FDA-approved, for example:

• Myocardial infarction (Zontivity)
• Nonvalvular atrial fibrillation (Savaysa)
• Peripheral artery disease (PAD) (Zontivity)
• Reduction of risk of major CV events in chronic coronary artery disease (CAD)/PAD (Xarelto 2.5 mg)
• Thromboprophylaxis in pediatric members with congenital heart disease after the Fontan procedure (Xarelto suspension)
• Treatment of DVT and/or PE (Savaysa)
• Treatment or reduction of risk of recurrent DVT and/or PE in pediatric members (Pradaxa oral pellet, Xarelto suspension)

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.

Pradaxa oral pellet

• Documentation of all of the following is required for the treatment or reduction of risk of recurrent DVT and/or PE in pediatric members:
  • appropriate diagnosis; and
  • member is ≥ three months of age and < 12 years of age; and 
  • member has received or will receive ≥ five days of injectable or intravenous anticoagulation prior to starting the requested agent; and 
  • inadequate response, adverse drug reaction, or contraindication to one of the following: Xarelto oral suspension, Xarelto tablets and
  • appropriate dosing; and
  • if the member is  ≥ eight years of age, one of the following:
    • inadequate response, adverse drug reaction, or contraindication to dabigatran capsule; or 
    • medical necessity for the requested formulation as noted by one of the following: 
      • member utilizes tube feeding (G-tube/J-tube); or 
      • member has a swallowing disorder or condition affecting ability to swallow tablets.

Savaysa

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • appropriate dosing; and
  • inadequate response, adverse drug reaction, or contraindication to all of the following: Eliquis, dabigatran capsule, and Xarelto.

Xarelto 2.5 mg tablet

• Documentation of all of the following is required:
  • diagnosis of reduction of risk of major CV events in chronic CAD/PAD; and
  • member is also receiving concomitant aspirin therapy; and
  • requested quantity is ≤ two tablets/day.

Xarelto suspension

• Documentation of all of the following is required for a diagnosis of thromboprophylaxis in pediatric members with congenital heart disease after the Fontan procedure:
  • appropriate diagnosis; and
  • member is ≥ two years of age and < 18 years of age; and
  • appropriate dosing; and
  • if current weight is ≥ 50 kg, medical necessity for use of Xarelto suspension instead of Xarelto 10 mg tablet as noted by one of the following:
    • member utilizes tube feeding (G-tube/J-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow tablets. 

• For recertification for thromboprophylaxis in pediatric members with congenital heart disease after the Fontan procedure, documentation of all of the following is required: 
  • updated member weight; and  
  • appropriate dosing; and 
  • if current weight is ≥ 50 kg or if member is ≥ 18 years of age, continued medical necessity for use of Xarelto suspension instead of Xarelto 10 mg tablet as noted by one of the following:  
    • member utilizes tube feeding (G-tube/J-tube); or  
    • member has a swallowing disorder or condition affecting ability to swallow tablets.

• Documentation of all of the following is required for the treatment or reduction of risk of recurrent DVT and/or PE in pediatric members:
  • appropriate diagnosis; and
  • member is < 18 years of age; and
  • appropriate dosing; and
  • if current weight is ≥ 30 kg, one of the following:
    • inadequate response, adverse reaction, or contraindication to Xarelto tablets available without PA; or 
    • medical necessity for use of Xarelto suspension instead of Xarelto 10 mg, 15 mg, and 20 mg tablets as noted by one of the following: member utilizes tube feeding (G-tube/J-tube) or member has a swallowing disorder or condition affecting ability to swallow tablets; and
  • if member is ≥ eight years of age and < 18 years of age, one of the following:
    • medical necessity for use of Xarelto suspension formulation as noted by one of the following:
      • member utilizes tube feeding (G-tube/J-tube); or
      • member has a swallowing disorder or condition affecting ability to swallow tablets; or
    • inadequate response, adverse reaction, or contraindication to dabigatran capsule; and
  • member has received or will receive ≥ five days of injectable or intravenous anticoagulation prior to starting Xarelto.

• For recertification for treatment or reduction of risk of recurrent DVT and/or PE in pediatric members, documentation of all of the following is required:
  • updated member weight; and
  • appropriate dosing; and
  • if current weight is ≥ 30 kg or if member is ≥ 18 years of age, continued medical necessity for use of Xarelto suspension instead of Xarelto 10 mg, 15 mg, and 20 mg tablets as noted by one of the following:
    • member utilizes tube feeding (G-tube/J-tube); or
    • member has a swallowing disorder or condition affecting ability to swallow tablets.

Zontivity

• Documentation of all of the following is required: 
  • diagnosis of myocardial infarction or PAD; and
  • requested quantity is ≤ one tablet/day; and
  • member does not have a history of stroke, transient ischemic attack, or intracranial hemorrhage; and
  • requested agent will be used in combination with one of the following: aspirin, clopidogrel.

^†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.