Zoster Vaccine Recombinant, Adjuvanted (Shingrix®) (Intramuscular)
NDC CODE(S) |
58160-0819-XX SHINGRIX 50MCG Suspension Reconstituted (GLAXO SMITH KLINE) 58160-0823-XX SHINGRIX 50MCG Suspension Reconstituted (GLAXO SMITH KLINE) 50090-3372-XX SHINGRIX 50MCG/0.5ML Suspension Reconstituted (A-S MEDICATION SOLUTIONS LLC) 50090-5147-XX SHINGRIX 50MCG/0.5ML Suspension Reconstituted (A-S MEDICATION SOLUTIONS) |
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 or government program (e.g., TennCare), the express terms of the health plan or government program will govern.
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
· Zoster vaccine recombinant, adjuvanted (Shingrix®) for the prevention of herpes zoster (HZ) (Shingles) and related complications in adults is considered medically necessary if the medical appropriateness criteria are met. (See Medical Appropriateness below.)
· Zoster vaccine recombinant, adjuvanted (Shingrixv®) for the prevention of other conditions/diseases is considered investigational, including, but not limited to, primary varicella infection (chickenpox)
MEDICAL APPROPRIATENESS
INITIAL APPROVAL CRITERIA
· The individual is 50 years of age or older (regardless of receipt of zoster live vaccine (Zostavax®); OR
· The individual is at least 18 years of age or older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression* caused by known disease or therapy.
* Immunodeficiency or Immunosuppression may include, but are not limited to hematopoietic stem cell transplant (HSCT) recipients, hematologic malignancies, renal or other solid organ transplants, solid tumor malignancies, HIV, primary immunodeficiencies, autoimmune conditions, and use of immunosuppressive medications/therapies
RENEWAL CRITERIA
· Zoster vaccine recombinant, adjuvanted (Shingrix®) is NOT considered medically appropriate for renewal
DOSAGE/ADMINISTRATION
· Two doses (0.5 mL each) administered intramuscularly according to the following schedules:
A first dose at Month 0 followed by a second dose administered 2 to 6 months later.
For individuals who are or will be immunodeficient or immunosuppressed and who would benefit from a shorter vaccination schedule: A first dose at Month 0 followed by a second dose administered 1 to 2 months later.
Note: This information is not meant to replace clinical decision making and should only be used as a guide. Patient variables should be taken into account. Additional information for vaccination including dosing schedule, timing of vaccinations & guidance for persons with altered immunocompetence should be consulted (see additional information).
LENGTH OF AUTHORIZATION
Coverage will be provided for a six month period and will NOT be renewed.
ACIP Recommendations
At the October 20, 2021 Advisory Committee on Immunization Practices (ACIP) meeting: The ACIP approved the following recommendation:
Two doses of recombinant zoster vaccine are recommended for the prevention of herpes zoster and its complications in adults aged ≥19 years who are or will be immunodeficient or immunosuppressed due to disease or therapy.
The new recommendations have been adopted by the CDC Director and will become official once published in MMWR.
https://www.cdc.gov/vaccines/hcp/acip-recs/vacc-specific/shingles.html#recs
https://www.fda.gov/vaccines-blood-biologics/vaccines/shingrix
https://www.fda.gov/media/108597/download
On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) voted that Shingrix® is:
Recommended for healthy adults aged 50 years and older to prevent shingles and related complications
Recommended for adults who previously received the current shingles vaccine (Zostavax®) to prevent shingles and related complications
The preferred vaccine for preventing shingles and related complications
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
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 July 23, 2021, the U.S. Food and Drug Administration (FDA) expanded the indication for the use of Shingrix® to include the prevention of herpes zoster (HZ) (shingles) in adults aged 18 years and older who are or will be at increased risk of HZ due to immunodeficiency or immunosuppression caused by known disease or therapy.
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.
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).
Zostavax is no longer available for use in the United States, as of November 18, 2020.
Additional links:
Clinical Considerations for Use of Recombinant Zoster Vaccine (RZV, Shingrix) in Immunocompromised Adults Aged ≥19 Years. CDC Available at: https://www.cdc.gov/shingles/vaccination/immunocompromised-adults.html
Best Practices Guidance of the Advisory Committee on Immunization Practices (ACIP). US Department of Health and Human Services, CDC. Available at: https://www.cdc.gov/vaccines/hcp/acip-recs/general-recs/downloads/general-recs.
Centers for Disease Control. Vaccines and Preventable Diseases. Shingles (Herpes Zoster) Vaccination Information for Healthcare Professionals Available at: https://www.cdc.gov/shingles/hcp/index.html
Centers for Disease Control. Vaccines and Preventable Diseases. Shingrix recommendations. Available at:
https://www.cdc.gov/vaccines/vpd/shingles/hcp/shingrix/recommendations.html
Centers for Disease Control. Shingles (Herpes Zoster) Available at: https://www.cdc.gov/shingles/
Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022 | MMWR (cdc.gov)
FDA product information July, 2021 available at: https://www.fda.gov/media/108597/download.
SOURCES
1. Anderson TC, Masters NB, Guo A, et al. Use of Recombinant Zoster Vaccine in Immunocompromised Adults Aged ≥19 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2022. MMWR. 2022;71(3):80–84.
2. Lexicomp Online. (2023, March) AHFS DI. Zoster Vaccine Recombinant. Retrieved April 2023 from Lexicomp Online with AHFS.
3. MICROMEDEX Healthcare Series. Drugdex Evaluations. (2023, April). Varicella virus vaccine; zoster vaccine recombinant, adjuvanted. Retrieved April 2023 from MICROMEDEX Healthcare Series.
4. U. S. Food and Drug Administration. (2021,July). Center for Biologics Evaluation and Research. Shingrix® (zoster vaccine recombinant, adjuvanted). Retrieved April 2023 from https://www.fda.gov/media/108597/download.
5. U. S. Food and Drug Administration. Statistical Review and Evaluation. Retrieved February 2022 from https://www.fda.gov/media/151229/download
ORIGINAL EFFECTIVE DATE: 1/18/2018
MOST RECENT REVIEW DATE: 7/11/2023
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.
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