From A Vast Injustice to A Vast Improvement
April 26, 2010
26 April, 2010
Address by André Marin, Ombudsman of Ontario, at the Healthcare Leaders Innovation and Policy Forum, Catastrophic Drug Coverage – Key Recommendations, Toronto.
1 It’s a privilege to be here today with so many innovators in the health care field. I want to thank you for the opportunity, because I believe this is an area where the role of the Ombudsman is becoming increasingly important.
2 I would like to start by quoting a great Canadian scholar of public administration named Donald Rowat, who died last year after devoting much of his life to promoting the institution of the Ombudsman across Canada. Prof. Rowat defined the Ombudsman’s role as protecting ordinary citizens from “being accidentally crushed by the vast juggernaut of the government’s administrative machine.”
3 That juggernaut image is particularly vivid when we talk about health care, where bureaucratic decisions really do involve life and death. As we all know, health care today is a juggernaut unto itself – one that is on track to consume as much as 70 cents of every government dollar in the next few years. In today’s economic climate, where administrators and government officials are struggling to make scarce dollars go further and balance that pressure with the needs of vulnerable patients, the Ombudsman can play a very important role. Not only can I, as the ombudsman, listen to and investigate the complaints of the people, but I can assist the government in making sure that when it makes tough decisions, they are still fair, compassionate and reasonable.
4 As you may know, my office has done many health-care-related investigations in the past five years, including the one I’m here to talk about today – the Avastin case. We’ve handled hundreds of individual complaints about OHIP and related services, and we’ve done systemic investigations into the funding of so-called “orphan” drugs, the out-of-country treatment program, and of course the newborn screening program. In that case, after our investigation, Ontario went from screening babies for just two disorders – the same as a lot of Third-World countries – to screening for 29 conditions, or one of the best systems in the world. Today, 50 babies are being saved from death or severe disability every year, thanks to those improvements.
5 People often ask me how we can do health care investigations without having a team of doctors or medical experts on staff. My answer is that we consult with experts in whatever field we happen to be investigating – but our expertise is in governance and administration; the fairness of government decisions.
6 The case I’m here to talk to you about today is a perfect example. It’s our investigation of the government’s funding of the drug Avastin for colorectal cancer patients. We found that the government’s policy was unreasonable and wrong.
7 Those aren’t my words; they’re in the language of the Ontario Ombudsman Act. It states that I can investigate any government action that is contrary to law, unreasonable, unjust, oppressive, improperly discriminatory, based on a mistake in law or fact – or just plain wrong. And it certainly didn’t take a medical degree to see that the province’s decision-making in this case was wrong. It simply didn’t meet the test of good governance.
8 Here are the facts of the case: As far back as January 2006, Ontario oncologists specializing in the treatment of colorectal cancer were calling for Avastin to be included as part of standard patient care. But at that time, a government advisory committee recommended against publicly funding it, saying the costs were too high when weighed against the increase in life expectancy it offered.
9 As many of you may know, Avastin is not a cure. Essentially, what it does for colorectal cancer patients is stop tumour growth, at least for a while. It prolongs life. By the spring of 2008, there were new clinical studies showing that the median increase in life expectancy for colorectal cancer patients who took Avastin was 11 months. Four other provinces had started funding it. Cancer Care Ontario recommended that Ontario do the same.
10 In July 2008, the Ministry of Health and Long-Term Care publicly announced it would fund Avastin. But what it didn’t really broadcast was that the funding would be limited to 16 treatment cycles, whether the patients were doing well on the drug or not. At this point, there were five other provinces funding Avastin – but none of them had a cap like this. It was the worst possible policy. Or, to use the title of my report, A Vast Injustice.
11 By the spring of 2009, the Ontario patients who were taking government-funded Avastin were starting to come up against this brick wall. They were told, sorry folks, your 16 cycles are up – if you want to keep taking Avastin, you’ll have to pay for it yourself, at $1,500 to $2,000 a pop.
12 Understandably, they were devastated. Many were desperate and confused. They had beaten the odds in surviving and fighting their cancer for so long – but now they felt as though the government was taking away their lifeline.
