Oncollogy

S w
909E20
THE CHALLENGE OF ACCESS TO ONCOLOGY DRUGS IN CANADA
Chander Sehgal wrote this note under the supervision of Professor Greg Zaric solely to provide material for class discussion. The
authors do not intend to provide legal, tax, accounting or other professional advice. Such advice should be obtained from a qualified
professional.
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Copyright © 2009, Ivey Management Services Version: (A) 2009-12-01
INTRODUCTION
According to the Canadian Institute for Health Information (CIHI), drugs (both prescription and non-
1
prescription) were estimated to account for 17.4 per cent ($29.8 billion ) of total national health care
2
expenditure ($171.9 billion) in 2008. For the past several years, countries with publicly funded health care
3
had used cost-effectiveness analysis (CEA) together with reviews of clinical data, as a means to both
assess the overall benefit of a new drug and set priorities within a health care budget. Cost-effectiveness
was formally incorporated into the Ontario drug review system in 1993 and into the Canadian drug review
system in 2003. The issue of using cost-effectiveness had become increasingly contentious in recent years:
some newly approved cancer drugs cost $3,000 to $6,000, or more, for one treatment cycle, but their high
prices often classified them as being not cost-effective.
CANCER DRUGS
Cancer chemotherapy (the treatment of cancer through the use of drugs) is a common modality in the
treatment of various forms of cancer. Drugs are used either for the treatment of advanced cancer or in
combination with other modalities, such as surgery and radiation therapy, or both, to prevent cancer from
spreading further. In recent years, a paradigm shift had occurred in the way some cancers were treated.
New generations of cancer drugs had been developed that belonged to a class of molecular and targeted
4
therapies that modified the growth and dissemination of cancer cells. This approach was different from the
1
All dollar amounts are in Canadian dollars unless specified otherwise.
2
Canadian Institute for Health Information, National Health Expenditure Trends, 1975–2008, page 15, http://secure.cihi.ca/
cihiweb/dispPage.jsp?cw_page=AR_31_E; Canadian Institute for Health Information, “Figure 1: Total Drug Expenditure as a
Percentage of Total Health Expenditure, 1985–2008,” National Health Expenditure Database, http://secure.cihi.ca/cihiweb/
en/media_20090416_fig1_e.html, accessed June 4, 2009.
3
See Appendix 1 for a brief review of cost-effectiveness analysis.
4
Targeted cancer therapies are drugs or other substances that block the growth and spread of cancer by interfering with
specific molecules involved in tumor growth and progression. Because scientists call these specific molecules “molecular
targets,” therapies that interfere with them are sometimes called “molecularly targeted drugs,” “molecularly targeted
therapies” or other similar names. Source: National Cancer Institute, “Targeted Cancer Therapies,” http://www.cancer.gov/
cancertopics/factsheet/Therapy/targeted, accessed June 4, 2009.
This document is authorized for use only in Prof. Arnab Mukherji's PGP- Healthcare Economics: Theory and Practice in a Fragmented Market 2023 (AM) at Indian Institute of Management -
Bangalore from Sep 2023 to Nov 2023.
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earlier approach of using primarily cytotoxic cancer drugs (drugs that kill cancer cells). A change had
occurred in the way the clinical benefit of cancer treatment was evaluated. Debates focused on whether
conventional measurements of “complete and partial response” and “overall survival” to treatment should
be replaced by the more appropriate surrogate end points of “stable disease,” “progression-free survival”
and “quality of life.” These changes meant that effective therapies were being given on a long-term basis
until disease progression or toxicity was unacceptable.
Targeted therapies had changed the standard of care for some cancers. For example, imatinib (trade name
5
Gleevec) had significantly improved the overall survival of patients with chronic myeloid leukemia
6
(CML) and gastrointestinal stromal tumor (GIST); trastuzumab (trade name Herceptin) for breast cancer
7
and rituximab (trade name Rituxan) for patients with aggressive non-Hodgkin lymphomas.
8 9
New cancer drugs had also made a significant difference in the disease-free or progression-free survival
of patients diagnosed with many types of cancers. For example, advances had been made with
10 11
bevacizumab (trade name Avastin) for advanced colorectal cancer; bortezomib (trade name Velcade)
12
for multiple myeloma and, more recently, sunitinib (trade name Sutent) and sorafenib (trade name
13
Nexavar) for patients with advanced kidney cancer. Some cancers were now being treated as a chronic
disease because more Canadians were surviving cancer as a result of earlier diagnoses and more effective
treatments. Although the availability of better treatment options for various cancers was good news for
patients, such widespread availability had also led to a continuously growing number of patients who were
on cancer drugs, resulting in increased concern by governments regarding financial strain on public drug
plans. However, cancer was not the only area where science had made progress. The number of newer and
relatively more expensive drugs approved by regulatory agencies had also surged for HIV/AIDS (human
immunodeficiency virus/acquired immunodeficiency syndrome) and diseases afflicting the cardiovascular
system and the central nervous system.
FUNDING DILEMMA
On one hand, some questioned the cost-effectiveness analyses and the decisions to use thresholds per
quality adjusted life year (QALY) gained as a measure for deciding whether to cover or deny a drug. On
the other hand, the high cost of new cancer drugs was an important issue with far-reaching consequences
for the sustainability of publicly funded drug coverage plans. An aging population, combined with
5
Cancer Care Ontario, “Imatinib,” http://www.cancercare.on.ca/pdfdrugs/Imatinib-Mesylate.pdf, accessed June 4, 2009.
6
Roche Canada, “Herceptin,” http://www.rochecanada.com/gear/glossary/servlet/staticfilesServlet?type=data&
communityId=re753001&id=static/attachedfile/re7300002/re77300002/AttachedFile_09523.pdf, accessed June 4, 2009.
7
Roche Canada, “Product Monographs: Rituxan,” http://www.rochecanada.com/gear/glossary/servlet/staticfilesServlet?
type=data&communityId=re753001&id=static/attachedfile/re7300002/re77300002/AttachedFile_09432.pdf, accessed June
4, 2009.
8
Disease-free survival: The length of time after treatment for a specific disease during which a patient survives with no sign
of the disease. Disease-free survival may be used in a clinical study or trial to help measure how well a new treatment
works. Source: National Cancer Institute, “Dictionary of Cancer Terms,” http://www.cancer.gov/Templates/db_alpha.aspx?
CdrID=44023, accessed June 4, 2009.
9
Progression-free survival: The length of time during and after treatment in which a patient is living with a disease that does
not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment
works. Source: National Cancer Institute, “Dictionary of Cancer Terms,” http://www.cancer.gov/Templates/db_alpha.aspx?
CdrID=44782, accessed June 4, 2009.
10
Roche Canada, “Avastin,” http://www.rochecanada.com/gear/glossary/servlet/staticfilesServlet?type=data&communityId
=re753001&id=static/attachedfile/re7300002/re77300002/AttachedFile_09632.pdf, accessed June 4, 2009.
11
Janssen-Ortho Inc., “Velcade,” http://www.janssen-ortho.com/JOI/pdf_files/velcade_E.pdf, accessed June 4, 2009.
12
Cancer Care Ontario, “Sunitinib,” http://www.cancercare.on.ca/pdfdrugs/sunitinib.pdf, accessed June 4, 2009.
13
Cancer Care Ontario, “Sorafenib,” http://www.cancercare.on.ca/pdfdrugs/sorafenib.pdf, accessed June 4, 2009.
