Gaps in coverage for take-home cancer drugs in Canada

Roxana Sultan | CHP | 17 OCT 2019

According to the latest statistics from the Canadian Cancer Society, about 1 in 2 Canadians will develop cancer in their lifetimes, and 1 in 4 will die of the disease.[i]  In the past, most cancer chemotherapy treatment has been delivered through intravenous administration in the acute care setting.

With advances in medical research and treatment, many cancer medications can now be taken at home. It is estimated that more than 50% of new cancer drugs are formulated for in-home administration.[ii] This results in lower hospital infrastructure utilization and human resource costs, and enables patients to safely receive care in the comfort of their own homes, minimizing the risk of nosocomial infections, lowering travel costs, and reducing the amount of time that patients need to spend away from work and family during treatment.

The geography of Canada presents an important case for driving innovative approaches to cancer therapy. Patients living in the more rural and remote parts of the country need to travel long distances to access hospitals where they can receive intravenous chemotherapy. The specialty knowledge required to safely prepare and deliver complex and often dangerous chemical treatments can be limited in more isolated regions. With the loss of a single specialist in smaller centres, there can be a complete halt to the organizational capacity to deliver chemotherapy, as was the case in the Haida Gwaii archipelago earlier this year when the Northern Health Authority was unable to recruit a new specialty-trained pharmacy technician, despite offering substantial incentives to fill the position.[iii]

A 2017 Cochrane review showed that amongst patients with colorectal cancer treated with the aim of cure, disease-free survival, and overall survival, there was no statistically significant difference in outcomes between those who received oral chemotherapy versus intravenous treatment.[iv] Take home oral treatments offer an innovative, patient-centred, and more efficient mechanism for delivering high quality, evidence based cancer treatment to Canadian patients.

Under the Canada Health Act, prescription drugs administered in Canadian hospitals are provided at no cost to the patient; however, outside of the hospital setting, provincial and territorial governments are responsible for the administration of their own publicly-funded drug plans.[v]

Given that the incidence of cancer spans the continuum of age and socioeconomic status, access to private insurance for coverage of take-home cancer drugs is variable amongst patients, as well as across provinces. As such, patients often encounter obstacles in accessing take home medications for cancer treatment, which can result in delays to treatment, or unnecessary utilization of hospital services.

Coordination of multiple reimbursement programs may be required for a single cancer patient to cover the cost of their take home treatment, and the process of obtaining authorization and reimbursement of approved cancer medications can be time consuming and challenging, particularly for patients and families grappling with a cancer diagnosis and its emotional and economic impact.

It is noted that Canadian caregivers are given 26 weeks of paid time off to care for a loved one living with cancer through the Compassionate Care Benefit; however, those actually living with cancer are only given 15 weeks of paid time off through the Employment Insurance Sickness Benefit. In addition to the potential economic burden of unpaid leave from employment, insufficient reimbursement and out of pocket expenses can present yet another economic hurdle for Canadian cancer patients.

One in six Ontario cancer patients report that their out-of-pocket expenses are significant or unmanageable.[vi]

The Atlantic provinces have different systems for intravenous versus take-home cancer therapies, with funding for the latter covered through a mix of private insurance, special programs, or out of pocket expenses.[vii] In Quebec, eligible take-home cancer treatments qualify for public coverage, though a deductible based on income may be required to be paid.[viii] In Manitoba, Saskatchewan, Alberta, and British Columbia, patients can also get coverage for take-home therapies.

A system in which some Canadians have access to modern cancer treatments and some do not presents an opportunity for all provinces to keep pace with innovation in cancer treatments. Provinces need to work to reduce barriers for Canadians to access the best possible cancer services and minimize the economic and personal burden of managing a cancer diagnosis, so that we do not simply transfer costs of care from health service institutions to the pocketbooks of cancer patients and their families.

The federal government has undertaken initial steps towards implementing a national pharmacare program. Questions will need to be addressed as to whether Canadians currently accessing cancer drug coverage through private insurance plans would be at risk of losing coverage for certain – or even all – therapies if their provinces shift to include some take home cancer therapies on their formularies, or to participate in a national pharmacare program, particularly if employment-based health benefits begin to be taxed as income following adoption of the national plan.

It is critical that Canada’s system of public health coverage keep pace with innovation in cancer therapy, particularly as escalating numbers of Canadians are impacted by cancer each year. This will require a carefully designed approach aimed at reducing disparities in access to innovative cancer treatment and mitigating unintended loss of current coverage for Canadians with cancer.

