Don’t miss our upcoming webinars. Subscribe today! About this webinar: In this webinar, presented by Dr. David J. Stewart, MD, we will discuss Why Cancer Still Sucks and So Does Access to Treatment in Canada. About the presenter: Dr. Stewart trained in medical oncology in the Department of Developmental Therapeutics at MD Anderson Cancer Centre in Houston, Texas, 1976-1978. He was on staff at MD Anderson from 1978 to 1980, then in Ottawa from 1980 to 2003, and back at MD Anderson in the Department of Thoracic/Head and Neck Medical Oncology from 2003 to 2011. He returned to Ottawa in 2011 and served as Head of the Division of Medical Oncology in Ottawa from 2011 to 2019. His areas of research have included (among others) resistance mechanisms to anticancer agents and resistance modulation; pharmacology and pharmacogenetics of platinums and other anticancer agents; new drug development and predictive biomarkers in lung cancer; the negative impact of dysfunctional regulation and clinical trial designs on the rate of clinical research progress; and the huge costs of this clinical research dysfunction in terms of increased healthcare costs and in terms of lives prematurely lost. He has published more than 340 peer-reviewed publications. He has also published several Op Eds in the lay press dealing predominantly with patient access to care, including an opinion piece published in the Ottawa Citizen 2022/06/21 (https://ottawacitizen.com/opinion/ste... canadas-response-to-it.) In April 2022 he also published A Short Primer on Why Cancer Still Sucks, intended for patients and the general public. It is available through Amazon books or his website, https://whycancerstillsucks.com/. View the Video: https://bit.ly/drdavidstewartwebinaronyoutube Follow CCSN on social media: Twitter - https://twitter.com/survivornetca Facebook - https://www.facebook.com/CanadianSurv... Instagram: https://www.instagram.com/survivornet... Pinterest - https://www.pinterest.com/survivornet...

1. Why Cancer Still Sucks, and So Does
Access to Treatment in Canada
David J Stewart, MD
Division of Medical Oncology
The Ottawa Hospital and University of Ottawa
https://whycancerstillsucks.com/
https://lifesavingtherapies.com/

2. Disclosures
• My approximate average annual income:
– 98.5% from government
– 1.3% from consulting for drug companies
– 0.1% from a patent on a test for a gene therapy
– 0.1% from completing insurance forms
• I will be collecting royalties (shared with
charities) on a cancer book that is aimed at
patients

3. Available online: https://whycancerstillsucks.com/ or Amazon books

4. Planned free distribution
- Decision Makers:
- Canadian MPs
- Canadian Senators
- Ontario MPPs
- Other selected Canadian and US opinion leaders

6. Dealing with the Deluge
• Cancer will at some point affect
– 49% of all Canadian males
– 45% of all Canadian females
• Causes 25-30% of all deaths

7. Age and cancer
• Body has:
– ~37 trillion cells
– ~100 billion cell divisions per day
– ~ 3 mutations / cell division = ~300 billion mutations /day:
• Most are repaired or are unimportant
• But some can contribute to cancer
• The more mutations you have, the higher the risk
– More mutations from getting one day older
– More mutations from damaging factors

8. Age and cancer
• Body has:
– ~37 trillion cells
– ~100 billion cell divisions per day
– ~ 3 mutations / cell division = ~300 billion mutations /day:
• Most are repaired or are unimportant
• But some can contribute to cancer
• The more mutations you have, the higher the risk
– More mutations from getting one day older
– More mutations from damaging factors

9. Age and cancer
• Body has:
– ~37 trillion cells
– ~100 billion cell divisions per day
– ~ 3 mutations / cell division = ~300 billion mutations /day:
• Most are repaired or are unimportant
• But some can contribute to cancer
• The more mutations you have, the higher the risk
– More mutations from getting one day older
– More mutations from damaging factors

10. Age and cancer
• Body has:
– ~37 trillion cells
– ~100 billion cell divisions per day
– ~ 3 mutations / cell division = ~300 billion mutations /day:
• Most are repaired or are unimportant
• But some can contribute to cancer
• The more mutations you have, the higher the risk
– More mutations from getting one day older
– More mutations from damaging factors

11. Factors that increase cancer risk
• Anything that increases mutations:
– Smoking
– Sun / radiation exposure
– Alcohol
– Processed foods
– Inflammation / overweight
– Beef, veal, lamb, not chicken, fish, pork
– Diets low in fruits and vegetables (vitamins do not explain)
• Anything that increases number of cell divisions:
– High calorie intake / overweight
– Hormonal drivers of cell division:
• Insulin / Insulin-like growth factor
• Estrogen, etc