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increasing rates of cancer and the resulting treatment needs created a growing demand on publicly funded
health care systems. According to the Canadian Cancer Statistics 2009 report, the “increase in the number
of new cases of cancer, exclusive from non-melanoma skin cancer, is primarily due to growing and aging
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population.”
The ability of publicly funded organizations to sustain the cost of cancer drugs had become an increasingly
important question. What trade-offs should be made to maintain a sustainable cancer care and ultimately a
sustainable health care system?
These issues resulted in mounting challenges for all the players involved: patients, physicians,
pharmaceutical companies, insurance companies, advocacy organizations and the government (see Exhibit
1).
On the government side, multiple stakeholders were involved in the decision-making process, from Health
Canada, which granted approval of a new drug, to the provincial drug formularies that facilitated final
access of the drug by patients (see Exhibit 2).
The funding dilemma was obvious when considering the costs of new treatments. For example, Sutent cost
$7,000 per six weeks of therapy (approximately $56,000 per year), and some kidney cancer patients had
been receiving the drug continuously for more than two years (see Exhibit 3).
THE DRUG REVIEW PROCESS IN CANADA
Government Agencies
The process of drug approval and final access by a patient involved a series of steps and approvals from
various governmental agencies.
Health Canada
The first step in the approval of a new investigational drug was to establish its efficacy and safety on the
basis of predetermined criteria from clinical trials conducted in accordance with International Conference
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on Harmonization (ICH) and Good Clinical Practice (GCP). The sponsor (usually a pharmaceutical or
biotechnology company) would submit the clinical data to the appropriate regulatory authorities for review
and marketing authorization: the Food and Drug Administration in United States (USFDA), the European
Medicines Agency (EMEA) in the European Union and Health Canada in Canada. In Canada, the
Therapeutics Products Directorate (TPD), a division of Health Canada, ensured that the new drug met the
highest standards of safety, efficacy and quality in accordance with the Food and Drugs Act and
Regulations. If TPD was satisfied with the manufacturer’s claims, it would grant NOCc (notice of
14
“Canadian Cancer Statistics 2009,” http://www.cancer.ca/Canada-wide/About%20cancer/Cancer%20statistics/~/media/
CCS/Canada%20wide/Files%20List/English%20files%20heading/pdf%20not%20in%20publications%20section/Stats%2020
09E%20Cdn%20Cancer.ashx, accessed June 4, 2009.
15
Health Canada Website, Guidance For Industry: General Considerations for Clinical Trials ICH, Topic E8, http://www.hc-
sc.gc.ca/dhp-mps/alt_formats/hpfb-dgpsa/pdf/prodpharma/e8-eng.pdf, accessed June 4, 2009.
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compliance with conditions) or NOC (notice of compliance)16 for a new drug or a new indication for an
17
existing drug.
Patented Medicine Prices Review Board (PMPRB)
Health Canada’s authorization for marketing was followed by a review by the Patented Medicine Prices
Review Board (PMPRB), an independent quasi-judiciary body created in 1987, under the Patent Act.
PMPRB put limits on the prices set by manufacturers for all patented medicines sold in Canada with the
objective to avoid excessive pricing. Neither TPD nor PMPRB reviewed the cost-effectiveness of a drug or
18
made recommendations to the drug plans.
19
PMPRB used the following criteria or factors to determine the price of a patented drug :
a) Most new patented drug prices are limited so that the cost of therapy is in the range of
the cost of therapy for existing drugs sold in Canada used to treat the same disease,
b) Breakthrough drug prices are limited to the median of the prices for the same drugs
charged in other specified industrialized countries that are set out in the Patented
Medicines Regulations (France, Germany, Italy, Sweden, Switzerland, U.K. and the U.S.),
c) Existing patented drug prices cannot increase by more than the Consumer Price Index
(CPI),
d) In addition, the Canadian prices of patented medicines can never be the highest in the
world. Public drug plans also play a role in drug pricing through the listing of drugs on
their respective formularies for purposes of reimbursement.
Canadian Agency for Drugs and Technologies in Health (CADTH)20
After approval of a new drug by Health Canada and a maximum price setting by PMPRB, the drug
manufacturers made a submission to the Canadian Agency for Drugs and Technologies in Health
(CADTH), a federal body. Under CADTH, various experts (both CADTH employees and external
independent reviewers) worked collaboratively as a part of one of the three programs: Canadian Optimal
21
Medication Prescribing and Utilization Service (COMPUS), Common Drug Review (CDR) and Health
Technology Assessment (HTA). COMPUS published systematic reviews and meta-analyses to identify
16
An NOC/c is authorization to market a drug (i.e. a Notice of Compliance (NOC), with the condition that the sponsor
undertakes additional studies to verify the clinical benefit. The NOC, qualifying under the NOC/c policy, is issued under
section C.08.004 of the Food and Drug Regulations.
17
Health Canada, “Access to Therapeutic Products in Canada,” http://www.hc-sc.gc.ca/ahc-asc/pubs/hpfb-dgpsa/access-
therapeutic_acces-therapeutique-eng.php#2, accessed June 14, 2009.
18
Patented Medicine Prices Review Board, “About the PMPRB,” http://www.pmprb-cepmb.gc.ca/english/View.asp?x=175&
mp=87, accessed June 14, 2009.
19
Patented Medicine Prices Review Board, “Frequently Asked Questions: (12) What Controls Exist To Ensure That The
Prices Canadians Pay For Drugs Are Reasonable?,” http://www.pmprb-cepmb.gc.ca/english/View.asp?x=272#10, accessed
June 14, 2009.
20
Canadian Agency for Drugs and Technologies in Health, “About CADTH,” http://www.cadth.ca/index.php/en/cadth,
accessed on June 14, 2009.
21
The CDR directorate was established in 2002 and began accepting submissions in 2003.
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and promote optimal drug therapy. CDR performed reviews of clinical evidence and cost-effectiveness
analyses based on data submitted by drug manufacturers for a new drug or a new indication of an existing
drug. CADTH also conducted HTAs of various drug and non-drug medical technologies. Under the CDR
process, Canadian Expert Drug Advisory Committee (CEDAC), an independent advisory group of experts
in drug therapy and drug evaluation, made recommendations to the participating publicly funded drug
plans (all plans participated except Quebec) with regards to listing on their formularies. CEDAC
considered the following criteria while making final recommendations:
a) clinical studies which assessed the efficacy and safety of the drug in appropriate
populations,
b) therapeutic advantages and disadvantages relative to current accepted therapy and
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c) cost-effectiveness analysis (CEA) relative to current accepted therapy.
Following its review, CEDAC would make one of the following recommendations to the publicly funded
drug plans:
i) A drug be listed,
ii) A drug be listed with criteria or conditions,
iii) A drug not be listed, or
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iv) A recommendation may be deferred pending clarification of information.
Following the recommendations made by CEDAC was not mandatory for the participating provincial and
territorial publicly funded drug plans.
Formation of the Joint Oncology Drug Review (JODR) Process

