michelle boudreau, vice president, private markets, march 11, 2015 presentation to cada
TRANSCRIPT
• 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
Rx&D: Who We Are
• Life expectancy in Canada1914
52 572014
80 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
Rx Medicines in Context
• 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
Embrace Ethics and Transparency
8 – 10 years
Drug discovery
Preclinical Clinical trials Regulatory review
Scale-up tomanufacturing
Market exclusivity
One approve
d drug
0.5–2 years6–7 years3–6 years
Number of volunteers
Phase 1
Phase 2
Phase 3
5250~ 5,000 – 10,000
compounds
Pre
-dis
covery
20–100 100–500 1,000–5,000C
lin
ical in
vesti
gati
on
Reg
ula
tory
su
bm
issio
n
High-risk research: more than $1 billion over 10–15 years
Market exclusivity following approval: 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.
Health Canada
PMPRB
HTA: CDR/pCODR
Private Payers
PCPA
5 to 7 years
Discovery to Development to Patients
10
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
accessvendor-credentialing price-freezes
private-plans PMPRBinvestment
regulatory barriers
queuingPCPAHTACADTH
regulatory barrierstransparency
reputationshortages
IPpCODR
Industry Challenges
Drug Development
Health Canada Review
Patented Medicine Prices Review Board
Health Technology Assessment
Hospitals
Patient Access
Complex pathway to
patient access
Private Drug PlansProvincial Drug Plans
PCPA
-80%
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
-77% -76%
-34%-40%
-45%
-78%
-26%
Acute MyocardialInfarction*
Heart Disease**
Respiratory Illnesses**
Breast Cancer****
Colon Cancer*
HIV***
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: Life and Longevity
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
-80%
-70%
-60%
-50%
-40%
-30%
-20%
-10%
0%
-50%
-71%
-31%
-50%
-60%
-8%
-70%
-20%
-29%
Asthma
Breast Cancer
Diabetes
Hypertensive diseases
Acute Myocardial Infarction
HIV/AIDS**
Prostate Cancer
RespiratoryInfections/InfluenzaUlcers
Fewer days in hospital: Canada
Source: OECD Health Data 2012, 1980-2009, except **: 1986-2008.
Broader Society
Broader Economy
Health Spending
Health Status
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
Broader Society• Better quality of life for patients and for the
informal caregivers
Value of Medicines
50%According to the WHO 50% of patients don’t take their medications and 33% never even fill their first prescription
$290New England health care Institute (NEHI) estimates
that overall poor adherence cost as much
as $290 billion/year
3.5XNon-adherent chronic diseases patients cost
their plan 3.5X more in claims
Source: Adherence to long-term therapies, Evidence for action, World Health Organization, 2003NEHI, How many more studies will it take? A collection of evidence that our health care system can do better, 2008Green Shield, GSC 2013 Drug Study, the inside story, 2013
The Cost of Non-Adherence