DENGVAXIA (dengue tetravalent vaccine)

DENGVAXIA (dengue tetravalent vaccine)

Office-Administration – injectable
Pharmacist-Administration – injectable

Diagnosis considered for coverage:

• Dengue disease prevention: Indicated for the prevention of dengue disease caused by dengue virus serotypes 1, 2, 3, and 4. Dengvaxia is approved for use in individuals 6 through 16 years of age with laboratory-confirmed previous dengue infection and living in endemic areas
• Limitations of use: 
  • Dengvaxia is not approved for use in individuals younger than 6 years of age. These individuals, regardless of previous infection by dengue virus, are at increased risk of severe and hospitalized dengue disease following vaccination with Dengvaxia and subsequent infection with any dengue virus serotype. 
  • Dengvaxia is not approved for use in individuals not previously infected by any dengue virus serotype or for whom this information is unknown. Those not previously infected are at increased risk for severe dengue disease when vaccinated and subsequently infected with dengue virus. Previous dengue infection can be assessed through a medical record of a previous laboratory-confirmed dengue infection or through serological testing prior to vaccination.
  • The safety and effectiveness of Dengvaxia have not been established in individuals living in dengue nonendemic areas who travel to dengue endemic areas.

Coverage Criteria:

For the prevention of dengue disease:

• Requested product is for Dengvaxia vaccine; AND
• Member is between ages 9-16 living in a dengue endemic area (endemic areas include Puerto Rico, American Samoa, US Virgin Islands, Federated States of Micronesia, Republic of Marshall Islands, and the Republic of Palau); AND
• Member has a laboratory confirmation of a previous dengue infection

Dosing:

• Three doses (0.5 mL each) 6 months apart (at month 0, 6, and 12)

Coverage Duration: 

• 1 year

Authorization is not covered for the following:

The use of this drug for indications not listed in this policy does not meet the coverage criteria established by the Western Health Advantage (WHA) Pharmacy and Therapeutics (P&T) Committee.

Additional Information: 

• For updated guidance on dengue endemic areas and pre-vaccination laboratory testing see: https://www.cdc.gov/mmwr/volumes/70/rr/rr7006a1.htm and https://www.cdc.gov/dengue/vaccine/hcp/index.html

Policy Updates:

• Effective 6/1/2024 – New policy approved by WHA P&T Committee. (P&T, 5/21/2024) 

References:

1. U.S. Department of Health and Human Services. Recommended Preventive Services. Available online at https://www.hhs.gov/healthcare/about-the-aca/preventive-care/index.html. Accessed October 25, 2018. 
2. Dengvaxia Prescribing Information. Sanofi Pasteur Inc. Swiftwater, PA. July 2023.