The Joint Oncology Drug Review (JODR) was established in early 2007, as a pilot provincial/territorial
(P/T) collaborative initiative, with the objective of building a national drug review process for cancer drugs
and supporting more consistent and transparent decision-making. CDR would participate in the new
process as an observer on the JODR Steering Committee. The option of bringing JODR under CDR was
kept open, upon completion of an evaluation of this pilot project. Under the interim JODR process,
oncology drug submissions to Ontario were considered submissions to all participating provinces and
territories. It had been decided that JODR would not accept submissions for supportive care products. All
participating provinces and territories would have access to recommendations made by both the Committee
to Evaluate Drugs (CED) and the CED-Cancer Care Ontario (CCO) subcommittee with respect to the
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listing of oncology drugs effective March 1, 2007. The final funding decision for all oncology drugs in a
respective province or territory reviewed through this interim process would remain the responsibility of
each participating jurisdiction. From March 2007 to April 2009, JODR reviewed 23 cancer drugs for 27
25
indications, and CED-CCO made public its recommendations on several new cancer drugs or new
26
indications (see Exhibit 3).
22
Canadian Agency for Drugs and Technologies in Health, “Common Drug Review Process,” http://www.cadth.ca/media/cdr
/process/CDR_Process_flowchart_e.pdf, accessed June 14, 2009.
23
Canadian Agency for Drugs and Technologies in Health, “CDR Overview,” http://www.cadth.ca/index.php/en/cdr/cdr-
overview, accessed June 20, 2009.
24
Ontario Ministry of Health, “Inter-Provincial Joint Oncology Drug Review Process,” http://www.health.gov.on.ca/english/
providers/program/drugs/drug_submissions/inter_oncology_drugs.htm, accessed June 24, 2009.
25
Ontario Ministry of Health, “Drugs Reviewed by Interim Joint Oncology Drug Review (from March 2007 to April 2009),”
http://www.health.gov.on.ca/english/providers/program/drugs/drug_submissions/pdf/drug_products
_reviewed2.pdf, accessed June 24, 2009.
26
Ontario Ministry of Health, “EO Decisions and CED Recommendations,” http://www.health.gov.on.ca/english/providers/
program/drugs/ced_rec_table.html (accessed June 24, 2009).
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PATIENTS
Since early 2006, the media had reported on several stories concerning perceived injustices when new
cancer drugs were approved by Health Canada but reimbursement was delayed or refused by provincial
drug plans.
For example, on July 15, 2006, the Globe and Mail reported the story of a medical doctor, Dr. Norman
Saunders, a colorectal cancer patient, who had sued the Ontario government because of its refusal to
provide Avastin. Said Dr. Saunders:
I strongly believe that the quality of care is not a function of a patient’s pocketbook.
This kind of approach where they won't fund proven therapies because of their expense
is counter to what I view our philosophy is in Canada and our view of universal health
care. It was clear their agenda was not into providing the best health care, but trying to
keep costs contained and avoid making this tough ethical decision as to who and what
27
should be funded in the province of Ontario.
The situation was not limited to colorectal cancer patients. Several media had reported reimbursement
issues around newly approved kidney cancer drugs sunitinib and sorafenib. Both these drugs had been
approved by Health Canada in 2006.
In February 2008, about 20 months after Health Canada’s approval of the two novel kidney cancer drugs,
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the London Free Press reported on two kidney cancer patients, Gary White and Bob Eaton. Eaton
reportedly had private health coverage and White did not. White was told that the province would not pay
for the kidney cancer drug recommended by his doctor. “I’m terribly disappointed. It leaves me without
options,” White said after learning the decision of the Ontario Drug Benefit Program. White’s private
health insurance plan did not cover the full cost of the drug, whereas Eaton received the drug through his
drug coverage plan he was entitled to as a former member of provincial parliament (MPP). “I was shocked
when my doctor informed me that other Ontarians and other Canadians have to pay for this drug out of
pocket,” Eaton was reported as saying. Eaton said if MPPs were covered, everyone should be covered.
This story highlighted the asymmetry of coverage of expensive drugs within the same province and raised
questions whether such a system was justified.
In November 2008, CBC News reported on Colin Spencer, a kidney cancer patient from Prince Edward
29
Island (P.E.I.). Spencer did not have private health insurance to pay for the drug recommended by his
doctor, and P.E.I. did not reimburse sunitinib. Spencer reportedly had to “cash in his pension and put his
family’s home on the market.”
Most people were proud of and valued the Canadian health care system but felt frustrated when a cancer
patient in their family did not have access to a cancer drug that had been approved for treatment by Health
Canada. Most people outside the health care system were not aware of the complexities of the drug review
process for funding and how decisions were made.
27
Lisa Priest, “Ruling on MD's Cancer Treatment Appealed,” Globe and Mail, July 14, 2006, http://www.provis.ca/pdf/8_
Globe_and_Mail_July_14_06.pdf; Lisa Priest, “Province Fights Back over Paying for Colorectal Cancer Drug Avastin,” Globe
and Mail, July 15, 2006, http://www.provis.ca/pdf/9_Globe_and_Mail_July_15_06.pdf, accessed June 14, 2009.
28
John Miner, “Two-tier Dose of Reality,” London Free Press, February 18, 2008, http://www.lfpress.com/perl-bin/publish.
cgi?x=articles&p=225219&s=health, accessed June 14, 2009.
29
CBC News, “P.E.I. Passing the Buck on Drug Coverage: Family,” November 4, 2008, http://www.cbc.ca/health/story/
2008/11/03/pe-spencer-drugs.html, accessed June 14, 2009.
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PHYSICIANS
Many medical oncologists (physicians who treat cancer patients with chemotherapy) were engaged in
clinical research. In general, they wanted to have access to new drugs to improve the standard of care for
all patients and to be able to participate in clinical trials. On April 30, 2007, Dr. Jennifer Knox, a medical
oncologist from Princess Margaret Hospital in Toronto, shared her concerns about the drug funding
process during a presentation to the House of Commons (federal government) Standing Committee on
Health. In reference to kidney cancer and two new drugs, sunitinib and sorafenib, she said:
This was science fiction 10 years ago and now we have real agents. Someone is going to
get a Nobel Prize for this. Thankfully, some of the drugs that have come along first in their
class, that are what we call these anti-angiogenesis inhibitors, actually are pretty much
home runs in kidney cancer. One of my big concerns is not only with the Common Drug
Review (CDR) recommending they not be funded and provinces then following that. It’s
that, first of all, the patients are not going to get what the world considers to be a standard
of care. Our patients are no longer getting good therapy. The second issue is that as
investigators, how do we go forward, especially as Canadian investigators, in trying to ask
the next questions? How do I build on that? All the next trials are going to be about what
30
you do next.
Another medical oncologist raised concerns about the impact of drug-access issues on the ability to
participate in clinical trials. Ralph Wong, a medical oncologist at St. Boniface General Hospital in
Winnipeg, said:
Not only are we screwing our patients by not offering them the standard of care, the only
way we can make advances is by running these clinical trials. It makes us look like a Third
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World country.
Physicians played an important role by offering their opinions to the decision makers regarding the clinical
effectiveness of a new drug or an existing drug in a new indication and recommending evidence-based
provincial guidelines. Cancer agencies in most provinces in Canada had formed disease site groups
(DSGs), which included physicians with expertise in the respective disease areas. The DSGs worked in
collaboration with local pharmacists and pharmaceutical evaluation committees both to assess the cost and
value added by inclusion of a new drug to the formulary and to make recommendations. The provincial-
level experts did not compute CEA for a new drug as part of their process. However, some clinical
researchers performed a clinical impact analysis using population-based studies, and applied the data to
32
guide and support their decisions.
INDUSTRY
Pharmaceutical and biotechnology companies were increasingly interested in finding and investing in new
treatments for cancer patients. Oncology drugs were seen as a growing opportunity for these companies
30
Canada, 39th Parliament, 1st session, Standing Committee on Health, Evidence Contents, Monday, April 30, 2007,
http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=2885566&Language=E&Mode=1&Parl=
39&Ses=1, accessed June 20, 2009.
31
Lisa Priest, “Provincial Drug Disparity a Roadblock to Cancer Research,” Globe and Mail, April 7, 2009, http://www.the