Roxana Sultan, Vice Chair and Member, Board of Directors, Canadian Cancer Society Ontario Division. The opinions expressed in this article are the independent views of the author and do not necessarily reflect the views of the author’s employers or affiliated organizations.

[i] https://www.cancer.ca/en/cancer-information/cancer-101/canadian-cancer-statistics-publication/?region=on

[ii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[iii] https://www.ctvnews.ca/health/remote-health-care-tested-as-haida-gwaii-loses-iv-chemo-treatment-next-month-1.4443517

[iv] https://www.cochrane.org/CD008398/COLOCA_oral-versus-intravenous-chemotherapy-colorectal-cancer

[v] https://www.canada.ca/en/health-canada/services/health-care-system/pharmaceuticals/access-insurance-coverage-prescription-medicines.html

[vi] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[vii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

[viii] https://www.cancer.ca/en/get-involved/take-action/what-we-are-doing/take-home-drugs-on/?region=on

Are the Real-World Data available in Canada suitable for drug reimbursement decisions?

Nigel Rawson | CHP | 24 SEP 2019

Much enthusiasm exists for the use of real-world data (RWD) sources for drug reimbursement and pricing decisions in Canada. However, a recent report providing insight into the views of various stakeholders about the use of these resources for decision-making demonstrated that the participants had several misperceptions about RWD. These misperceptions are likely the result of the RWD resources currently available in Canada being predominantly administrative health care utilization data.

Researchers in Saskatchewan and Manitoba were innovative pioneers in the use of administrative data for health services research in the 1970s and for pharmacoepidemiology in the 1980s and 1990s. Later, researchers in other provinces also used their local administrative data for research purposes. However, Canada has failed to capitalize on its lead. Other nations have moved forward by combining administrative data with electronic medical records (EMRs), laboratory test data and, in some cases, social, psychological and genetic information to develop more comprehensive RWD.

Despite billions of dollars being spent on the Canada Health Infoway, a not-for-profit government corporation created to foster and accelerate the implementation of a pan-Canadian EMR network, Canada has been slow to introduce large-scale EMR systems, and few provinces have complete laboratory, screening and other test information that are fully linkable with their administrative data or other resources such as registries. This slowness to develop more advanced resources is perhaps not surprising when many physicians, hospitals and pharmacies still communicate about patients using faxes.

The existing RWD available in Canadian provinces are frequently challenging to access and use. Examples of access difficulties are a lack of a central point of data procurement in some provinces, data use restricted to local accredited academics, and lengthy time required to obtain administrative and ethics approvals. In addition, differences exist in how data are provided; some provinces deliver a tested dataset, while others provide a data dump that necessitates much effort by the end user to organize into a useable format. Moreover, there is a lack of consistent data standards across different provinces; for example, the primary hospital discharge diagnosis in Quebec is the most important condition encountered by the patient during hospitalization, which may not be equivalent to the most responsible hospital diagnosis (the one requiring the greatest consumption of resources) used in Saskatchewan.

Additional limitations in utilizing administrative health care data include the need to assess the validity of diagnoses in each use because diagnostic validity is not of high importance when services are recorded, and the restrictive clinical criteria that patients must fulfill to obtain access to many drugs in government programs that often vary between provinces, which can lead to biased results. These issues also make analyses based on amalgamated data from different provinces questionable because combining data from resources with differing recording criteria does not eliminate the variation – more likely, it accentuates differences resulting in misleading outcomes.

Canada has long had a need for better information on the effectiveness of its health care system, but progress towards this goal is hindered by the country’s fragmented health care system. Moreover, the siloed approach of separate branches within each provincial government supporting different health care services results in little evaluation of the impact of each branch’s expenditure on the others. For example, an increase in spending on a high-cost innovative drug is frequently seen solely as a problem for the budget of the pharmacy service branch, even if it reduces the need for hospitalizations resulting in a saving for the hospital service branch that exceeds the additional medication expenditure.

Canada’s provincial governments have generally failed to invest in improving and extending their data beyond the information recorded to manage their health care delivery budgets because they have little incentive to do so. Administrative health care utilization data mainly record diagnoses, procedures performed and dispensed prescriptions, which indicate that services were required. They do not record whether a patient benefited from a medicine or treatment. Administrative data have a role in drug safety research, but they are an inappropriate resource with which to evaluate the effectiveness of new therapies. The lack of repeat prescriptions or further visits to the physician does not necessarily mean that the patient’s condition improved. The patient may have given up on the treatment because it was not working or it caused unpleasant side effects and tried something else. Alternatively, an absence of data could mean that the patient moved away or, more extremely, that they died suddenly. An assessment of the effectiveness of new therapies requires linked access to both administrative and clinical outcome data.

