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.

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.

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.