globeandmail.com/servlet/story/RTGAM.20061122.wcancertrials22/BNStory/cancer/home, accessed June 20, 2009.
32
Daniel Y. C. Heng et al., “A Population-Based Study Evaluating the Impact of Sunitinib on Overall Survival in the
Treatment of Patients with Metastatic Renal Cell Cancer,” Cancer, 2009, Vol. 115, Iss. 4, pp. 776–783.
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due both to the rising incidence of cancer and the room for improving cancer outcomes. The demand for
cancer treatments was mainly the result of an increasing senior population in the developed world. In 2008,
as the developing world spent more on health care, the global market for cancer drugs was expected to
grow twice as fast as the markets for all other pharmaceuticals. Globally, cancer drug spending was
33
expected to grow between 12 and 15 per cent annually through 2012, to $75 billion to 80 billion.
Pharmaceutical companies claimed that drug development included a high risk of failure (according to one
analysis, only a few drugs of tens of thousands investigated made to the market). The pre-market projected
34
cost of a new drug development was, on average, $800 million. The pharmaceutical companies defended
the high price of new cancer drugs by referring to the high risk of attrition involved in research and
development, the innovative treatments, the high investment and the limited patent period.
In addition to pharmaceutical companies, the private players included companies managing the private
clinics that were emerging for the administration of cancer drugs. Bay Shore, a private for-profit company
had expanded its services by providing infusion of cancer drugs in the company-operated private clinics.
To some, such clinics were controversial and were seen as conflicting with the principle of equal access
under Canada’s health care system. Such private facilities were seen to be creating a two-tiered care system
35
for cancer patients; patients could purchase and receive a treatment if they could afford it.
ADVOCACY ORGANIZATIONS
Canada had several patient- and volunteer-led advocacy organizations; for example, The Colorectal Cancer
Association and The Kidney Cancer Association. A national organization, Cancer Advocacy Coalition of
Canada (CACC), was run primarily by oncology experts from different provinces. CACC published an
annual scorecard that listed cancer treatment drugs and under which provincial health plans their costs
were reimbursed. It also produced reports that attempted to correlate cancer drug access to clinical
36
outcomes across provinces. CACC had also challenged the process of decision-making with regards to
reimbursement decisions on cancer drugs.
In April 2007, Dr. William Hryniuk, past chair, Cancer Advocacy Coalition of Canada, had written in his
presentation to the House of Commons Standing Committee on Health:
Why was the CEDAC [Canadian Expert Drug Advisory Committee] committee of CDR
[Common Drug Review] unable to comprehensively evaluate oncology drugs and how
JODR (Joint Oncology Drug Review) can do better? First of all, CEDAC was not well
suited to deal with the complexity of the oncology problems presented. In the first
instance, committee members were prevented from accessing the best knowledge about
each new treatment and were therefore unable to judge data in context. It is becoming
increasingly difficult to maintain the knowledge level required to adequately judge what
is the state-of-the-art medicinal treatment in any given situation at any given time. The
investigators who actually did the clinical research establishing the drugs’ effectiveness
33
Matthew Perrone, “Global Market Expected to Drive Cancer Drug Growth,” USA Today, May 15, 2008,
http://www.usatoday.com/money/economy/2008-05-15-2197938540_x.htm, accessed June 24, 2009.
34
Christopher P. Adams and Van V. Brantner, “Estimating the Cost of a New Drug Development: Is It Really $802 Million?”
Health Affairs, 2006, Vol. 25, No. 2, http://www.content.healthaffairs.org/cgi/reprint/25/2/420, accessed June 24, 2009.
35
Lisa Priest, “Clinics Let Cancer Patients Purchase Treatment,” Globe and Mail, April 7, 2009, http://www.theglobeand
mail.com/servlet/story/RTGAM.20061208.wcancer08/BNStory/specialComment/?pageRequested=al, accessed June 24,
2009.
36
Cancer Advocacy Coalition of Canada, “Report Card on Cancer in Canada,” http://www.canceradvocacy.ca/, accessed
June 20, 2009.
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in the applications before CEDAC arguably best hold the requisite knowledge applying
to each unique situation. Yet CEDAC has been prohibited from accessing the detailed
knowledge of these investigators. As I understand it, this prohibition was based on the
premise that the judgment, and therefore the advice, of such investigators would be
tainted by their affinity for the trial results or their affiliation with the drug company who
sponsored the trial showing the drug was effective. After all, the investigators are
physicians who not only have the requisite knowledge to place the treatment results in
proper context, it is safe to assume they also have the interests of their patients at heart
and the commitment to improve treatment for their patients. Otherwise they would not
37
have done the study in the first place”
According to the cancer report card published by CACC in 2008:
Two-tier medicine had arrived in Canada, with a person’s access to new cancer drugs often
dependent on their private insurance coverage. Of the 18 new cancer drugs available,
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Ontario had approved only seven for public funding.
GROWING DEMAND ON PROVINCIAL ONCOLOGY DRUG PLANS
According to a report published by CACC, in 2007, the total extrapolated cost of cancer drugs in all 10
provinces of Canada was approximately $1.1 billion. A significant portion of this cost comprised take-
39
home cancer drugs (THCD), which accounted for approximately 50 per cent of the overall expenditure.
THCDs were reported to be increasing as a proportion of all cancer drugs because of the ability of many
effective cancer drugs to be administered orally.
The provincial cancer agencies were facing an increasing financial burden on the cancer care systems.
According to Dr. Susan O’Reilly, vice president, Cancer Care of the British Columbia Cancer Agency, the
number of patients receiving active cancer drugs was increasing at 7 per cent per annum, and cancer drug
expenditures were increasing at the rate of 20 to 30 per cent per annum. In some provinces, the oncology
40
drug budgets accounted for approximately 25 per cent of total operating costs of the cancer agencies. In
2006, Cancer Care Manitoba demanded $12 million a year from the Manitoba government to cover
expensive, breakthrough cancer drugs. This request was in addition to Manitoba’s existing drug budget of
41
$7.7 million. In fiscal year 2000/01, Cancer Care Ontario’s New Drug Funding Program (NDFP) made
14 intravenous drugs available for 24 indications for a total provincial expenditure of approximately $37.7
42
million. In 2007, NDFP funding had grown to 27,000 intravenous chemotherapy injections at a cost of
37
Canada, 39th Parliament, 1st session, Standing Committee on Health, Evidence Contents, Monday, April 30, 2007,
http://www2.parl.gc.ca/HousePublications/Publication.aspx?DocId=2885566&Language=E&Mode=1&Parl=39&Ses=1,
accessed June 20, 2009.
38
Cancer report card: Available from: http://www.canceradvocacy.ca/reportcard/2008/reportcard-2008.pdf, accessed June
24, 2009.
39
Kong Khoo et al., “The Cost of Cancer Drugs in Canada: Part 2—Who Is Bearing the Cost?” http://www.cancer
advocacy.ca/reportcard/2008/The%20Cost%20of%20Cancer%20Drugs,%20Part%202.pdf, accessed June 24, 2009.
40
Susan O’Reilly, “Planning for Cancer Drugs: The BCCA Provincial Cancer Drug Budget in 21st Century,” PowerPoint
Presentation, http://www.bccancer.bc.ca/NR/rdonlyres/02314BDF-D758-49C3-A79C-01A9FD1E521C/1942/Planningfor
CancerDrugs.ppt, accessed June 24, 2009.
41
Government of Manitoba, “Manitoba Announces $13.3 Million Increase in Funding for Cancer Drugs,” press release, May
19, 2006, http://www.gov.mb.ca/chc/press/top/2006/05/2006-05-19-01.html, accessed June 24, 2009.
42
Alan Hudson, “Building on Our Foundations: First Annual Address—Dr. Alan Hudson, President and CEO, Cancer Care
Ontario, Ontario CCO Spending on Cancer Drugs in 2000/2001, http://www.cancercare.on.ca/pdf/stateoftheunion.pdf ,
Page 10 9B09E020
$176 million and was expected to grow to 49,000 intravenous injections at a cost of $446 million in 2011.
This funding did not cover oral cancer drugs, supportive care drugs or the drugs provided through private
43
insurance drug plans.
The payers were becoming increasingly concerned due to the rising drug costs for cancer patients. Terry
Sullivan, president of Cancer Care Ontario, said:
The decision about whether a province would pay for new cancer drugs was made by a
panel of health professionals, not bureaucrats or politicians. In evaluating a drug, the
Ontario panel weighs the cost with the medical benefit, including looking at the life years
gained. It is very difficult when a patient wants a drug and the drug isn’t paid for publicly.
But the line has to be drawn somewhere. All the new cancer drugs are very expensive, he
said. Some of these drugs are $150,000 per life-year gained. Our process in Ontario is a
good one, it is a sound one and it's based on good evidence and the cost effectiveness of
these drugs.44
