In Canada, doctors’ associations regularly incorporate new evidence about medications into clinical practice guidelines that are intended to influence patient care.
The Ontario Ministry of Health and Long-Term Care reviews the same evidence to decide which medications it will pay for, and often comes to different conclusions.
This results in doctors recommending medications which are not paid for by governments. Is there a better approach?
The example of dabigatran
Paul Chan is a fictional 78-year-old man who has just been diagnosed with a common heart rhythm disorder called atrial fibrillation. Aside from the occasional flutter in his chest, the atrial fibrillation doesn’t bother him. However, his cardiologist recommends that he should take a ‘blood thinner’ on a daily basis for the rest of his life because people with atrial fibrillation are at high risk of having a stroke. Blood thinners can prevent most of these strokes. The doctor says that the best blood thinner is a new medication called dabigatran, and that the Canadian Cardiovascular Society recommends dabigatran over the older blood thinner called warfarin.
The Ontario Drug Benefit Program has reviewed the same studies as the Canadian Cardiovascular Society and has decided not to pay for dabigatran at this time.
However, the Ontario Drug Benefit Program does pay for warfarin, which is almost as good as, but more inconvenient than, dabigatran.
What should Mr. Chan do – take warfarin and pay virtually nothing for the drug, or pay over $1000 a year for dabigatran?
Dueling guidance
Mr. Chan’s experience is played out every day in Ontario for a variety of medications. The guidance given to patients and doctors about new drugs from associations where doctors work independently from government, such as the Canadian Cardiovascular Society or the Canadian Diabetes Association often differs from the funding decisions made by the government drug program. Why is this?
Guidelines developed by doctor’s associations rarely consider costs, even though new drugs may only be slightly better than existing drugs, but much more expensive. Braden Manns, a nephrologist in Calgary who served as past chair of the expert committee of the Canadian Agency for Drugs and Technology in Health, which advises most of Canada’s publicly funded drug plans about which drugs to pay for, says most doctor’s associations are uncomfortable taking costs into account when developing guidelines. Manns explains that “we are trained as doctors to do everything for the patient in front of us … and if we are taking resources into account [then some physicians feel that] we maybe aren’t doing the best thing for the patient.”
On the other hand, for over three decades, the Ontario Ministry of Health and Long-Term Care has used both clinical effectiveness and cost as major factors in its decisions about which drugs it will pay for. The rationale is that because resources are limited, only drugs that provide good value for money should be covered.
Differences between guidelines and government drug plans
Doctor’s associations that produce clinical practice guidelines and provincial public drug plans develop their recommendations in isolation from each other. The reason for this is partly historical, but also reflects different perspectives.
Allan Skanes, a cardiologist at the University of Western Ontario and lead author of the recent Canadian Cardiovascular Society guidelines says that the degree to which doctor’s associations consider costs is a “philosophical question, rather than data driven” and notes that “among our group there was a difference of opinion about whether cost considerations should play a role. We decided that costs do play a role but do not carry the same weight as some of the clinical issues related to the drug.” Nevertheless, cost is not mentioned explicitly in the guidelines.
Some are concerned that doctor’s associations are unduly influenced by pharmaceutical companies. Recent studies have shown that more than 50% of individuals who sit on guideline development committees have declared conflicts of interest.
Conflicts of interest can be partly mitigated, even when they are not eliminated. For example, Skanes noted that while the guideline development process of the Canadian Cardiovascular Society did include experts with conflicts, “they were part of a group and could generate discussion, but abstained from voting”.
On the other hand, some clinicians view the drug benefit plans as being excessively focused on cost containment, and setting too high a bar for new drugs to meet before they are paid for.
Opportunities for the two to come together
In an era of financial belt tightening, there are increasing calls for doctors to consider health system costs when developing clinical recommendations and guidelines. For example, the recent Drummond Report in Ontario argued that doctors need to be better integrated with the health care system.
Braden Manns suggests that doctors may need to shift their thinking, given increasing emphasis on improving the cost effectiveness of services provided in publicly-funded health systems. He suggests that recommending treatments or drugs that offer limited additional clinical value and are costly may deprive other patients from more beneficial forms of health care. He suggests that doctors broaden their thinking to ask “what if my decision means resources aren’t available for the next person in my waiting room?”
