What you should know about drug approval bodies in Canada 101:

The Elevator Length Pitch

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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 hospitalsSource: Prescribed Drug Spending in Canada 2012 Report, CIHI

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In 2014, Canadians spent an estimated $28.8 billion on prescribed drugs

Total Health Expenditure, by Use of Funds, Canada, 2014f

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Complex Pathway to Patient Access

Drug Development

Health Canada Review

Patented Medicine Prices Review Board

Health Technology Assessment

Hospitals

Patient Access

Private Drug Planspan-Canadian

Pharmaceutical Alliance

Provincial Drug Plans

Marketing Authorizatio

n

Pricing Review

Public Reimbursement Review

Individual Formulary Decision-Making

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

or

or

or

NoC or NoC/cMax. Avg. Potential

Price (MAPP)Formulary Listing Recommendation

Formulary Listing Decision/Inclusion

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Growth in prescribed drug spending has slowed in both the public and private sectors since 2000

Prescribed Drug Spending, Canada, 2000 to 2014f

Inception of the CDR

Interim jODR

process

Bill 102 in Ontario

Beginning of pCPA

Federal Government Jurisdiction – Public PlansLegal Framework

• Canada Health Act and Regulations

• Vanessa’ s Law

• Food and Drugs Act and Regulations

• Patent Act and Regulations

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

Public Jurisdictions in HealthFederal/ 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

Public Drug CoverageFederal 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

Food and Drugs ActRequires 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

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

Patent Act and RegulationsThe 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

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

Public Drug CoverageProvincial/ 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

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

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

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

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)

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.

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

Provincial /Territorial Jurisdiction

• Determination of public drug coverage in that province/territory

• Drug budgets

• Cancer agencies

• Issues for consideration are plan sustainability, budget

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

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

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