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Prior Authorization Protocol

Medi-Cal Non-Formulary Vaccines
ACTHIBR (Haemophilus influenza type B), FLUZONE INTRADERMALR (intradermal influenza), FLUMISTR (nasal influenza)


HNMC

Interim Guidelines; Final Review and Approval by the P&T Committee Pending

Coverage of drugs is first determined by the member’s pharmacy or medical benefit. Please consult with or refer to the Evidence of Coverage document.
  1. FDA Approved Indications:
    • Acthib: for the prevention of invasive disease caused by Haemophilus influenzae type b
    • Fluzone Intradermal: for the prevention of influenza disease caused by influenza A subtype viruses and type B virus contained in the vaccine
    • FluMist: for the prevention of influenza disease caused by influenza A subtype viruses and type B viruses contained in the vaccine
  2. Health Net Approved Indications and Usage Guidelines:
    • Member is 19 years of age or older

    AND

    • Use is per the Center for Disease Control (CDC) and/or the Advisory Committee on Immunization Practices (ACIP) Guidelines

    AND

    • For Fluzone Intradermal and FluMist: medical justification for why intramuscular influenza cannot be used.
  3. Coverage is Not Authorized For:
    • Non-FDA approved indications, which are not listed in the Health Net Approved Indications and Usage Guidelines section, unless there is sufficient documentation of efficacy and safety in the published literature.
  4. General Information:
    • Any vaccine other than those listed on the Medi-Cal formulary and the vaccines specifically listed in these criteria are not eligible for administration at a pharmacy. Members must contact their primary care physician to obtain any other vaccines.
    • Vaccines are available for administration at the pharmacy for adults aged 19 years or older. Members younger than 19 years old must contract their primary care physician.
    • The California Vaccines for Children (VFC) Program helps families by providing free vaccines to doctors who serve eligible children 0 through 18 years of age. Enrolled VFC providers are able to order vaccine through the program and receive routine vaccines at no cost. For more information visit eziz.org
    • FluMist is a live attenuated influenza vaccine and is not recommended for use in pregnant women, immunosuppressed persons, or persons who have taken influenza antiviral medications within the previous 48 hours. Persons who care for severely immunosuppressed persons who require a protective environment should not receive FluMist, or should avoid contact with such persons for 7 days after receipt.
    • FluMist is approved for use in persons 2 through 49 years of age.
    • FluZone Intradermal is approved for use in persons 18 through 64 years of age.
    • Medi-Cal vaccines eligible for administration at a pharmacy include:

    Vaccine

    Brand Name

    Tetanus, Diphtheria, Pertussis

    ADACEL, BOOSTRIX

    Hepatitis A Virus

    HAVRIX, VAQTA

    Hepatitis A & B Virus

    TWINRIX

    Hepatitis B Virus

    RECOMBIVAX HB, ENGERIX-B

    Human Papillomavirus

    GARDASIL, CERVARIX

    Haemophilus Influenza Type B (Hib)

    ACTHIB

    Measles, Mumps and Rubella Virus

    MMR II

    Meningococcal Group B (Bexsero)

    BEXSERO

    Meningococcal Group B (Trumemba)

    TRUMENBA

    Meningococcal Oligosaccharide Diptheria Conjugate

    MENVEO

    Meningococcal Polysaccharide Diphtheria Conjugate

    MENACTRA

    Meningococcal Polysaccharide

    MENOMUNE

    Pneumococcal 13-Valent, Conjugated

    PREVNAR 13

    Pneumococcal 23-Valent, Non-Conjugated

    PNEUMOVAX 23

    Rabies

    IMOVAX RABIE, RABAVERT

    Tetanus and Diphtheria Toxoids Adsorbed

    TET/DIP TOX, TENIVAC

    Varicella Virus

    VARIVAX

    Zoster

    ZOSTAVAX

    Nasal Flu

    FLUMIST

    Intramuscular (IM) influenza

    2016-2017 IM influenza

    Intradermal (ID) influenza

    2016-2017 ID influenza

    • Adult use of Haemophilus influenzae type b (Hib) vaccination includes:
      • One dose of Hib vaccine should be administered to persons who have anatomical or functional asplenia or sickle cell disease or are undergoing elective splenectomy if they have not previously received Hib vaccine. Hib vaccination 14 or more days before splenectomy is suggested.
      • Recipients of a hematopoietic stem cell transplant (HSCT) should be vaccinated with a 3-dose regimen 6–12 months after a successful transplant, regardless of vaccination history; at least 4 weeks should separate doses.
      • Hib vaccine is not recommended for adults with HIV infection since their risk for Hib infection is low.
  5. Therapeutic Alternatives:
    Drug Dosing Regimen Dose Limit/ Maximum Dose

    Intramuscular influenza

    1 dose IM

    One dose per flu season

    * Requires Prior Authorization
  6. Recommended Dosing Regimen and Authorization Limit:
    Drug Dosing Regimen Authorization Limit

    ActhibR (haemophilus influenza type b strain 1482 capsular polysaccharide tetanus toxoid conjugate antigen)

    0.5 mL IM
    (Into the anterolateral aspect of the thigh or deltoid. Do not administer IV, ID, or SQ.)

    1-3 doses per lifetime based on indication

    Fluzone IntradermalR (intradermal influenza)

    0.1 mL ID

    One dose per flu season

    FluMistR (nasal influenza)

    0.1 mL in each nostril
    (0.2 mL per dose)

    One dose per flu season

  7. Product Availability:

    Acthib: single-dose vial with single-dose diluent vial
    Fluzone Intradermal: 0.1 mL single-dose prefilled microinjection system
    FluMist: 0.2 mL single-dose prefilled intranasal sprayer

  8. References:

    1. ActHIB (Haemophilus B conjugate vaccine) [prescribing information]. Swiftwater, PA: Sanofi Pasteur Inc; December 2015. Accessed June 24, 2016.
    2. Centers for Disease Control and Prevention (CDC). Recommended Adult Immunization Schedule. Recommendations of the Advisory Committee on Immuization Practices-United States, 2016, cdc.gov,
    3. FluMist [prescribing information] Gaithersburg, MD: MedImmune, LLC; July 2013. Accessed June 24, 2016.
    4. Fluzone [prescribing information] Swiftwater, PA: Sanofi Pasteur Inc; June 2015. Accessed June 24, 2016.

The material provided to you are guidelines used by this plan to authorize, modify or determine coverage for persons with similar illnesses or conditions. Specific care and treatment may vary depending on individual need and the benefits covered under your contract.