Independence has updated our commercial coverage positions for Shingrix, a recombinant, adjuvanted zoster vaccine, and Heplisav-B, a recombinant, adjuvanted hepatitis B vaccine, in accordance with recent recommendations from the Advisory Committee on Immunization Practices (ACIP). Shingrix and Heplisav-B were approved by the U.S. Food and Drug Administration (FDA) in 2017. These changes to our commercial coverage positions were communicated on the Medical Policy Portal in an updated news article Zoster and Hepatitis B Vaccines Approved by the U.S. Food and Drug Administration and Advisory Committee on Immunization Practices (Revised 05/30/2018).
Note: Medicare Advantage members should refer to their Medicare Part D benefit for the coverage position for Shingrix. Medicare Advantage members should refer to their Medicare Part B benefit for the coverage position for Heplisav-B.
Background
The following outlines the history related to the FDA approval and ACIP recommendations for these vaccines:
- Shingrix: On October 23, 2017, the 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 ACIP released its final recommendations for Shingrix (Zoster Vaccine Recombinant, Adjuvanted), which states, ?On October 25, 2017, the 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 the zoster vaccine live. According to the ACIP, Shingrix is preferred over Zostavax.
- Heplisav-B: On November 11, 2017, the FDA approved Heplisav-B (Hepatitis B Vaccine Recombinant, Adjuvanted) for the prevention of infection caused by all known subtypes of the hepatitis B virus in individuals ages 18 years and older.
On April 20, 2018, the ACIP released their final recommendations for Heplisav-B (Hepatitis B Vaccine Recombinant, Adjuvanted), which states, ?On February 21, 2018, the ACIP recommended Heplisav-B (HepB-CpG), a yeast-derived vaccine prepared with a novel adjuvant, administered as a two-dose series (zero, one month) for use in persons ages 18 years and older.?
Coverage statement
The following outlines Independence?s coverage of these vaccines for commercial members:
- Shingrix: Effective October 25, 2017, Shingrix (Zoster Vaccine Recombinant, Adjuvanted) is covered as a preventive service. The two-dose regimen is administered two to six months apart for the prevention of herpes zoster in immunocompetent individuals ages 50 years and older.
- Heplisav-B: Effective February 21, 2018, Heplisav-B (Hepatitis B Vaccine Recombinant, Adjuvanted) is covered as a preventive service. The two-dose regimen is 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
Use the following codes to represent these vaccines:
- Shingrix: 90750
- Heplisav-B: 90739
For more information
The coverage information in the news article Zoster and Hepatitis B Vaccines Approved by the U.S. Food and Drug Administration and Advisory Committee on Immunization Practices (Revised 05/30/2018) will be incorporated into the following commercial policies accordingly:
- #00.06.02u: Preventive Care Services
- #08.01.04r: Immunizations
To view the news article and these policies, visit our Medical Policy Portal and select Accept and Go to Medical Policy Online. Then select Commercial and type the article title, policy name, or policy number in the Search field.