Adrian Levy PhD, Associate Professor, University of British Columbia, Director, Oxford Outcomes, Vancouver,
Pharmaceutical Outcomes Research and Policy
in Canada - Context and Recent Developments
Canadian academic institutions have proven fertile for pharmaceutical outcomes
research. Innovative research contributions have been made in
the fields of pharmacoeconomics, pharmacoepidemiology, pharmaceutical
policy and health-related quality of life. While multifactorial in nature, this
focus on high quality outcomes research has arisen in part because of the
structure and organization of health care in Canada.
The Canadian health care system is often identified as an example where
publicly funded health care coverage is made available to all citizens. While
this is largely true for the cost of physician and hospital services, the situation
with coverage for medications is more complicated. Delivery of health
care falls under provincial jurisdiction while regulatory approval is mandated
federally and the setting of prices is, in reality, a shared responsibility. All ten
provinces and three territories, as well as several other federally-funded
recipient groups in Canada, have drug benefit programs which subsidize the
cost of medications for eligible beneficiaries. The amount of these subsidies
and definition of eligible beneficiaries varies from province to province.
The Canada Health Act describes agreed upon desired characteristics of the
health care system. The Act is federal health insurance legislation which provides
universal, publicly financed coverage of most hospital and physician
services. This means that when a Canadian seeks medical care, the individual
goes to a physician or hospital of his or her choice and presents a health
insurance card, which is issued to each eligible resident of the province.
The individual does not pay directly for medically necessary services and no
dollar limits or deductibles apply. Thus, the Canada Health Act ensures that
the provision of health care services do not depend on an individual's ability
to pay. However, while legislation creates national standards, the Canadian
health care system is actually a complex arrangement of funding mechanisms
worked out between the governments at the federal, provincial and territorial
levels. It is worthwhile noting that the Canada Health Act focuses on
funding mechanisms, and in contrast to the United Kingdom's National
Health Service, the health care system in Canada is not centrally organized
or coordinated. This mean that, in Canada, hospitals are not-for-profit privately
owned institutions, most physicians are private contractors to the public
system, and the roles of governments include funding, legislation, regulation
and the delivery of a small number of programs. The system is not population-
based insofar as hospitals do not have defined catchment areas and
family physicians do not have defined patient populations. Thus, Canadians
have freedom to choose their own physicians and hospitals.
Prescription drugs are not considered an insurable benefit under the Canada
Health Act. The direct costs of paying for medications falls to provincial and
territorial drug plans and the payment arrangements differ in each of Canada's
jurisdictions. Overall, the medications for approximately one-quarter of the
Canadian population are paid for by governments (ranging from 9% in
Manitoba to 43% in Quebec). The elderly over 65 years of age and recipients
of social assistance have been covered in all provinces since the 1970s. In a
majority of provinces, universal coverage only starts for persons who have
relatively high drug costs. The actual plans differ substantially between
provinces such that, while the net effect is that subsidies are typically bigger
for lower income households, out of pocket expenses vary widely. Many
employed individuals have the costs of medications subsidized through
extended health benefits plans provided by private insurance companies.
The federal government in Canada has two fundamental roles for new medications
entering the market. First, new drugs must meet national standards
of efficacy and safety set by the ministry called Health Canada (analagous to
the process undertaken by the Food and Drug Administration in the United
States). Second, the Federal government is charged with regulating the
country-wide price manufacturers can charge for newly patented medications
through the Patented Medicine Price Review Board.
This division of responsibilities creates tension between the provincial governments
which have to pay for medications and the federal government which regulates prices. Transfer payments from the federal government offset
a portion of health care costs. Provincial and territorial ministries face
perennial shortfalls in health care budgets and constantly seek ways of delivering
the same or better health care within budget constraints.
Following a trend established in Australia in the early 1990s, first Ontario and
then Canadian provinces inplemented reimbursement review processes for
newly marketed pharmaceutical products. As the trend for reimbursement
review spread, there was an obvious and rapid multiplication of the efforts.
For example, there were ten health ministries, three territories and at least five
federal funding programs that each required definitions of eligibility criteria
for registrants, levels of pharmaceutical coverage, reimbursement criteria
and independently reviewed economic submissions.
In response to variations in coverage of prescription medications and substantial
duplication of efforts in reviewing the economic submissions, in
2002 the federal, provincial and territorial health ministers established the
Common Drug Review process within the Canadian Agency for Drugs and
Technologies in Health. This centralized reimbursement review process now
provides recommendations to 18 participating publicy-funded drug plans
(the province of Quebec, which inlcudes approximately one quarter of the
population of Canada, does not participate). Despite the centralized review
process, there continues to exist wide variability in the medications that are
included on formularies in different Canadian jurisdictions and the amount
that is paid by the public purse.