Cancer Care Ontario estimated that 3,000 patients were seeking Avastin in 2008, at a cost of $40,000 per
45
treatment, noting that this medication alone could add as much as $120 million to the drug budget.
Because new drugs were in the pipeline for various cancers, and multiple indications were under
development for existing drugs, such as Avastin, the improving standard of care would likely further strain
the health care budget. This situation raised important issues regarding the long-term sustainability of the
Canadian health care system and the dilemma facing the payers.
INTERNATIONAL PERSPECTIVE AND COMPARISON
When comparing 20 countries in the Organisation for Economic Co-operation and Development (OECD),
the United States had the highest level of 2005 per capita drug spending ($988), followed by Canada
($735), a similar result to previous years. In 2005, Canada was below the OECD median in terms of the
proportion of total drug spending that was publicly financed.46 The percentage of the public drug spending
on cancer treatments across various OECD countries was unknown.
In Europe, some drug companies had proposed innovative methods for payment for their cancer drugs, a
practice known as risk-sharing agreements. Although new to oncology drugs, risk-sharing deals had been
47
in place for some drugs used to treat multiple sclerosis. In 2007, Janssen-Cilag, a Johnson & Johnson
group company, entered a risk-sharing agreement with the National Health Service (NHS) in the United
48
Kingdom with regards to its cancer drug bortezomib (tradename Velcade). The United Kingdom’s
43
Cancer Care Ontario, “Outlook for Cancer in Ontario,” http://www.cancercare.on.ca/cms/one.aspx?pageId=14537,
accessed on June 24, 2009.
44
John Miner, “Two-tier Dose of Reality,” London Free Press, February 18, 2008, http://www.lfpress.com/perl-
bin/publish.cgi?x=articles&p=225219&s=health, accessed June 14, 2009.
45
Robert Benzie, “$50M Earmarked for Cancer Drugs,” Toronto Star, July 2, 2008, http://www.thestar.com/article/452457,
46
OECD, “Executive Summary,” Pharmaceutical Pricing Policies in a Global Market, http://www.oecd.org/dataoecd/36/2/
41303903.pdf, accessed June 24, 2009; OECD, “Trend Growth in Pharmaceutical and Total Health Expenditure for 15
OECD Countries, and GDP, 1980–2005,” http://www.oecd.org/dataoecd/20/62/41566396.pdf, accessed June 24, 2009.
47
Mark Pickin et al., “The Multiple Sclerosis Risk Sharing Scheme Monitoring Study — Early Results and Lessons for the
Future,” BMC Neurology, January 2009, http://www.biomedcentral.com/content/pdf/1471-2377-9-1.pdf, accessed June 30,
2009.
48
Andrew Pollack, “Pricing Pills by Results,” New York Times, July 14, 2007, http://www.nytimes.com/2007/07/14/business/
14drugprice.html, accessed July 10, 2009.
Page 11 9B09E020
National Institute for Health and Clinical Excellence (NICE) had earlier rejected the drug on the grounds
of it not being cost-effective. According to the proposal, the company would refund the money to patients
who did not respond to the drug, and NHS would thus pay only for patients who demonstrated a complete
or partial response to treatment. Partial response was defined as reduction in the load of M-protein in
serum by 50 per cent or more, after four cycles of treatment with bortezomib monotherapy. Under this
arrangement, all patients would be eligible to receive their first four cycles of treatment with bortezomib
(the cost of four cycles was approximately US$24,000), and use of the drug would be discontinued for
49
those patients who did not respond to the treatment. When used for patients with first relapse, the cost-
effectiveness analysis data submitted by the manufacturer revealed a base-case cost of £31,000 per life
year gained or £38,000 per QALY. NICE’s final guidance was included only for patients receiving
bortezomib on first relapse. This pay-for-performance proposal was not without criticism, and some
experts opined that stopping bortezomib would be unfair for patients who demonstrated minor response but
who did not meet the criteria laid out by the government. When sunitinib (trade name Sutent) was
approved by NICE in February 2009 for treatment of metastatic renal cell cancer, the manufacturer Pfizer
had reportedly agreed to pay for the first six-week cycle of treatment, and NHS would pay for the balance
50
of the treatment.
NICE had been at the center of controversy due to its decisions to advise NHS not to pay for certain cancer
drugs on the grounds of cost-effectiveness. In response to criticism by top cancer experts in the United
Kingdom, NICE Chief Executive Andrew Dillon and Sir Michael Rawlins, the chairman of NICE said:
There is a finite pot of money for the NHS, which is determined annually by parliament. If
one group of patients is provided with cost-ineffective care, other groups — lacking
powerful lobbyists — will be denied cost-effective care for miserable conditions like
51
schizophrenia, Crohn’s disease or cystic fibrosis.
In the United States too, the regulatory environment for approval of new cancer treatments had become
much more challenging compared with the situation in the past. After the emergence of technologies with
novel mechanism of action, opinions differed on the evaluation of clinical efficacy. In 2007, the agency
denied approval of Dendreon’s prostate cancer vaccine Provenge, despite an overwhelmingly positive
review by the agency’s outside advisors (the FDA always retains the right on final decision irrespective of
the advisors’ opinion). The decision by the FDA followed a challenge to the advisory panel’s
recommendations in the case by two experts, and the result was overwhelming protests from patients and
52
advocacy groups. This case was unique because the initial clinical trial pursued time to treatment
progression (TTP) as the primary end point although some experts had argued that overall survival was the
more appropriate end point. The initial trial missed the primary end point but instead demonstrated
significant difference in overall survival. The FDA recommended the need for additional clinical data to
prove beyond doubt that the vaccine added a definite survival benefit. Dendreon had initiated a 512-patient
53
phase-3 study with overall survival being the primary end point. This case highlighted the complexity
49
National Institute for Health and Clinical Excellence, “NICE Guidance on Bortezomib Monotherapy for Relapsed Multiple
Myeloma,” http://www.nice.org.uk/nicemedia/pdf/TA129Guidance.pdf, accessed July 10, 2009.
50
Kate Devlin, “Kidney Cancer Patients Should Get Sutent on the NHS, says NICE,” The Telegraph, February 4, 2009,
http://www.telegraph.co.uk/health/healthnews/4449605/Kidney-cancer-patients-should-get-Sutent-on-the-NHS-says-
NICE.html, accessed on July 10, 2009.
51
Sarah-Kate Templeton, “Top Doctors Slam NHS Drug Rationing,” Sunday Times, August 24, 2008, http://www.timesonline
.co.uk/tol/life_and_style/health/article4597174.ece, accessed July 10, 2009.
52
Mike Huckman, “Dendreon’s Saga over Provenge ’Edited Up’ a Notch,” Pharma’s Market, http://www.cnbc.com/id/
22609898/site/14081545, accessed July 10, 2009.
53
Bruce Goldman and Laura DeFrancesco, “The Cancer Vaccine Roller Coaster,” Nature Biotechnology, 27, 129–139
(2009)doi:10.1038/nbt0209-129.
Page 12 9B09E020
involved in the evaluation of new cancer treatments and the potential impact of the choice of end points
when cost-effectiveness was evaluated as part of regulatory approval and market authorization. A rigorous
regulatory process by agencies such as the FDA or Health Canada ensured the highest standards of safety
and efficacy for the new drugs when compared with the existing standard of care. However, the
requirement of more clinical trials and increasing numbers of subjects required to have a robust clinical
trial design with adequate sample size, would add to the cost of drug development, shortening the period of
market-exclusivity.
THE CHALLENGE
Under growing pressure from patients, physicians, advocacy organizations and pharmaceutical companies,
payers and drug plans needed to use their limited budget with due diligence because they were responsible
for addressing the needs of patients across all therapeutic areas, one of which was oncology. The high cost
of new oncology drugs focused attention on cost-effectiveness analysis and the large number of
government bodies assigned to evaluate it. JODR was still a pilot process, and its long-term direction
remained uncertain. The bio-pharmaceutical industry demanded incentives for developing innovations in
treating difficult diseases such as cancer and, in some cases, had been amenable to adopting different forms
of risk-sharing agreements with publicly funded drug plans. The issue of CEA review and optimal access
to cancer drugs would become more important with time as new and more expensive drugs and
technologies were brought to market. Many feared that the private insurance would also not be able to
compensate for gaps in the coverage of new cancer drugs. Whether the public versus private payment for
cancer drugs would change in the future remained uncertain. How would the provincial governments and
cancer care agencies deal with this situation in years to come and continue to maintain the sustainability of
the publicly funded Medicare plans — and eventually the health care system — without compromising the
standards of care?
Page 13 9B09E020
Exhibit 1
STAKEHOLDERS INVOLVED IN CANCER DRUG REVIEW AND ACCESS
Decision Makers (government-based)

