how prescription drugs are approved in canada

ACCESS TO PRESCRIPTION MEDICINES IN CANADA

April 2015

Access to prescription medicines in Canada

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ii)How do the authorization, evaluation and funding processes impact patient

access to medication?

iii)How can patients be

involved in these processes?

i)Who is responsible for prescription

approval in Canada

Who is involved and at which level? Manufacturer clinical trials:

quality, safety and efficacy

Regulatory review:quality, safety and efficacy

“Pricing” review:maximum “non-excessive” price

Funding recommendations: Comparative safety, efficacy and cost effectiveness

FUNDING DECISIONS

Patient criteria /appropriate use

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Drug Development

Health Canada Review

Patented Medicine Prices Review Board

Health Technology Assessment

Hospitals and Cancer Agencies

Private Drug Plans

Provincial Drug Plans

Patient Access

• Impact:• Access to clinical trials for many means patient access

• Influence:• Manufacturers and research organizations increasingly engaging

in dialogue with patients on new therapeutic areas, health outcomes and quality of life issues

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Drug Development

• Impact:• 1st hurdle only – Health Canada approval means the treatment

can be considered for coverage / funding• Canada’s record doesn’t compare well with FDA and Europe

• Influence:• No formal role for patients currently• Orphan drug pilot projects underway

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Rawson, Nigel, Access to New Oncology Drugs in Canada Compared to the United States and Europe, Fraser Alert, Fraser Institute, July 2012

Health Canada Review

• Impact:• Ensures that Canadians do not pay “excessive” prices using

price tests that compare ex-factory gate prices to therapeutic comparators and/or a basket of developed countries

• Influence:• No patient role in the individual price-test review process• On policies, excellent stakeholder engagement and consultation

processes – however, patients usually do not get involved

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Patented Medicine Prices Review Board

• Impact:• Evaluate comparative clinical and cost-effectiveness of therapies• Agencies conduct individual product and “class” or therapeutic

reviews and optimal use programs – make funding recommendations to public payers

• Set the negotiation framework for manufacturers and payers to determine reimbursement

• Influence:• Extensive patient role in public HTA processes for individual

products and policies • Few opportunities for patients to influence private health benefit

providers

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Health Technology Assessment

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Source: pCODR’s performance review report (Apr. 2014)

Health Technology Assessment

Public Payer Decision-Making

C -PAY

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Hospitals and Cancer Agencies

• Impact:• Funded medications covered under Medicare• No co-payments or deductibles

• Influence:• No role for patients• Due to the nature of the discussions (i.e., financial negotiations,

tenders, procurement policies) the dialogue involves only the payer and the supplier

Payer Supplier

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Private Drug Plans

• Impact:• Most cancer medications are ineligible for private plan coverage

due to the plans’ restrictions on hospital-based medicines• Oral take-home meds are covered by open plans and subject to

intense scrutiny in managed plans

• Influence:• Generally no role for patients in private plan coverage decision-

making or policy

Private Plan

Coverage(not all plans are like this!)Rx meds

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Public Drug Plans

• Impact:• All meds subject to pCPA consideration and potential national

negotiations• No role for public plans in provinces where cancer agencies fund

all cancer treatments (BC, AB, SK)• Public plans decision-making processes apply re: funding

decisions for oral meds in all other provinces (MB, ON, QC, NB, NS, NS, PE)

• Hospital / Cancer agency decision-making applies to IV meds in those provinces

• Influence:• Patients have no direct role in public drug plan funding decisions• Indirect influence through GR and PR efforts

pCPA

What can patients do in this context?

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DISCUSSION