PHARMACEUTICAL OUTCOMES RESEARCH IN
Perhaps as a result of the circumstances in delivering health care in Canada,
university scholars have taken leading roles in the various domains of pharmaceutical
outcomes research and health technology assessment.
One reason for Canada's pivotal role in pharmacoepidemiological research is
the availability of many population-based sources of data. Canadian administrative
health databases are among the most well developed anywhere and
provide an excellent resource for pharmacoepidemiologic research. For this
reason, Canada has been characterized as an “information-rich” environment.
Canadian investigators have taken a leading role in using populationbased
administrative databases for pharmacoepidemiologic studies of both
the intended and unintended effects of medications. In addition to routine
collection of administrative data, supplementary information may be collected
through population-based disease and treatment registries. Canadian
scholars have written seminal descriptions of various forms of bias and confounding,
developed innovative study designs, and made other important
methodological and statistical advances, in pharmacoepidemiologic studies.
The early implementation of reimbursement review processes in various jursidictions
in Canada has led to continuously improving guidelines on the submission
requirements and processes. Also, there has been a large number
of published economic appraisals in the Canadian context as the reports
submitted to public drug plans go on to appear in the peer-reviewed literature.
Many of these studies have been published by investigators outside of
academic environments, including the industry and government sectors.
These developments have provided incentives for developing robust methods
and interpretations of economic evaluations.
The structure of the health care system, with provincial governments responsible
for the delivery of health care and public drug plans being the largest
payors in the country, has led to the implementation of new policies aimed at
making drug coverage more equitable, limiting the reimbursed amounts within
specific classes of medication, and increased cost-sharing. These new
policies have led to changes in coverage status of different sectors of the
population and typically led to decreases in public reimbursement for prescribed
medications. Several groups of investigators have focused on the
system outcomes such as the changes in prescribing and the estimated
reduced expenditures occuring after a new policy is implemented. Much
less is known about the effects on patient outcomes of the new policies.
Canadian scholars have also been at the forefront of designing techniques for
measuring and valuing health-related quality of life. Utility elicitiation techniques
that are now used ubiquitously, such as the time trade off, were pioneered
in Canada. Also developed in Canada, the Health Utilities Index® is
a generic, preference-scored, comprehensive system for measuring health
status and producing utility scores.
RECENT DEVELOPMENTS IN PHARMACEUTICAL
POLICY INNOVATIONS IN CANADA
The Common Drug Review was established in March 2002, began reviewing
in September 2003, and since then has reviewed over 100 submissions.
The process has undergone two reviews and many positive changes have
occurred in response. Some of the notable changes have been: 1) to include
two members of the public in all deliberations. These persons' opinions are
helpful in identifying the non-evidentiary factors that may be considered and
included in the process; 2) to enhance transparency through several means
including developing non-technical versions of the recommendations; and 3)
to establish standardized approaches for reviewing both “first-in-class” medications
and those for rare disorders.
Joint Oncology Drug Review (JODR)
Implemented in March 2007, the inter-provincial Joint Oncology Drug Review
Process was established to create a more consistent review process of
ambulatory-based oncology medications across the country. This process
is now distinct from Common Drug Review.
In response to the advances in pharmaceutical sciences, drug development,
and changes in public expectations, many countries are changing the
processes around regulatory approval for medications. The Government of
Canada is keeping pace through a new program called the Progressive
Licensing project. Under this system, the current point-in-time licensing system
will evolve in a cyclical progressive licensing model. The daunting task
of jointly evaluating benefits and risks of medications in an environment in
which different and often conflicting objectives must be balanced will require
substantial input and compromise from all interested parties.
There is a growing need worldwide for high quality drug outcomes research
and discourse on pharmaceutical policy. Canadian academics, policy- and
decision-makers and industry employees have assumed leadership roles to
fill that need. ISPOR is responding in kind by providing a forum for broad
communications between different sectors and its members continue to generate
leading outcomes research. The 13th annual ISPOR meeting in
Toronto, with its record-breaking attendance, entertaining and informative
oral and poster presentations around the meeting theme “Vive la Différence -
Enhancing/Expanding Outcomes Research One Country at a Time”, attests to
the fact that both outcomes research on medications and ISPOR are thriving