13 Several patients and their families complained to my office, and I launched my investigation last May. Our investigators consulted medical and health policy experts in Ontario and other provinces. We interviewed Ministry bureaucrats and officials from Cancer Care Ontario. We talked to dozens of patients and their families.
14 What we found was very clear. There was absolutely no medical justification for the cap. It was completely arbitrary – and Ontario was alone in standing by its shameful policy. All the evidence indicated that the cap was nothing more than a cost-containment measure, in diametric opposition to the generally accepted standard of oncology practice in Ontario and elsewhere.
15 A lot of our analysis involved the thorny question of the cost of drugs – and the difficult decisions that governments face when they weigh the benefits that a new drug promises against the costs, which are usually very high. We reviewed, for example, the Ontario Drug Benefit Act, which requires that funding decisions be based on the best economic AND clinical evidence. The Act specifically identifies “value for money” as one of the fundamental principles of the public drug system, and makes it clear that government policy-makers have the right to decide not to fund a drug if they find it is simply too expensive.
16 To be clear, I have absolutely no quarrel with this. I’m not here to tell the government how to spend its money. But whenever the government makes these kinds of decisions, it must observe the basic tenets of good governance. Funding decisions – not just decisions to spend, but decisions to restrict funding as well – must be well-informed and reasonable. From an ethical perspective, once a decision is made to fund a drug, any limit on the duration of funding should be firmly supported by medical evidence. Otherwise, government funding practices might interfere with medical protocols – the arbitrary funding cutoff could even prove to be medically harmful.
17 In the case of Avastin, the government could have said no. It could have chosen not to fund the drug at all, based on financial considerations. Some provinces still don’t fund it, for that reason. But instead, it chose the worst of both worlds. It gave the drug to colorectal cancer sufferers with one hand, only to take it away 16 cycles later with the other. Whatever their intentions, in trying to balance patient needs against the bottom line, the policy-makers failed to factor in the human element and the moral obligations of the medical community.
18 Think about it: No doctor would recommend that a patient who is doing well on a drug should be forced to stop taking it after an arbitrary number of treatments. Clearly, patient progress should be the primary factor in decisions about limiting funding. But instead of extending coverage on a case-by-case basis, based on the patient’s condition and the advice of their physician – as other provinces were doing – Ontario drew an inflexible line at 16 cycles.
19 My investigation clearly showed that neither the Committee to Evaluate Drugs or its precursors, or Cancer Care Ontario, or any other experts consulted by the government, ever recommended a cap at 16 cycles. However, the Ministry did research the cost of funding Avastin to various points, and chose to stop at 16 cycles, concluding that this would meet the needs of most patients. Again, this was not borne out by clinical studies. There was one clinical study where the median duration of treatment was 17 cycles, meaning that half of the patients in the trial had to stop taking it because their disease progressed before 17 cycles, but half were still doing well and needed more than 17 cycles. There was NO suggestion in this or any other study that treatment should stop before 17 cycles. All the studies said it should only be stopped at whatever point at which the patient experiences disease progression, or tumour growth. In addition, Cancer Care Ontario’s Gastrointestinal Disease Site Group, the drug’s manufacturer, and other provincial and international guidelines all recommend that Avastin be used until disease progression.
20 We all know health care money is not unlimited and tough decisions must be made. But once a decision is reached to fund a drug treatment, any limit on duration of funding must be based on solid medical evidence – not on the financial bottom line.
21 In any event, when we investigated how much more it would cost to lift the cap and simply continue to fund Avastin for those patients who still needed it beyond 16 cycles, we found it would only be about $9 million more a year. That’s hardly a huge difference in the high-cost world of health care.
22 There was also a disturbing lack of transparency in the way the government handled the Avastin cap. In 2006, amendments to the Ontario Drug Benefit Act came into force, thanks to the Transparent Drugs System for Patients Act. The amendments included a set of guiding principles for the public drug system, which stress that “the public drug system aims to operate transparently to the extent possible for all persons with an interest in the system” and that funding decisions “will be openly communicated in as timely a manner as possible.”
