Published Online, 13 May 2008, www.theannals.com, DOI 10.1345/aph.1K373.
The Annals of Pharmacotherapy: Vol. 42, No. 6, pp. 869-873. DOI 10.1345/aph.1K373
© 2008 Harvey Whitney Books Company.
Drug Reimbursement Policies in Canada—Need for Improved Access to Critical Therapies
Jacques LeLorier, MD PhD FRCPC
Director of Pharmaco-economics and Pharmaco-epidemiology Research Unit,
Centre Hospitalier de L'Université de Montréal, Montréal,
Quebec, Canada
Alan Bell, MD MCFP
Active Staff, Department of Family and Community Medicine, Humber River
Regional Hospital, Toronto, Ontario, Canada
David J Bougher, BSP MHSA
Principal Consultant, D Bougher Consulting, Edmonton, Alberta,
Canada
Jafna L Cox, MD FRCPC FACC
Professor, Departments of Medicine and of Community Health and
Epidemiology, Dalhousie University, Halifax, Nova Scotia, Canada
Alexander GG Turpie, MD FRCP FRCPC FACC
Professor, Department of Medicine, Hamilton Health Sciences, McMaster
University, Hamilton, Ontario
Reprints: Dr. LeLorier, Pharmaco-economics and Pharmaco-epidemiology
Research Unit, Centre Hospitalier de L'Université de Montréal,
CRCHUM—Pavillon Masson, 3850 Saint-Urbain, Montréal, QC, Canada
H2W 1T8, fax 514/412-7174,
massicoa{at}umontreal.ca
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Abstract
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Public drug programs in Canada are increasingly implementing cost
management strategies. A multidisciplinary review of these
strategies—specifically, the special authorization (SA)
process—found that implementation of the SA practice is costly and
causes inequity in access, underutilization, and delays in treatment for
urgently required therapies, all potentially leading to negative health
outcomes. We present potential solutions and a set of recommendations for
decision-makers to base reimbursement decisions on the best clinical evidence,
eliminate regional variability in access, ensure timely access to urgently
required treatments, and monitor the impact of reimbursement policies on
health outcomes.
Key Words: health outcomes, health policy, medications, reimbursement
Published Online, May 13, 2008. www.theannals.com, DOI 10.1345/aph.1K373
After hospital costs, drug costs are the second largest component of
healthcare spending, accounting for 18% of the Canadian health
budget.1 To
control annual budget increases of 10%, public drug programs have implemented
strategies limiting patients' access to certain medications. While it is clear
that costs must be contained, formulary decisions are not
consistent2,3
and are often made based on varying evaluations of effectiveness,
demographics, self-interest, government priorities, and patient
advocacy.4,5
Differing reimbursement restrictions cause inconsistency of care and can lead
to untoward
consequences.6
In light of these concerns, 5 physicians and reimbursement experts
assembled to review collective experience related to the impact of restricted
access and to develop a set of recommendations to address limitations of the
current system. This article reports the group's findings.
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Methods
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Four physicians (JL, JLC, AB, AGGT) with expertise in reimbursement issues,
who represent differing jurisdictions and specialties, met as a subgroup of a
Board of Advisors to Bristol-Myers Squibb and Sanofi-Aventis over concern with
delays in reimbursement for urgently required medications. A former provincial
drug plan manager (DJB) was included on the panel to ensure a balanced
perspective. The working group met twice to examine their experiences
concerning the impact of delayed reimbursement. A MEDLINE search (key terms:
restricted reimbursement, Canada, outcomes, special authorization) was
conducted to compare their experiences with published findings. Provincial
reimbursement criteria were obtained from online formularies. Panel members
drafted a manuscript aimed at bringing the group's concerns to the attention
of decision-makers. Ideas presented in the final version were developed
through consensus.
