Michelle Boudreau, Vice President, PrivateMarkets,

March 11, 2015Presentation to CADA

Who we areMedicines in context

Regulatory environmentComplex path to access

Discussion

Our Members

• 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 Science Clusters

Canadian Footprint: Economic

• 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

Questions and Discussion

14

• Extra slides

PMPI – Lower than CPI 24 of 26 years

16

Prices – Lower than International Median

17

Rx Meds -- % over last five years

-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