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Oral Anticoagulant - Eliquis (apixaban), Pradaxa (dabigatran), Savaysa (edoxaban), Xarelto (rivaroxaban) Quantity Limit Program Summary

Policy Number: PH-91024

This program applies to Blue Partner, Commercial, GenPlus, NetResults A series, SourceRx and Health Insurance Marketplace formularies.            

POLICY REVIEW CYCLE                                                                                                                                                                           

Effective Date

Date of Origin 

07-01-2024            

FDA LABELED INDICATIONS AND DOSAGE

Agent(s)

FDA Indication(s)

Notes

Ref#

Eliquis®

(apixaban)

Tablet

Reduce the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation

Prophylaxis of deep vein thrombosis (DVT), which may lead to pulmonary embolism (PE), in patients who have undergone hip or knee replacement surgery

Treatment of DVT and PE
Reduce the risk of recurrent DVT and PE following initial therapy

1

Pradaxa®

(dabigatran)

Capsule*

To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation

For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days

To reduce the risk of recurrence of DVT and PE in adult patients who have been previously treated

For the prophylaxis of DVT and PE in adult patients who have undergone hip replacement surgery

For the treatment of venous thromboembolic events (VTE) in pediatric patients 8 to less than 18 years of age who have been treated with a parenteral anticoagulant for at least 5 days

To reduce the risk of recurrence of VTE in pediatric patients 8 to less than 18 years of age who have previously been treated

* generic available

2

Pradaxa®

(dabigatran)

Oral Pellets

For the treatment of venous thromboembolic events (VTE) in pediatric patients aged 3 months to less than 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days.

To reduce the risk of recurrence of VTE in pediatric patients aged 3 months to less than 12 years of age who have been previously treated 

5

Savaysa®

(edoxaban)

Capsule

To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF)

For the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

3

Xarelto®

(rivaroxaban)

Tablet

Suspension

To reduce risk of stroke and systemic embolism in nonvalvular atrial fibrillation

Treatment of deep vein thrombosis (DVT)

Treatment of pulmonary embolism (PE)

Reduction in the risk of recurrence of DVT or PE

Prophylaxis of DVT, which may lead to PE in patients undergoing knee or hip replacement surgery

Prophylaxis of venous thromboembolism (VTE) in acutely ill medical patients

Reduction of risk of major cardiovascular events in patients with coronary artery disease (CAD)

Reduction of risk of major thrombotic vascular events in patients with peripheral artery disease (PAD), including patients after recent lower extremity revascularization due to symptomatic PAD  

Treatment of VTE and reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years

Thromboprophylaxis in pediatric patients 2 years and older with congenital heart disease after the Fontan procedure

4

See package insert for FDA prescribing information:  https://dailymed.nlm.nih.gov/dailymed/index.cfm

REFERENCES                                                                                                                                                                           

Number

Reference

1

Eliquis prescribing information. Bristol-Myers Squibb Company. August 2021.

2

Pradaxa Capsule prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. June 2021.

3

Savaysa prescribing information. Daiichi Sankyo Co., LTD. March 2021.

4

Xarelto prescribing information. Janssen Pharmaceuticals, Inc. February 2023.

5

Pradaxa Oral Pellets prescribing information. Boehringer Ingelheim Pharmaceuticals, Inc. March 2022.

POLICY AGENT SUMMARY QUANTITY LIMIT

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

QL Amount

Dose Form

Day Supply

Duration

Addtl QL Info

Allowed Exceptions

Targeted NDCs When Exclusions Exist

Eliquis

Apixaban Tab 2.5 MG

2.5 MG

60

Tablets

30

DAYS

Eliquis

Apixaban Tab 5 MG

5 MG

74

Tablets

30

DAYS

2 tablets/day for maintenance

Eliquis starter pack

Apixaban Tab Starter Pack

5 MG

1

Pack

180

DAYS

Pradaxa

dabigatran etexilate mesylate cap

110 MG ; 150 MG ; 75 MG

60

Capsules

30

DAYS

Pradaxa

Dabigatran Etexilate Mesylate Cap 110 MG (Etexilate Base Eq)

110 MG

120

Capsules

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

20 MG

60

Packets

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

30 MG

120

Packets

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

40 MG

120

Packets

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

50 MG

120

Packets

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

110 MG

120

Packets

30

DAYS

Pradaxa

dabigatran etexilate mesylate pellet pack

150 MG

60

Packets

30

DAYS

Savaysa

edoxaban tosylate tab

15 MG ; 30 MG ; 60 MG

30

Tablets

30

DAYS

Xarelto

Rivaroxaban For Susp

1 MG/ML

4

Bottles

30

DAYS

Xarelto

Rivaroxaban Tab 10 MG

10 MG

30

Tablets

30

DAYS

Xarelto

Rivaroxaban Tab 15 MG

15 MG

60

Tablets

30

DAYS

Xarelto

Rivaroxaban Tab 2.5 MG

2.5 MG

60

Tablets

30

DAYS

Xarelto

Rivaroxaban Tab 20 MG

20 MG

30

Tablets

30

DAYS

Xarelto starter pack

Rivaroxaban Tab Starter Therapy Pack 15 MG & 20 MG

15 & 20 MG

51

Tablets

30

DAYS

CLIENT SUMMARY – QUANTITY LIMITS

Target Brand Agent Name(s)