Health Canada: reviews evidence and provide notice of
compliance (NOC) or notice of compliance with conditions
(NOCc)
Patented Medicine Prices Review Board (PMPRB): sets
maximum price of patented medicines
Canadian Expert Drug Advisory Committee (CEDAC):
provides cost-effectiveness analysis
JODR: reviews evidence and cost-effectiveness
Provincial Cancer Agencies: provides final reimbursement
decision
Hospital pharmacies: provides final listing of drugs
Industry-Manufacturer
Physicians
Pharmaceutical/ Biotech
Evidence-based medicine
New Drug Development and
Clinical efficacy important
Marketing
Advocacy Industry and Private

Patients-run advocacy groups Insurance
Cancer Advocacy Coalition of Employer-provided plans
Canada Personal plans
Media Patients
Providing voice to the all Patients themselves
stakeholders Patients’ families
Page 14 9B09E020
Exhibit 2
SUB-FRAMEWORK FOR GOVERNMENT BODIES INVOLVED IN THE PROCESS OF ONCOLOGY

DRUG REVIEW AND ACCESS
Health Canada
Reviews the clinical trial data and other scientific information
submitted by the manufacturer
Grants notice of compliance (NOC)
or notice of compliance with conditions (NOCc)
Patented Medicine Prices Review Board (PMPRB)

