑C.
- Prolastin‑C is the preferred (lower cost) product.
- Aralast NP, Glassia, and Zemaira are medically necessary only if Prolastin‑C is contraindicated, not tolerated, or ineffective.
Required clinical documentation
Documentation submitted with precertification must include the member's pretreatment serum AAT level, pretreatment post‑bronchodilator FEV1 (% predicted), and genotype/phenotype confirming PiZZ, PiZ (null), or equivalent homozygous deficiency; if requesting Aralast NP, Glassia, or Zemaira, include documentation of contraindication, intolerance, or ineffective trial to Prolastin‑C.
- Pretreatment serum AAT level < 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry).
- Pretreatment post‑bronchodilator FEV1 ≥ 25% and ≤ 80% of predicted.
- Documented PiZZ, PiZ (null), or Pi (null,null) homozygous AAT deficiency (or equivalent phenotype/genotype).
- If requesting Aralast NP, Glassia, or Zemaira, documentation that Prolastin‑C was contraindicated, not tolerated, or ineffective.
Denial risk for brand selection without Prolastin‑C trial
Requests for Aralast NP, Glassia, or Zemaira may be denied as not medically necessary if Prolastin‑C has not been tried and shown to be contraindicated, not tolerated, or ineffective.
Definitions
Background
Alpha1‑antitrypsin (AAT) deficiency is a hereditary condition that can lead to panacinar emphysema in some affected individuals. Augmentation therapy with purified human alpha‑1 proteinase inhibitor is used to treat emphysema in patients with severe AAT deficiency and clinical evidence of emphysema. Because not all persons with AAT deficiency develop emphysema, replacement therapy has no proven benefit for individuals without clinical emphysema and is therefore considered experimental and investigational in that group.
For brand selection, Curative regards Aralast NP, Glassia, and Zemaira as more costly alternatives to Prolastin‑C. There is a lack of reliable evidence that these brands are superior to Prolastin‑C; consequently, they are authorized only when Prolastin‑C is contraindicated, not tolerated, or ineffective. Precertification of alpha‑1 proteinase inhibitors (Aralast NP, Glassia, Prolastin‑C, and Zemaira) is required for participating providers and members in applicable plan designs.
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