12. Factors that increase cancer risk
• Anything that increases mutations:
– Smoking
– Sun / radiation exposure
– Alcohol
– Processed foods
– Inflammation / overweight
– Beef, veal, lamb, not chicken, fish, pork
– Diets low in fruits and vegetables (vitamins do not explain)
• Anything that increases number of cell divisions:
– High calorie intake / overweight
– Hormonal drivers of cell division:
• Insulin / Insulin-like growth factor
• Estrogen, etc

14. -Why screening does not work better
-Why it works much better in high-risk vs low-risk people

23. Chapters 11-14: Issues with Access
• Issues with:
– Drug development
– Drug approval
– Drug costs and funding
– Diagnostic and therapy resources

29. -Issues with drug discovery and development

30. Life-years lost worldwide per year delay in drug approval
Life-years lost worldwide per year
For every year of approval delay:
- 80,000 life-years lost per drug
- 1 for every 7 minutes delay
Stewart . Cancer Med. 2018;7:1824

31. High cost of caution
• Time from discovery to approval for new
effective drug:
– 12 years (average) if randomized clinical trial
required
– 4-6 years with “breakthrough therapy” designation

32. High cost of caution
• Time from discovery to approval for new
effective drug:
– 12 years (average) if randomized clinical trial
required
– 4-6 years with “breakthrough therapy” designation

33. Life-years lost worldwide from patent application to approval
Life-years lost worldwide
Life-years lost per drug from
discovery to approval (median):
- 1,000,000
Stewart . Cancer Med. 2018;7:1824

34. Publication of data on life-years lost
due to delays
• Paper declined by 8 journals before #9 accepted it
• Reviewers’ comments:
– “The losses are so huge that this cannot possibly be true”:
but anyone can calculate it using readily-available public
data
– “It makes no difference since we can not fix the problem
even if we know about it.”
– “It makes no difference since so few patients worldwide
would be able to afford them, even if they were
approved.”

35. Publication of data on life-years lost
due to delays
• Paper declined by 8 journals before #9 accepted it
• Reviewers’ comments:
– “The losses are so huge that this cannot possibly be true”:
but anyone can calculate it using readily-available public
data
– “It makes no difference since we can not fix the problem
even if we know about it.”
– “It makes no difference since so few patients worldwide
would be able to afford them, even if they were
approved.”

36. Publication of data on life-years lost
due to delays
• Paper declined by 8 journals before #9 accepted it
• Reviewers’ comments:
– “The losses are so huge that this cannot possibly be true”:
but anyone can calculate it using readily-available public
data
– “It makes no difference since we can not fix the problem
even if we know about it.”
– “It makes no difference since so few patients worldwide
would be able to afford them, even if they were
approved.”

37. Publication of data on life-years lost
due to delays
• Paper declined by 8 journals before #9 accepted it
• Reviewers’ comments:
– “The losses are so huge that this cannot possibly be true”:
but anyone can calculate it using readily-available public
data
– “It makes no difference since we can not fix the problem
even if we know about it.”
– “It makes no difference since so few patients worldwide
would be able to afford them, even if they were
approved.”

38. Op Eds in lay press on approval delays
• Several submitted, but declined
• Globe and Mail finally accepted, but absolutely no reaction
• Stalin: “If one man dies it’s a tragedy. When thousands die, it’s
statistics.”

39. Op Eds in lay press on approval delays
• Several submitted, but declined
• Globe and Mail finally accepted, but absolutely no reaction
• Stalin: “If one man dies it’s a tragedy. When thousands die, it’s
statistics.”

40. Op Eds in lay press on approval delays
• Several submitted, but declined
• Globe and Mail finally accepted, but absolutely no reaction
• Stalin: “If one man dies it’s a tragedy. When thousands die, it’s
statistics.”

