Please share this webinar with anyone who may be interested! Watch all our webinars: https://www.youtube.com/playlist?list=PL4dDQscmFYu_ezxuxnAE61hx4JlqAKXpR In this webinar: ● Primer for attendees attending the November 15-16 Drug Pricing Policy Summit ● Broad conceptual blueprint of federal and provincial/territorial public health policy structures across Canada ● Description of legal frameworks, government responsibility centres and their mandates for treatment access, with reference to specific opportunities for patient engagement View the video: https://youtu.be/X9AB70om-Dw Follow our social media accounts: Twitter - https://twitter.com/survivornetca Facebook - https://www.facebook.com/CanadianSurvivorNet Pinterest - https://www.pinterest.com/survivornetwork YouTube - https://www.youtube.com/user/Survivornetca

1. What you should know about
drug approval bodies in Canada
101:
The Elevator Length Pitch

2. Who Pays for Pharmaceuticals in
Canada?
Total 2013 Rx Meds Expenditure
$29.3 B*; 100%
Private Sector Share
$17.1 B; 58.4% of total
Public Sector Share
$12.2 B; 41.6% of total
Other Publicly Funded
Drug Expenditure;
1.1 B; 3.8% of total;
9.0% of public share
Federal Drug Benefit
Plan;
0.6 B; 2.0% of total;
4.9% of public share
Provincial Drug
Benefit Plan;
10.5 B; 35.8% of total;
86.1% of public share
Out-of-Pocket
Contributions;
7.0 B; 23.9% of total;
40.9% of private share
Private Insurers;
10.1 B; 34.5% of total;
59.1% of private share
* Not including medicines dispensed in hospitals
Source: Prescribed Drug Spending in Canada 2012 Report, CIHI
2

3. In 2014, Canadians spent an estimated $28.8 billion
on prescribed drugs
3
Total Health Expenditure, by Use of Funds, Canada, 2014f

4. Complex Pathway to Patient Access
Drug Development
Health Canada
Review
Patented Medicine
Prices Review Board
Health Technology
Assessment
Hospitals
Patient Access
Private Drug Plans
pan-Canadian
Pharmaceutical Alliance
4
Provincial Drug
Plans

5. Health Canada
review
Safety, efficacy,
and
manufacturing
quality
Patented
Medicine Prices
Review Board
(PMPRB) review
Common Drug Review (CDR)
Pan-Canadian Oncology Drug
Review (pCODR)
Local /Regional Review
(For generics and older medications)
and INESSS
Private drug plan health
technology analysis / evaluation –
resources
Public and Private
Drug Benefit Plan
review (budgetary
capacity, plan
characteristics,
determination of
clinical criteria, price
and utilization
negotiations and
reimbursement status
o
r
o
r
o
r
NoC or NoC/c
Max. Avg. Potential
Price (MAPP)
Formulary Listing
Recommendation
Formulary Listing
Decision/Inclusion

6. Growth in prescribed drug spending has slowed
in both the public and private sectors since 2000
6
Prescribed Drug Spending, Canada, 2000 to 2014f
Inception
of the CDR
Interim
jODR
process
Bill 102 in
Ontario
Beginning
of pCPA

7. Federal Government Jurisdiction –
Public Plans
Legal Framework
• Canada Health Act and Regulations
• Vanessa’ s Law
• Food and Drugs Act and Regulations
• Patent Act and Regulations

8. Federal Health Regulatory Agencies
• Health Canada reporting to Minister of Health
– Food and Drugs Act and Regulations
– Vanessa’s Law
• Patented Medicine Prices Review Board
reporting to Minister of Health
– Patent Act and Regulations

9. Public Jurisdictions in Health
Federal/ Provincial/ Territorial
Canada Health Act
• Federal legislation requiring universal access to doctors and
hospitals
• Treatments prescribed in hospital are also covered
generally
• Hospitals decide what drugs and tests they will cover
• Hospital administered drugs and tests outside that list must
be paid for by patients

10. Public Drug Coverage
Federal Jurisdiction
The federal government covers:
> federal employees and retirees
> the military
> the RCMP
> First Nations on Reserves ( Non-Insured
Health Benefits )
> inmates in federal penitentiaries
> refugees

11. Food and Drugs Act
Requires drugs approved for sale in Canada to be safe, effective and of
good quality
Oversight is through Health Canada for :
> drugs- brand and generic
> biologics and biosimilars
> medical devices
> natural and non-prescription health products
> marketed health products
> compliance and enforcement
Clinical trial approval, approval for sale, post market monitoring,
Special Access Programme

12. Vanessa’s Law
Amended the Food and Drugs Act to include
rules that:
• Strengthen safety oversight
• Improves reporting by health care institutions
of serious adverse drugs reactions and
medical device incidents