When clinical data are in electronic form in Canada, they tend to be in small-scale EMR systems. The few large EMR systems that do exist are generally not linkable with administrative data and access is often restricted to specific researchers. Clinical data may also be available in registry systems, some of which have been highly successful (e.g. Cystic Fibrosis Canada has a registry that includes virtually all Canadians with this disorder that provides valuable information about sufferers), but again they are rarely linkable with government administrative data.

In June 2019, the federal government’s Advisory Council on the Implementation of National Pharmacare submitted its final report on how a national public drug insurance system should be introduced in Canada. One of the Advisory Council’s recommendations is the collection and analysis of real-world evidence to help inform formulary decision-making, especially about the benefits and risks of drugs for rare disorders.

However, except in unusual circumstances, no Canadian RWD about a drug’s use exist when a reimbursement recommendation is made about the drug and negotiations regarding its price are undertaken. Moreover, public payers and the Canadian Agency for Drugs and Technologies in Health (CADTH), which provides recommendations to the governments that fund and manage it regarding whether medications should be reimbursed by the public payers, continue to want to see randomized clinical trial results in health technology assessment submissions, even those for drugs for rare disorders where such trials are difficult to accomplish. CADTH and the public payers regard results from randomized clinical trials more highly because they are committed supporters of evidence hierarchies that place RWD at a lower level of reliability, regardless of the circumstances.

Unless RWD analyses are available from other countries and accepted by CADTH, reimbursement recommendations will most likely continue to be made on “cost-effectiveness” assessments based on the results of efficacy data derived from randomized clinical trials and the manufacturer’s anticipated list price. From July 2020, maximum prices for new drugs are also going to be based on these assessments. Although constituting the best available information at the time, efficacy is an inadequate estimate of effectiveness and the list price does not represent the discounted price offered by the manufacturer to the provincial drug programs. Only once a drug is in everyday clinical use in Canada can genuine cost-effectiveness analyses based on RWD be performed.

The Advisory Council’s recommendation for the use of RWD to inform formulary decision-making may be apposite, but the pertinent question is, are valid and reliable evaluations of the effectiveness of medicines possible with the RWD currently available? Even if the present resources were considered to be adequate for this purpose, the numerous issues related to accessing and using these data create a significant challenge, if not a total blockage, for putting this recommendation into action. The situation is only likely to change if the federal, provincial and territorial governments genuinely want improved drug reimbursement and pricing decision-making (as well as better safety evidence), become more cognizant of the problems of the inadequacy of their data resources for valid analyses, and invest in developing and expanding their RWD assets.

National pharmacare advisory council’s report leaves many unanswered questions

Nigel Rawson | CHP | 24 JUL 2019

The 2019 federal budget announced that the government will take initial steps towards implementing national pharmacare to improve the affordability and accessibility of prescription drugs across Canada. The government’s plan includes the development of “three foundational” elements – a national Canadian Drug Agency (CDA), a comprehensive national drug formulary, and a national strategy for high-cost rare-disorder medicines.

The CDA will assess the cost-effectiveness of new prescription medicines and negotiate prices on behalf of public drug plans to recommend those that represent the best value-for-money. In other words, it will merge the present health technology assessment (HTA) agencies – the Canadian Agency for Drugs and Technologies in Health (CADTH), and INESSS, Quebec’s equivalent – and the pan-Canadian Pharmaceutical Alliance (pCPA), which currently negotiates prices for all public drug plans.

The government intends the CDA to be a powerful tool in reducing drug costs. Cost reduction aligns with the government’s commitment to provide affordable, accessible and appropriate prescription drug coverage for all Canadians.

As these documents usually are, the federal budget was long on generalities and short on details. The final report of the Advisory Council on the Implementation of National Pharmacare is consistent with the federal budget in the three foundational elements. The Council’s numerous recommendations provide greater insight into what is being proposed.

The CDA would not only bring together CADTH, INESSS and the pCPA but also resources and expertise from Health Canada, the Patented Medicine Prices Review Board (PMPRB), which currently regulates patented drug prices, and the Canadian Institutes for Health Research. The national formulary would start with “essential medicines” and only become a comprehensive list by January 2027. The national strategy for high-cost rare-disorder drugs would have a “distinct pathway” for the consideration of these medicines and a national expert panel “working with patients” to determine which drugs would be funded and which patients would receive them.