Considering the next patient in the waiting room
The National Institute for Health and Clinical Excellence (NICE) is a quasi-independent organization in the United Kingdom whose functions include developing evidence-based guidance to help achieve quality and value for money. NICE brings together clinical experts, as well as economists, to make recommendations about new treatments, including drugs. In the case of dabigatran, NICE has recommended that dabigatran can be used as an option in patients with atrial fibrillation. When NICE makes such a recommendation, the NHS in England is obliged to pay for the drug when physicians prescribe it.
Ami Banerjee, a cardiologist in Birmingham says NICE is an authoritative voice when it comes to guidelines and he explains that “once something is approved by NICE, it becomes part of the National Health System and patients have the right to ask for the drug, and doctors can prescribe it in accordance with the guideline”. Banerjee suggests that in the UK, “professional societies don’t have the same kind of teeth” as NICE when it comes to setting clinical guidelines. Peter Littlejohns, the past Clinical and Public Health Director for NICE says that “specialist societies still produce guidance but usually not in the area where NICE is operating.”
In Ontario, there seems to be little movement towards collaboration between doctor’s associations developing clinical practice guidelines and government-funded bodies that decide which drugs should be covered by public drug plans.
Health Quality Ontario, an agency mandated to monitor and support the quality of Ontario’s health care system was tasked through the Excellent Care for All Act to “promote health care that is supported by the best available scientific evidence” and to make recommendations about standards of care. However, Steini Brown, former Assistant Deputy Minister of Health System Strategy for the Ministry of Health and Long-Term Care says that “the legislation gives Health Quality Ontario the power to make recommendations to government on funding. However, the connection between quality and funding in Ontario has not yet been firmly established.”
A more collaborative approach to developing guidelines and drug coverage decisions that considers both clinical evidence and costs could provide better clarity for providers, governments and patients.
The comments section is closed.
I find it disconcerting that the government of Ontario is involved in creating clinical practice guidelines such as what Cancer Care Ontario does. Guidelines, if they are going to be created in the first place, should be created by medical organizations or associations that would not be as biased as the provider, in this case the government of Ontario, would be. The credibility of guidelines such as that produced by Cancer Care Ontario therefore lack fundamental credibility and it is evident that in a managed care environment cost factors are the overriding principle rather than science in government created clinical practice guidelines.
yes please, most seniors are living below the poverty line and are most likely to be diagnosed with atrial fibrillation and require pradaxa. the covered medication is warfarin…rat poison… and carries with it increased risk of intracranial and gastrointestinal bleeding which will cost us more in emergency and long term care than the cost of pradaxa. it is decisions like this that frustrate the ontario people with the ODB decisions.
Thank you for you writing a story on such an important topic. I note that the writers seem to indicate that Dabigatran is superior to warfarin with the following statement, “However, the Ontario Drug Benefit program does pay for warfarin, which is almost as good as, but more inconvenient than, Dabigatran.” The original RE-LY trial for non-valvular afib was a non-inferiority trial and although the NEJM article (which published RE-LY data) uses language that may seem to claim superiority of Dabigatran, the FDA has clearly stated that non-inferiority trials should not be used for superiority claims. These trials are powered for non-inferiority outcomes and for the hypothesis that the two drugs are equal (non-inferior). I think it is important that as clinicians we are clear to patients that Dabigatran has both benefits and risks as compared to warfarin but given the RE-LY trial design I do not think we can say that it is better than warfarin.
Stick to the evidence with factor of number needed to treat to make “signifacant” outcome improvement for public pay. Newer is not always better.
Patient choice for scedule etc., if not supported by evidence, should and could be available in private insurance options.
Guideline writers may claim independent thought and disclose their conflicts of interest but these actions do not segregate them from their previous and future primary and secondary gains from their pharma sponsors.
Issues of cost and incremetal patient benefits for newer medications under patent protection tend to be downplayed while most guideline committees review clinical trials seeking statistical significance and evidence-based data for their publications.
In many cases, funders and clinical experts already work together quite extensively. The Cdn Diabetes Association is one example about which Dr Laupacis has written. The CCS states it accepts “third party” funding for guideline dissemination but not development, however Alan Skanes who is interviewed for this article and played a leading role in CCS guideline development declares a conflict of interest because of financial ties to Sanofi, Boehringer Ingelheim, Medtronic and Biosense Webster.
I think this is the wrong question to ask. Evidence and cost considerations should be part of the guideline development process, but this will always be difficult if experts and organizations maintain financial relationships with the companies whose drugs are being considered. Perhaps the question should have been “Should steps be taken to establish a firewall between clinical experts and funders?”
Great article. Definitely need to consider costs. Clinicians, particularly those involved in guideline production, need to be more aware of economic/budget implications.