CurrentNeighborhood Health Plan of Rhode IslandPolicy N/A

Aralast NP; Glassia; Prolastin-C; Zemaira (Intravenous)

Coverage policy for intravenous alpha1-proteinase inhibitor augmentation/maintenance therapy (Aralast NP, Glassia, Prolastin-C, Zemaira) for Medicaid, Commercial, and Medicare-Medicaid Plan members; defines approval duration, quantity limits, dosing, clinical initial and renewal criteria, exclusions and billing codes/NDCs/HCPCS.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAralast NP; Glassia; Prolastin-C; Zemaira (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2020

Next Review DateN/A

Key ActionInitial coverage provided for 6 months and may be renewed; renewals require documentation of continued criteria, disease response, and absence of unacceptable toxicity.

POLICY UPDATE CHANGES

No material clinical or coverage changes.

1Covered ICD-10 diagnosis

6 monthsInitial authorization length

700/7 daysHCPCS max units

Coverage Summary

Policy defines coverage for the FDA‑labeled indication of chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary alpha1‑proteinase inhibitor (AAT/Alpha1‑PI) deficiency. Covered products include Aralast NP, Glassia, Prolastin‑C, and Zemaira. The policy scope includes Medicaid, Commercial, and Medicare‑Medicaid Plan (MMP) members.

Initial Therapy Criteria

Initial Approval Criteria

Coverage requires ALL of the following:

ALL of the following

Universal Criteria
- Age: Patient is at least 18 years of age
- Smoking status: Patient is not a tobacco smoker
- Optimal medical therapy: Patient is receiving optimal medical therapy (e.g., comprehensive case management, pulmonary rehabilitation, vaccinations, smoking cessation, self-management skills, etc.)
- IgA status: Patient does not have immunoglobulin-A (IgA) deficiency with antibodies against IgA
Indication-specific (Emphysema due to AAT deficiency applies to Prolastin-C; additional restriction for Aralast/Glassia)
- Emphysema due to alpha-1-antitrypsin (AAT) deficiency (applies to Prolastin-C)
  - FEV1: Patient has an FEV1 in the range of 30-65% of predicted30-65%
  - Genotype: Patient has alpha-1-antitrypsin (AAT) deficiency with PiZZ, PiZ (null), or Pi (null, null) phenotypes
  - Radiographic evidence: Patient has AAT-deficiency and clinical evidence of panacinar/panlobular emphysema
  - Serum AAT: Patient has low serum concentration of AAT ≤ 57 mg/dL or ≤ 11 µM/L as measured by nephelometry

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Applicable Codes

Covered ICD-10 Diagnosis CodesICD-10Covered

E88.01

Alpha-1-antitrypsin deficiency

HCPCS codes (drug J-codes) / billingHCPCS

J0256	Aralast NP / Prolastin-C / Zemaira (10 mg unit) listed in billing section
J0257	Aralast NP 0.5 g/25 mL (10 mg unit) listed in billing section

NDCs referencedNDC

00944-2815-xx	Aralast NP 1 g/50 mL
00944-2814-xx	Aralast NP 0.5 g/25 mL
00944-2884-xx	Aralast NP 1 g/50 mL (alternate)
13533-0700-xx	Prolastin-C NDC (multiple package sizes referenced)
13533-0701-xx	Prolastin-C NDC
13533-0702-xx	Prolastin-C NDC
13533-0703-xx	Prolastin-C NDC
13533-0705-xx	Prolastin-C Liquid NDC
00053-7201-xx	Zemaira NDC (1 g/20 mL format)
00053-7202-xx	Zemaira NDC (4 g/76 mL)

1–10 of 11

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Provider Actions & Prior Authorization

Prior Authorization

Authorization duration and renewal

Initial coverage is provided for 6 months and may be renewed. Renewal requires documentation that the patient continues to meet applicable criteria, demonstrates disease response (e.g., elevation of AAT above baseline, substantial reduction in decline of percent predicted FEV1, or improvement in CT lung density), and has no unacceptable toxicity from the drug.

Documentation Required

Indication and lab documentation

Document patient age, tobacco smoking status, receipt of optimal medical therapy, IgA deficiency status (anti-IgA antibodies), genotype when required (PiZZ, PiZ null, or Pi null/null), clinical evidence of panacinar/panlobular emphysema, percent predicted FEV1, and serum AAT concentration measured by nephelometry.

Step Therapy

Product sequencing for Commercial and MMP

For Commercial and MMP patients requesting Aralast or Glassia, require documented failure, intolerance, or contraindication to Prolastin or Zemaira prior to approving Aralast or Glassia.

Billing Rule

Quantity limits (NDC unit)

Adhere to the product-specific maximum vials per week (NDC unit limits) as listed below.

Aralast NP 1 g/50 mL: 7 vials/week
Aralast NP 0.5 g/25 mL: 1 vial/week
Glassia 1 g/50 mL: 3 vials/week
Glassia 4 g/150 mL: 2 vials/week
Glassia 5 g/250 mL: 2 vials/week
Prolastin-C 1 g/20 mL: 7 vials/week
Prolastin-C Liquid 1 g/20 mL: 7 vials/week
Zemaira 1 g/20 mL: 3 vials/week
Zemaira 4 g/76 mL: 1 vial/week
Zemaira 5 g/95 mL: 1 vial/week

Billing Rule

HCPCS unit limit

HCPCS codes J0256 and J0257 apply to these products. Limit billing to a maximum of 700 billable units every 7 days.

Background & Definitions

Purpose: to define coverage criteria for intravenous Alpha1‑proteinase inhibitor augmentation/maintenance therapy consistent with FDA‑approved indications. FDA‑labeled indication is chronic augmentation and maintenance therapy in adults with clinically evident emphysema due to severe hereditary Alpha1‑PI deficiency. Covered products are Aralast NP, Glassia, Prolastin‑C, and Zemaira. The Neighborhood Health Plan P&T Committee reviewed these products and the policy aligns with FDA labeling and the clinical literature.

Universal CriteriaBaseline requirements applicable to all requests: age ≥ 18 years; non-smoker; receiving optimal medical therapy (e.g., case management, pulmonary rehabilitation, vaccinations, smoking cessation, self-management skills); and absence of IgA deficiency with anti‑IgA antibodies.

Policy Summary

PayerNeighborhood Health Plan of Rhode Island

PolicyAralast NP; Glassia; Prolastin-C; Zemaira (Intravenous)

Policy CodePolicy N/A

Change TypeNo material change

Effective Date01/01/2020

Next Review DateN/A

Key ActionInitial coverage provided for 6 months and may be renewed; renewals require documentation of continued criteria, disease response, and absence of unacceptable toxicity.

On This Page

OpenPayer

Aralast NP; Glassia; Prolastin-C; Zemaira (Intravenous)

Coverage Summary

Initial Therapy Criteria

Step Therapy Exception

Continuation / Renewal Criteria

Dosage & Administration

Unproven / Exclusions

Applicable Codes

Provider Actions & Prior Authorization

Clinical Evidence

Background & Definitions

Medicare Determinations

Revision History