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Drug Approval Bodies in Canada 101: The Elevator Length Pitch


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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

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Drug Approval Bodies in Canada 101: The Elevator Length Pitch

  1. 1. What you should know about drug approval bodies in Canada 101: The Elevator Length Pitch
  2. 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. 3. In 2014, Canadians spent an estimated $28.8 billion on prescribed drugs 3 Total Health Expenditure, by Use of Funds, Canada, 2014f
  4. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 25. 613-898-1871 or @survivornetca Facebook: CanadianSurvivorNet Pinterest: survivornetwork 1.800.460.5832 / @saveyourskinfdn @sauvetapeau Facebook: @SaveYourSkinFoundation @SauveTaPeau 1.800.449.6830 or @peace_of_minds Facebook: Schizophrenia Society of Ontario
  26. 26. Questions?