A Level Playing Field
July 17, 2023
A level playing field is the dream for Canadian patients who need specialty medications – and we have the means to make it happen
Ask someone what the word “Canadian” makes them think of, and chances are the list will include politeness, hockey, and universal healthcare. While not without challenges, our publicly funded healthcare system elicits pride in over 90% of Canadians, reflecting our shared belief in equality and solidarity.21 We also take pride in our diversity, as evidenced by our immigration policies and practices. Over 450 ethnic and cultural groups call Canada home,7 and about 22% of the population was born abroad as of the 2016 census.8
These shared values bode well for health equity – the opportunity for everyone to reach their optimal state of health.1 At the same time, medical research has not always put equity front and centre, creating a drag on the quest for health equity. Traditionally, the “reference man” used to develop drugs is a Caucasian male, aged 20 to 30 years old and weighing 70 kg.22 This legacy may help explain why, in a recent analysis of clinical trials used to support FDA approval of cancer drugs, only 27% of the trials fairly represented older adults and only 11% included an adequate number of subjects from minority racial and ethnic groups.23
Fortunately, awareness of such systemic inequities has pierced through the status quo – and stakeholders are doing something about it. In the US, the FDA will soon require late-stage clinical trials to include a plan for ensuring representative diversity among subjects.23 Along similar lines, Health Canada will institute a formal process to verify whether clinical evidence for new drug submissions includes fair representation of age, sex, and race.19 Canada’s Sex- and Gender-Based Analysis Plus Action Plan, launched in 2009 and updated in 2021 to emphasize intersectional identities such as age, ethnicity, geographical location, and education, has made a commitment to “identify and characterize different risks between populations.”24
But how? “Real-world data can help us understand which patient populations are affected by a disease and set recruitment goals that reflect this mix,” says Nina Lathia, a pharmacist and health economist based in Toronto.25 We saw a similar process play out during the COVID-19 pandemic, when real-world data revealed excess cases and deaths in socioeconomically disadvantaged communities.26 Governments responded with equity-oriented policies, such as prioritizing elderly and Indigenous populations in vaccine distribution.27 We have the opportunity to increase equity with specialty medications as we did for the Covid-19 vaccines.
What factors drive the prevailing inequities in the specialty pharmaceutical space? Which populations are underserved? What are stakeholders doing – and what could they be doing – to close equity gaps in Canada? Let’s explore together.
Disclaimer: While we don’t have the space to report on all health inequities, we hope to shine a light on some pain points to help move the equity agenda forward.
THE ROOTS OF HEALTH INEQUITY
Health depends not only on individual genetics and lifestyle, but on what the World Health Organization (WHO) defines as social determinants – the wider social forces that shape people’s daily lives.28 Not surprisingly, inequalities in the social arena may lead to disparities in health outcomes.29 When we have the ability to prevent or mitigate these disparities through policy and action, they are considered unjust, or inequitable.29 Within specialty medicine, inequity may arise from geographical and financial disparities as well as discrimination due to ethnicity, gender and religion, among other factors.
Location, location
In a country as geographically diverse as Canada, we don’t have to look hard to find inequities based on where people live. For people living in remote locations, time, distance, and money often stand in the way of specialty treatments. Inequities may also arise from policy differences between provinces/territories. Often substantial, these differences in funding, copays, and coverage criteria work against the Canadian vision of healthcare access based on need. When one province funds a drug and another does not, a patient’s access to that drug may depend more on their bank balance and postal code than on their need.