42. Speedbumps on the Autobahn
• There have been numerous problems with clinical research and new drug
development: ethics / human rights/ safety/ data integrity
Regulation is essential!
• Thousands of speedbumps on the research highway:
– Markedly slow progress
• Increase research costs: hence increase drug costs
• Costs thousands of lives due to delays in access
– There has been little attempt to:
• Quantitate their costs
• Consider more efficient, less costly alternatives
– This chapter is a call to action on problems & alternatives

43. Speedbumps on the Autobahn
• There have been numerous problems with clinical research and new drug
development: ethics / human rights/ safety/ data integrity
Regulation is essential!
• Thousands of speedbumps on the research highway:
– Markedly slow progress
• Increase research costs: hence increase drug costs
• Costs thousands of lives due to delays in access
– There has been little attempt to:
• Quantitate their costs
• Consider more efficient, less costly alternatives
– This chapter is a call to action on problems & alternatives

44. Speedbumps on the Autobahn
• There have been numerous problems with clinical research and new drug
development: ethics / human rights/ safety/ data integrity
Regulation is essential!
• Thousands of speedbumps on the research highway:
– Markedly slow progress
• Increase research costs: hence increase drug costs
• Costs thousands of lives due to delays in access
– There has been little attempt to:
• Quantitate their costs
• Consider more efficient, less costly alternatives
– This chapter is a call to action on problems & alternatives

45. Speedbumps on the Autobahn
• There have been numerous problems with clinical research and new drug
development: ethics / human rights/ safety/ data integrity
Regulation is essential!
• Thousands of speedbumps on the research highway:
– Markedly slow progress
• Increase research costs: hence increase drug costs
• Costs thousands of lives due to delays in access
– There has been little attempt to:
• Quantitate their costs
• Consider more efficient, less costly alternatives
– This chapter is a call to action on problems & alternatives

46. Speedbumps on the Autobahn
• There have been numerous problems with clinical research and new drug
development: ethics / human rights/ safety/ data integrity
Regulation is essential!
• Thousands of speedbumps on the research highway:
– Markedly slow progress
• Increase research costs: hence increase drug costs
• Costs thousands of lives due to delays in access
– There has been little attempt to:
• Quantitate their costs
• Consider more efficient, less costly alternatives
– This chapter is a call to action on problems & alternatives

47. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

48. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

49. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

50. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

51. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

52. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

53. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

54. Years
1.1%
37%
41,600
200,000
1
12
- If it only takes one year to develop a
Covid vaccine, then cancer drug
development should be much faster
than it is
- The regulatory framework must
change
12

56. The number of effective, approved new anticancer drugs
is rising rapidly
https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf: EMA data

57. As number of drugs increases, the
price per drug is also exploding
Median
$90,000

58. As number of drugs increases, the
price per drug is also exploding
Median
$178,000

59. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

60. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

61. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

62. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

63. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

64. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

65. Factors driving rapidly escalating drug prices
• Drug development costs: rising much faster than inflation:
– 1962: $4 million
– 1987: $231 million
– 2013: $2.9 billion
• High development costs limit competition
• Short patent protection (8-year average)
• High failure rate:
– 92-97% of drugs entering trials fail to be approved
• Personalization of therapies:
– must recoup much higher development costs from sales for far fewer
patients
• “Distortion of market forces”
• Pharmaceutical company profits

66. High pharmaceutical company profits:
a double-edged sword
High price
High profits
High investment
Rapid progress

67. High pharmaceutical company profits:
a double-edged sword
High price
High profits
High investment
Rapid progress

68. High pharmaceutical company profits:
a double-edged sword
High price
High profits
High investment
Rapid progress

69. The number of effective, approved new anticancer drugs
is rising rapidly
https://www.oecd.org/health/health-systems/Addressing-Challenges-in-Access-to-Oncology-Medicines-Analytical-Report.pdf: EMA data

70. High pharmaceutical company profits:
a double-edged sword
High price
High profits
High investment
Rapid progress

71. High pharmaceutical company profits:
a double-edged sword
High price
High profits
High investment
Rapid progress
- We need solutions to high prices that do not gut the
profits that drive progress!

72. Solutions
• Two major camps:
– Government price controls
– “Restore market forces”

73. Solutions
• Two major camps:
– Government price controls: usually fail by creating:
• Shortages
• End runs & “special considerations”:
– Drive prices up rather than down
– “Restore market forces”

74. Solutions
• Two major camps:
– Government price controls: usually fail by creating:
• Shortages
• End runs & “special considerations”:
– Drive prices up rather than down
– “Restore market forces”

75. Solutions
• Two major camps:
– Government price controls: usually fail by creating:
• Shortages
• End runs & “special considerations”:
– Drive prices up rather than down
– “Restore market forces”:
• Chapter 13 outlines examples

