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Drug Category: Respiratory Tract Agents

Medication Class/Individual Agents: Individual Agent: Immunologic Agents

I. Prior-Authorization Requirements

 Palivizumab (Synagis)

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

palivizumab Synagis PA  

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.

 

Synagis Evaluation Criteria:

  • Evaluation criteria are based on recommendations from the Massachusetts Chapter of the American Academy of Pediatrics (AAP).
  • Synagis is intended for the prophylaxis of respiratory syncytial virus (RSV) and not for the treatment of patients currently infected with RSV
  • In most regions of the Northern Hemisphere, the first dose of palivizumab should be administered at the beginning of November and the last dose should be administered at the beginning of March, which will provide protection into April.

RSV outbreak is defined by the National Respiratory and Enteric Virus Surveillance System (NREVSS) as the first of two consecutive weeks when 50% of participating laboratories report RSV detection and the mean percentage of positive specimens is >10%.

 
Table Footnotes

II. Therapeutic Uses

FDA-approved, for example:

  • prevention of serious lower respiratory tract disease caused by respiratory syncytial virus (RSV) in pediatric patients at high risk of severe RSV disease

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 prior-authorization 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.
  • For recertification requests, approval may require submission of additional documentation including, but not limited to, documentation of: some or all criteria for the original approval; response to therapy; clinical rationale for continuation of use; status of member’s condition; appropriate diagnosis; appropriate age; appropriate dose, frequency, and duration of use for requested medication; complete treatment plan; current laboratory values; and member’s current weight.
  • Additional criteria may apply, depending upon the member's condition and requested medication (see below).

 

Chronic lung disease (CLD) of prematurity or bronchopulmonary dysplasia (BPD)

  • Documentation of one of the following is required:
    • member is < 12 months of age at the start of the RSV season and has all of the following:
      • diagnosis of CLD or BPD; and
      • gestational age < 32 weeks 0 days; and
      • a requirement for supplemental oxygen for at least the first 28 days after birth; or
    • member is < 24 months of age at the start of the RSV season and has all of the following:
      • diagnosis of CLD or BPD; and
      • gestational age < 32 weeks 0 days; and
      • a requirement for supplemental oxygen for at least the first 28 days after birth; and
      • member continues to require medical support for the six months prior to the start of the RSV season with chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen.

  

Prematurity

  • Documentation of the following is required:
    • member is < 12 months of age at the start of the RSV season with a gestational age < 29 weeks 0 days.

  

Congenital heart disease (CHD)

  • Documentation of the following is required:
    • member is < 12 months of age at the start of the RSV season and has all of the following:
      • hemodynamically significant CHD; and
      • one of the following:
        • moderate-to-severe pulmonary hypertension; or
        • member requires medication (s) to control congestive heart failure and will require cardiac surgical procedures; or
        • member has evidence of cyanotic heart disease and prescriber is a pediatric cardiologist or has consulted with a pediatric cardiologist.

 

  


Original Effective Date: 05/2007

Last Revised Date: 08/2019


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Last updated 08/29/19