Consider the example, described in a report from the Government of Canada on the potential for National Pharmacare, of a 58-old mechanic with an income of $50,000. After a recent diagnosis of advanced lung cancer, he takes an oral drug that costs $100,000 per year. Depending on where he lives, his public plan may completely cover the drug – or leave him with out-of-pocket expenses ranging from $250 to $8,000.30 An even larger equity gap exists for Spinraza (nusinersen), a life-changing medication for spinal muscular atrophy (SMA). In 2022, CADTH’s recommendation against reimbursing the drug for adult indications left Canada’s SMA community in “stunned disbelief.”31 At present, Quebec is the only province to fund the medication to all SMA patients, irrespective of age or disease type, a policy followed by more than 25 countries worldwide. “We as a country cannot possibly accept healthcare based on age and postal code,” says Susi Vander Wyk, Executive Director of Cure SMA Canada. “[Patients’] lives all have equal value.”31
“We as a country cannot possibly accept healthcare based on age and postal code. Patients’ lives all have equal value”
Ethnicity and gender
At present, neither ethnicity nor language are routinely coded in administrative health data in Canada,32 thus opening the door to inequities based on ethnicity. It is no secret, for example, that Indigenous peoples face systemic disadvantages that result in worse health. When it comes to cancer care, a scoping study determined that these populations face inequitable access across the care continuum, from screening to treatment, with individual, health-system, and societal factors feeding into the imbalance.33
In Black communities, systemic discrimination continues to create barriers that threaten access to advanced cancer care, an especially troubling scenario in light of the disproportionate burden of breast, colorectal and prostate cancer among Black Canadians.34 Inadequate access to such technologies as molecular diagnostics results in substandard care, while accessing costly personalized treatments through private coverage or out-of-pocket payments places heavy financial burdens on Black patients.34
Historically, clinical trials have not equitably represented females, resulting in medications developed primarily for male physiology.35 A case in point: while females account for 51% of cancer patients, one analysis found that only 41% of subjects in cancer trials were female.36 Research also finds women up to 50% less likely than men to attend a cardiac rehabilitation program, with barriers ranging from lack of referral to a tendency to minimize personal needs.14 As noted by Dr. Paula Harvey, a cardiologist and department head at Women’s College Hospital in Toronto: “We have one of the best healthcare systems in the world, and we’re not serving women. We have to do better.”14
“We have one of the best healthcare systems in the world, and we’re not serving women. We have to do better.”
In support of this view, a recent report from the Heart and Stroke Foundation of Canada uncovered significant inequities in women’s heart and brain healthcare, particularly in women belonging to racialized, Indigenous, LGBTQ2S+ communities.35 The report’s troubling conclusion: these gaps in research and care are putting lives at risk. 35
Genetic inequity: a case study
Cystic fibrosis (CF) is associated with thousands of different genetic mutations, and recently about 90% of Canadian CF patients who have at least one copy of the most common CF mutation have become eligible to access the drug Trikafta (elexacaftor/tezacaftor/ivacaftor).55 Among the remaining 10% of the Canadian CF population, about 4-5% of people who have rare CF mutations could benefit from Trikafta – if they could access it.55
Two years ago, the FDA approved laboratory evidence to expand the use of Trikafta to cover some of the rarer mutations associated with CF – including a very rare mutation found among Hutterites. Predominantly located in the Western Canadian provinces, the Hutterite community has a high rate of cystic fibrosis (CF), and the condition is often more severe in this group.37
France, Israel, and England have also accepted laboratory evidence to enable an expanded Trikafta indication and patient access, but to date Canada has not. “We have a group that Trikafta can treat, but who won’t get treated because Canada is not accepting evidence that will allow people with rare and ultra-rare mutations to get access to medicines,” says Kim Steele, Director of Government and Community Relations at Cystic Fibrosis Canada. In effect, “these patients face layers of inequities – being born with a rare mutation, insufficient numbers for clinical trials, and Canada’s unwillingness to review laboratory evidence.”
But there’s hope: “We are calling on Health Canada to accept laboratory evidence, and the drug manufacturer has studied 18 of the 177 rare and ultra-rare mutations that cause CF, including mutations often found in the Hutterite community. Depending on the results, we hope to see some expansion of the approved indication, and ultimately access for patients.”