Regulates the price of each patented drug (both prescription and
nonprescription), including each strength of each dosage form
Common Drug Review-Canadian Expert Drug

Advisory Committee/Joint Oncology Drug Review
(CDR-CEDAC/JODR)
Makes recommendations to each of the participating federal
and provincial, or territorial, publicly funded drug plans
regarding the listings on their formularies. The
recommendations are evidence-based; based on clinical,
scientific and cost-effectiveness analyses.
Provincial Cancer Agencies/ Boards

Review clinical and scientific data, take into consideration
CEDAC’s/ JODR’s recommendations but make their own
decisions (Quebec follows its own drug-review system after
receiving an NOC or NOCc from Health Canada for a new
drug or a new indication)
Drug Listed on Hospital Formularies or Employer- Drug Not Listed on Hospital Formularies, and
Paid Insurance Private Coverage Not Available
Based on provincial cancer agency’s or hospital board’s Province or a hospital decides not to list a drug on its
decisions, hospitals list drugs in their formularies. Some formularies.
hospitals have an independent process for listing drugs on Patient does not have a private drug coverage plan that would
formularies; thus, variations may occur across hospitals in the cover the drug.
same province.
Patient Receives New Treatment Options

Patients receive a listed drug from the hospital formulary. Self-pay for new treatment
The drug is either paid for by the province or is under a Enroll as a participant in clinical trials
co-pay agreement with a private insurance program. Receive existing standard of care
No treatment
Page 15 9B09E020
Exhibit 3
CANCER DRUGS REVIEWED BY THE COMMITTEE TO EVALUATE DRUGS-CANCER CARE

1
ONTARIO SINCE FORMATION OF JOINT ONCOLOGY DRUG REVIEW
Drug Trade Disease/ Condition Cost of a Decision

Name Course of
(Generic Name) Treatment
Gleevec Chronic myeloid $3,070– Listed on the Ontario

(imatinib) leukemia (CML) $4,605 Drug Benefit (ODB)
formulary
Gleevec Gastrointestinal stromal $3,600 Funded through
(imatinib) tumor (GIST) Exceptional Access
Program (EAP)
Taxol (paclitaxel) Recurrent ovarian Funded through Cancer
cancer Care Ontario’s (CCO’s)
New Drug Funding
Program (NDFP)
Sutent (sunitinib) GIST $7,000/ 6- Funded through EAP
week cycle
Sutent (sunitinib) Metastatic renal cell $6,950/ 6- Funded through EAP
cancer (MRCC) week cycle
Xeloda Gastric cancer No funding
(capecitabine)
Nexavar MRCC $5,200 Funded through EAP
(sorafenib)
Sprycel CML $137– Funded through EAP
(dasatinib) $151/ day
Nexavar Hepatocellular cancer $175/day Funded through EAP
(sorafenib) (HCC)
Vectibix Metastatic colorectal $2,500– Funded through CCO’s
(panitumumab) cancer (MCRC) 3,000 NDFP
Source: Ontario Ministry of Health and Long-Term Care, “EO and CED Decisions,” available from:
http://www.health.gov.on.ca/english/providers/program/drugs/ced_rec_table.html (accessed on July 10, 2009).
1
The CED (Committee to Evaluate Drugs)/CCO (Cancer Care Ontario) subcommittee reviews, evaluates and provides
advice to the CED on the cancer products that should be made available through either the Ontario Drug Benefit (ODP)
program or the New Drug Funding Program (NDFP). The CED then makes a final recommendation to the Executive Officer.
This subcommittee aligns the review processes to allow for consistency in approach for cancer drugs under ODB and
NDFP. Source: Ontario Ministry of Health and Long-Term Care, “How Drugs Are Approved: Funding Decisions,”
http://www.health.gov.on.ca/english/providers/program/drugs/how_drugs_approv/funding_cco.html, accessed on July 5,
2009.
Page 16 9B09E020
Exhibit 4
COMPARISON OF COST AND QUALITY OF ADJUSTED LIFE YEAR (QALY) OF SOME CANCER
DRUGS AS DETERMINED BY CANADIAN EXPERT DRUG ADVISORY COMMITTEE (CEDAC) AND
NATIONAL INSTITUTE FOR HEALTH AND CLINICAL EXCELLENCE (NICE)
DrugTrade Name Company Disease/ Condition National Institutes Canadian Expert Drug
(Generic Name) for Health and Advisory Committee
Clinical Excellence1 (manufacturer)2
(manufacturer) Cost/Quality Adjusted
Cost/Quality Life Year gained
Adjusted Life Year (in Cdn$000)
Gained
(in £000)
Avastin Roche Metastatic colorectal 63 (88)
(bevacizumab) cancer
Nexavar (sorafenib) Bayer Metastatic renal cell 103 (91) 78 (36) per Life Year
cancer Gained3
Sutent (sunitinib) Pfizer Metastatic renal cell 72 (29) (56)4

cancer (42) per Life Year Gained
Sutent (sunitinib) Pfizer Gastrointestinal (80)5

stromal tumours
Erbitux (cetuximab) Imclone/ Metatstatic colorectal >30 (33)

