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Coverage criteria policies

Alpha-1 antitrypsin (AAT) deficiency enzyme replacement therapy: alpha-1 proteinase inhibitor (Aralast/NP®, Glassia®, Prolastin/C® and Zemaira®)

These services may or may not be covered by your HealthPartners plan. Please see your plan documents for your specific coverage information. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage.

Administrative Process

Drug therapies to replace alpha-1 proteinase inhibitor in individuals with alpha-1 antitrypsin deficiency require prior authorization from HealthPartners Pharmacy Administration. The setting of drug administration will be reviewed as part of the prior authorization.


For all inquiries, transfer to the Medical Injectable Line (ext 26135).


Coverage for drug therapy in alpha-1 antitrypsin deficiency is generally covered subject to the indications listed below when all of the following criteria are met, and per member plan documents.

Initial Authorizations:

Alpha-1 antitrypsin (AAT) inhibitor therapy is medically necessary for members with emphysema due to AAT deficiency when all the following criteria are met:

  1. Low serum concentration of AAT < 11 micromoles/L (or less than 80mg/dL or less than 0.8 g/L), which is considered the threshold thought to protect against emphysema; and,
  2. Progressive panacinar emphysema is present with a documented rate of decline in forced expiratory volume in 1 second (FEV1); and,
  3. Ex-smoker or non-smoker; and,
  4. Prescribed within the FDA approved dosing regimen; and,
  5. For commercial products only (does not apply to Medicare or Minnesota Health Care Programs products), medication administration must occur at a clinic office or home-infusion setting unless medical necessity is met based on the criteria below, supported by medical documentation:
    1. The patient has experienced a severe or life-threatening reaction with previous infusions of the same or similar products; or,
    2. The patient has a medical condition that renders him or her unstable, exceptionally complex, immunocompromised or otherwise high-risk such that continued oversight in the current facility is required; or,
    3. There are no alternative settings available to the patient as a result of both of the following:
      1. The patient is unable to use home-infusion services as documented by the physician, social worker, or infusion provider; and,
      2. The patient is unable to access alternative settings due to unreasonable distance [>30 miles] or other extenuating circumstances.

Initial approvals will be for 12 months.

  1. Medical chart documentation that the patient has been seen in the past 12 months; and,
  2. Documentation that markers of disease have been improved by therapy including one of the following:
    1. Improvement or normalization in alpha-1 antitrypsin blood levels; or,
    2. Improvement in lung function from baseline based upon recent spirometry values or CT imaging.

Reauthorizations will be approved for 12 months.


Alpha-1 antitrypsin deficiency: Alpha-1 antitrypsin is an antiprotease found in human plasma that inhibits the neutrophil elastase enzyme from degrading elastin tissues in the lung. Deficiency is an inherited disorder associated with the early onset of pulmonary emphysema in adults. Although replacement therapies have not been shown to prevent or reverse emphysema in AAT deficiency, population studies suggest a minimum plasma threshold of 11 micromoles/L, below which there is insufficient AAT to protect the lung leading to emphysema.

Alpha-1 proteinase inhibitor therapy is indicated for chronic augmentation and maintenance therapy in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor. The effect of augmentation therapy on pulmonary exacerbations and on the progression of emphysema in alpha1-deficiency has not been demonstrated in randomized, controlled clinical trials. Clinical data demonstrating the long-term effects of chronic augmentation and maintenance therapy of individuals is not available. It is not indicated as therapy for lung disease in patients in whom severe alpha1-proteinase deficiency has not been established.

Currently available alpha-1 proteinase inhibitor products include Aralast NP®, Glassia®, Prolastin®-C and Zemaira®.

Setting: The type of physical site where the drug is provided. Settings include inpatient hospital, outpatient hospital, clinic office, or home-infusion.

  • Outpatient Hospital sites have physicians and practitioners on-site and are the appropriate site to manage unstable patients and patients experiencing certain moderate to severe adverse events. Hospital settings are typically the highest-cost, most-intensive, and are the highest level settings.
  • Clinic offices are lower level settings which are not outpatient hospital settings that can manage some unstable patients and patients experiencing adverse events. Physicians may or may not be readily available.
  • Home-infusion is a lower level setting, and is performed by a licensed nurse supported by a licensed pharmacy who have expertise in administering complex medications in a patient’s home. Home infusion providers regularly manage mild to moderate adverse events, and are prepared to manage severe adverse events if needed.

If available, codes are listed below for informational purposes only, and do not guarantee member coverage or provider reimbursement. The list may not be all-inclusive.





Injection, alpha-1 proteinase inhibitor (human), (Glassia), 10 mg


Injection, alpha-1 proteinase inhibitor, human, 10 mg, not otherwise specified. (Aralast NP, Prolastin-C, Zemaira)


Home infusion therapy, alpha-1-proteinase inhibitor (e.g., Prolastin); administrative services, professional pharmacy services, care coordination and all necessary supplies and equipment (drugs and nursing visits coded separately), per diem

NDC Codes




Zemaira 1000 MG SOLR


Glassia 1000 MG/50ML SOLN


Aralast NP 400 MG SOLR


Aralast NP 800 MG SOLR


Alpha-1 Proteinase Inhibitor Human, Aralast NP 500mg SOLR


Alpha-1 Proteinase Inhibitor Human, Aralast NP 1000mg SOLR


Prolastin-C 1000 MG SOLR


Prolastin-C 1000 MG SOLR


Prolastin-C 1000 MG SOLR


Prolastin-C 1000 MG SOLR


Prolastin-C 1000 MG/20ML SOLN


Prolastin-C 1000 MG/20ML SOLN

CPT Copyright American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.


This information is for most, but not all, HealthPartners plans. Please read your plan documents to see if your plan has limits or will not cover some items. If there is a difference between this general information and your plan documents, your plan documents will be used to determine your coverage. These coverage criteria may not apply to Medicare Products if Medicare requires different coverage. For more information regarding Medicare coverage criteria or for a copy of a Medicare coverage policy, contact Member Services at 952-883-7979 or 1-800-233-9645.


  1. Prolastin/C Prescribing Information. Grifols Therapeutics, Inc., Research Triangle Park, NC. February 2017.
  2. Aralast/NP Prescribing Information. Baxter Healthcare Corporation, Westlake Village, CA. March 2014
  3. Glassia Prescribing Information. Baxalta US Inc. Westlake Village, CA June 2016
  4. Zemaira Prescribing Information. CSL Behring LLC, Kankakee, IL. September 2015.
  5. Gotzsche PC, Johansen HK. Intravenous alpha-1 antitrypsin augmentation therapy for treating patients with alpha-1 antitrypsin deficiency and lung disease (Review). The Cochrane Collaboration.2010:7.
  6. American Thoracic Society/European Respiratory Soceity Standards document for the diagnosis and management of individuals with alpha-1 antitrypsin deficiency. Am J Respir Crit Care Med 2003;168:818.
  7. Abboud RT, Ford GT, and Chapman KR. Alpha1-antitrypsin deficiency: a position statement of the Canadian Thoracic Society. Can Respir J 2001 Mar-Apr;8(2):81-8.

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Policy activity

  • 07/01/2011 - Date of origin
  • 07/01/2019 - Effective date
Review date
  • 11/2018
Revision date
  • 05/06/2019

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