CurrentMass General Brigham Health PlanPolicy N/A

Alpha-1 Proteinase Inhibitors (human) — Pharmacy Benefit Prior Authorization

Clinical coverage policy governing pharmacy benefit prior authorization for human plasma alpha-1 antitrypsin (AAT) products (Aralast NP, Glassia, Prolastin-C, Zemaira) for members with AAT deficiency and clinically evident emphysema.

Policy Summary

PayerMass General Brigham Health Plan

PolicyAlpha-1 Proteinase Inhibitors (human) — Pharmacy Benefit Prior Authorization

Policy CodePolicy N/A

Change TypeMoved to pharmacy benefitapproval duration clarified

Effective DateJan 1, 2026

Next Review DateJan 1, 2026

Key ActionObtain prior authorization under the pharmacy benefit and document AAT deficiency, clinically evident emphysema, pretreatment serum AAT, and pretreatment post-bronchodilation FEV1.

SourceLink

POLICY UPDATE CHANGES

Updated policy to no longer apply to the medical benefit and clarified language for members who are new to the plan.

Updated criteria for members new to the plan within the past 90 days who are currently receiving treatment with the requested medication.

Changed approval duration from indefinite to 36 months for initial approvals and reauthorizations.

4Products listed

36 monthsApproval duration (initial/reauth)

<=11Pretreatment serum AAT

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25%-80%FEV1 requirement

Coverage Criteria

Initial Authorization

Authorization may be granted when ALL of the following are met (or OR per new-to-plan rule):

New-to-plan continuity: Member new to the plan within the past 90 days and currently receiving treatment with the requested medication (excluding products obtained as samples or via manufacturer's patient assistance programs)

Alternative pathway to authorization

Standard initial criteria: 1. Member has a diagnosis of alpha 1-antitrypsin (AAT) deficiency; 2. Member has clinically evident emphysema; 3. Member's pretreatment serum AAT level is < 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry); 4. Member's pretreatment post-bronchodilation FEV1 is >= 25% and <= 80% of predicted; 5. For Aralast NP, Glassia, and Zemaira: documented intolerance, inadequate response, or contraindication to Prolastin-C must be provided

All conditions must be met

Continuation of Therapy

Requests for reauthorization will be approved when ALL of the following are met:

Continuation requirement: Documentation of improvement of member's condition

Approval duration up to 36 months per Limitations

Products obtained as samples or through a manufacturer's patient assistance program are excluded from the new-to-plan continuity pathway. For members who are new to the plan within the past 90 days, authorization for ongoing therapy will only be considered when the member is currently receiving the requested medication and the product was not acquired as a sample or via the manufacturer's assistance program.

Laboratory and Pulmonary Function Thresholds

Pretreatment serum AAT level

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

Measurement methods specifiedRadial immunodiffusion (RID) reported as 80 mg/dL; nephelometry reported as 50 mg/dL

Role in eligibilityPretreatment value must be below this threshold to meet initial authorization criteria

Pretreatment post-bronchodilation FEV1

Pretreatment post-bronchodilation FEV1>= 25% and <= 80% of predicted

Timing of measurementFEV1 must be measured post-bronchodilation prior to initiation

Provider Actions and Authorization Rules

Prior Authorization

Prior authorization required (Pharmacy Benefit)

Prior authorization is required under the pharmacy benefit for Aralast NP, Glassia, Prolastin-C, and Zemaira. Members new to the plan within the past 90 days who are currently receiving treatment may be authorized through the new-to-plan pathway (see continuity rules).

This policy applies to the pharmacy benefit (policy effective 01/01/2026).

Step Therapy

Step therapy: must trial or fail Prolastin‑C

For Aralast NP, Glassia, and Zemaira, approval requires documentation that the member has had a documented intolerance, inadequate response, or a contraindication to Prolastin-C prior to authorizing those products.

This step-therapy requirement applies specifically to Aralast NP, Glassia, and Zemaira (not Prolastin-C).

Background

Human plasma alpha-1 antitrypsin (AAT) products (Aralast NP, Glassia, Prolastin-C, Zemaira) are indicated for long-term augmentation and maintenance therapy in adults with severe hereditary AAT deficiency who have clinically evident emphysema. These products are used to raise circulating AAT levels to help protect the lung from ongoing protease-mediated damage due to inadequate inhibition of neutrophil elastase.

Definitions

Clinically evident emphysema

DefinitionPresence of emphysema symptoms and objective evidence attributable to AAT deficiency

Clinical contextAAT products are indicated for adults with severe hereditary AAT deficiency with clinically evident emphysema

Documentation expectationProviders should document both symptoms and objective findings linking emphysema to AAT deficiency

Policy Summary

PayerMass General Brigham Health Plan

PolicyAlpha-1 Proteinase Inhibitors (human) — Pharmacy Benefit Prior Authorization

Policy CodePolicy N/A

Change TypeMoved to pharmacy benefitapproval duration clarified

Effective DateJan 1, 2026

Next Review DateJan 1, 2026

Key ActionObtain prior authorization under the pharmacy benefit and document AAT deficiency, clinically evident emphysema, pretreatment serum AAT, and pretreatment post-bronchodilation FEV1.

SourceLink

On This Page

Value must fall within this range to meet initial authorization criteria

Documentation Required

Required documentation for authorization

Documentation must include the diagnosis of alpha-1 antitrypsin (AAT) deficiency, evidence of clinically evident emphysema, the pretreatment serum AAT level with the laboratory method and value, and the pretreatment post-bronchodilation FEV1 percent predicted. For reauthorization, include documentation of improvement in the member's condition.

Pretreatment serum AAT level with method: radial immunodiffusion (80 mg/dL) or nephelometry (50 mg/dL).
Pretreatment post-bronchodilation FEV1 percent predicted.

Denial Risk

Criteria-based denial risks

Authorization may be denied if the member does not have a documented diagnosis of AAT deficiency, lacks clinically evident emphysema, has a pretreatment serum AAT level at or above the specified threshold, or has a pretreatment post-bronchodilation FEV1 outside 25%–80% predicted. For Aralast NP, Glassia, and Zemaira, authorization may also be denied if there is no documented intolerance, inadequate response, or contraindication to Prolastin‑C.

Pretreatment serum AAT threshold: less than 11 micromol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry).
Pretreatment post-bronchodilation FEV1 requirement: ≥25% and ≤80% of predicted.

Denial Risk

New-member and acquisition restrictions

Authorization may be denied for members new to the plan who are not currently receiving the requested medication, and continuity authorization does not apply if the product was obtained as samples or through the manufacturer's patient assistance programs.

New-to-plan continuity applies only to members within the past 90 days who are currently receiving the medication and excludes products obtained as samples or via manufacturer assistance.