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Findings
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FORMULARY COST-CONTAINMENT IN CANADA: AN OVERVIEW
Public drug programs employ a variety of funding options for beneficiaries
in need (eg, senior citizens without private insurance, social assistance
recipients, those with high drug costs relative to income). Most often, drugs
are placed on an open formulary whereby all beneficiaries can access all
listed medications. An increasingly common option is to restrict medications
to patients who meet explicit criteria upon preapproval or "special
authorization" (SA; Table
1). The SA criteria are usually a subset of the approved
indications or are used for failure of, or intolerance to, less costly
treatments. To obtain SA medications, physicians submit an application to the
drug program. Applications are generally reviewed within 2
weeks.7,8
Some patients pay for their own supply of medication during the waiting period
or obtain a temporary supply from the manufacturer; many, if not most,
patients go untreated during the waiting period. The patient or physician is
notified of the reimbursement decision in writing. If reimbursement is not
granted, patients can be treated with an approved alternative or can opt to
pay out-of-pocket for the restricted medication.
The SA process originated as a safety measure to constrain expenses in
exceptional circumstances. Drug programs have now expanded its use and
typically provide reimbursement for over 100 different medications in this
way.9,10
Updates to SA lists are made several times annually, although the list and
eligibility criteria for each medication are not publicly available in every
province. In Ontario, the number of beneficiaries receiving SA medications has
grown from 8000 in 1997–1998 to over 98,000 in
2005–2006.11
Expansion of SA programs has occurred as a result of our aging population and
as a reaction to the ever-increasing number of medications receiving
regulatory approval.
SPECIAL AUTHORIZATION IS EXPENSIVE AND TAKES TIME AWAY FROM PATIENT CARE
The sheer number of SA requests makes the programs expensive to administer.
Physicians, pharmacists, and their staff must generate documentation
supporting the requests. Drug plan employees review thousands of applications
annually. When the rate of approval of SA applications is high
(Table 2), physicians and
pharmacists find the
time-consuming12
and costly13
paperwork counterproductive to patient care.
SPECIAL AUTHORIZATION LEADS TO INEQUITIES IN ACCESS
Examples of unequal access to medications are increasingly being
recognized.2,5,14
In Quebec, where a universal drug plan ensures coverage for all patients
without private insurance, the likelihood of receiving a thiazolidinedione
(TZD) was reported to be higher for patients younger than 65 years of age
(51–64 y: OR 1.33, 95% CI 1.11 to 1.59; 19–50 y: OR 1.81, 95% CI
1.40 to 2.33) than for patients older than 65
years.14
Prescribing of TZDs was also more frequent in patients with the highest income
(OR 1.55, 95% CI 1.21 to 1.98) versus the lowest income. Because younger and
higher-income patients were more likely to be treated with a TZD and to have
unrestricted private insurance, the investigators speculated that the observed
social inequities were created by the "bureaucratic hurdle" of SA
within the public plan.
An analysis of 6 formularies found that interprovincial agreement, measured
as pairwise 
coefficients across chemical subgroups (not individual
drugs), varied from a rating of poor (0.23) between British Columbia and
Quebec to only fair (0.45) between Alberta and
Manitoba.5 Of
15 pairwise comparisons, 9 had poor agreement ( < 0.40) and 6 were
rated fair ( = 0.4–0.45). The analysis showed that Canadians do
not have equal access to whole classes of medication.
SPECIAL AUTHORIZATION IS ASSOCIATED WITH NEGATIVE HEALTH OUTCOMES
Some provinces do not have an expedited SA mechanism for cases of acute
need (Table 1). The 10
medications requested most often in Ontario
(Table 2) are primarily
required for chronic conditions; however, some (eg, clopidogrel, filgrastim)
have indications for more urgent
use.15,16
Ontario reports that 71% of all requests are approved within 3 weeks, although
29% take
longer.11
These timeframes do not include the time required to notify the patient of the
approval and for the patient to fill the prescription.
Not surprisingly, delays in initiating therapy have been associated with
negative health outcomes. Clopidogrel— the most frequently requested SA
medication in several provinces—is a commonly cited example. In Alberta,
clopidogrel fill rates within a traditional SA process were compared with
those in a "designated prescriber" system, whereby a physician
registered as an approved prescriber could secure immediate access to
clopidogrel for patients meeting specific
criteria.17
Under the traditional SA process, only 31% of patients had their prescription
filled on the day of coronary artery stent placement. After introducing the
designated prescriber system, the proportion of patients filling their
prescription at discharge increased to 54% (p = 0.02). Two repeat
revascularizations were necessary within 6 weeks of stent placement; both
occurred in the SA cohort in patients who delayed filling, or failed to fill,
their prescription.
