Asset Publisher

ph-1024

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 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. 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 The requested quantity (dose) does NOT exceed the program quantity limit OR The requested quantity (dose) exceeds the program quantity limit AND ONE of the following: BOTH of the following: The requested agent does NOT have a maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication 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 The requested quantity (dose) does NOT exceed the program quantity limit OR 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 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: The requested dosage form is NOT 110 mg AND ONE of the following: BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR The indicated use is other than those listed above AND there is support for 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	Quantity limit for the Target Agent(s) will be approved when ONE of the following is met The requested quantity (dose) does NOT exceed the program quantity limit OR 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 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: BOTH of the following: The requested quantity (dose) does NOT exceed the maximum FDA labeled dose for the requested indication AND There is support for why the requested quantity (dose) cannot be achieved with a lower quantity of a higher strength that does NOT exceed the program quantity limit OR BOTH of the following: The requested quantity (dose) exceeds the maximum FDA labeled dose for the requested indication AND There is support for therapy with a higher dose for the requested indication OR The indicated use is other than those listed above AND there is support for 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.