CurrentAetnaPolicy N/A

Alpha‑1 Proteinase Inhibitor Precertification Request

This document is Aetna's precertification request form and required clinical information for initiation or continuation of alpha-1 antitrypsin (AAT) proteinase inhibitor therapy (Aralast NP, Glassia, Prolastin-C, Zemaira) for affected members and their providers.

Policy Summary

PayerAetna

PolicyAlpha‑1 Proteinase Inhibitor Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain precertification and submit completed form with required clinical documentation (AAT level/phenotype, FEV1, prior product response) for initiation or continuation.

SourceLink

POLICY UPDATE CHANGES

No material clinical or coverage changes in this revision.

4listed product options

>=25–<=80%FEV1 initiation range

<11 μmol/LAAT threshold

Precertification phonePrecert phone

Coverage Criteria for Alpha-1 Proteinase Inhibitors

Initial Therapy

Covered when ALL of the following are met:

Initiation criteria: Request is for Aralast NP, Glassia, or Zemaira.

Initiation criteria: Patient has pretreatment post-bronchodilation FEV1 greater than or equal to 25% and less than or equal to 80% of predicted.FEV1 >=25% and <=80% predicted

Initiation criteria: Patient has AAT serum concentration and phenotype/genotype consistent with AAT deficiency (including phenotypes associated with serum AAT < 11 micromol/L [80 mg/dL by radial immunodiffusion] or 50 mg/dL by nephelometry).AAT <11 μmol/L (80 mg/dL) or 50 mg/dL (nephelometry)

Policy Summary

PayerAetna

PolicyAlpha‑1 Proteinase Inhibitor Precertification Request

Policy CodePolicy N/A

Change TypeNo material changes

Effective Date

Next Review Date

Key ActionObtain precertification and submit completed form with required clinical documentation (AAT level/phenotype, FEV1, prior product response) for initiation or continuation.

SourceLink

On This Page

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Continuation Therapy

Covered when ALL of the following are met:

Continuation criteria: Patient is currently receiving the requested drug (including via samples or manufacturer's patient assistance program).

Form asks whether drug is received through samples or assistance program.

Continuation criteria: Patient is experiencing a beneficial clinical response to therapy.benefit documented

Form asks if patient is experiencing beneficial clinical response.

Site of Care / Safety Criteria

Infusion in an outpatient hospital setting is required when any of the following are present:

Outpatient hospital setting required: Patient has experienced an adverse event with the requested product that did not respond to conventional interventions or immediately after an infusion.

Outpatient hospital setting required: Patient has laboratory-confirmed IgA antibodies.

Outpatient hospital setting required: Patient has severe venous access issues requiring special interventions only available in the outpatient hospital setting.

Outpatient hospital setting required: Patient has significant behavioral issues and/or physical or cognitive impairment that would impact infusion safety and does not have access to a caregiver.

Outpatient hospital setting required: Patient is medically unstable (including respiratory, cardiovascular, or renal conditions) that may limit ability to tolerate infusion volume or predispose to severe adverse events that cannot be managed outside the outpatient hospital setting.

The form does not list blanket exclusions by drug; instead coverage is framed around completion of required clinical documentation and meeting specified clinical parameters. Requests must document a diagnosis of alpha-1 antitrypsin (AAT) deficiency and, when applicable, a diagnosis of emphysema due to AAT deficiency. The form directs providers to indicate whether the infusion is to occur in an outpatient hospital setting and to document any conditions (adverse events unresponsive to conventional measures, laboratory‑confirmed IgA antibodies, severe venous access issues, significant behavioral/physical/cognitive impairments without caregiver support, or medical instability) that would necessitate that site of care. Absent the required documentation or indications, approval is unlikely because review depends on the information requested on the form.

Common reasons a request may be non‑covered or deemed incomplete include failure to provide the required clinical fields on the precertification form. Specifically, missing documentation can include lack of a documented diagnosis of AAT deficiency or absence of confirmation that emphysema is due to AAT deficiency; omission of the pretreatment post‑bronchodilation FEV1 value; failure to report the AAT serum concentration and the phenotype/genotype; no statement about prior intolerance, ineffective response to, or contraindication to Prolastin‑C for initiation requests; or missing documentation of benefit for continuation requests. The form notes that all required clinical information must be completed and legible for precertification review and that incomplete submissions may prevent review.

