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Table 37: Respiratory Syncytial Virus (RSV) Prophylaxis Agents


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Drug Category: Respiratory Tract Agents

Medication Class/Individual Agents: Individual Agent: Immunologic Agents

I. Prior-Authorization Requirements

 RSV Prophylaxis Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

nirsevimab-alip Beyfortus PA   - ≥ 8 months of age
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.

 

RSV Prophylaxis Agents Evaluation Criteria:

  • Evaluation criteria are based on recommendations from the Massachusetts Chapter of the American Academy of Pediatrics (AAP).
  • Nirsevimab-alip and palivizumab are 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.

Polymerase chain reaction (PCR) testing for RSV uses a 3% threshold to determine the weekly percentage of tests positive and allows for a reasonable estimation of RSV season where RSV testing is not performed or reported throughout the year. This method (3% threshold) defines season onset as the first of two consecutive weeks when the weekly percentage of tests positive for RSV was >3%.

 
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.
  • Dispensing in a 90-day supply of medication may be mandated or allowable for agents in this therapeutic class (designated by M90 or A90, respectively, in the Drug Notes section above). Applicable quantity limits are described below as units per day, per month, per 28 days, or as clinically appropriate, and may be extrapolated for fills of longer day supply. 
  • 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 diagnosis and/or requested medication (see below). Other factors, including rebate and FDA-approval status, may change independently of scheduled MassHealth updates, which may result in additional restrictions.

 

Beyfortus in members ≥ eight months of age

  • Documentation of all of the following is required: 
    • appropriate indication; and
    • member is ≥ eight months to < 20 months of age; and
    • appropriate dosing; and
    • one of the following: 
      • member is severely immunocompromised; or
      • cystic fibrosis with manifestations of severe lung disease; or
      • member is American Indian or Alaska Native descent; or
      • chronic lung disease of prematurity who require medical support (chronic corticosteroid therapy, diuretic therapy, or supplemental oxygen) any time during the six-month period before start of the RSV season or bronchopulmonary dysplagia; or
      • congenital diaphragmatic hernia and comorbid chronic lung disease; or
      • Down syndrome and comorbid congenital heart disease, chronic lung disease, airway clearance issues, or prematurity; or
      • congenital abnormality of the airway or neuromuscular disease; or
      • congenital heart disease; or
      • underwent cardiopulmonary bypass procedure.

 

Synagis for chronic lung disease (CLD) of prematurity or bronchopulmonary dysplasia (BPD)

  • Documentation of all of the following is required:
    • appropriate indication; and
    • one of the following: 
      • 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.

  

Synagis for prematurity

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

  

Synagis for congenital heart disease (CHD)

  • Documentation of all of the following is required:
    • appropriate indication; and
    • 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: 03/2024


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Last updated 05/16/24

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