BlueCross BlueShield of Tennessee Medical Policy Manual

Zoster Vaccine, Live

NDC CODE(S)

00006-4963-XX Zostavax 19400 UNT/0.65ML SUSR (MERCK SHARP & DOHME)

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.

REFER TO DECISION SUPPORT TREE

POLICY

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Prevention of herpes zoster (shingles)*

Single 0.65 mL subcutaneous injection

APPLICABLE TENNESSEE STATE MANDATE REQUIREMENTS

BlueCross BlueShield of Tennessee’s Medical Policy complies with Tennessee Code Annotated Section 56-7-2352 regarding coverage of off-label indications of Food and Drug Administration (FDA) approved drugs when the off-label use is recognized in one of the statutorily recognized standard reference compendia or in the published peer-reviewed medical literature.

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

*In March 2011, the Food and Drug Administration (FDA) expanded the approval for the herpes zoster vaccine to include immunization of individuals 50 to 59 years of age in addition to those aged 60 years and above. In reviewing the evidence for the change, the Advisory Committee on Immunization Practices (ACIP) of the Centers for Disease Control and Prevention (CDC) declined to recommend the expanded ages for routine immunization.  The ACIP cited multiple reasons for this stance, including herpes zoster vaccine safety, effectiveness, long-term protection, cost-effectiveness and supply.  Intermittent shortages of the vaccine have been experienced, making a strong argument against expanding the approved age group due to concerns that the most at-risk population, those 60 years of age and older, would not have ready access to the vaccine.  Full explanation of their stance may be found in the Morbidity Mortality Weekly Report (MMWR) volume 63, number 33, August 22, 2014, pages 729-731, found on the CDC website (see sources below).  The ACIP states it will continue to monitor supply issues and consider possible changes to their recommendation.  BlueCross BlueShield of Tennessee will consider changes to this policy based on their conclusions.

For appropriate chemotherapy regimens, dosage information, contraindications, precautions, warnings, and monitoring information, please refer to one of the standard reference compendia (e.g., the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) published by the National Comprehensive Cancer Network®, Drugdex Evaluations of Micromedex Solutions at Truven Health, or The American Hospital Formulary Service Drug Information).

No controlled studies were found in the published literature that validate the use of zoster vaccine, live, for the treatment or prevention of other conditions or diseases.

SOURCES

Center for Disease Control and Prevention. (2014, August). Morbidity and Mortality Weekly Report (MMWR), 63(33), 729-731. Update on Recommendations for Use of Herpes Zoster Vaccine. Retrieved August 20, 2012 from http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6333a3.htm.

Lexi-Comp Online. (2017, March). AHFS DI. Zoster vaccine, live. Retrieved May 5, 2017 from Lexi-Comp Online with AHFS.

MICROMEDEX Healthcare Series. Drugdex Drug Evaluations. (2017, February). Varicella virus vaccine. Retrieved May 4, 2017 from MICROMEDEX Healthcare Series.

U. S. Food and Drug Administration. (2017, March). Center for Biologics Evaluation and Research. Zostavax® (zoster vaccine live)(frozen). Retrieved May 4, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM132831.pdf.

U. S. Food and Drug Administration. (2017, March). Center for Biologics Evaluation and Research. Zostavax® (zoster vaccine live)(refrigerator stable). Retrieved May 4, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM285015.pdf.

ORIGINAL EFFECTIVE DATE:  1/13/2007

MOST RECENT REVIEW DATE:  7/11/2017

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®)

  1. Is this the initial request for the agent?

If yes, go to question #2

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for prevention of herpes zoster (shingles) in an individual aged 60 years or above?

If yes, go to question #3

If no, this does not meet medical necessity and/or medical appropriateness criteria

  1. Is the request for a single 0.65 mL subcutaneous injection of the zoster vaccine?

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.