Transcript www.cadaonline.ca

Michelle Boudreau, Vice President, Private
Markets,
March 11, 2015
Presentation to CADA
Who we are
Medicines in context
Regulatory environment
Complex path to access
Discussion
Our Members
Rx&D: Who We Are
• Over 50 research-based companies
(international and Canadian start-up)
• Account for 46,000 Canadians jobs
(direct and indirect)
• Annually invest over $1B into
pharmaceutical R&D and related
activities
• 3,000+ clinical trials across Canada
• $750M into hospitals/communities
• Annually contribute $3B to GDP
• Support a vibrant and national
life-sciences community
Life Science Clusters
Canadian Footprint: Economic
Rx Medicines in Context
• Life expectancy in Canada
1914
2014
52
80
57
84
• Public Health partner in newborn, school-age, seasonal and
pandemic vaccination efforts
• Steady increases in cancer, cardiovascular, diabetes, HIV/AIDs and
other disease survival rates due to new innovative therapies
– Cancer survival rates, especially in prostate, breast, lung and colorectal
cancers have declined steadily since Canada’s peak of deaths/1,000 in 1988
• Total Rx medicines spend (public & private) in Canada -- 6.2%*
* PMPRB/CIHI derivation -- 2012
Embrace Ethics and Transparency
• Developed in 1988
• Promotes Reputation
and Trust
• Demonstrates value and
builds the reputation of the
industry with key
stakeholders
• Helps us communicate the
high standards we set
ourselves as an industry
Discovery to Development to Patients
High-risk research: more than $1 billion over 10–15 years
Market exclusivity following approval: 8-10 years *
Drug discovery
Preclinical
Regulatory
review
Clinical trials
Scale-up to
manufacturing
Market
exclusivity
~ 5,000 – 10,000
250
PMPRB
5
compounds
3–6 years
Phase
1
Phase
2
Phase
3
Number of volunteers
20–100
100–500
6–7 years
1,000–5,000
Regulatory submission
One
approved
drug
Clinical investigation
Pre-discovery
Health
Canada
HTA:
CDR/pCODR
Private
Payers
PCPA
0.5–2 years
8 – 10 years
Adapted from: Drug Discovery and Development: Understanding the R&D Process, www.innovation.org;
DiMasi et al. Managerial and Decision Economics 2007; 28:469-79.
Regulatory environment – Health Canada – at
a glance
•
•
•
•
•
Authorization to conduct clinical trials
Authorization to sell
Post-market monitoring
Establishment licenses
Abreviated submission processes for changes, any new
indications
• Oversight on labelling
• Restrictions on advertising
• Transparency of compliance
10
Industry Challenges
access
price-freezes
vendor-credentialing
private-plans
shortages
reputation
PMPRB
CADTH
investment
queuing
IP HTAPCPA
regulatory barriers
transparencypCODR
regulatory barriers
Complex
pathway to
patient access
Drug Development
Health Canada
Review
Patented Medicine
Prices Review Board
PCPA
Provincial Drug Plans
Health Technology
Assessment
Hospitals
Patient Access
Private Drug Plans
Questions and
Discussion
• Extra slides
14
PMPI – Lower than CPI 24 of 26 years
Prices – Lower than International Median
16
Rx Meds -- % over last five years
17
Value of Medicines: Life and Longevity
Acute Myocardial
Infarction*
0%
-10%
Heart Disease**
-20%
Respiratory Illnesses**
-26%
-30%
-40%
-50%
-34%
-40%
-45%
Breast Cancer****
Colon Cancer*
-60%
HIV***
-70%
-80%
-77% -76%
-78%
Prostate Cancer*****
Sources: OECD Health Data, *1980-2009; ** 1970-2009, ***1995-2009; *****1990-2004;
Canadian Cancer Society, Canadian Cancer Statistics, ****1986-2012.
Value of Medicines: System Impacts
Fewer days in hospital: Canada
Asthma
0%
Breast Cancer
-8%
-10%
Diabetes
-20%
-20%
-30%
-29%
-31%
-40%
-50%
-80%
Acute Myocardial Infarction
HIV/AIDS**
-50%
-50%
-60%
-70%
Hypertensive diseases
Prostate Cancer
-60%
-71%
-70%
Respiratory
Infections/Influenza
Ulcers
Sources: OECD Health Data, *1980-2009; ** 1970-2009, ***1995-2009; *****1990-2004;
Canadian Cancer Society, Canadian Cancer Statistics, ****1986-2012.
Source: OECD Health Data 2012, 1980-2009, except **: 1986-2008.
Value of Medicines
Broader
Society
Broader
Economy
Health
Spending
Better Health Outcomes
• Superior clinical outcomes and prevent
downstream complication
• Better SE profile
• Better adherence
Health Spending
• Decreased need for adjacent health services
• Increased efficiency in health care resources
• Better value compared to alternative therapies
Broader Economy
•
•
Productivity gains
Reduced disability and absenteeism claims
Health
Status
Broader Society
• Better quality of life for patients and for the
informal caregivers
The Cost of Non-Adherence
50%
According to the WHO
50% of patients don’t
take their medications
and 33% never even fill
their first prescription
$290
3.5X
New England health care
Institute (NEHI) estimates
that overall poor
adherence cost as much
as $290 billion/year
Non-adherent chronic
diseases patients cost
their plan 3.5X more in
claims
Source: Adherence to long-term therapies, Evidence for action, World Health Organization, 2003
NEHI, How many more studies will it take? A collection of evidence that our health care system can do better, 2008
Green Shield, GSC 2013 Drug Study, the inside story, 2013