Economic barriers
Financial constraints can impede access to healthcare, especially among people with multiple chronic conditions, and thus worsen health outcomes. If an Ontario study is any indication, the inequity gap appears to be widening: between 1993 and 2014, while overall avoidable mortality (AM) decreased in Ontario neighbourhoods, the AM gap between the poorest and wealthiest neighbourhoods increased more than twofold.38 With inconsistent public coverage of prescription drugs across the country, many people rely on employee benefits to make up the shortfall – an option available to 75% of Ontarians overall, but only 58% of the poorest people in the province.39
This leaves far too many people shouldering the financial burden of their care. Take diabetes, for example, a progressive condition that requires not just prescription medications but devices and supplies. In certain parts of the country, annual out-of-pocket costs can top $10,000 for people with type 2 diabetes and $18,000 for people with type 1.40 “While many people my age are saving $10,000 for a down payment on a house, as a Manitoba resident who has never been eligible for publicly funded diabetes programs, I have been saving for a safe pregnancy, which includes a [continuous glucose monitoring device] and insulin pump,” say advocate Nikki Webb, who lives with type 1 diabetes.40
You don’t have to be poor to feel the pinch: with diseases such as cystic fibrosis now treated with advanced and expensive medications, the middle class also struggles to carry the load. As CF patient and advocate Stephanie Stavros explains, “medications for rare diseases are often expensive. In Ontario, the Trillium program will cover the cost of drugs only after patients contribute the equivalent of 4% of their household income. This can be quite a big chunk of money for most dual income families” – especially after you throw in the cost of special diets, equipment, and loss of income due to illness. Indeed, an Ontario family earning $125,000 would face out-of-pocket costs of $5,143 to access the CF drug Trikafta through the province’s Trillium drug program.41 In Quebec, the same family would have to contribute $1,183. As Stavros sees it, “the provinces need to find a way to step up and help rare disease patients that are getting lost in a system that is not designed for them.”
EQUITY INITIATIVES IN MOTION
The goal of health equity calls for change on several fronts, from drug development and distribution to access and administration. The past few years have seen patients and their advocates band together, get loud, and redefine what is possible in access, exemplifying the adage that strength lies in numbers. This paradigm shift reflects the increasing prominence of the patient voice in healthcare decision-making, captured in the iconic phrase “nothing about us without us.”
Initiatives supporting specific populations
Over the past three years, Boehringer Ingelheim Canada, an Indigenous consultancy called Bimaadzwin, and an Indigenous Advisory Circle have been collaborating to address the needs of this population.42 Called PATHWAYS, the Indigenous-led and Indigenous-informed collaboration intertwines upholding the right to health and access to health services with nation building, reconciliation, and self-governance.
The program’s individual projects, which focus on distinct Indigenous communities and regions of the country, include42:
Improving diabetes care in British Columbia’s Nuu-chah-nulth Nations in BC
Leveraging technology to connect patients with resources, such as nurse practitioners, who can assess patients’ needs and provide immediate care in Maskwacis, AB
- Point-of-care testing with 1,200 citizens to identify clinical markers for type 2 diabetes in Manitoba
- Engaging multi-disciplinary health care practitioners to support diabetes patients with lifestyle and food security challenges in rural Nova Scotia communities
In marginalized communities such as First Nations, the goal of health equity often requires bridging the cultural gaps that keep access barriers in place. Ontario cancer centres carry out this work with Indigenous Patient Navigators (IPNs), who help to make the cancer journey a culturally and spiritually safe experience for First Nations, Inuit, and Métis patients and their families.43 One of the first of these navigators, Jeannie Simon, currently works at the Cancer Centre in Thunder Bay. In a video for Canadian Virtual Hospice, Simon explains how she connects with the patients under her watch44: “Most of the cancer patients who come to our centre are from fly-in communities… they are overwhelmed and there are so many steps to go through. I sit with them, talk with them before they see the doctor… I am a second ear to them.” Not just that, but she offers the invaluable asset of speaking Ojibway.
The University of Toronto at Scarborough, meanwhile, has set up a new Black Health Equity Lab headed by Dr. Notisha Massaquoi, an assistant professor at the university’s Department of Health and Society, to tackle health disparities faced by Toronto’s Black Community.45 As its first project, the lab is developing a case-based HIV program aiming to reduce transmission rates and improve health outcomes through early detection, treatment, and support. To ensure immediate support for newly diagnosed patients, the case management team will include a nurse practitioner, social worker, and two community outreach workers.
