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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 |
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 fibrillationProphylaxis 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)
|
|
3 |
Xarelto® (rivaroxaban) Tablet Suspension |
Reduction of risk of stroke and systemic embolism in adult patients with NVAF
Treatment of PE
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
|
|
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:
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:
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:
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