Interactive Drug Benefit List
DIN/NPN/PIN 02415992 EYLEA 2 MG / VIAL INJECTION AFLIBERCEPT
520000 EYE, EAR, NOSE, AND THROAT (EENT) PREPARATIONS
529200 MISCELLANEOUS EENT DRUGS
Date Listed/Coverage Update: 01-Aug-2017
Unit Price: 1,418.0000
LCA Price: N/A
MAC Price:

N/A

Unit of Issue: Vial
Manufacturer: BAYER INC. (BAI)
ATC: S01LA05
1
Interchangeable Products: No

Coverage Status: RESTRICTED BENEFIT
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:

N/A

RESTRICTED BENEFIT

This Drug Product is a benefit to a member of an Alberta Government Sponsored Drug Plan when the Drug Product is prescribed by a registered prescriber and pursuant to the following criteria:

"For the treatment of neovascular (wet) age-related macular degeneration (AMD) if all of the following apply to the eye to be treated:

- The best corrected visual acuity (BCVA) is between 6/12 (20/40) and 6/96 (20/320); and
- There is active disease activity (choroidal neovascularization) and no permanent structural damage to the central fovea; and
- There is evidence of recent (< three (3) months) presumed disease progression (blood vessel growth, as indicated by fluoroscein angiography, optical coherence tomography (OCT) or recent visual acuity changes); and
- No concurrent verteporfin PDT treatment; and
- The injection will be administered by a qualified ophthalmologist with experience in intravitreal injections.

Treatment with anti-VEGF agents should be continued only in patients who maintain adequate response to therapy.

The anti-VEGF agent should be discontinued if any of the following occur:
- Reduction in BCVA in the treated eye to less than fifteen (15) letters (absolute) on two (2) consecutive visits in the treated eye, attributed to AMD in the absence of other pathology; or
- Reduction in BCVA of thirty (30) letters or more compared to either baseline and/or best recorded level since baseline as this may indicate either poor treatment effect or adverse event or both; or
- There is evidence of deterioration of the lesion morphology despite optimum treatment over three (3) consecutive visits.

The interval between the doses should be no less than 1 month.

Coverage will not be provided for patients who have failed to respond to a previous anti-VEGF agent."

"For the treatment of diabetic macular edema (DME), in patients with severe visual impairment as defined by:

Best-Corrected Visual Acuity (using the Early Treatment Diabetic Retinopathy Study visual acuity test) of seventy-eight (78) to twenty-four (24) letters and a central retinal thickness greater than or equal to three hundred (300) micrometres meeting all of the following criteria:
- clinically significant diabetic macular edema for whom laser photocoagulation is also indicated, and
- a hemoglobin A1c of less than or equal to 12%.

Coverage will not be provided to patients who have failed to respond to a previous anti-VEGF agent."

"For the treatment of visual impairment due to macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO).

Aflibercept is administered by intravitreal injection once every month. The interval between doses should not be shorter than one month. The treatment interval may be extended up to 3 months based on visual and anatomic outcomes. Prescribers are advised to periodically assess the need for continued therapy.

Clinical trial experience of a monthly dosing regimen of 2 mg aflibercept beyond 6 months in the CRVO and BRVO indications is limited. The dosing regimen of once every 4 weeks changed, at 24 weeks, to a regimen that allowed for extension of the treatment based on visual and anatomic outcomes in the CRVO clinical trials and to once every 8 weeks in the BRVO clinical trial.

Coverage will not be provided for patients who have failed to respond to a previous anti-VEGF agent."

Review Status / Past Decisions

Indication Reviewing
Body
Submission
Completion
Date
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
Review
Status
MACULAR EDEMA SECONDARY TO BRVO Common Drug Review 2016/01/05 2016/07/27 View CDR - List with clinical criteria and/or conditions
MACULAR EDEMA SECONDARY TO RVO Common Drug Review 2014/10/31 2015/09/01 Under Review
MACULAR EDEMA SECONDARY TO RVO Common Drug Review 2014/10/31 2015/05/07 View CDR - List with clinical criteria and/or conditions
MACULAR EDEMA SECONDARY TO RVO Common Drug Review 2014/10/31 2017/08/01 Restricted Benefit
MACULAR EDEMA, DIABETIC Common Drug Review 2014/09/30 2015/05/07 View CDR - List with clinical criteria and/or conditions
MACULAR DEGENERATION, AGE-RELATED Common Drug Review 2013/11/25 2015/04/01 Under Review
MACULAR DEGENERATION, AGE-RELATED Common Drug Review 2013/11/25 2014/10/20 View CDR - List with clinical criteria and/or conditions
Indication MACULAR EDEMA SECONDARY TO BRVO
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2016/01/05
CDR
Recommendation
Date
2016/07/27
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
Indication MACULAR EDEMA SECONDARY TO RVO
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/31
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2015/09/01
CDR
Recommendation
Review
Status
Under Review
Indication MACULAR EDEMA SECONDARY TO RVO
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/31
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 MACULAR EDEMA SECONDARY TO RVO
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/10/31
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2017/08/01
CDR
Recommendation
Review
Status
Restricted Benefit
Indication MACULAR EDEMA, DIABETIC
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2014/09/30
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 MACULAR DEGENERATION, AGE-RELATED
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/11/25
CDR
Recommendation
Date
Expert Committee
Recommendation
Date
ADBL
Effective
Date
2015/04/01
CDR
Recommendation
Review
Status
Under Review
Indication MACULAR DEGENERATION, AGE-RELATED
Reviewing
Body
Common Drug Review
Submission
Completion
Date
2013/11/25
CDR
Recommendation
Date
2014/10/20
Expert Committee
Recommendation
Date
ADBL
Effective
Date
CDR
Recommendation
View
Review
Status
CDR - List with clinical criteria and/or conditions
To return to the printable Drug Benefit List and related publications, click here
Last Updated:
NOTICE:
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.