A large study in Quebec found that, of 13,663 patients who underwent
coronary stenting, patients who did not fill any clopidogrel prescription
(11.5%) and those who delayed filling their prescription by at least one day
(8.6%) had significantly higher risks of death (HR 1.70, 95% CI 1.35 to 2.15
and HR 1.34, 95% CI 1.01 to 1.80,
respectively).18
A prospective study of 124 patients in Ontario found that the mean time for
clopidogrel SA requests to be approved (98% approval rate) and filled was 28
days (range
1–92).6
The patients' physicians reported 79 adverse health outcomes or incidents of
additional healthcare resource utilization directly attributable to the delay,
including 4 emergency department visits, 7 hospitalizations, 61 physician
encounters, and 7 deteriorations of the medical condition.
While observational studies have acknowledged methodologic limitations,
they provide insight into the adverse consequences of the SA process.
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Discussion
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There is a clear need for different processes to adjudicate drugs required
to manage chronic versus urgent conditions. Administrators have a
responsibility to ensure that appropriate reimbursement is granted in a timely
manner. Potential methods of ensuring immediate access to required medications
include (1) provision of short courses of therapy to cover the authorization
period following hospital discharge; (2) a Web-based system for automated
adjudication of urgent requests; (3) monitoring of SA approval rates to
determine which medications to move to an open list or alternate mechanism of
control; and (4) increased use of preapproved prescriber lists.
The clinical impact of restricted drug reimbursement has generally been
underinvestigated. Some publications demonstrate cost benefit without a
negative effect on health
outcomes,19,20
while others suggest that restrictions may increase spending by shifting
expenditures from drugs to other healthcare
resources.21
Governments have not been held accountable for measuring these consequences.
The increasing availability of electronic data and the ability of payers to
link data resources to compare resource utilization with prescribing patterns
could facilitate ongoing monitoring.
It is unlikely that any one SA process will be ideal for all medications,
all situations, and all patients. As a result, we urge decision makers to
adopt the following principles around each reimbursement decision. First,
solutions must be transparent and equitable, with consistency across
jurisdictions in terms of which drugs are covered, for which indication(s),
and for what duration. Second, urgently required therapies must be immediately
available. Third, the economic, clinical, and human impact of decisions must
be measured. Last, where issues are identified after implementation,
experimentation with alternate reimbursement processes and continued
monitoring are required.
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Summary
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Through adherence to these principles, we believe that the greatest number
of Canadians can receive optimal treatment at an affordable cost. While the
experience and opinions presented in this article represent those of the
authors and may not be reflective of all clinicians in Canada, the information
serves as a basis to conduct a nationwide survey of practicing physicians to
document experience with the SA process and for health policy authorities to
begin to evaluate the impact of very restrictive reimbursement.
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Footnotes
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Sanofi-Aventis Canada and Bristol-Myers Squibb Canada provided the funding
that allowed the authors to meet, plan, and draft this article. The ideas
presented in this work are solely those of the authors and do not reflect the
views of either company.
Dr. LeLorier has received consultancy, research, travel, and/or speaking
grants from the following commercial organizations: AstraZeneca, Altana,
Abbott, Amgen, Sanofi-Aventis, Bristol Myers Squibb, Merck Frosst, Pfizer,
Novartis, and GlaxoSmithKline.
Dr. Cox has received honoraria from, and has given talks for,
Sanofi-Aventis and Bristol Myers Squibb. In addition, he is a member of a
national advisory board relating to clopidogrel.
Dr. Bell has received consultancy, research, travel, and/or speaking grants
from the following commercial organizations: AstraZeneca, Altana, Abbott,
Amgen, Sanofi-Aventis, Bristol Myers Squibb, Merck Frosst, Pfizer, Novartis,
Servier, and GlaxoSmithKline.
Mr. Bougher has provided pharmaceutical policy advice to various private
and public sector organizations, including Bristol Myers Squibb and
Sanofi-Aventis.
Dr. Turpie has received honoraria from, and has given talks for,
Sanofi-Aventis and Bristol Myers Squibb.
We thank Lindy Forte for her assistance in preparing the manuscript.
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Abstract
Methods
