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Drug Category: Anti-infectives

Medication Class/Individual Agents: Antiviral/Influenza

I. Prior-Authorization Requirements

 Influenza Prophylaxis and Treatment Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

baloxavir Xofluza PA  
oseltamivir 30mg Tamiflu BP PA   - all quantities (June 1st to September 30th); PA > 20 capsules/season (October 1st to May 31st)
oseltamivir 45 mg and 75 mg Tamiflu BP PA   - all quantities (June 1st to September 30th); PA > 10 capsules/season (October 1st to May 31st)
oseltamivir 6 mg/mL suspension Tamiflu BP PA   - all quantities (June 1st to September 30th); PA > 180 mL/season (October 1st to May 31st)
zanamivir Relenza PA   - all quantities (June 1st to September 30th); PA < 5 years of age and > 20 inhalations/season (October 1st to May 31st)

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

 

Contraindications:

Zanamivir: Hypersensitivity to any component of the product including lactose (milk proteins)

Warnings:

  • Zanamivir: airway disease (e.g., COPD, asthma)
  • Oseltamivir: hereditary fructose intolerance (with suspension), renal impairment, self-injury and delirium, and serious skin reactions.
 
Table Footnotes
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Influenza Type A and B (oseltamivir ≥ two weeks of age; zanamivir ≥ seven years of age, Xofluza)
  • Prophylaxis of Influenza Type A and B (oseltamivir ≥ 1 year of age; zanamivir ≥ five years of age)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

Please note: In the case where the prior authorization (PA) status column indicates PA, both the brand and generic (if available) require PA. Typically, the generic is preferred when available unless the brand-name drug appears on the MassHealth Brand Name Preferred Over Generic Drug List. In general, when requesting the non-preferred version, whether the brand or generic, the prescriber must provide medical records documenting an inadequate response or adverse reaction to the preferred version, in addition to satisfying the criteria for the drug itself.

  • All PA requests must include clinical diagnosis, drug name, dose, and frequency.
  • A preferred drug may be designated for this therapeutic class. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing a non-preferred drug within a therapeutic class. Additional information about these agents, including PA requirements and preferred products, can be found within the MassHealth Drug List at www.mass.gov/druglist.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

  

 

Prophylaxis

oseltamivir and Relenza

  • Documentation of all of the following is required for prophylaxis requests during flu season (from October 1st – May 31st) above the seasonal quantity limit due to previous prophylactic or treatment courses within the current season:
    • if the request is for Relenza, member is five years of age or older; and
    • one of the following:
      • member is a resident in an institutional setting; or
      • both of the following:
        • one of the following:
          • member with likely exposure to others with confirmed, probable, or suspected influenza infection and are at risk of developing influenza-related complications with at least one risk factor, including:
            • adults ≥ 65 years of age; or
            • children ≤ five years of age; or
            • individuals < 19 years of age who are receiving long-term aspirin therapy; or
            • residents of nursing homes or chronic care facilities; or
            • pregnant women and women up to two weeks postpartum; or
            • individuals with chronic medical conditions including: 
              • chronic pulmonary disease (e.g., asthma, chronic obstructive pulmonary disease, cystic fibrosis); or
              • cardiovascular disease (except isolated hypertension); or
              • renal dysfunction; or
              • hepatic dysfunction; or
              • chronic metabolic or endocrine disease (e.g., diabetes mellitus, mitochondrial disease); or
              • hemoglobinopathies (e.g., sickle cell disease); or
              • immunosuppression, including HIV infection, organ or hematopoietic cell transplantation, malignancy (if prescriber notes immunosuppression is a concern), and inflammatory disorders treated with immunosuppressants; or
              • neurologic conditions that compromise handling of respiratory secretions (e.g., cognitive dysfunction, spinal cord injuries, seizure disorders, neuromuscular disorders); or
            • Native American or Alaska Native heritage; or
            • individuals who are morbidly obese (body mass index ≥ 40); or
          • members who work in institutions caring for individuals at high risk of serious complications of influenza infection during an institutional outbreak; and
        • one of the following:
          • requested dose and duration is consistent with current CDC recommendations; or
          • medical necessity for going above standard dosing or duration recommendations.

