Alpha 1-Proteinase Inhibitor (Human)
DESCRIPTION
Alpha 1-proteinase inhibitor (human) is a serum glycoprotein synthesized in the liver. It acts as an elastase inhibitor, primarily inhibiting neutrophil elastase. Alpha 1-proteinase inhibitor (human) is prepared from pooled human plasma.
Examples of preparations of alpha 1-proteinase inhibitor (human) are: Aralast®, Aralast NP, Prolastin® and Zemaira®.
REFER TO DECISION SUPPORT TREE
POLICY
Alpha 1-proteinase inhibitor (human) for the treatment of panacinar emphysema is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Alpha 1-proteinase inhibitor (human) for the treatment of other conditions/diseases, including, but not limited to, the following: cystic fibrosis, lung disease in which congenital alpha 1-proteinase has not been established, prevention of bronchopulmonary dysplasia in preterm neonates and gene therapy is considered investigational.
MEDICAL APPROPRIATENESS
Alpha 1-proteinase inhibitor (human) for the treatment panacinar emphysema is considered medically appropriate if ALL of the following criteria are met:
The individual is 18 years of age or older
Has clinically apparent panacinar emphysema due to a congenital deficiency of alpha 1-antitrypsin
Has a serum alpha 1-antitrypsin deficiency documented by ALL the following:
A low serum alpha 1-antitrypsin concentration of less than 50mg per deciliter (mg/dL)
An alpha 1-antitrypsin phenotype of PiZZ, PiZ (null), or Pi (null, null)
APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS
Tennessee State law requires coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is relative to life-threatening illnesses, such as cancer, AIDS, and coronary heart disease and recognized in one of the standard reference compendia (As defined in the statute: The United States Pharmacopoeia Drug Information, The American Medical Association Drug Evaluations, & The American Hospital Formulary Service Drug Information) or in the medical literature. This law is applicable to all fully insured members. The law is not applicable to self-funded accounts, but coverage for off-label uses may be provided based on the contractual agreement.
IMPORTANT REMINDER
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
ADDITIONAL INFORMATION
For appropriate dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., The American Hospital Formulary Service Drug Information).
The safety and efficacy for the use of alpha 1-proteinase inhibitor (human) in the pediatric population has not been established.
There is insufficient evidence supporting the use of alpha 1-proteinase inhibitor (human) for the treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. AHFS DI. (2010). α1-proteinase inhibitor (human). Retrieved September 9, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. DrugDex Evaluations. (2010). Alpha-1 proteinase inhibitor human. Retrieved September 9, 2010 from MICROMEDEX Healthcare Series.
Talecris Biotherapeutics, Inc. (2008, June). Alpha1 -proteinase inhibitor (human): Prolastin®. Retrieved January 29, 2009 from http://www.talecris-pi.info/inserts/Prolastin.pdf. http://www.talecris-pi.info/inserts/Prolastin-C.pdf.
U. S. Food and Drug Administration. (2002, December). Center for Biologic Research and Evaluation. Product Approval Information. Alpha-1-Proteinase Inhibitor (Human): (Aralast). Retrieved September 9, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM092856.pdf.
U. S. Food and Drug Administration. (2003, July). Center for Biologic Research and Evaluation. Product Approval Information. Alpha-1-Proteinase Inhibitor (Human): Zemaira. Retrieved September 9, 2010 from http://www.fda.gov/cber/products/zemaira.htm.
U. S. Food and Drug Administration. (2007, May). Center for Biologic Research and Evaluation. Product Approval Information. Alpha-1-Proteinase Inhibitor (Human): Aralast NP. Retrieved September 9, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/BloodBloodProducts/ApprovedProducts/LicensedProductsBLAs/FractionatedPlasmaProducts/UCM051590.pdf.
U. S. Food and Drug Administration. (2009, October). Center for Biologic Research and Evaluation. Product Approval Information. Alpha-1-Proteinase Inhibitor (Human): Prolastin C. Retrieved September 14, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/UCM209676.pdf.
ORIGINAL EFFECTIVE DATE: 8/1/2004
MOST RECENT REVIEW DATE: 11/3/2010
ID_BT
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
Pharmaceutical Decision Support Tree
Alpha 1-Proteinase Inhibitor (Human): Aralast®, Aralast NP, Prolastin® and Zemaira®
Is the requested medication being used to treat cystic fibrosis, or lung disease in which congenital alpha 1-proteinase has not been established, or prevention of bronchopulmonary dysplasia in preterm neonates?
If yes, this does not meet medical necessity and/or medical appropriateness criteria
If no, go to question #2
Does the individual have a diagnosis of panacinar emphysema and evidence of ALL the following?
The individual is 18 years of age or older
Has clinically apparent panacinar emphysema due to a congenital deficiency of alpha 1-antitrypsin
Has a serum alpha 1-antitrypsin deficiency documented by ALL the following:
A low serum alpha 1-antitrypsin concentration of less than 50mg per deciliter (mg/dL)
An alpha 1-antitrypsin phenotype of PiZZ, PiZ (null), or Pi (null, null)
If yes, this satisfies medical necessity and medical appropriateness criteria
If no, this does not meet medical necessity and/or medical appropriateness criteria
This document has been classified as public information.