DESCRIPTION
Zoster vaccine is a lyophilized preparation of live, attenuated varicella-zoster virus. The virus was initially obtained from a child with naturally-occurring varicella, then introduced into human embryonic lung cell cultures, adapted to and propagated in embryonic guinea pig cell cultures and finally propagated in human diploid cell cultures.
Herpes zoster, commonly called shingles or zoster, is a manifestation of the reactivation of varicella zoster virus, which, as a primary infection, produces chickenpox (varicella). Following initial infection, the virus remains latent in the dorsal root or cranial sensory ganglia until it reactivates, producing zoster.
An example of a preparation of zoster vaccine live is Zostavax®.
REFER TO DECISION SUPPORT TREE
POLICY
Zoster vaccine live for the prevention of herpes zoster (shingles) is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Zoster vaccine live for the prevention of other conditions/diseases is considered investigational.
MEDICAL APPROPRIATENESS
Zoster vaccine live for the prevention of herpes zoster (shingles) is considered medically appropriate in individuals 60 years of age or older.
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
This agent is not covered under the pharmacy benefit. Medical benefits are available under the Well Care Services benefit, subject to the Well Care Services benefit maximum, if applicable.
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).
There is insufficient evidence supporting the use of zoster vaccine, live, for other ages or in the prevention and/or treatment of other conditions/diseases.
SOURCES
Lexi-Comp Online. (2010). AHFS DI. Zoster vaccine live. Retrieved January 6, 2010 from Lexi-Comp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2010). Varicella virus vaccine. Retrieved January 6, 2010 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2009, November). Center for Biologics Evaluation and Research. Product approval letter. BL 125123/461. Retrieved January 6, 2010 from http://www.fda.gov/cber/approvltr/zostavax070607L.htm.
U. S. Food and Drug Administration. (2009, November). Center for Biologics Evaluation and Research. Zostavax® (zoster vaccine live). Retrieved January 6, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.
U. S. Food and Drug Administration. (2009, November). Center for Biologics Evaluation and Research. Patient information about Zostavax®. Retrieved January 6, 2010 from http://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM176340.pdf.
ORIGINAL EFFECTIVE DATE: 1/13/2007
MOST RECENT REVIEW DATE: 3/24/2010
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
Zoster Vaccine, Live (Zostavax®)
This agent is not covered under the pharmacy benefit. Medical benefits are available under the Well Care Services benefit, subject to the Well Care Services benefit maximum, if applicable.
Is the vaccine being used for the prevention of herpes zoster (shingles) in an individual 60 years of age or older?
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.