BMS cancer
(1st line)
Tykerb (lapatinib) GSK Metastatic breast 70-94 (81)
cancer
Tarceva (erlotinib) Roche Metastatic lung cancer (71) per LYG6
1
Source: James Raftery, “NICE and the Challenge of Cancer Drugs,” BMJ, 2009, 338:b67, pp. 271–272.
2
In Canada, the cost-effectiveness analysis (CEA) was submitted by the manufacturer and assessed by the Canadian
Expert Drug Advisory Committee (CEDAC). CEDAC did not conduct any incremental cost-efficiency ratios (ICER) or
incremental cost-utility ratio (ICUR) computation.
3
Canadian Agency for Drugs and Technologies in Health, “CEDAC Final Recommendation on Reconsideration and
Reasons for Rrecommendation: Sorafenib for Locally Advanced and Metastatic Renal Cell Cancer,”
http://www.cadth.ca/media/cdr/complete/cdr_complete_Nexavar_Fe-28-07.pdf, accessed July 10, 2009.
4
Reasons for Recommendation: Sunitinib Malate,” http://www.cadth.ca/media/cdr/complete/cdr_complete_Sutent_e_April-26-
2007%20.pdf, accessed July 10, 2009.
5
Reasons for Recommendation: Sunitinib,” http://www.cadth.ca/media/cdr/complete/cdr_complete_Sutent_March-28-07.pdf,
accessed July 10, 2009.
6
Reasons for Recommendation: Erlotinib,” http://www.cadth.ca/media/cdr/complete/cdr_complete_Tarceva_Dec605.pdf,
accessed July 10, 2009.
Page 17 9B09E020
Appendix 1
COST-EFFECTIVENESS ANALYSIS (CEA)
The cost-effectiveness analysis (CEA) of health technologies is a comparative evaluation of the relative
costs versus benefits or outcomes of two or more alternative drugs or technologies. The incremental cost-
efficiency ratio (ICER) is defined by the following equation:
Expenditure New Technology

− Expenditure
ExistingStandard of Care ΔE
ICER = =
Health Benefit New Technology
− Health Benefit
ExistingStandard of Care
ΔH
The ICER is a measure of the incremental cost (ΔE) associated with adoption of a new health technology
per unit of incremental health benefit (ΔH) associated with the adoption of a new health technology. The
absolute measure of health benefit varies by health or disease condition and the type of technology used.
The preferred measure of health benefit is Quality Adjusted Life Year (QALY). A QALY places a weight
on time in different health states. QALYs are life years that have been scaled between 0 (representing
death) and 1 (representing perfect health) according to the utility associated with the health state.1 QALY
offers a common measure to evaluate the health benefits added by different health technologies with
regards to health-related quality of life and life years gained or survival. ICER is referred to as incremental
cost-utility ratio (ICUR) when it is possible to evaluate incremental health benefit in terms of QALYs
gained.
In reviewing CEA and making recommendations, a willingness to pay (WTP) threshold was followed in
some countries. In Canada, one suggested WTP ranged from an ICER of $20,000/QALY (a favorable
value for adoption of a new health technology), to $100,000/QALY (an unfavorable value for adoption).
Values between $20,000/QALY and $100,000/QALY require decisions by the payers based on judgment.2
In comparison, in the United Kingdom, an implied threshold of £30,000/QALY has been reportedly
followed by National Health Service (NHS).3 Thresholds of $50,000/QALY or $100,000/QALY were
commonly quoted in U.S. analyses. A variation was often noted between the ICUR submitted by a
manufacturer and the ICUR computed by the National Institute for Health and Clinical Excellence (NICE)
in the United Kingdom (see Exhibit 4).4
1
Robert M. Kaplan, “Utility Assessment for Estimating Quality-Adjusted Life Years,” in Valuing Health Care: Costs, Benefits,
and Effectiveness of Pharmaceuticals and Other Medical Technologies, Frank A. Sloan, editor, Cambridge University Press,
Cambridge, UK, 1995, pp. 31–60.
2
Andreas Laupacis et al., “How Attractive Does a New Technology Have to Be to Warrant Adoption and Utilization?
Tentative Guidelines for Using Clinical and Economic Evaluations,” Canadian Medical Association Journal, 1992, Vol. 146,
No. 4, pp. 473–481.
3
Nancy Devlin and David Parkin, “Does NICE Have a Cost-Effectiveness Threshold and What Other Factors Influence Its
Decisions? A Binary Choice Analysis,” Health Economics, 2004. Vol. 13, No. 5, pp. 437–452.
4
James Raftery, “NICE and the Challenge of Cancer Drugs,” BMJ, January 31, 2009, Vol. 338, pp. 271–272,
http://www.bmj.com/cgi/section_pdf/338/jan13_1/b67.pdf, accessed June 20, 2009.

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THE CHALLENGE OF ACCESS TO ONCOLOGY DRUGS IN CANADA

Copyright © 2009, Ivey Management Services Version: (A) 2009-12-01

THE DRUG REVIEW PROCESS IN CANADA

Patented Medicine Prices Review Board (PMPRB)

Canadian Agency for Drugs and Technologies in Health (CADTH)20

Formation of the Joint Oncology Drug Review (JODR) Process

According to the cancer report card published by CACC in 2008:

GROWING DEMAND ON PROVINCIAL ONCOLOGY DRUG PLANS

INTERNATIONAL PERSPECTIVE AND COMPARISON

STAKEHOLDERS INVOLVED IN CANCER DRUG REVIEW AND ACCESS

Decision Makers (government-based)

Advocacy Industry and Private

SUB-FRAMEWORK FOR GOVERNMENT BODIES INVOLVED IN THE PROCESS OF ONCOLOGY

Patented Medicine Prices Review Board (PMPRB)

Common Drug Review-Canadian Expert Drug

Provincial Cancer Agencies/ Boards

Patient Receives New Treatment Options

CANCER DRUGS REVIEWED BY THE COMMITTEE TO EVALUATE DRUGS-CANCER CARE

Drug Trade Disease/ Condition Cost of a Decision

Gleevec Chronic myeloid $3,070– Listed on the Ontario

Sutent (sunitinib) Pfizer Metastatic renal cell 72 (29) (56)4

Sutent (sunitinib) Pfizer Gastrointestinal (80)5

Erbitux (cetuximab) Imclone/ Metatstatic colorectal >30 (33)

Tarceva (erlotinib) Roche Metastatic lung cancer (71) per LYG6

COST-EFFECTIVENESS ANALYSIS (CEA)

Expenditure New Technology

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