76. Solutions
• My take:
– We must start by drastically reducing the cost of new drug
development:
• Give room to cut prices without eradicating the profits
that drive investment and progress
• Will increase competition if many small companies can
compete

77. Solutions
• My take:
– We must start by drastically reducing the cost of new drug
development:
• Give room to cut prices without eradicating the profits
that drive investment and progress
• Will increase competition if many small companies can
compete

78. Solutions
• My take:
– We must start by drastically reducing the cost of new drug
development:
• Give room to cut prices without eradicating the profits
that drive investment and progress
• Will increase competition if many small companies can
compete

80. United States
• Most expensive health care system in the world
• Average life-expectancy: 46th in world:
– Underinsured young people:
• High death rates from preventable causes
• High maternal death rate
• High infant death rate
– High death rates in young people from:
• Traffic accidents
• Drug overdoses
• Homicides
• Health impacts of imprisonment

81. United States
• Most expensive health care system in the world
• Average life-expectancy: 46th in world:
– Underinsured young people:
• High death rates from preventable causes
• High maternal death rate
• High infant death rate
– High death rates in young people from:
• Traffic accidents
• Drug overdoses
• Homicides
• Health impacts of imprisonment

82. United States
• Most expensive health care system in the world
• Average life-expectancy: 46th in world:
– Underinsured young people:
• High death rates from preventable causes
• High maternal death rate
• High infant death rate
– High death rates in young people from:
• Traffic accidents
• Drug overdoses
• Homicides
• Health impacts of imprisonment

83. Canada
• 11th most expensive health care in world
• Life expectancy:
– 1985-1995: 7th
– 2020: 16th
– 2040 (projected): 27th
• Much longer wait times for elective surgery than US, UK, France, Germany

84. Canada
• 11th most expensive health care in world
• Life expectancy:
– 1985-1995: 7th
– 2020: 16th
– 2040 (projected): 27th
• Much longer wait times for elective surgery than US, UK, France, Germany

85. Cancer
• 5-year cancer survival:
– US: 67%
• Whites: 68%
• Blacks: 63%
– Canada: 63%
– Cancer survival vs income:
• Lowest income quintile do better in Canada
• Top 4 quintiles do better in US
– If the average Canadian had the same access to rapid diagnosis and
treatment as the average American, about 9,000 of the 84,600
Canadians who died of cancer in 2021 might have survived

86. Cancer
• 5-year cancer survival:
– US: 67%
• Whites: 68%
• Blacks: 63%
– Canada: 63%
– Cancer survival vs income:
• Lowest income quintile do better in Canada
• Top 4 quintiles do better in US
– If the average Canadian had the same access to rapid diagnosis and
treatment as the average American, about 9,000 of the 84,600
Canadians who died of cancer in 2021 might have survived

87. Cancer
• 5-year cancer survival:
– US: 67%
• Whites: 68%
• Blacks: 63%
– Canada: 63%
– Cancer survival vs income:
• Lowest income quintile do better in Canada
• Top 4 quintiles do better in US
– If the average Canadian had the same access to rapid diagnosis and
treatment as the average American, about 9,000 of the 84,600
Canadians who died of cancer in 2021 might have survived

88. Cancer
• 5-year cancer survival:
– US: 67%
• Whites: 68%
• Blacks: 63%
– Canada: 63%
– Cancer survival vs income:
• Lowest income quintile do better in Canada
• Top 4 quintiles do better in US
– If the average Canadian had the same access to rapid diagnosis and
treatment as the average American, about 9,000 of the 84,600
Canadians who died of cancer in 2021 might have survived

89. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

90. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

91. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

92. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

93. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

94. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

95. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

96. https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2019.html

97. https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf
Time to Health Canada approval for new drug compared to US
and earliest European approval

98. Time to Health Canada approval for new drug compared to US
and earliest European approval
- On average, companies apply to Health Canada 10 months after US and 8 months after European
Medicines Agency (EMA)
- Market size and prices willing to pay determine where companies apply 1st
- US market (review time: 10.6 m): 330 million people and world’s highest drug prices
- EMA (review time: 12 m): 500 million people and some countries with high prices
- Canada (review time: 12.9 m): 35 million people and has typically paid high prices
- Health Canada:
- 4th fastest in approval
- permits drug purchase “out of pocket” or by insurance
- does not come with public funding
https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf

