Asset Publisher

ph-1024

print Print Back Back

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

Policy Number: PH-1024

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 

7/1/2023

FDA APPROVED 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

2

Pradaxa®

(dabigatran)

Oral Pellets

For pediatric patients aged 3 months to less than 2 years: age- and weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant

For pediatric patients 2 years to less than 12 years: weight-based dosage, twice daily after at least 5 days of parenteral anticoagulant

5

Savaysa®

(edoxaban)

Capsule

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


Treatment of DVT and PE following 5 to 10 days of initial therapy with a parenteral anticoagulant

3

Xarelto®

(rivaroxaban)

Tablet

Suspension

Reduction of risk of stroke and systemic embolism in adult patients with NVAF


Treatment of DVT

 

Treatment of PE


Reduction in the risk of recurrence of DVT and/or PE in patients at continued risk for recurrent DVT and/or PE after completion of initial treatment lasting at least 6 months


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

 

Reduction of risk of major cardiovascular (CV) events (CV death, myocardial infarction [MI], and stroke) in adult patients with chronic coronary artery disease (CAD) 

 

Reduction of risk of major thrombotic vascular events (myocardial infarction, ischemic stroke, acute limb ischemia, and major amputation of a vascular etiology) in adult patients with peripheral artery disease (PAD), including patients who have recently undergone a lower extremity revascularization procedure due to symptomatic PAD

 

Prophylaxis of venous thromboembolism (VTE) and VTE-related death during hospitalization and post-hospital discharge in adult patients admitted for an acute medical illness who are at risk for thromboembolic complications due to moderate or severe restricted mobility and other risk factors for VTE and not at high risk of bleeding

 

Treatment of VTE and the reduction in the risk of recurrent VTE in pediatric patients from birth to less than 18 years after at least 5 days of initial parenteral anticoagulant treatment


Thromboprophylaxis in pediatric patients aged 2 years and older with congenital heart disease who have undergone 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. December 2021.

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

50 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

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 -  Eliquis (apixaban), Pradaxa (dabigatran), Savaysa (edoxaban), Xarelto (rivaroxaban) Quantity Limit _ProgSum_ 7/1/2023