Alpha1-Proteinase Inhibitors (Human): Aralast NP, Glassia, Prolastin-C, Zemaira
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Defines prior authorization, coverage criteria, and renewal requirements for human alpha1-proteinase inhibitor products (Aralast NP, Glassia, Prolastin-C, Zemaira) for treatment of congenital alpha1-antitrypsin deficiency with emphysema for Maryland Physicians Care members and prescribers.
No material clinical or coverage changes in this revision.
Coverage Criteria for Alpha1-Proteinase Inhibitors
Initial Therapy
Covered when ALL of the following are met:
Initial approvals are for 6 months per policy; dosing must follow manufacturer's guidelines
Continuation Therapy
Reauthorization considered annually when ALL of the following are documented:
Initial approvals are 6 months; reauthorization may be extended at 12-month intervals when criteria are met. Members with prior approvals from other insurers or receiving samples should be re-evaluated under the initial criteria.
Alpha1-Proteinase Inhibitors (human) are investigational or experimental and will not be covered for any indications other than augmentation/maintenance therapy for congenital alpha1‑antitrypsin deficiency with clinically evident emphysema. This limitation applies to all uses outside of the approved augmentation indication and includes off‑label and investigational applications; such requests will be denied and referred for Medical Director review per policy.
Coding and Laboratory Thresholds
Provider Requirements, Prior Authorization, and Documentation
Prior authorization required for listed AAT products
Prior authorization is required for Aralast NP, Glassia, Prolastin‑C, and Zemaira. Initial approvals are granted for 6 months; reauthorization is reviewed and may be extended at 12‑month intervals when renewal criteria are met.
Attest to concurrent conventional emphysema therapy
The prescriber must attest that conventional (standard) therapy for emphysema will continue to be used concurrently with augmentation therapy.
Required documentation to support authorization
Documentation must include proof the medication is prescribed by or in consultation with a pulmonologist, baseline AAT phenotype and quantitative serum level, smoking history, an attestation that conventional emphysema therapy continues, and for renewals chart documentation of continued candidacy and positive response to therapy.
- Pulmonologist prescribing or consultation
- Baseline AAT phenotype (PI*ZZ, PI*ZNull, or PI*NullNull) and baseline (pretreatment) serum AAT < 11 μmol/L (or <50 mg/dL by nephelometry or <80 mg/dL by radial immunodiffusion)
- Non‑smoker or quit smoking ≥ 6 months (smoking history)
- Prescriber attestation that conventional therapy for emphysema will continue concurrently
- For renewals: provider documentation member remains a candidate and chart evidence of positive response to therapy
Denial triggers and investigational uses
Requests that do not meet the established criteria are referred to a Medical Director for review; agents used for indications other than augmentation/maintenance therapy for AAT deficiency with clinically evident emphysema are considered investigational and not covered.
- Requests failing to meet all initial or renewal criteria will be escalated to Medical Director review
- Use of Alpha1‑Proteinase Inhibitors for any indication other than augmentation/maintenance in AAT deficiency with clinically evident emphysema is investigational and will not be covered
Background
Alpha1‑antitrypsin (AAT) deficiency is a hereditary disorder characterized by reduced circulating AAT, the major inhibitor of neutrophil elastase. Loss of AAT’s protective effect permits unopposed elastase activity, leading to degradation of elastin and extracellular matrix and increased risk of early‑onset panacinar emphysema. Augmentation therapy with human alpha1‑proteinase inhibitor products is used to provide chronic augmentation and maintenance of serum AAT levels in individuals with congenital AAT deficiency and clinically evident emphysema to slow progression of lung tissue destruction.
Definitions
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