Zoster and Hepatitis B Vaccines Approved by the US Food and Drug Administration and Advisory Committee on Immunization Practices (Revised 05/30/2018)




    Policies Impacted

    00.06.02z Preventive Care Services (Independence)
    08.01.04u Immunizations

    Purpose

    The purpose of this communication is to provide the Company's coverage position for Shingrix, a recombinant, adjuvanted zoster vaccine, and Heplisav-B, a recombinant, adjuvanted Hepatitis B vaccine, which were recently approved by the US Food and Drug Administration.

    This information was updated to communicate the preventive coverage for Heplisav-B, a recombinant, adjuvanted Hepatitis B vaccine, in accordance with the Advisory Committee on Immunization Practices ACIP recommendations.

    Background

    SHINGRIX

    On October 23, 2017, the US Food and Drug Administration (FDA) approved Shingrix (Zoster Vaccine Recombinant, Adjuvanted) for the prevention of herpes zoster (shingles) in individuals ages 50 years and older. According to the FDA-approved label, Shingrix (Zoster Vaccine Recombinant, Adjuvanted) is not indicated for prevention of primary varicella infection (chickenpox).

    On January 26, 2018, the Advisory Committee on Immunization Practices (ACIP) released their final recommendations for Shingrix (Zoster Vaccine Recombinant Adjuvanted). In the final recommendation ACIP states, "On October 25, 2017, the Advisory Committee on Immunization Practices (ACIP) recommended the recombinant zoster vaccine (RZV) for use in immunocompetent adults ages 50 years and older." Shingrix is recommended for the prevention of herpes zoster and related complications for immunocompetent adults who previously received zoster vaccine live. According to ACIP, Shingrix is preferred over Zostavax.

    HEPLISAV-B

    On November 11, 2017, the US Food and Drug Administration (FDA) approved Heplisav-B (Hepatitis B Vaccine (Recombinant), Adjuvanted) for the prevention of infection caused by all known subtypes of hepatitis B virus in individuals 18 years of age and older.

    On April 20, 2018, the Advisory Committee on Immunization Practices (ACIP) released their final recommendations for Heplisav-B (Hepatitis B Vaccine (Recombinant), Adjuvanted). In the final recommendation ACIP states, "On February 21, 2018, the Advisory Committee on Immunization Practices (ACIP) recommended Heplisav-B (HepB-CpG), a yeast-derived vaccine prepared with a novel adjuvant, administered as a 2-dose series (0, 1 month) for use in persons aged 18 years and older."

    Coverage Statement

    SHINGRIX

    Shingrix (Zoster Vaccine Recombinant, Adjuvant) is covered as a preventive service as a two-dose regimen administered two to six months apart for the prevention of herpes zoster in immunocompetent individuals ages 50 years and older.


    HEPLISAV-B

    Heplisav-B (Hepatitis B Vaccine [Recombinant], Adjuvanted) is covered as a preventive service as a two-dose regimen administered one month apart for the prevention of infection caused by all known subtypes of hepatitis B virus in individuals 18 years of age and older.

    Coding

    THE FOLLOWING CODE IS USED TO REPRESENT HEPLISAV-B: 90739

    THE FOLLOWING CODE IS USED TO REPRESENT SHINGRIX: 90750

    Issued on - 05/30/2018


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Independence Blue Cross is an independent licensee of the Blue Cross and Blue Shield Association, serving the health insurance needs of Philadelphia and southeastern Pennsylvania.