23 This didn’t happen in the Avastin case. The cap on funding was not mentioned in the widely circulated press release, although it was contained in an accompanying background document. No details were disclosed about the reason for the cap. A number of oncologists we spoke to were concerned about this. They found it frustrating to have to explain the cutoff to their patients when they didn’t understand the basis for it themselves. Even some of the Ministry officials we spoke to had trouble explaining why the 16-cycle cutoff point was chosen. They acknowledged that there was no clinical support for the cap and confirmed that the decision to limit funding was purely financial. All of this adds up to a policy that doesn’t meet the test of good governance.
24 To me, the solution seemed as clear as the problem. I recommended that the government lift the cap and fund Avastin according to standard medical practice: Until the patient’s disease progresses, period. The sad reality of cancer is that many patients will never reach the 16th treatment – their cancer will become aggressive and Avastin will simply stop working. The patients who are fortunate enough to make it past 16 cycles should be able to continue treatment as long as Avastin is keeping their condition stable.
25 To address the transparency issues and avert similar problems in the future, I recommended that the Ministry ensure that decisions to fund new drugs be publicly posted, along with a detailed summary of the supporting financial and medical considerations.
26 Finally, I recommended that the Ministry centrally monitor the number of patients receiving drugs under the New Drug Funding Program, including the costs and duration of treatment. Surprisingly enough, despite its financial concerns, we found that the Ministry had not been closely monitoring the Avastin funding program.
27 Exactly two months after my report was released, the government announced it would lift the cap on Avastin. Now Ontario covers Avastin treatment for colorectal cancer up to 24 cycles for patients whose disease has not progressed – and will extend it further if advised by a patient’s doctor. It still has not agreed to my recommendation that the people who paid for their own Avastin be compensated, but the patients we’ve spoken to have been thrilled with the change in policy. Here is what one woman, the daughter of a patient, wrote on our website:
As a daughter watching my mom do so well with Avastin, only to be told after 16 cycles she would now have to pay out of pocket for a medicine that was allowing her to live, made me furious and quite frustrated... I thank God for Avastin and what it did for my mother, and I thank you for the investigating you have done, and the report you have filed.
28 We also expect to hear back from the government soon on its promise to implement a specific compassionate review policy for cancer drugs, which would be a great improvement over what exists now. For the Avastin patients, the existing compassionate review process was a bad fit. The policy required them to show that they had tried other courses of treatment that failed. But that wasn’t the case for them. Their treatment was working. It was the government’s policy that failed them.
29 I think there are clear lessons here for future drug funding decisions, and how to ensure they adhere to the principles of good governance. The good news is that some of these principles are also stressed in the guidelines in the Act, calling for a transparent and publicly communicated process. Drug funding decisions should be based on solid evidence, made in a timely fashion and communicated clearly. As well, although affordability and value for money must be considered when the initial funding decision is made, any decisions thereafter on limiting treatment should be based on medical evidence.
30 Quite simply, people who are sick should not have to negotiate a labyrinth of complicated rules or jump through unnecessary hoops. Good government policy – whether it’s in the health care field or any other aspect of government – has to allow for flexibility, compassion and simple humanity when necessary.
31 Our office has been able to work with the Ministry of Health and Long-Term Care and countless organizations throughout the government on improving and humanizing policies in this way. It’s a field where, much like health care, there is no shortage of work to do.
 Information on the Ombudsman’s investigations in these and other cases can be found online here: /en/what-we-do/special-ombudsman-response-team/sort-investigations.aspx
 The report A Vast Injustice can be viewed on the Ombudsman’s website. Related materials, including press releases on the report and video of the Ombudsman’s news conference, can be found through this link: /en/media/press-releases/2009/ontario-uncaps-avastin-funding-in-wake-of-ombudsman-probe.aspx. Hard copies of the report can also be obtained by contacting the Ombudsman’s office – email firstname.lastname@example.org or call 416-586-3300. All materials are also available in French.