FDA-approved, for example:

• Myocardial infarction (Zontivity)
• Nonvalvular atrial fibrillation (Pradaxa, Savaysa)
• Peripheral artery disease (PAD) (Zontivity)
• Prophylaxis of DVT and PE in patients undergoing total hip replacement surgery (Pradaxa)
• Prophylaxis of DVT in patients undergoing total hip replacement surgery (Iprivask)
• Reduction in the risk of recurrence of DVT and/or PE (Pradaxa)
• Reduction of risk of major CV events in chronic coronary artery disease (CAD)/PAD (Xarelto)
• Treatment of DVT and/or PE (Pradaxa, Savaysa)

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).

Iprivask

• Documentation of all of the following is required:      
  • appropriate diagnosis; and
  • member is ≥18 years old; and
  • inadequate response, adverse reaction, or contraindication to fondaparinux; and
  • inadequate response, adverse reaction, or contraindication to warfarin; and
  • one of the following:      
    • inadequate response, adverse reaction, or contraindication to low molecular weight heparin (LMWH); or
    • history of heparin-induced thrombocytopenia (HIT)/thrombosis syndrome (HITTS).

Pradaxa 75 mg and 150 mg, and Savaysa for nonvalvular atrial fibrillation

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • adverse reaction or contraindication to warfarin; or
  • inadequate response to ≥ 30 days of warfarin for reasons other than noncompliance; or
  • medical necessity for anticoagulation that does not require INR monitoring.

Pradaxa 110 mg > 70 capsules/365 days

• Documentation of all of the following is required:
  • diagnosis of prophylaxis of DVT and PE in members undergoing total hip replacement surgery; and
  • if request is for > 70 capsules/365 days, member is undergoing a second hip replacement surgery within 365 days.

SmartPA: Claims for Pradaxa 110 mg will usually process at the pharmacy without a PA request if within the quantity limit of 70 capsules/35 days and if the member does not have a history of paid MassHealth pharmacy claims for Pradaxa in the past year.^†

Pradaxa 150 mg for reduction in the risk of recurrence of DVT and/or PE following 6 months of treatment

• Documentation of all of the following is required: 
  • appropriate diagnosis; and
  • member has just completed treatment for DVT or PE with apixaban, dabigatran, or rivaroxaban; or
  • adverse reaction or contraindication to warfarin; or
  • inadequate response to ≥ 30 days of warfarin for reasons other than noncompliance; or
  • medical necessity for anticoagulation that does not require INR monitoring.

Pradaxa 150 mg and Savaysa for treatment of DVT and/or PE

• Documentation of all of the following is required:
  • appropriate diagnosis; and
  • adverse reaction or contraindication to warfarin; or
  • inadequate response to ≥ 30 days of warfarin for reasons other than noncompliance; or
  • medical necessity for anticoagulation that does not require INR monitoring.

Xarelto 2.5 mg

• 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 ≤ 60 tablets/30 days; and
  • concomitant diagnosis of atrial fibrillation or venous thromboembolic disease; or
  • member is currently stabilized on the requested agent.

Zontivity

• Documentation of all of the following is required: 
  • diagnosis of myocardial infarction or PAD; and
  • requested quantity ≤ 30 tablets/30 days; and
  • member does not have a history of stroke or TIA; 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.