Concerns About Off-Label Drug Use in BC

In May, 2009 the CCB wrote a letter to the BC Health Minister George Abbott requesting that Avastin not be included in the BC government’s reimbursement program for treatment of age-related macular degeneration, which became effective in June of that year. Eye doctors in BC are now concerned about rising numbers of an increased risk of sever glaucoma and peripheral blindness.

The Canadian Council of the Blind is the “Voice of the Blind” in Canada and was founded in 1944 by blind war veterans. With over 80 chapters across the country it is the largest membership-based organization for the blind. Since the CCB is concerned with the welfare fo those with blindness and visual impairement, it was encouraged by the government’s decision to join the ranks of provinces that are making available new treatments for the we age-related macular degeneration, the leading cause of severe vision loss for Canadians over the age of 50, but had serious concerns about the inclusion of the unapproved drug Avastin being included.

CCB emphasize that vision loss is a devastating diagnosis because it impacts almost every task and activity related to daily living. In every case, early diagnosis and an individualized approach to treatment are essential to effectively combat rapid vision loss. Only Health Canada approved Anti-VEGF drugs such as Lucentis (ranibizumab) and Eylea (aflibercept)should be used in the treatment of eye conditions such as wet macular degeneration (AMD, diabetic macular edema (DME), retinal vein occlusion (RVO) or ), choroidal neovascularization (CNV) not “off-label” such as Avastin (bevacizumab).

There is a clear economic benefit to sight-saving and restoring therapies, but economics should not be the only determinant. The benefit that anti-VEGF’s provide to peoples’ ability to function independently – to engage in the activities of everyday life that most of us take for granted – has to be the determining factor.

In Canada, people should have the right to choose the therapy to improve or at least stabilize their eyesight so that they can have equality as well as quality of life. Any improvement of vision loss incurred as a result of treatment with anti-VEGF therapies will undoubtedly result in an improvement in individual quality of life. Lack of fully informed consent and lack of knowledge base re differing drugs can lead to possible long term complications – hence, defeating economics of using a cheaper treatment.

CCB takes the position on using only Health Canada approved drugs for use on persons diagnosed with Vision-Threatening Eye Conditions such as wet AMD, DME, RVO, and CNV. This would be the anti-VEGF drugs – Lucentis (ranibizumab) and Eylea (aflibercept). (Avastin (bevacizumab) should not be used “off-label” except in very extenuating circumstances where no other “on label” drug is available. Also, we believe that the patient needs a “fully” informed discussion with his/her medical team prior to consenting to the treatment. This would include cost factors, side effects, benefits (to both patient and Ophthalmologist), and most importantly that they are not receiving medication based on economic benefits.

In speaking with a number of patients who have been receiving treatment for AMD they expressed their joy in regaining some vision following therapy allowing them to drive their car again. Some also expressed fear as they learned about their diagnosis.  The unpredictable nature of side effects adds to the patient’s unease. Also, patients indicated that they want to ensure they are not put at any major risks by receiving treatment that has not been approved by Health Canada. 

The patient is not the only person in a family when the diagnosis is received. Caregivers experience many challenges such as: a caregiver having to take time off work or stop working entirely. This can be impacted if the patient is being treated with “off label” drugs. The social impact on the caregiver in doing this is significant and the financial cost in terms of lost productivity and earning ability has an additional impact on the economy.

CCB supports FBC in requesting a safety study which has been recommended since 2015 in a joint submission by Foundation Fighting Blindness (now Fighting Blindness Canada), Canadian Council of the Blind (CCB) and the Canadian National Institute for the Blind to CADTH.