58160-0819-XX Shingrix 50 MCG SUSR (GLAXO SMITH KLINE)
58160-0823-XX Shingrix 50 MCG SUSR (GLAXO SMITH KLINE)
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.
Zoster vaccine recombinant, adjuvanted (Shingrix®) for the prevention of herpes zoster (shingles) and related complications is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
Zoster vaccine recombinant, adjuvanted (Shingrix®) for the prevention of other conditions/diseases is considered investigational, including, but not limited to, primary varicella infection (chickenpox)
See also: Zoster Vaccine, Live (Zostavax®)
Zoster vaccine recombinant, adjuvanted (Shingrix®) for the prevention of herpes zoster (shingles) and related complications is considered medically appropriate if the individual is 50 years of age or older (regardless of receipt of live vaccine)
Zoster vaccine recombinant, adjuvanted (Shingrix®) is NOT considered medically appropriate for renewal.
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.
Refer to DOSAGE LIMITS below
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.
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.
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.
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).
Lexicomp Online. (2018, December). AHFS DI. Zoster Vaccine Recombinant. Retrieved February 18, 2019 from Lexicomp Online with AHFS.
MICROMEDEX Healthcare Series. Drugdex Evaluations. (2019, February). Varicella virus vaccine; zoster vaccine recombinant, adjuvanted. Retrieved February 18, 2019 from MICROMEDEX Healthcare Series.
U. S. Food and Drug Administration. (2018, September). Center for Biologics Evaluation and Research. Shingrix® (zoster vaccine recombinant, adjuvanted). Retrieved February 18, 2019 from https://www.fda.gov/downloads/BiologicsBloodVaccines/Vaccines/ApprovedProducts/UCM581605.pdf.
ORIGINAL EFFECTIVE DATE: 1/18/2018
MOST RECENT REVIEW DATE: 4/9/2019
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.
Maximum billable units per dose and over time by indication as a Medical Benefit; 1 billable unit = 0.5 mL