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 patients 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 patients (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.
• 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).

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, Pradaxa, 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 ≤ two tablets/day.

Xarelto suspension

• Documentation of all of the following is required for a diagnosis of thromboprophylaxis in pediatric patients with congenital heart disease after the Fontan procedure:
  • appropriate diagnosis; and
  • member is ≥ 2 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 patients 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 a diagnosis of treatment or reduction of risk of recurrent DVT and/or PE in pediatric patients:
  • appropriate diagnosis; and
  • member is < 18 years of age; and
  • appropriate dosing; and
  • if current weight is ≥ 30 kg, 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 ≥12 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 Pradaxa capsules; and
  • member has received or will receive ≥ 5 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 patients, 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 ≤ one tablet/day; and
  • member does not have a history of stroke, transient ischemic attack, or intracranial hemorrhage; and
  • member is also receiving aspirin or 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.