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Table 58: Anticoagulants and Antiplatelet Agents


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Drug Category: Blood and Circulation

Medication Class/Individual Agents: Anticoagulants and Antiplatelet Agents

I. Prior-Authorization Requirements

 Intravenous/Subcutaneous Anticoagulants

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

dalteparin Fragmin test  
enoxaparin Lovenox test   #
fondaparinux Arixtra test   #
heparin test  
heparin lock flush test  

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.

  

Antiplatelet Agents:

  • Antiplatelet agents play a major role in the management of cardiovascular (CV), cerebrovascular, and peripheral vascular diseases. The recommendation for use of these agents as monotherapy or combination therapy depends on the specific clinical indication and the member’s risk for thromboembolic events and/or bleeding events.
  • Vorapaxar is the first in a new class of antiplatelet agents called protease-activated receptor-1 (PAR-1) antagonists. This drug is FDA approved for the reduction of thrombotic cardiovascular events in members with a history of myocardial infarction or with peripheral arterial disease. Vorapaxar has been studied only as an addition to aspirin and/or clopidogrel. There is no experience with the use of vorapaxar administered as monotherapy.

Anticoagulant Agents:

  • There are several oral and injectable anticoagulants commercially available for the management of a variety of medical conditions. The oral anticoagulants include apixaban, dabigatran, edoxaban, rivaroxaban, and warfarin.
  • Warfarin is a vitamin K antagonist that works by interfering with the synthesis of vitamin K dependent clotting factors (II, VII, IX, and X) as well as the anticoagulant proteins C and S. It is dosed once daily. Due to its narrow therapeutic window and various food and drug interactions, it requires frequent monitoring of international normalized ratios (INR) to monitor for safety and efficacy. Warfarin does not require dosage adjustments in members with renal impairment.
  • The direct oral anticoagulants (DOACs) target a single enzyme involved in the coagulation cascade. Dabigatran etexilate mesylate is a prodrug that is converted to dabigatran, a potent, competitive inhibitor of thrombin. Apixaban, edoxaban and rivaroxaban all selectively inhibit factor Xa, thereby preventing the generation of thrombin and ultimately preventing platelet activation and the formation of fibrin clots. These agents require dose adjustments in members with renal impairment. When used for non-valvular atrial fibrillation, apixaban may be used in severe renal impairment, including members on hemodialysis.
  • Edoxaban and rivaroxaban are both approved for once-daily dosing (with the exception of the first 21 days for treatment of a deep vein thrombosis [DVT] or pulmonary embolism [PE] with rivaroxaban) whereas dabigatran and apixaban are both administered twice daily. In addition, these DOACs are not associated with the same food and drug interactions as with warfarin treatment. Available antidotes are currently FDA-approved for apixaban, dabigatran, rivaroxaban, and warfarin.
 

 Oral Anticoagulants

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

apixaban Eliquis test  
dabigatran etexilate mesylate Pradaxa test   BP, M90
edoxaban Savaysa PA  
rivaroxaban 10 mg, 15 mg, 20 mg tablet, starter pack Xarelto test  
rivaroxaban 2.5 mg tablet, suspension Xarelto PA  
warfarin test   A90

 Platelet Aggregation Inhibitors

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

anagrelide Agrylin test   # , A90
aspirin / extended-release dipyridamole test   M90
cilostazol test   A90
clopidogrel Plavix test   # , A90
dipyridamole test   M90
prasugrel Effient test   # , A90
ticagrelor Brilinta test  
vorapaxar Zontivity PA  

 Salicylates

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

Drug
Notes

aspirin 325 mg, 500 mg, 650 mg test   *, A90
aspirin 81 mg test   *, M90
aspirin suppository test   *
aspirin with buffers test   *, A90
Table Footnotes
# This designates a brand-name drug with FDA “A”-rated generic equivalents. Prior authorization is required for the brand, unless a particular form of that drug (for example, tablet, capsule, or liquid) does not have an FDA “A”-rated generic equivalent.
 
BP Brand Preferred over generic equivalents. In general, MassHealth requires a trial of the preferred drug or clinical rationale for prescribing the non-preferred drug generic equivalent.
 
* The generic OTC and, if any, generic prescription versions of the drug are payable under MassHealth without prior authorization.
 
A90 Allowable 90-day supply. Dispensing in up to a 90-day supply is allowed. May not include all strengths or formulations. Quantity limits and other restrictions may apply.
 
M90 Effective 12/19/22, mandatory 90-day supply. After dispensing up to a 30-day supply initial fill, dispensing in a 90-day supply is required. May not include all strengths or formulations. Quantity limits and other restrictions may also apply. Prior to 12/19/22, allowable 90-day supply and dispensing in up to a 90-day supply is allowed.
 

II. Therapeutic Uses

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 (Xarelto suspension)

Note: The above list may not include all FDA-approved indications.

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III.  Evaluation Criteria for Approval

 

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 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, dabigatran etexilate mesylate, 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 members 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 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 a diagnosis of 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, 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 dabigatran etexilate mesylate 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 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 ≤ 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.


Original Effective Date: 01/2012

Last Revised Date: 09/2022


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Last updated 09/19/22

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