Interactive Drug Benefit List
DIN/NPN/PIN 02397714 ELIQUIS 5 MG ORAL TABLET APIXABAN
200000 BLOOD FORMULATION, COAGULATION AND THROMBOSIS
201200 ANTITHROMBOTIC AGENTS
201204 ANTICOAGULANTS
20120492 MISCELLANEOUS ANTICOAGULANTS
Date Listed/Coverage Update: 01-Mar-2014
Unit Price: 1.6336
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Tablet
Manufacturer: BRISTOL-MYERS SQUIBB (BMS)
ATC: B01AF02
1
Interchangeable Products: No

Coverage Status: STEP THERAPY/ SPECIAL AUTHORIZATION
Applies to Clients of: Non-Group Coverage (Group 1)
Coverage for Seniors (Group 66)
Palliative Coverage (Group 20514, Please note:Your client may have Group 1 or Group 66 coverage)
Child and Family Services (Group 20403)
Alberta Child Health Benefit (Group 20400)
Children and Youth Services (Group 19824)
Income Support (Group 19823)
Learners Program (Group 22128)
Alberta Human Services (AISH) (Group 19823)
Alberta Adult Health Benefit (AAHB) (Group 23609)

Special Authorization Request Form:

Apixaban/Dabigatran/Edoxaban/Rivaroxaban Special Authorization Request Form (ABC 60019)

Expand all Collapse all



SPECIAL AUTHORIZATION (step therapy approval process)

FIRST-LINE DRUG PRODUCT(S): WARFARIN

Coverage Criteria

"Subject to the Exclusions From Coverage noted below, Members of Alberta Government Sponsored Drug Plans who are At-Risk with non-valvular atrial fibrillation (AF) who require the Drug Products for the prevention of stroke and systemic embolism AND in whom one of the following is also present:

- Inadequate Anticoagulation following at least a two month trial of warfarin; OR
- Anticoagulation using warfarin is contraindicated or not possible due to inability to regularly monitor the patient via International Normalized Ratio (INR) testing (i.e. no access to INR testing services at a laboratory, clinic, pharmacy, or at home).

Exclusions from Coverage:
- Patients with impaired renal function (creatinine clearance or estimated glomerular filtration rate <25 mL/min),
- Patients who are greater than or equal to 75 years of age and who do not have Documented Stable Renal Function,
- Patients who have hemodynamically significant rheumatic valvular heart disease, especially mitral stenosis, or,
- Patients who have a prosthetic heart valve.

Definitions:
- "At-Risk" means patients with atrial fibrillation are defined as those with a CHADS2 score of greater than or equal to 1. Prescribers may consider an antiplatelet regimen or oral anticoagulation for patients with a CHADS2 score of 1.
- "Inadequate Anticoagulation" is defined as INR testing results that are outside the desired INR range for at least 35% of the tests during the monitoring period (i.e. adequate anticoagulation is defined as INR test results that are within the desired INR range for at least 65% of the tests during the monitoring period).
- "Documented Stable Renal Function" is defined as creatinine clearance or estimated glomerular filtration rate that is maintained for at least 3 months

Notes:
- The usual recommended dose for the Drug Products is 5mg twice daily. A reduced dose of 2.5mg twice daily is recommended for patients with at least two (2) of the following three (3) characteristics:
- an age that is equal to or greater than 80 years
- a body weight that is equal to or lower than 60kg, and
- serum creatinine that is equal to or greater than 133 micromole/litre.
- Since renal impairment can increase bleeding risk, renal function should be regularly monitored. Other factors that increase bleeding risk should also be assessed and monitored (see Drug Products monograph).
- Patients starting on the Drug Products should have ready access to appropriate medical services to manage a major bleeding event.
- There is currently no data to support that the Drug Products provide adequate anticoagulation in patients with rheumatic valvular disease or those with prosthetic heart valves, so the Drug Products are not recommended in these populations.

Special Authorization may be granted for up to 24 months."

Note: If a claim for the Step therapy drug product is rejected, pharmacists can use their professional judgment to determine the appropriateness of using the intervention code(s) noted below to re-submit a claim. The pharmacist is responsible to document on the patient's record the rationale for using the second-line therapy drug.

UP - First-line therapy ineffective
UQ - First-line therapy not tolerated



SPECIAL AUTHORIZATION

COVERAGE:

"For the treatment of deep vein thrombosis (DVT) or pulmonary embolism (PE).

The recommended dose of apixaban for patients initiating DVT or PE treatment is 10 mg twice daily for 7 days, followed by 5 mg taken orally twice daily.

Drug plan coverage for apixaban is an alternative to heparin/warfarin for up to 6 months. When used for greater than 6 months, apixaban is more costly than heparin/warfarin. As such, patients with an intended duration of therapy greater than 6 months should be considered for initiation on heparin/warfarin.

Special authorization may be granted for up to 6 months."

All requests for apixaban must be completed using the Apixaban/Dabigatran/Edoxaban/Rivaroxaban Special Authorization Request Form (ABC 60019).

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE Common Drug Review 2014/10/02 2015/09/01 Under Review
THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE Common Drug Review 2014/10/02 2015/05/07 View CDR - List with clinical criteria and/or conditions
THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE Common Drug Review 2014/10/02 2015/10/01 Special Authorization Criteria Change
THROMBOEMBOLIC EVENTS, PREVENTION (ATRIAL FIBRILLATION) Common Drug Review 2012/10/10 2013/03/20 View CDR - List with criteria/condition
Indication THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/02
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2015/09/01
CDR
Recommendation
Review
Status
Under Review
Indication THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/02
CDR
Recommendation
Date
2015/05/07
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication THROMBOEMBOLIC EVENTS (VENOUS), TREATMENT & PREVENTION OF RECURRENCE
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/02
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2015/10/01
CDR
Recommendation
Review
Status
Special Authorization Criteria Change
Indication THROMBOEMBOLIC EVENTS, PREVENTION (ATRIAL FIBRILLATION)
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2012/10/10
CDR
Recommendation
Date
2013/03/20
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with criteria/condition
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The DBL, DBS and related publications require knowledgeable interpretation and are intended primarily for professional health care practitioners, pharmacies, hospitals and organizations associated with the manufacture, distribution and use of pharmaceutical preparations.
Electronic versions of all DBL and DBS related publications are unofficial versions and are provided for convenience and private use only. Official paper versions can be obtained from Alberta Blue Cross who publishes them on behalf of Alberta Health and Alberta Human Services.
Alberta Health reserves the right to make changes, without notice, to the List through the Interactive DBL(iDBL), and any such changes to the Interactive DBL(iDBL) are effective the date of the change (unless otherwise stated) and regardless of the date of publication in the paper version or updates.