    

  • Documentation of all of the following is required for prophylaxis requests during flu season (from October 1st – May 31st) above the seasonal quantity limit due to dose or duration beyond current CDC recommendations:
    • one of the following:
      • member is a resident in an institutional setting; or
      • medical necessity for going above the standard dosing or duration recommendations; and
    • if the request is for Relenza, member is five years of age or older.

      

  • Documentation of all of the following is required for prophylaxis requests from June 1st – September 30th:
    • one of the following:
      • member with likely exposure to others with confirmed, probable, or suspected influenza infection and are at risk of developing influenza-related complications with at least one risk factor (see above); or
      • members who work in institutions caring for individuals at high risk of serious complications of influenza infection during an institutional outbreak; and
    • one of the following:
      • requested dose and duration is consistent with current CDC recommendations; or
      • medical necessity for going above standard dosing or duration recommendations; and
    • if the request is for Relenza, member is five years of age or older.

SmartPA: Claims for oseltamivir and claims for Relenza in members ≥ 5 years will usually process at the pharmacy without a PA from October 1st to May 31st if MassHealth pharmacy claims data indicate the member is currently in an institutional setting.

     

Treatment

oseltamivir and Relenza

  • Documentation of all of the following is required for treatment requests during flu season (from October 1st – May 31st) above the seasonal quantity limit due to previous prophylactic or treatment courses within the current season:
    • if the request is for Relenza, member is seven years of age or older; and
    • one of the following:
      • member is a resident in an institutional setting; or
      • all of the following:
        • member with confirmed, probable, or suspected influenza; and
        • member is within 48 hours of illness onset; and
        • member is at high risk for developing serious influenza-related complications with at least one risk factor (see above); and 
        • one of the following:
          • requested dose and duration is consistent with current CDC recommendations; or
          • medical necessity for going above standard dosing or duration recommendations.

      

  • Documentation of all of the following is required for treatment requests during flu season (from October 1st – May 31st) above the seasonal quantity limit due to dose or duration beyond current CDC recommendations:
    • if the request is for Relenza, member is seven years of age or older; and
    • one of the following:
      • member is a resident in an institutional setting; or
      • all of the following:
        • member with confirmed, probable, or suspected influenza; and
        • member is within 48 hours of illness onset; and
        • medical necessity for going above the standard dosing or duration recommendations.

  

  • Documentation of all of the following is required for treatment requests from June 1st – September 30th:
    • member with confirmed, probable, or suspected influenza; and
    • member is within 48 hours of illness onset; and
    • member is at high risk for developing serious influenza-related complications with at least one risk factor (see above); and 
    • one of the following:
      • requested dose and duration is consistent with current CDC recommendations; or
      • medical necessity for going above standard dosing or duration recommendations; and
    • if the request is for Relenza, member is seven years of age or older.

SmartPA: Claims for oseltamivir and claims for Relenza in members ≥ 5 years will usually process at the pharmacy without a PA from October 1 to May 31 if MassHealth pharmacy claims data indicate the member is currently in an institutional setting.

 

Xofluza

  • Documentation of all of the following is required for treatment requests during flu season (from October 1st – May 31st):
    • member is 12 years of age or older; and
    • member with confirmed, probable, or suspected influenza; and
    • member is within 48 hours of illness onset; and
    • medical necessity for the use of single-dose preparation instead of 5-day treatment course with oseltamivir; and
    • appropriate dosing; and
    • request is within quantity limit of 2 tablets/treatment.

  

  • Documentation of all of the following is required for treatment requests from June 1st – September 30th:
    • member is 12 years of age or older; and
    • member with confirmed, probable, or suspected influenza; and
    • member is within 48 hours of illness onset; and
    • medical necessity for the use of single-dose preparation instead of 5-day treatment course with oseltamivir; and
    • member is at high risk for developing serious influenza-related complications with at least one risk factor (see above); and 
    • appropriate dosing; and
    • request is within quantity limit of 2 tablets/treatment.

    

† Note: The decision on whether PA is required is based upon information available in the MassHealth medical claim and pharmacy claim databases. The MassHealth database contains member information exclusive to MassHealth, and no other health plans.


Original Effective Date: 09/2003

Last Revised Date: 01/2019


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Last updated 07/15/19