BlueCross BlueShield of Tennessee Medical Policy Manual

Zoster Vaccine Recombinant, Adjuvanted

NDC CODE(S)

58160-0819-XX Shingrix 50 MCG SUSR (GLAXO SMITH KLINE)

 

58160-0823-XX Shingrix 50 MCG SUSR (GLAXO SMITH KLINE)

DESCRIPTION

Zoster vaccine recombinant, adjuvanted (Shingrix®) is the first recombinant vaccine approved by the FDA for the prevention of herpes zoster (shingles) and their related complications.  It is a sterile suspension for intramuscular injection.  The vaccine is supplied as a vial of lyophilized recombinant varicella zoster virus surface glycoprotein E (gE) antigen component which must be reconstituted at the time of use with the accompanying vial of AS01B adjuvant suspension component. There are no preservatives in the recombinant version of the vaccine.

POLICY

Policies with similar titles:  Zoster Vaccine, Live

MEDICAL APPROPRIATENESS

INITIAL APPROVAL

RENEWAL CRITERIA

INDICATION(S)

DOSAGE & ADMINISTRATION

Prevention of shingles

2 doses (0.5 mL each) at 0 and 2 to 6 months

LENGTH OF AUTHORIZATION

Coverage will be provided for a six month period and will NOT be renewed.

Click here to view DOSAGE LIMITS

ACIP Recommendations

On October 20, 2017, the U.S. Food and Drug Administration (FDA) licensed Shingrix® for adults aged 50 years and older to prevent shingles.

On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) voted that Shingrix® is:

Once approved by the CDC director, these ACIP recommendations will be published in the Morbidity and Mortality Weekly Report. At that time, the recommendations will become official policy.

https://www.cdc.gov/vaccines/vpd/shingles/hcp/index.html

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 

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).

SOURCES

National Organization for Rare Disorders (NORD). (2017). Mucopolysaccharidosis type vii, diagnosis. Retrieved December 12, 2017 from https://rarediseases.org/rare-diseases/sly-syndrome/.

U. S. Food and Drug Administration. (2017, December). Center for Biologics Evaluation and Research. Shingrix® (zoster vaccine recombinant, adjuvanted). Retrieved December 7, 2017 from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.

ORIGINAL EFFECTIVE DATE:  1/18/2018

MOST RECENT REVIEW DATE:  1/18/2018

ID_MRxEx

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.

This document has been classified as public information.

 

 

DOSAGE LIMITS

Maximum billable units per dose and over time by indication as a Medical Benefit  

Diagnosis

Maximum Units

Prevention of shingles

2 doses (0.5 mL each) over  6 months