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Drug Category: Blood and Circulation

Medication Class/Individual Agents: Anticoagulants and Antiplatelet Agents

I. Prior-Authorization Requirements

 Antiplatelet Agents

Clinical Notes

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

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

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 patient’s risk for thromboembolic events and/or bleeding events.
  • Prasugrel has a more rapid onset of action, is more potent than clopidogrel, and produces more consistent platelet inhibition. Ticagrelor belongs to a newer class called cyclopentyltriazolopyrimidines. Unlike clopidogrel and prasugrel that bind irreversibly, ticagrelor binds reversibly to the P2Y12 receptor on the surface of platelets. Ticagrelor is not a prodrug and as a result is not subject to potential drug interactions associated with the other agents. Ticagrelor has a more rapid onset and more pronounced platelet inhibition than clopidogrel.
  • Vorapaxar is the first in a new class of antiplatelet agents called protease-activated receptor-1 (PAR-1) antagonists. Vorapaxar has been studied only as an addition to aspirin and/or clopidogrel.
  • Aspirin extended-release should not be used in situations where a rapid onset of action is required.
  • Aspirin/omeprazole is an oral delayed-release product that consists of an enteric coated delayed-release aspirin core surrounded by an immediate-release omeprazole layer. This agent should also not be used in situations where a rapid onset of action is required.

Anticoagulant Agents:

  • There are several oral and injectable anticoagulants commercially available for the management of a variety of medical conditions. The oral anticoagulants consist of 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 available generically and 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 patients with renal impairment.
  • The newer oral anticoagulants (NOACs) 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 newer agents require dose adjustments in patients with renal impairment.
  • 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 NOACs are not associated with the same food and drug interactions as with warfarin treatment. Antidotes are currently available only for warfarin and dabigatran.
 

 Intravenous/Subcutaneous Anticoagulants

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

dalteparin Fragmin test  
desirudin Iprivask PA  
enoxaparin Lovenox # test  
fondaparinux Arixtra # test  
heparin test  
heparin lock flush test  

 Oral Anticoagulants

Drug Details

Drug Generic Name

Drug Brand Name

PA
Status

apixaban Eliquis PA  
dabigatran etexilate mesylate 110 mg Pradaxa PA   - > 70 capsules/365 days
dabigatran etexilate mesylate 75 mg, 150 mg Pradaxa PA  
edoxaban Savaysa PA  
rivaroxaban 10 mg, 15 mg, 20 mg, starter pack Xarelto test  
rivaroxaban 2.5 mg Xarelto PA  
warfarin Coumadin # test  
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.
 

II. Therapeutic Uses

FDA-approved, for example:

  • Myocardial infarction (Brilinta, prasugrel, Zontivity)
  • Nonvalvular atrial fibrillation (Eliquis, 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 knee or hip replacement surgery (Eliquis)
  • Prophylaxis of DVT in patients undergoing total hip replacement surgery (Iprivask)
  • Reduction in the risk of recurrence of DVT and/or PE (Eliquis, Pradaxa)
  • Reduction in the risk of death and recurrent stroke in patients who have had a transient ischemic attack (TIA), or an ischemic stroke (Durlaza)
  • Reduction of risk of major CV events in chronic coronary artery disease (CAD)/PAD (Xarelto)
  • Secondary prophylaxis to reduce the risk of death and myocardial infarction in patients with chronic CAD (Durlaza)
  • Treatment of DVT and/or PE (Eliquis, Pradaxa, Savaysa)
  • Unstable angina (Brilinta, prasugrel)

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.
  • 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).

 

Brilinta

  • Documentation of all of the following is required: 
    • diagnosis of non-ST elevation myocardial infarction, ST-elevation myocardial infarction, or unstable angina; and
    • requested quantity ≤ 60 tablets/30 days; and
    • member is NOT on > 100 mg/day of concomitant aspirin therapy; and
    • one of the following:
      • member has been started and stabilized on the medication while a hospital inpatient; or
      • inadequate response, adverse reaction, or contraindication to clopidogrel; or
      • clinical rationale for bypassing clopidogrel trial.

  

Durlaza

  • Documentation of all of the following is required: 
    • appropriate diagnosis; and
    • inadequate response or adverse reaction to one aspirin product that does not require PA; and
    • medical necessity for extended-release formulation; and
    • requested quantity ≤ 30 tablets/30 days.

  

Eliquis 2.5 mg for prophylaxis of DVT in knee or hip replacement surgery

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • requested quantity is ≤ 24 tablets/365 days following knee replacement surgery; or
    • requested quantity is ≤ 70 tablets/365 days following hip replacement surgery.

  

Eliquis 2.5 mg and 5 mg, 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.

  

Eliquis 5 mg and Starter Pack for treatment of DVT and/or PE

  • Documentation of all of the following is required:
    • appropriate diagnosis; and
    • appropriate dose and duration of therapy; 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.

  

Eliquis 2.5 mg and 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.

  

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 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 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.

  

prasugrel

  • Documentation of all of the following is required: 
    • diagnosis of non-ST elevation myocardial infarction, ST-elevation myocardial infarction, or unstable angina; and
    • member has a history of PCI; and
    • requested quantity ≤ 30 tablets/30 days; and
    • member is also receiving concomitant aspirin therapy; and
    • one of the following: 
      • member has been started and stabilized on the medication while a hospital inpatient; or
      • inadequate response, adverse reaction or contraindication to clopidogrel; or
      • clinical rationale for bypassing clopidogrel trial.  

  

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.


Original Effective Date: 01/2012

Last Revised Date: 08/2019


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Last updated 08/29/19