13. Patent Act and Regulations
The Patent Act establishes PMPRB to regulate prices of patented drugs
sold in Canada to ensure that the prices are not excessive
The Regulations include the list or basket of countries to be taken into
account in determining excessive pricing i.e. U.S., Germany, Spain, U.K.,
France , Switzerland, Sweden and the automatic increases annually
based on CPI
Compendium of Policies, Guidelines and Procedures are non-binding
guidance from the PMPRB Board to staff and patentees including the
role of therapeutic benefit and the way to rely on the basket to
determine excessive pricing
Oversight through the Patented Medicine Prices Review Board that
also reports on generic drug price trends

14. Joint Federal/Provincial/ Territorial
Health Jurisdiction
The Canadian Agency for Drugs and Technologies
in Health (CADTH)
• Not for profit corporation reporting to a Board of
Directors
pan-Canadian Pharmaceutical Alliance (pCPA)
• Created by and reporting to the Council of the
Federation

15. Public Drug Coverage
Provincial/ Territorial Jurisdiction
Provinces and territories cover:
> eligible people residing in the province
/territory
> inmates in provincial correctional institutions
> First Nations not on reserve
> refugees
> provincial employees and retirees
Coverage is limited to a specific list of drugs, biologics and
diagnostics, specific populations, ages or incomes and
may have deductibles and copays

16. Role of CADTH
• Recommendation making body to the provinces
and territories about what drugs, biologics,
companion diagnostics are good value to be
covered under public reimbursement processes
• These are a guide only, non-binding
• This is done through a health technology
assessment process

17. Health Technology Assessment
(HTA)
• Assessment of value to the public drug plans
• Based on an evidence based formula
• If value is determined to be “good “ based on the
formula chosen for measurement, a reimburse or
reimburse with clinical criteria and/or conditions is
made
• If value is not acceptable, a do not reimburse
recommendation is made

18. Common Drug Review
• Housed within CADTH to reviews new drugs and new indications
for drugs except oncology
• Looks at clinical data, economic analyses, patient perspectives
• Does therapeutic class reviews as well
• Recommendations are made public
• Patient groups may submit information about a specific review
or class review and there are public members on the Canadian
Drug Expert Committee

19. pan-Canadian Oncology Drug Review
• Housed in CADTH to review new oncology therapies and new
indications
• Looks at clinical data, economic analyses, patient perspectives and
practicalities of implementation in a formal deliberative framework
• Draft recommendation are open for comment before formalized
• Recommendations to reimburse or reimburse with clinical
criteria/and conditions or not to reimburse made to P/T are public
• Patient groups may submit information about a specific review or
class review and there are patient members on the pCODR Expert
Review Committee (pERC)

20. Institut national d’excellence en santé et en
services sociaux (INESSS) in Québec
• The evaluation process considers five criteria as established
by the Institute’s founding Act: therapeutic value,
reasonableness of price, cost effectiveness, and the
advisability of entering the drug on the list and its impact
on the health and social services system.
• The drug’s therapeutic value is a prerequisite to
consideration of the other four criteria.
• Appraisal is part of a deliberative process involving
clinicians, researchers, ethicists, pharmaco-economists and
citizens.
• Following this deliberation, INESSS communicates its
recommendations to the Minister of Health and Social
Services.

21. pan-Canadian Pharmaceutical Alliance
(pCPA)
• Housed by the Government of Ontario with an administrative Office
• Leads non- time limited public plan negotiations for drug prices for
all provinces/ territories and federal plans for First Nations and
inmates
• Negotiation details and outcomes including price are not made
public
• Provinces can opt in to negotiations from the outset or not and may
also leave the negotiations at any point
• Ontario and Nova Scotia facilitate patented drugs negotiations with
one province agreeing to lead each negotiation

22. Provincial /Territorial Jurisdiction
• Determination of public drug coverage in that
province/territory
• Drug budgets
• Cancer agencies
• Issues for consideration are plan sustainability,
budget

23. Private Drug Coverage
Eligible people may have additional private
coverage:
• through employer sponsored drug plans or
• spousal or family coverage or
• individually purchased drug coverage
This is intended to augment limited public
insurance
• Subject of a CCSN webinar on the website

24. Conclusions
• Complex
• Multi jurisdictional
• Layered structures
• Unequal across Canada
• Discretionary powers, often not transparent
• Some patient engagement but not always
meaningful
• Not universal coverage either in who is covered
or what is covered

25. 613-898-1871
jmanthorne@survivornet.ca or
mforrest@survivornet.ca
www.survivornet.ca
@survivornetca
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Pinterest: survivornetwork
1.800.460.5832
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saveyourskin.ca / sauvetapeau.ca
@saveyourskinfdn @sauvetapeau
Facebook:
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@SauveTaPeau
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@peace_of_minds
Facebook: Schizophrenia Society of
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26. Questions?