Description

Aralast NP™, Glassia®, Prolastin C^®, Prolastin-C Liquid^® or Zemaira™ are alpha1-proteinase inhibitors that are indicated for chronic augmentation and maintenance therapy administered intravenously weekly in adults with emphysema due to congenital deficiency of alpha1-proteinase inhibitor (A1-PI), also known as alpha1- antitrypsin deficiency (A1AD).

Criteria

Coverage is subject to the specific terms of the member’s benefit plan.

Federal Employee Program members (FEP) should check with their Retail Pharmacy Program to determine if prior approval is required by calling the Retail Pharmacy Program at 1-800-624-5060 (TTY: 1-800-624-5077). FEP members can also obtain the list through the www.fepblue.org website.

Alpha-1 antitrypsin (AAT) inhibitor augmentation therapy with Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid, or Zemaira may be considered medically necessary when ALL the following criteria are met:

• The individual is 18 years of age or older; and
• Individual diagnosed with emphysema due to Alpha-1 antitrypsin deficiency; and
• There is a documented high risk phenotype** resulting in a low serum concentration of Alpha 1 antitrypsin (AAT), as evidenced by less than 80 mg per deciliter (mg/dL) (0.8 g/L) by radial immundiffusion (or less than 50 mg/dL (0.5 g/L) if measured by nephelometry) or less than 11 µM/L (35 % of normal); and
• ONE of the following is present:
  • Moderate airflow obstruction is evidenced by forced expiratory volume (FEV1) of 30-65% of predicted value, prior to initiation of therapy; or
  • Individual has a rapid decline in lung function as measured by a change in FEV1 greater than 120 ml/year; and
• The individual is a non-smoker or is a smoker undergoing active smoking cessation therapy; and
• Must be on standard therapy for chronic obstructive pulmonary disease (COPD) (i.e. inhaled bronchodilators, inhaled steroids) as defined by current clinical guidelines (i.e. the Global Initiative COPD- GOLD guidelines); and
• The individual is likely to be compliant with the prescribed protocol.

** PiZZ, PiZ, or Pi phenotype (homozygous) or other phenotypes, (PiSZ or PiMS) when associated with serum AAT concentrations of less than 80 mg/dL.

AAT inhibitor therapy (i.e. Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid, or Zemaira) is considered experimental/investigational and therefore non-covered for any other indication. The safety and/or effectiveness of the treatment cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

Reauthorization Criteria

Repeat doses of AAT inhibitor therapy with Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid, or Zemaira may be considered medically necessary for individuals who meet the clinicalrequirements for AAT inhibitor at therapy initiation and who demonstrate a substantial reduction in therate of deterioration of lung function as evidenced by AAT levels greater than 80mg/dL (greater than 11 EM or greater than 0.8g/L).

AAT inhibitor therapy (i.e. Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid or Zemaira)is considered experimental/investigational and therefore non-covered for any other indication. The safety and/or effectiveness of the treatment cannot be established by review of the available published peer-reviewed literature.

Procedure Codes

Safety and effectiveness in pediatric individuals has not been established.

NOTE: In addition to the above criteria, product specific dosage and/or frequency limits may apply in accordance with the U.S. Food and Drug Administration (FDA)-approved product prescribing information, national compendia, Centers for Medicare and Medicaid Services (CMS) and other peer reviewed resources or evidence-based guidelines. Blue Cross Blue Shield of North Dakota may deny, in full or in part, reimbursement for utilization that does not fall within the applicable dosage and/or frequency limits.

Diagnosis Codes

Covered Diagnosis Codes for Procedure Codes J0256 and J0257 when reported with diagnosis code E88.01

Professional Statements and Societal Positions

Global initiative for Chronic Obstructive Lung Disease (GOLD). Global strategy for the diagnosis, management, and prevention of chronic obstructive pulmonary disease. Bronchodilators – Recommendations 2010

• For both beta2-agonists and anticholinergics, long-acting formulations are preferred over short-acting formulations.
• The combined use of short- or long-acting beta2-agonists and anticholinergics may be considered if symptoms are not improved with single agents.
• Based on efficacy and side effects inhaled bronchodilators are preferred over oral bronchodilators.
• Based on evidence of relatively low efficacy and more side effects, treatment with theophylline is not recommended unless other long-term treatment bronchodilators are unavailable or unaffordable.

Professional Claims

This policy is applied on a post-payment basis for Professional claims. The services will pay on initial processing and are subject to retrospective review.

Note the following pre-payment applications within the body of the bulletin:

Diagnosis codes are applied on a pre-payment basis.

Note:

Use of Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid, or Zemaira (alpha1-proteinase inhibitors) for any other indication is considered experimental/investigational and, therefore, non-covered and applies to professional claims.

Facility Claims

This policy is applied on a post-payment basis for Facility claims. The services will pay on initial processing and are subject to retrospective review.

Note the following pre-payment applications within the body of the bulletin:

Diagnosis codes are applied on a pre-payment basis.

Note :

Use of Aralast NP, Glassia, Prolastin C, Prolastin-C Liquid, or Zemaira (alpha1-proteinase inhibitors) for any other indication is considered experimental/investigational and, therefore, non-covered and applies to facility claims.

ND Committee Review

Internal Medical Policy Committee 1-22-2020 Annual Review

Internal Medical Policy Committee 3-16-2020 Wording updates

Links