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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 |
10-01-2024 |
|
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 surgeryTreatment of DVT and PE |
|
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. November 2023. |
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. November 2023. |
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 |
50 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 |
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 |
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 |
110 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 |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met
Length of Approval: 12 months or as requested by the prescriber, whichever is shorter |
Pradaxa |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met
Length of Approval: 12 months or as requested by the prescriber, whichever is shorter |
Xarelto |
Quantity limit for the Target Agent(s) will be approved when ONE of the following is met
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_ 10-01-2024