99. Time to Health Canada approval for new drug compared to US
and earliest European approval
- On average, companies apply to Health Canada 10 months after US and 8 months after European
Medicines Agency (EMA)
- Market size and prices willing to pay determine where companies apply 1st
- US market (review time: 10.6 m): 330 million people and world’s highest drug prices
- EMA (review time: 12 m): 500 million people and some countries with high prices
- Canada (review time: 12.9 m): 35 million people and has typically paid high prices
- Health Canada:
- 4th fastest in approval
- permits drug purchase “out of pocket” or by insurance
- does not come with public funding
https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf

100. Time to Health Canada approval for new drug compared to US
and earliest European approval
- On average, companies apply to Health Canada 10 months after US and 8 months after European
Medicines Agency (EMA)
- Market size and prices willing to pay determine where companies apply 1st
- US market (review time: 10.6 m): 330 million people and world’s highest drug prices
- EMA (review time: 12 m): 500 million people and some countries with high prices
- Canada (review time: 12.9 m): 35 million people and has typically paid high prices
- Health Canada:
- 4th fastest in approval
- permits drug purchase “out of pocket” or by insurance
- does not come with public funding
https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf

101. https://lifesciencesontario.ca/wp-content/uploads/2020/06/EN_LSO_Global-Launch-Benchmarking_Webinar-June22-20_Final.pdf

102. Health Canada approval on average 248 days after 1st global approval, with
launch in Canada after 119 more days (365 days total)
2012-2018
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

103. But it then averages 559 more days (1.5 years) for public reimbursement in
Canada, giving access to most Canadians
2012-2018
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

104. M Aitken, IQVIA 2021/11/30
Canada ranked 14th out of 19 in proportion of new cancer drugs
launched and reimbursed 2011-2020

105. Generally, the more a country was willing to pay, the shorter
the time to public funding
Calculated using PMPRB price data & public funding data from SL Hoskyn, Innovative Medicines Canada, 2020/07
p = 0.0003

106. But Canada and New Zealand were exceptions: long public
funding delays despite paying high prices
NZ
Canada
Calculated using PMPRB price data & public funding data from SL Hoskyn, Innovative Medicines Canada, 2020/07

107. This suggests a fundamental problem in Canada’s approach to
public funding of drugs
NZ
Canada
Calculated using PMPRB price data & public funding data from SL Hoskyn, Innovative Medicines Canada, 2020/07

108. - These drugs can meaningfully prolong life and alleviate suffering

109. - These drugs can meaningfully prolong life and alleviate suffering
- Thousands of Canadians may suffer unnecessarily due to these delays

110. - These drugs can meaningfully prolong life and alleviate suffering
- Thousands of Canadians may suffer unnecessarily due to these delays
- Thousands of Canadian years of life may be lost due to these delays

111. Canada’s process for public funding
Health technology assessment by Canadian Agency for Drugs and
Technologies in Health (CADTH)
CADTH Recommendation:
- Approve or not
- Price based on target of $50,000 per Quality Adjusted Life-Years (QALYs) gained
Price negotiations with company by pan-Canadian Pharmaceutical
Alliance (pCPA)
Further price negotiations between individual provinces and the
company

112. Canada’s process for public funding
Health technology assessment by Canadian Agency for Drugs and
Technologies in Health (CADTH)
CADTH Recommendation:
- Approve or not
- Price based on target of $50,000 per Quality Adjusted Life-Years (QALYs) gained
Price negotiations with company by pan-Canadian Pharmaceutical
Alliance (pCPA)
Further price negotiations between individual provinces and the
company

113. Canada’s process for public funding
Health technology assessment by Canadian Agency for Drugs and
Technologies in Health (CADTH)
CADTH Recommendation:
- Approve or not
- Price based on target of $50,000 per Quality Adjusted Life-Years (QALYs) gained
Price negotiations with company by pan-Canadian Pharmaceutical
Alliance (pCPA)
Further price negotiations between individual provinces and the
company

114. Canada’s process for public funding
Health technology assessment by Canadian Agency for Drugs and
Technologies in Health (CADTH)
CADTH Recommendation:
- Approve or not
- Price based on target of $50,000 per Quality Adjusted Life-Years (QALYs) gained
Price negotiations with company by pan-Canadian Pharmaceutical
Alliance (pCPA)
Further price negotiations between individual provinces and the
company

115. http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

116. http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

117. 1.8 years
6.9 months 5.1 months 7.7 months
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

