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ACCESS TO PRESCRIPTION MEDICINES IN CANADA
April 2015
Access to prescription medicines in
Canada
2
ii)
How do the authorization, evaluation
and funding processes impact patient...
Who is involved and
at which level? Manufacturer clinical trials:
quality, safety and efficacy
Regulatory review:
quality,...
• Impact:
• Access to clinical trials for many means patient access
• Influence:
• Manufacturers and research organization...
• Impact:
• 1st hurdle only – Health Canada approval means the treatment
can be considered for coverage / funding
• Canada...
• Impact:
• Ensures that Canadians do not pay “excessive” prices using
price tests that compare ex-factory gate prices to ...
• Impact:
• Evaluate comparative clinical and cost-effectiveness of therapies
• Agencies conduct individual product and “c...
8
Source: pCODR’s performance review report (Apr. 2014)
Health Technology
Assessment
Public Payer
Decision-Making
C
-PAY
9
Hospitals and
Cancer Agencies
• Impact:
• Funded medications covered under Medicare
• No co-payments or deductibl...
10
Private
Drug Plans
• Impact:
• Most cancer medications are ineligible for private plan coverage
due to the plans’ restr...
11
Public
Drug Plans
• Impact:
• All meds subject to pCPA consideration and potential national
negotiations
• No role for ...
What can patients do in this context?
12
13
DISCUSSION
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How Prescription Drugs are Approved in Canada

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This webinar provides insight into how the drug approval process affects what prescription drugs are available to patients in Canada. The presentation will cover the following topics: Who is responsible for prescription drug approval in Canada? How does the drug approval process impact patient access to medication? How can patients be involved in the drug approval process?

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How Prescription Drugs are Approved in Canada

  1. 1. ACCESS TO PRESCRIPTION MEDICINES IN CANADA April 2015
  2. 2. Access to prescription medicines in Canada 2 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
  3. 3. 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 3 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
  4. 4. • 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 4 Drug Development
  5. 5. • 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 5 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
  6. 6. • 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 6 Patented Medicine Prices Review Board
  7. 7. • 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 7 Health Technology Assessment
  8. 8. 8 Source: pCODR’s performance review report (Apr. 2014) Health Technology Assessment Public Payer Decision-Making
  9. 9. C -PAY 9 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
  10. 10. 10 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
  11. 11. 11 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
  12. 12. What can patients do in this context? 12
  13. 13. 13 DISCUSSION

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