Coding: Diagnosis and Administration Codes, Clinical Thresholds

Administration codesCPT

Administration code(s) (CPT)

Administration CPT codes to be supplied by provider on form

Diagnosis codesICD-10

Primary ICD Code	Primary diagnosis ICD code to be specified on form
Secondary ICD Code	Secondary diagnosis ICD code to be specified

inv-08: Pretreatment post-bronchodilation FEV1 — numeric eligibility range

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

Assessment timingMeasured pretreatment and after bronchodilator administration

Required response on formProvider must indicate Yes/No that FEV1 is within specified range

inv-09: AAT serum concentration threshold — numeric thresholds and measurement methods

Primary AAT serum concentration threshold< 11 micromol/L (80 mg/dL by radial immunodiffusion) or 50 mg/dL by nephelometry

Acceptable reported unitsmg/dL, μmol/L, g/L, or uM/L as specified on form

Provider actionForm requests the patient’s pretreatment AAT serum concentration to be specified with result and units

Provider Actions, Documentation & Precertification Requirements

Prior Authorization

Precertification Required for Alpha-1 Proteinase Inhibitors

Precertification is required for initiation or continuation of alpha‑1 proteinase inhibitor products listed on the precertification request form (e.g., Aralast NP, Glassia, Prolastin‑C, Zemaira). Contact Aetna Precertification Notification to submit requests: Phone 1-866-752-7021 (TTY: 711), Fax 1-888-267-3277. For Medicare Advantage Part B, use the Medicare request form.

Affected products: Aralast NP; Glassia; Prolastin‑C; Zemaira
Submission channels: Phone 1-866-752-7021 (TTY: 711) or Fax 1-888-267-3277
Medicare Advantage Part B: use Medicare request form

Denial Risk

Incomplete Submission Risk

All required clinical fields and supporting documentation listed on the Alpha 1 – Proteinase Inhibitors Medication Precertification Request form must be completed and legible. Incomplete clinical information or missing fields may prevent review and delay or result in denial of the request.

All fields on the precertification form must be completed and legible
Incomplete clinical information or missing fields may prevent review and delay or deny the request

Documentation Required

Required Documentation

Providers must submit the completed precertification request form with all required patient, insurance, prescriber, product, diagnosis, and clinical information. Include supporting clinical documentation as indicated for initiation or continuation requests.

Patient information: name, DOB, contact, weight, height, allergies
Insurance information: Aetna Member ID, group #, other coverage details, Medicare/Medicaid IDs when applicable
Prescriber information: name, specialty, credentials, address, phone, fax, NPI, state license, DEA (if applicable), office contact
Product information: requested product (Aralast NP, Glassia, Prolastin‑C, Zemaira), dose, frequency
Diagnosis information: primary and other relevant ICD codes
Clinical information (all requests): outpatient infusion setting indicator, adverse events to requested product, IgA antibody status, venous access issues, behavioral/physical/cognitive issues affecting infusion safety, medical instability details, documented diagnosis of AAT deficiency and emphysema due to AAT deficiency
Initiation-specific documentation: intolerance/ineffective response or contraindication to Prolastin‑C when requesting Aralast NP, Glassia, or Zemaira; pretreatment post‑bronchodilation FEV1 percent predicted; pretreatment AAT serum concentration and AAT phenotype/genotype (e.g., PiZZ, PiMZ, PiMS, other associated with AAT <11 μmol/L or unknown)
Continuation-specific documentation: indication if receiving samples/manufacturer assistance; documentation of beneficial clinical response to therapy; date of last treatment for continuation requests

Background

Alpha‑1 antitrypsin (AAT) deficiency is an inherited condition addressed by intravenous AAT replacement (augmentation) therapy. The precertification form covers the four listed products and requests clinical information to establish eligibility for initiation or continuation of therapy. For initiation, the form asks whether the request is for Aralast NP, Glassia, or Zemaira, whether the patient had intolerance or ineffective response to Prolastin‑C (or has a contraindication), the patient’s pretreatment post‑bronchodilation FEV1 (≥25% and ≤80% predicted), the measured AAT serum concentration, and the AAT phenotype/genotype (including selections for PiZZ, PiZ (null), Pi (null,null), PiMZ, PiMS, or other phenotypes associated with AAT < 11 μmol/L (80 mg/dL by radial immunodiffusion) or 50 mg/dL by nephelometry). For continuation, the form documents whether the patient is currently receiving drug via samples or assistance programs and whether the patient is experiencing a beneficial clinical response.

Definitions and Laboratory Thresholds

inv-15: AAT level and phenotype/genotype — serum concentration thresholds and phenotype/genotype references

AAT serum concentration and phenotype/genotype linkageForm lists phenotypes/genotypes (PiZZ, PiZ (null), Pi (null,null), PiMZ, PiMS) and an option for other phenotypes associated with AAT < 11 μmol/L (80 mg/dL by radial immunodiffusion or 50 mg/dL by nephelometry)

Phenotype/genotype options on formPiZZ; PiZ (null); Pi (null, null); PiMZ; PiMS; Other phenotype/genotype associated with AAT < 11 μmol/L; Unknown

Documentation requirementProvider must specify both the pretreatment AAT serum concentration (with units) and the protein phenotype or genotype on the form