The most fundamental recommendation of the Advisory Council is that national pharmacare should be publicly funded and administered, eliminating the need for most of the current private and all the public drug insurance programs. The Advisory Council suggests that Canadians could purchase private insurance to cover the cost of copayments or provide extra benefits. However, since a totally public program is proposed, the federal government would probably tax employment-based health benefits as income, which would likely eliminate demand for private insurance.

Both the federal budget and the Advisory Council’s report leave important and concerning questions unanswered. These questions must be answered before such a sea change in the country’s pharmaceutical environment is allowed to occur.

Being part of national pharmacare would not be mandatory for the provinces and territories. They would have to choose to opt-in. Will they do this because they would be surrendering part of their autonomy over their prescription drug budgets and allowing the federal government to say which drugs they should fund? In particular, would Quebec relinquish its current comprehensive drug coverage programs for something potentially less inclusive, and would the province relinquish its jurisdiction by allowing INESSS to be combined with CADTH? Without a sufficient proportion of the Canadian population in the system, the bargaining power for pharmaceuticals needed to achieve the savings anticipated by the Advisory Council are unlikely to be realized.

The budget conspicuously did not mention the PMPRB, but the Advisory Council report recommends that  the substantial changes proposed by the federal government in 2018 to the PMPRB’s guidelines to further reduce drug prices should be implemented. The proposed changes could have far-reaching impacts for drug manufacturers that could delay or prevent the timely introduction of new medicines, which would deny Canadians with unmet pharmaceutical needs access to innovative therapies. The proposals have led to some serious concerns among patients. However, since the pCPA has achieved prices lower than the legal maximum for a growing number of drugs, the PMPRB’s pricing role has become less relevant to government drug plans. The question here is, is the PMPRB still needed?

Other questions relate to what is meant by a “comprehensive” national formulary and how it would be implemented across Canada. According to the budget, the development of a comprehensive, evidence-based list would “provide the basis for a consistent approach to formulary listing and patient access across the country.” Does this imply that the formulary would include the several thousand of medicines that many private insurance plans cover? Or would it be restricted to, for example, the 125 so-called essential medications proposed by some academics? Or, perhaps, it would resemble New Zealand’s formulary which, excluding vaccines, diagnostic products and oncology drugs, includes approximately 550 medicines (the often-criticized Ontario public plan has about 750 medicines)?

Provincial governments are protective of their autonomy in deciding which medicines are listed in their formularies based on perceived needs and priorities of residents and provincial budgets. Having provinces list all the medicines recommended for reimbursement by the CDA would likely be interpreted as federal interference and resisted, unless the federal government provided funding for the coverage of additional medicines. However, until all drug coverage plans are required to include every drug in the national formulary, inequity is likely to continue across Canada.

national strategy to regulate high-cost rare disorder medicines is long overdue. Some CADTH staff recognize that the current rigid methods of the HTA do not work for rare disorder drugs and that a unique approach to assess their value is required. A relevant question here is, will a national strategy include more flexible HTA methods for these types of drugs? If so, will public and private drug plans accept the recommendations, or will they continue to impose restrictive clinical criteria that limits drug access to highly specific patient types?

How will the federal government pay for national pharmacare? The usual method of federal transfers provides provincial and territorial funding based on the size of their populations. Some provincial drug plans are less comprehensive than others and would need greater funds to bring their plans up to a national standard. Moreover, some of the same province have a higher proportion of elderly residents who frequently require more drugs. If equity is to be achieved, disproportionate funding would be required. Would provinces with better current drug plans accept this?

Different estimates of the cost of national pharmacare have been put forward. Given the federal government’s notorious under-estimating of spending on large-scale projects and the time required to implement them, can Canadians trust the Advisory Council’s estimate? The Phoenix pay system and plans to purchase planes and ships for the armed forces raise the question, can Canadians trust the federal government to introduce national pharmacare without large tax increases and much delay?

The national pharmacare program recommended by the Council seems designed primarily to reduce out-of-pocket costs from copayments and deductibles under existing public drug plans and safety-net programs. Canadians who have public or private insurance should be concerned about whether it would reduce their benefits and increase their expenses. Without answers to the questions raised here, Canadians will not know whether the plan is to create the truly comprehensive program the Advisory Council proposes or a tight cost-containment system with limited access and options.