On June 1 2009, The BC Ministry of Health introduced the AMD Expansion Program, a program designed to fund the high costs associated with intravitreal injections into the eye for patients affected by wet age-related macular degeneration. (Add further detail)
Following receipt of details regarding the Province of British Columbia’s AMD Expansion Program(covering fiscal 2010/2011), which we obtained through a Freedom of Information request to the Provincial Health Services Authority, a number of details came to our attention which supported our underlying concerns with respect to the treatment options for British Columbians living with age-related macular degeneration (AMD).
Our primary concerns with the 2010/2011 AMD Expansion Program rest with three particular issues:
- An unapproved drug being funded under the program:
The BC Ministry of Health was, and continues to fund the cost of an off-label drug (Avastin®), developed and approved for the treatment of colo-rectal cancer, and permits only a select group of specialists to administer this drug via an intravitreal injection into the eye. Given it is a cheaper treatment, Avastin® has been included in the provinces AMD program despite the fact both the drug manufacturer and Health Canada issued a joint release aimed at health care professionals in December 2011 warning of potentially serious (possibly fatal) side effects that could lead to hospitalization (e.g. strokes, heart attacks and/or blood clots.) A similar release from the drug manufacturer and Health Canada was made public to advise consumers at t same time.
- Financial incentive for specialist to use the cheaper drug:
Within Section 23(b) of the AMD Expansion Program, it states that the amount available for physician reimbursement under the program equaled the net amount remaining after the expense of the drug was deducted. Simply put, this meant that the specialists’ fees would be significantly higher if they could keep the drug cost as low as possible. As taxpayers, this appeared to be sound policy with respect to controlling a health care cost. We might have agreed if the alternate drug was, in fact, approved for the treatment of AMD by Health Canada. Further, it would need to have been as safe as the properly approved drug, had sound scientific research to support the recommendation and the cost savings had not provided a financial benefit for the specialist involved to the degree that it influenced their drug treatment preference.We questioned what treatment patients would have chosen had they been given all the facts and full disclosure about the various treatment options available to them. Patients living with AMD may wish to view an informative on-line video currently available on the Insider Medicine web site. This short video, entitled “Avastin Riskier than Lucentis in Eye Injections for Macular Degeneration”, features Dr. Sanjay Sharma of Queen’s University. First, click on this “Avastin Riskier than Lucentis in Eye Injections for Macular Degeneration” link and then click on “View QuickTime Video” link to view Dr. Sharma’s informative report.We also questioned whether our members were fully aware of their right to choose their treatment options under the BC Health Care (Consent) and Care Facility (Admission) Act? In other words, if they wanted to be treated with Lucentis® instead of Avastin®, it was their right to insist on that treatment. And we further questioned the extraordinary costs resulting from additional medical intervention or hospitalization from potential side effects associated with the cheaper drug.
- Availability of treatment from doctors in your community:
Until the province announced the AMD program to pay for these treatments, many people were treated in their home community by their own eye specialist. However, under the program, permission to bill the Ministry of Health has been restricted to a handful of ophthalmologists in BC. There does not appear that there is an opportunity for other ophthalmology specialists to provide the same level of care to their patients without a referral, possibly leading to delays in treatment and very likely additional travel time and expense for patients with AMD.In response to our letter to BC’s Minister of Health, the Honourable Michael DeJong, Q.C. dated May 17 2012, we received a disappointing response from Assistant Deputy Minister Barbra Walman, Pharmaceutical Services.On July 2 2012, we sent a follow-up letter to the Minister requesting clarification on a number of issues. In response to that letter, we were invited to meet with Assistant Deputy Minister Barbara Walman on September 21 2012 to discuss our concerns. Accompanied by Mr. John Mulka, Executive Director – CNIB BC-Yukon Division and Dr. Keith Gordon, Vice-President – Research, CNIB National (the latter via teleconference, we met with Assistant Deputy Minister Barbra Walman and her colleague, Dr. Eric Lun, Executive Director – Drug Intelligence Branch, Pharmaceutical Services Division within the Ministry of Health as scheduled. )While the meeting was beneficial in terms of building bridges and establishing rapports, we were informed that:
- Statistical data kept by the Ministry reports that Avastin® is used 75% of the time when an intravitreal injection is administered into the eye;
- The Ministry is monitoring all reported incidents of side effects from the use of either drug therapy and to date have had minimal occurrences reported;
- The current AMD Expansion Program is costing the Ministry approximately $13million per year whereas the use of Lucentis® exclusively would increase the costs to approximately $41million; and
- The Ministry is currently satisfied with the program and has no immediate plans to alter its execution.
Access for Sight-Impaired Consumers immediately followed through on its commitment to contract with a national research firm to undertake a telephone survey of British Columbian residents living with AMD to determine how people felt about issues relating to AMD treatment in the province. We are pleased to be able to share the “Perceptions of Treatment for Wet AMD in British Columbia” survey results which confirmed that BC’s AMD patients are not getting full disclosure of treatment options nor are they receiving a thorough explanation of the possible side effects of the drug therapy that their ophthalmologist has often, unilaterally chosen on their patient’s behalf.
We sent a follow-up letter to Assistant Deputy Minister Barbra Walman along with a copy of our “Perceptions of Treatment for Wet AMD in British Columbia” survey results on April 12, 2013. We noted the survey clearly demonstrated a majority of patients in British Columbia were not being made aware of available AMD treatment options nor what intravitreal medication they had received. Further to this, the survey revealed a majority of patients in BC were neither given a treatment option nor told about the potential for serious adverse events as a result of treatment with off-label Avastin. In our aforementioned follow up letter to the ADM, we asked her to comment on the survey results and to provide an explanation for the fees paid to specialists in BC versus the much lower fee that is paid in Ontario for the identical procedure.
The response received from the ADM’s office, dated June 13 2013 was both puzzling and misleading.
As we planned for the release of our survey results, we submitted our second Freedom of Information request on April 10 2013. Again, we requested a copy of the 2011/2012 AMD Expansion Program so that we could determine any changes or modifications to the earlier program. What we received reflected only minor modifications in comparison to the earlier program. The material we did receive back from the Provincial Health Services Authority was for the AMD Expansion Program effective April 1 2011 and was somewhat disappointing in that a large portion of communications to AMD Program Participants in April of 2012 was blacked out: the explanation being “Some portions of the email that contained the amendments giving effect to the updated program for 2012/13 have been redacted because they do not relate to your request.”
This is far from the final chapter on this file and we will continue our dialogue with the Assistant Deputy Minister’s office in efforts to have BC’s AMD Expansion Program modified.