118. 1.8 years
6.9 months 5.1 months 7.7 months
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

119. 1.8 years
6.9 months 5.1 months 7.7 months
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

120. 1.8 years
6.9 months 5.1 months 7.7 months
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

121. 6.9 months 5.1 months 7.7 months
1.8 years
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

122. Most CADTH and pCPA personnel will have work-related private insurance that
gives them, their spouses and dependents access right after Health Canada
approval and drug launch
2012-2018
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

123. But most members of the public on whose behalf CADTH and pCPA are slowly
negotiating must wait an additional 1.5 years for access
2012-2018
http://innovativemedicines.ca/wp-content/uploads/2020/07/CADTH-TTL-8.5x11-EN-Final.pdf

124. C Balijepalli et al. ISPOR conf 2022
- CADTH recommended price reductions of >50% for 49 of 61 new drugs 2020-2021
- Used threshold of $50,000 per quality adjusted life years (QALYs)
- QALY measurement has many issues
- $50,000 per QALY is same level as 1975 (when $1 was worth 5 x as much as now)
CADTH is demanding inappropriately large price reductions

125. - CADTH recommended price reductions of >50% for 49 of 61 new drugs 2020-2021
- Used threshold of $50,000 per quality adjusted life years (QALYs)
- QALY measurement has many issues
- $50,000 per QALY is same level as 1975 (when $1 was worth 5 x as much as now)
CADTH is demanding inappropriately large price reductions
C Balijepalli et al. ISPOR conf 2022

126. - CADTH recommended price reductions of >50% for 49 of 61 new drugs 2020-2021
- Used threshold of $50,000 per quality adjusted life years (QALYs)
- QALY measurement has many issues
- $50,000 per QALY is same level as 1975 (when $1 was worth 5 x as much as now)
CADTH is demanding inappropriately large price reductions
C Balijepalli et al. ISPOR conf 2022

127. - CADTH recommended price reductions of >50% for 49 of 61 new drugs 2020-2021
- Used threshold of $50,000 per quality adjusted life years (QALYs)
- QALY measurement has many issues
- $50,000 per QALY is same level as 1975 (when $1 was worth 5 x as much as now)
CADTH is demanding inappropriately large price reductions
C Balijepalli et al. ISPOR conf 2022

128. The larger the price reduction recommended by CADTH, the longer it takes for
pCPA to engage and negotiate, and the greater the delay in public reimbursement
C Balijepalli et al. ISPOR conf 2022

129. In 2015 election, Liberals promised Canadians lower drug prices
But the cost of lower prices is reduced access to effective new drugs!

130. In 2015 election, Liberals promised Canadians lower drug prices
But the cost of lower prices is reduced access to effective new drugs!

131. M Aitken, IQVIA 2021/11/30
CADTH is recently demanding major price cuts (gold bars) on
higher proportion of drugs

132. • Provincial government funding cannot move faster than
federal level institutions like CADTH and pCPA
• pCPA member to my colleague:
– “Why are you oncologists always in such a rush?”
• We are in a rush because we are trying desperately to
alleviate our patients’ suffering and save their lives
• CADTH and pCPA don’t seem to get that:
– In my opinion, this is a problem of leadership

133. • Provincial government funding cannot move faster than
federal level institutions like CADTH and pCPA
• pCPA member to my colleague:
– “Why are you oncologists always in such a rush?”
• We are in a rush because we are trying desperately to
alleviate our patients’ suffering and save their lives
• CADTH and pCPA don’t seem to get that:
– In my opinion, this is a problem of leadership

134. • Provincial government funding cannot move faster than
federal level institutions like CADTH and pCPA
• pCPA member to my colleague:
– “Why are you oncologists always in such a rush?”
• We are in a rush because we are trying desperately to
alleviate our patients’ suffering and save their lives
• CADTH and pCPA don’t seem to get that:
– In my opinion, this is a problem of leadership

135. • Provincial government funding cannot move faster than
federal level institutions like CADTH and pCPA
• pCPA member to my colleague:
– “Why are you oncologists always in such a rush?”
• We are in a rush because we are trying desperately to
alleviate our patients’ suffering and save their lives
• CADTH and pCPA don’t seem to get that:
– In my opinion, this is a problem of leadership

136. • Provincial government funding cannot move faster than
federal level institutions like CADTH and pCPA
• pCPA member to my colleague:
– “Why are you oncologists always in such a rush?”
• We are in a rush because we are trying desperately to
alleviate our patients’ suffering and save their lives
• CADTH and pCPA don’t seem to get that:
– In my opinion, this is a problem of leadership

137. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

138. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

139. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

140. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

141. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

142. Patented Medicine Prices Review Board (PMPRB)
• 2nd player in regulating Canadian drug prices
• Sets maximum price a company can charge for drug
• In 2017, PMPRB proposed new regulations to reduce prices:
– Mandated initial price reduction of ~20%
– As sales increase, decrease price further:
• Creates uncertainty for company
• Ultimate price reduction of 50-80% (Rawson et al. Canadian
Health Policy Jan 2020)

143. https://www.canada.ca/content/dam/pmprb-cepmb/documents/consultations/draft-guidelines/2020/PMPRB-Public-Webinar-July8-2020.pdf
Slide from PMPRB 2020 public presentation to justify
forcing prices down

144. - PMPRB cherry picked the times patented drug prices as % of GDP were the
lowest and among the highest since 2002
- 2019 % was lower than 2002
- Drug prices are high, but PMPRB presentation appears misleading
https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2019.html

145. - PMPRB cherry picked the times patented drug prices as % of GDP were the
lowest and among the highest since 2002
- 2019 % was lower than 2002
- Drug prices are high, but PMPRB presentation appears misleading
https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2019.html

146. - PMPRB cherry picked the times patented drug prices as % of GDP were the
lowest and among the highest since 2002
- 2019 % was lower than 2002
- Drug prices are high, but PMPRB presentation appears misleading
https://www.canada.ca/en/patented-medicine-prices-review/services/annual-reports/annual-report-2019.html

147. - Intent appeared to be to make the point that reducing Canadian prices
would not negatively impact drug access
Slide from PMPRB 2020 public presentation to justify
forcing prices down
https://www.canada.ca/content/dam/pmprb-cepmb/documents/consultations/draft-guidelines/2020/PMPRB-Public-Webinar-July8-2020.pdf

148. - Intent appeared to be to make the point that reducing Canadian prices
would not negatively impact drug access
Slide from PMPRB 2020 public presentation to justify
forcing prices down
https://www.canada.ca/content/dam/pmprb-cepmb/documents/consultations/draft-guidelines/2020/PMPRB-Public-Webinar-July8-2020.pdf

149. - Intent appeared to be to make the point that reducing Canadian prices
would not negatively impact drug access: WISHFUL THINKING!!
Slide from PMPRB 2020 public presentation to justify
forcing prices down
https://www.canada.ca/content/dam/pmprb-cepmb/documents/consultations/draft-guidelines/2020/PMPRB-Public-Webinar-July8-2020.pdf

150. Both European Medicines Agency (EMA) countries and others get access to
more effective new dugs if willing to pay more
p < 0.0001
p = 0.0006
European Medicines Agency (EMA) Non-EMA
US
Canada
Analyses using PMPRB data from 2020 public presentation

151. Both European Medicines Agency (EMA) countries and others get access to
more effective new dugs if willing to pay more
p < 0.0001
p = 0.0006
European Medicines Agency (EMA) Non-EMA
US
Canada
Analyses using PMPRB data from 2020 public presentation

152. p < 0.0001
p = 0.0006
European Medicines Agency (EMA) Non-EMA (excluding USA)
Canada
Both European Medicines Agency (EMA) countries and others get access to
more effective new dugs if willing to pay more
- Analysis of PMPRB data indicate that arbitrarily forcing drug prices down 20%
would be expected to decrease drugs launched in Canada from 48% of drugs
launched elsewhere to about 35-39%, worsening access for Canadians
Analyses using PMPRB data from 2020 public presentation

153. • Canada’s huge error:
– CADTH and PMPRB try to force down price while ignoring
access
• This will worsen Canada’s already impaired access
– Health Canada approvals
– Provincial funding of approved drugs
– We instead need to concentrate on improving access while
looking at innovative approaches to cost control

154. • Canada’s huge error:
– CADTH and PMPRB try to force down price while ignoring
access
• This will worsen Canada’s already impaired access
– Health Canada approvals
– Provincial funding of approved drugs
– We instead need to concentrate on improving access while
looking at innovative approaches to cost control

155. • Canada’s huge error:
– CADTH and PMPRB try to force down price while ignoring
access
• This will worsen Canada’s already impaired access
– Health Canada approvals
– Provincial funding of approved drugs
– We instead need to concentrate on improving access while
looking at innovative approaches to cost control

156. Factors impacting time to drug access
• Drug development / clinical trials
• When does company apply to a country?
– Varies with:
• How much country typically willing to pay
• Size of country / market size
• How long does it take for country to review application?
• How long does it take drug to “launch” after approval?
• How long does it take for country to start paying for drug (“public
reimbursement”)?
• How long does it take for diagnosis and treatment initiation?