A subject matter expert in health equity, anti-oppression, anti-black racism, and race-based data collection, Dr. Massaquoi will also be leading a new research project that spans the University of Toronto’s three campuses.46 Developed with the Black Research Network, the project will receive $250,000 seed money through the university’s Connaught Fund and will see 13 experts from across the university joining forces to address Canada’s racial health gap.
Funding fairness
As part of its commitment to equity research, the Canadian Cancer Society launched the Health Equity Research Grants program in May 2022.47 The funding program supports research projects that seek to advance cancer-related health equity. To compete for a grant, projects must be co-created by people affected by cancer and by structural marginalization and must address the myriad social determinants of health inequity in Canada.
The inaugural competition yielded 21 full applications and 6 approvals for funding – a 35% success rate – with a total of over $1.6M over the full term of the grants.47 Successful applications came from Alberta, British Columbia, Manitoba, New Brunswick, Nova Scotia, Ontario, and Québec and included projects serving Black, immigrant, 2SLGBTQI+, First Nations, Métis and Inuit communities.
Focus on specific therapeutic areas
In tandem with these population-based initiatives, governments and other stakeholders have been developing strategies focused on specific therapeutic areas, with rare diseases as an urgent priority. As a recent Ipsos survey confirmed, Canadians with rare diseases face long delays in diagnosis, lack of accessible care, and lack of access to drugs.16 These findings may reflect the fact that, until recently, Canada did not have a national plan for rare diseases.
The outlook for rare diseases is poised to improve with the federal government’s announcement, in March 2023, of a $1.5 billion investment over three years to implement the Rare Disease Drug Strategy endorsed by the government in 2019.18 “Canada [now] has the opportunity to implement the very best program in the world for rare disease patients,” said Canadian Organization for Rare Diseases (CORD) president Durhane Wong-Rieger in response to the announcement. If all goes as planned, the strategy will accelerate equitable access across Canada with a national formulary covering the medications that these patients have been waiting – and waiting – for.
To assess improvement in access, you need a benchmark. That’s exactly what the patient-led Arthritis Consumer Experts (ACE) group seeks to establish with its Arthritis Medications Report Card. The initiative compares the provincial drug plans by tracking the coverage of advanced disease modifying anti-rheumatic drugs (DMARDs) for the most common types of inflammatory arthritis, such as rheumatoid arthritis, ankylosing spondylitis, and psoriatic arthritis, and groups its findings into 5 categories48:
- Declined: The provincial/territorial formulary does not reimburse the medication
- Listed – “CBC”: Reimbursement occurs on a case-by-case basis
- Listed – “ORC”: The medication is listed, but with overly restrictive criteria
- Not applicable: Health Canada has not approved the medication
- Under review: The medication is approved, and the province is considering whether to reimburse it
This is not just an academic exercise for ACE: the group intends the information to spur Canadians to action. Specifically, ACE encourages Canadians in poorly performing provinces to “write and speak to your elected provincial or federal representative about the lack of equitable reimbursement access [and thus] choice in treating inflammatory arthritis.” 48
Forward-thinking drug manufacturers also have equity on their radar. When developing patient support programs (PSPs), Hoffman-La Roche recruits patient councils to weigh in on program design – and is experimenting with mixed councils of patients and healthcare professionals. As Anne Marie Hayes, the company’s director of patient experience, explains, “we design our programs through the lens of the experts - namely, those living with the condition.” The biggest challenge – and opportunity – lies in recruiting patient councils “with a DEI [diversity, equity and inclusion] mindset so their voice is truly representative,” she explains. “This mimics the DEI ambitions in our clinical trial programs, and we still have a long way to go.”
