FDA-approved, for example:

• Maternal use for the prevention of lower respiratory tract disease (LRTD) and severe LRTD caused by respiratory syncytial virus (RSV) in infants from birth through six months of age – Abrysvo
• Prevention of diseases caused by human papillomavirus (HPV) types 6, 11, 16, 18, 31, 33, 45, 52, and 58 – Gardasil-9
• Prevention of herpes zoster – Shingrix
• Prevention of influenza – Fluad and Fluzone High-Dose 
• Prevention of LRTD caused by RSV in individuals ≥ 60 years of age – Abrysvo, Arexvy

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 PA 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.

Herpes zoster vaccine (Shingrix)

• Documentation of the following is required:
  • appropriate indication; and
  • one of the following:
    • member ≥ 50 years of age; or
    • member is ≥ 18 years of age and is at increased risk of herpes zoster due to immunodeficiency or immunosuppression caused by known disease or therapy.

SmartPA: Claims for Shingrix for ≤ two doses in all MassHealth pharmacy claims history will usually process at the pharmacy without a PA request if the member is ≥ 18 years of age, has a history of MassHealth medical claims indicative of immunodeficiency or immunosuppression (including history of autologous hematopoietic stem cell transplant, hematologic malignancy, renal transplant, solid tumor receiving chemotherapy, HIV-infection).^†

Human papillomavirus 9-valent vaccine (Gardasil-9)

• Documentation of the following is required:
  • appropriate indication; and
  • member is ≥ 9 and < 46 years of age; or
  • member is ≥ 46 years of age who has already begun the sequence while within the appropriate age range.

Inactivated influenza virus vaccine, high-dose (Fluzone High-Dose), and influenza virus vaccine, adjuvanted (Fluad) in members < 65 years of age

• Documentation of the following is required:
  • appropriate indication; and
  • requested quantity of one dose/season; and
  • medical necessity for high-dose instead of standard formulation in members < 65 years of age.

Respiratory syncytial virus vaccine (Abrysvo) in members < 60 years of age

• Documentation of the following is required for prevention of LRTD caused by RSV in adults < 60 years of age:
  • appropriate indication; and
  • medical necessity for the requested agent in member < 60 years of age.

• Documentation of the following is required for maternal use for the prevention of LRTD and severe LRTD caused by RSV in infants from birth through six months of age:
  • appropriate indication; and
  • vaccine will be administered between weeks 32 and 36 of pregnancy.

Respiratory syncytial virus vaccine, adjuvanted (Arexvy) in members < 60 years of age

• Documentation of the following is required:
  • appropriate indication; and
  • medical necessity for the requested agent in member < 60 years of age.

^†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.