157. CT scanners per million population 2017-2020: Canada ranked
30th out of 33 OECD countries
https://data.oecd.org/healtheqt/computed-tomography-ct-scanners.htm#indicator-chart

158. https://data.oecd.org/healtheqt/magnetic-resonance-imaging-mri-units.htm#indicator-chart
MRI scanners per million population 2017-2020: Canada ranked
26th out of 31 OECD countries

159. Hospital beds per 1,000 population 2017-2020: Canada ranked
30th out of 37 OECD countries
https://data.oecd.org/healtheqt/hospital-beds.htm#indicator-chart

160. Radiotherapy machines per 1,000,000 population 2017-
2020: Canada ranked 27th out of 29 OECD countries
https://data.oecd.org/healtheqt/radiotherapy-equipment.htm#indicator-chart

161. Adapted from https://stats.oecd.org/Index.aspx?DataSetCode=HEALTH_REAC
Medical specialists per 1,000 population 2017-2020:
Canada ranked 31st out of 34 OECD countries

162. Adapted from https://journals.plos.org/plosone/article?id=10.1371/journal.pone.0213209#sec014
%
Risk
of
Death

163. % dying if not yet treated
Weeks
from
diagnosis
In untreated metastatic non-small cell lung cancer, 4% of remaining patients
die each week treatment is delayed
Stewart. Cancer Med 2021; 10:9040

164. % dying if not yet treated
Weeks
from
diagnosis
-Untreated patients can rapidly become too sick to be considered for Rx
In untreated metastatic non-small cell lung cancer, 4% of remaining patients
die each week treatment is delayed
Stewart. Cancer Med 2021; 10:9040

165. % dying if not yet treated
Weeks
from
diagnosis
-Untreated patients can rapidly become too sick to be considered for Rx
-Takes weeks for biopsy, staging, molecular testing
In untreated metastatic non-small cell lung cancer, 4% of remaining patients
die each week treatment is delayed
Stewart. Cancer Med 2021; 10:9040

166. % dying if not yet treated
Weeks
from
diagnosis
-Untreated patients can rapidly become too sick to be considered for Rx
-Takes weeks for biopsy, staging, molecular testing
Only 25% of Ontario metastatic NSCLC patients make it to treatment!!
In untreated metastatic non-small cell lung cancer, 4% of remaining patients
die each week treatment is delayed
Stewart. Cancer Med 2021; 10:9040

167. Probability of surviving cancer based on cancer deaths per year
divided by cases (mortality-to-incidence ratio)
Calculated from https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/
Proportion
surviving

168. Probability of surviving cancer based on cancer deaths per year
divided by cases (mortality-to-incidence ratio)
Calculated from https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/
Proportion
surviving
Of the 84,600 Canadians who died from cancer in 2021, ~9,000 might have survived if they
had same access to diagnosis and treatment as average American (green bar)

169. Probability of surviving cancer vs CT
scanners per million population
p = 0.002
Calculated from https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/ and OECD CT data

170. Probability of surviving cancer vs drug
availability
Calculated from https://www.wcrf.org/cancer-trends/global-cancer-data-by-country/ and PMPRB drug data
p = 0.01

171. Solutions
• Prioritize access!
• Not just cost or safety or ideology

172. Solutions
• Prioritize access!
• Not just cost or safety or ideology

173. Solutions
• Prioritize access!
• Not just cost or safety or ideology

174. Solutions
• Prioritize access!
• Not just cost or safety or ideology

175. Solutions
• Prioritize access!
• Not just cost or safety or ideology

176. This is a problem of leadership that starts at the highest
political and public servant levels of the Canadian
federal government

177. Thank you!
Available online: https://whycancerstillsucks.com/ or Amazon books

178. Canadian Cancer Survivor Network
Contact Info
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail: jmanthorne@survivornet.ca or info@survivornet.ca
Website: www.survivornet.ca
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Instagram: @survivornet_ca
Pinterest: http://pinterest.com/survivornetwork/