An equity perspective on health policy
For Gail Attara, President & Chief Executive Officer of the Gastrointestinal (GI) Society, the term “health equity” belongs, above all, to patients. This philosophy informed the GI Society’s Patient-Focused Health Policy Report,49 developed under Attara’s guidance and with contributions from more than 30 other patient groups. Recognizing “the uniqueness of individuals,” the report urges governments to orient the healthcare system toward greater equity, including:
• Providing connectivity for geographical, social, and cultural variances
• Addressing the social determinants of health, such as food security and housing
• Providing timely healthcare access to people with disabilities and communication barriers
• Making treatments available to patients regardless of where they live or relocate in Canada
HOW DATA CAN SUPPORT HEALTH EQUITY
To reach their full potential, these exciting initiatives depend on good data collection, which isn’t happening consistently yet. As noted earlier, administrative health data in Canada does not routinely include ethnicity or language.32 Without the collection, use, and governance of race-based data, the members of the Black Health Equity Working Group assert that “our disproportionate pain and deaths go unacknowledged, unaddressed and invisible.”50
Routine collection of race and ethnicity data can help researchers and healthcare providers target interventions to underserved groups and reduce inter-group disparities.34 This is exactly what Cécile Petitgand sought to achieve when she founded Data Lama, a Québec company supporting individuals and organizations in ethical data management. “Health data should be evaluated based on its ability to reflect the richness and variety of individuals and communities,” says Petitgand, who serves as the company’s CEO. “Otherwise, data-driven solutions in healthcare will only cater to the needs and interests of a fraction of society.”
Fortunately, interest in including DEI in data collection continues to grow. Dr. Winson Cheung, a professor of medicine at the University of Calgary and principal director at Oncology Outcomes, has noticed the shift: “Years ago, we were told to treat everyone the same without acknowledging inherent differences in people. Now the lens has changed, and not asking people about differences is seen as a missed opportunity to better individualize their care. We see the value of collecting racial and ethnic data, because without collecting it we cannot study it and improve patient outcomes.”
Camille Orridge, a senior fellow at Wellesley Institute, a research and policy group that seeks to improve health and health equity in the Greater Toronto Area, has been labouring to put such data on the map for over a decade. “You don’t make any decision without evidence, and I realized [that data on Black communities] was not part of the evidence,” says Orridge, who ranked among the top 25 Women of Influence in Health in 2012. “My goal was to reduce disparities. Data is simply a tool to get there.”51
“My goal is to reduce disparities. Data is simply a tool to get there. You can’t make decisions without evidence, and I realized that data on Black communities wasn’t part of the evidence.”
As a testament to Orridge’s vision, Statistics Canada recently published mortality data on the Black population for the first time.50 The findings highlight the urgent need for systematic collection, analysis and use of race-based data. Also encouraging: since 2016, the Canadian Institutes of Health Research (CIHR) has been working to address DEI in the research sphere and plans to update its equity strategy to align with its evolving mandate.52
SO WHERE DOES THIS LEAVE US?
Specialty pharmaceutical stakeholders in Canada share the goal of improving patient outcomes – this means outcomes for all patients – which will require our full attention and ingenuity. To close systemic equity gaps, pharmaceutical manufacturers, healthcare providers, government agencies, advocacy groups, and patients themselves need to continue to form creative partnerships that put equity at the forefront.Stakeholders also need to reflect and consider the unpredictable effect of certain initiatives on patient equity. For example, clinical trials – largely conducted in urban centres and inaccessible to many people living far from cities – may inadvertently widen the equity gap. Consider the ongoing trial of Zolgensma (onasemnogene abeparvovec), a gene therapy medication for spinal muscular atrophy, in children aged 2 to 12 years.53 Described as “ultra-competitive,” the multicentre trial has a recruitment target of just 28 patients worldwide. That’s great news for the selected 28, but children who live far from the 15 hospital sites face additional barriers to partaking in the trial. This is not to say we must stop conducting clinical trials in urban centres, but that we need take steps to give more participation opportunities to Canadians from all parts of the country.
Most importantly, clinical research in Canada must keep a close eye on the geographic, socioeconomic, ethnic and cultural diversity in the country and represent this diversity in clinical trials and other healthcare initiatives. There’s every reason to believe we can do it, especially when we have so much to gain. As DEI strategist Arthur Chan so aptly put it: “Diversity is a fact. Equity is a choice. Inclusion is an action. Belonging is an outcome.”54
“Diversity is a fact. Equity is a choice. Inclusion is an action. Belonging is an outcome.”
All Canadian patients deserve access to the specialty medicines and other treatments they need. A focus on health equity will ensure they get it.
References
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