Target Generic Agent Name(s)

Strength

Client Formulary

Eliquis

Apixaban Tab 2.5 MG

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Eliquis

Apixaban Tab 5 MG

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Eliquis starter pack

Apixaban Tab Starter Pack

5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate cap

110 MG ; 150 MG ; 75 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

Dabigatran Etexilate Mesylate Cap 110 MG (Etexilate Base Eq)

110 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

150 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

110 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

40 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

50 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

30 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Pradaxa

dabigatran etexilate mesylate pellet pack

20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Savaysa

edoxaban tosylate tab

15 MG ; 30 MG ; 60 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto

Rivaroxaban For Susp

1 MG/ML

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto

Rivaroxaban Tab 10 MG

10 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto

Rivaroxaban Tab 15 MG

15 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto

Rivaroxaban Tab 2.5 MG

2.5 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto

Rivaroxaban Tab 20 MG

20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

Xarelto starter pack

Rivaroxaban Tab Starter Therapy Pack 15 MG & 20 MG

15 & 20 MG

Blue Partner ; Commercial ; GenPlus ; Health Insurance Marketplace ; NetResults A Series ; SourceRx

QUANTITY LIMIT CLINICAL CRITERIA FOR APPROVAL

Module

Clinical Criteria for Approval

Eliquis and Savaysa

Quantities above the program quantity limit for Eliquis and Savaysa will be approved when ONE of the following is met:

  1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
  2. The requested quantity (dose) is greater than the maximum FDA labeled dose for the requested indication AND the prescriber has provided information in support of therapy with a higher dose for the requested indication

Length of Approval:  12 months or as requested by the prescriber, whichever is shorter

Pradaxa

Quantities above the program quantity limit for Pradaxa will be approved when ONE of the following is met:

  1. The indicated use is prophylaxis of DVT and PE in an adult patient who has undergone hip replacement surgery AND the prescriber has provided information in support of therapy with a higher quantity (duration) for the requested indication OR
  2. The indicated use is to reduce the risk of stroke and systemic embolism in an adult patient with nonvalvular atrial fibrillation OR treatment of DVT and PE OR reduction in the risk of recurrence of DVT and PE AND BOTH of the following:
    1. The requested dosage form is NOT 110 mg AND
    2. ONE of the following:
      1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
      2. The requested quantity (dose) requested is greater than the maximum FDA labeled dose for the requested indication AND the prescriber has provided information in support of therapy with a higher dose for the requested indication OR
  3. The indicated use is other than those listed above AND the prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication

Length of Approval:  12 months or as requested by the prescriber, whichever is shorter

Xarelto

Quantities above the program quantity limit for Xarelto will be approved when ONE of the following is met:

  1. The indicated use is prophylaxis of DVT which may lead to PE in a patient undergoing hip or knee replacement surgery AND the prescriber has provided information in support of therapy with a higher quantity (duration) for the requested indication OR
  2. The indicated use is reduction of risk of stroke and systemic embolism in a patient with nonvalvular atrial fibrillation OR treatment of DVT/PE AND ONE of the following:
    1. The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does not exceed the program quantity limit OR
    2. The requested quantity (dose) requested is greater than the maximum FDA labeled dose for the requested indication AND the prescriber has provided information in support of therapy with a higher dose for the requested indication OR
  3. The indicated use is other than those listed above AND the prescriber has provided information in support of therapy with a higher quantity (dose) for the requested indication

Length of Approval:  12 months or as requested by the prescriber, whichever is shorter

This pharmacy policy is not an authorization, certification, explanation of benefits or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All pharmacy policies are based on (i) information in FDA approved package inserts (and black box warning, alerts, or other information disseminated by the FDA as applicable); (ii) research of current medical and pharmacy literature; and/or (iii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.

The purpose of Blue Cross and Blue Shield of Alabama’s pharmacy policies are to provide a guide to coverage. Pharmacy policies are not intended to dictate to physicians how to practice medicine. Physicians should exercise their medical judgment in providing the care they feel is most appropriate for their patients.

Neither this policy, nor the successful adjudication of a pharmacy claim, is guarantee of payment.

 

 

 

Commercial _ PS _ Oral_Anticoagulant_QL _ProgSum_ 07-01-2024