Decision Makers and Decision-Making Processes Diagram
Model description and Symbols:
The ultimate decision maker is listed at the top of the model
Boxes: Decision-making bodies
Solid Arrows: Required step in decision-making process
Broken Arrows: May or may not impact decision
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Canada’s population is 34 million people, about 75 percent of whom live within 100 miles (161 kilometers) of the US border.1 Over 60 percent of the population lives in the central provinces of Ontario and Quebec, the two largest of the 10 provinces.
Canada has Medicare, a universal (publicly funded) healthcare since the 1960s; however, medication, except drugs administered in hospitals and for certain special populations, is not covered through the universal, publicly funded, Medicare program.2 Thus, the majority of the population (about 66%) obtains drug coverage through private insurers, either through their employers or purchased individually.2 For public funding, each Canadian province and territory operates its own drug plan, which primarily covers seniors, welfare recipients, and other groups for whom drug costs represent a significant financial burden. Some provinces (such as Alberta, British Columbia, Saskatchewan and Quebec) make their drug plans available to all residents who choose to join the plan (Alberta, British Columbia, Saskatchewan) or lack private drug coverage (Quebec). Moreover, the federal government has established drug plans for First Nations (Non-Insured Health Benefits), veterans, penitentiary inmates, armed services personnel, and the federal police. Altogether, approximately 10 million Canadians are covered by publicly funded drug plans, nine million through the provincial plans and another million through the federal one while 10 percent of Canadians lack basic drug coverage.2
Health Canada (the federal health is responsible for product licensure while provincial bodies control healthcare funding. However, national bodies are important in advising formulary decision making. Quebec, predominately French speaking, does not, for the most part, participate in such pan-Canadian processes that serve the rest of the country (English speaking). Formulary decisions are rendered province by province, hospital by hospital and in some cases, separately for diseases such as cancer and HIV/AIDS.
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DECISION-MAKERS AND INFLUENCERS
The federal health department is responsible for approving new drugs based on their safety and efficacy, among other factors. Health Canada releases a formal marketing and distribution authorization (Notice of Compliance [NOC]) if the new drug’s profile conforms to the Food and Drugs Act and Regulations. Health Canada is also responsible for promoting healthy living to Canadians by communicating information on disease prevention, drug safety, and other health-related issues.
The Patented Medicine Prices Review Board (PMPRB)
The PMPRB is an independent body within the federal health portfolio, responsible for regulating drug prices for all prescription and non-prescription patented drugs sold in Canada. PMPRB submits to the federal parliament, through the Minister of Health, an annual report including analyses of patented drug prices, price trends, and research and development expenditures of patent-holding drug manufacturers.
The Canadian Agency for Drugs and Technologies in Health (CADTH)
CADTH is an independent, not-for-profit agency funded by federal, provincial, and territorial governments, to provide evidence-based information about the effectiveness of drugs and other health technologies to Canadian healthcare decisionmakers. CADTH fulfils its mandate through the Health Technology Assessment (HTA) program, the Common Drug Review (CDR; see below) process, and the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) which identifies and promotes optimal drug therapy.
The Common Drug Review (CDR)
Under CADTH’s mandate, the CDR process accepts drug submissions from manufacturers, conducts systematic drug reviews, and provides participating public drug plans (federal, territorial, and all Canadian provinces except Québec) with evidence-based clinical and economic information, and expert advice, to support their formulary listing decisions.
The Canadian Expert Drug Advisory Committee (CEDAC)
As part of the CDR process, CEDAC is composed of drug therapy and evaluation experts, who make formulary listing recommendations to participating drug plans based on scientific evidence and current clinical practice.
pan-Canadian Oncology Drug Review Process (pCODR)
pCODR is a cross-jurisdictional review process for all oncology drugs, based on Ontario’s existing cancer drug review. Participating provinces (Manitoba, Saskatchewan, British Columbia, Alberta, Nova Scotia, Newfoundland, Prince Edward Island, and New Brunswick) each make their own final funding decision based on input from the Committee to Evaluate Drugs (CED) and the CED-Cancer Care Ontario (CCO) Subcommittee.
Conseil du médicament - Québec
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This provincial body accepts drug submissions from manufacturers and makes recommendations concerning listing a drug on the provincial drug formulary (Liste de medicaments). Final listing decision is made by Québec’s Minister of Health.
The Common Drug Review (CDR) process (all provinces except Quebec)
Until 2002, separate submissions for formulary listing were made to each regional health plan. Submission requirements varied between drug plans. However, all economic evaluations had to comply with either the Ontario economic guidelines3 or those developed under the auspices of the Canadian Coordinating Office for Health Technology Assessment (CCOHTA, now CADTH) in 1994.4
In 2002, Canada initiated the Common Drug Review (CDR) to harmonize the drug review process across the country, in an attempt to optimize the use of healthcare resources and reduce duplication of effort. A CDR submission represents a submission to all participating institutions, including all federal (this covers Non-Insured Health Benefits, the Department of National Defense, Veterans Affairs Canada, the Royal Canadian Mounted Police and Correctional Service Canada), provincial (all provinces, except Quebec) and territorial (Northwest Territories, Yukon, Nunavut) drug plans.5 The CDR accepts submissions for drugs and combination products (i.e., drugs consisting of two or more active moieties) not previously marketed in Canada, and, under specific circumstances, submissions for new indications.5 Alberta and British Columbia continue to want submissions for oral HIV/AIDS products made directly to their reimbursement agencies (i.e., Alberta Health and Wellness and British Columbia Centre of Excellence in HIV/AIDS).5
The goal of the CDR is to provide participating drug plans with formulary listing recommendations based on a consistent, scientifically rigorous, evidence-based review. Manufacturers submit a dossier to CDR. A review of each product submission is performed by internal reviewers (CDR staff) and external clinical and health economic experts, and sent to the manufacturer for comment.5 The review, manufacturer comments and reviewer replies to the comments are then submitted to CEDAC who meet monthly for deliberation and recommendation.5 CEDAC may recommend a drug (a) be listed, (b) be listed with restrictions, or (c) not be listed at all. The listing recommendation is posted on CADTH’s website. The final listing decision rests with each public drug plan and depends on individual mandates, priorities, and local resources.
The CDR does not review products used for the active treatment of cancer; these are submitted to the pan-Canadian Oncology Drug Review (pCODR). Line extensions for established products are also not submitted to the CDR but directly to individual drug plans. Quebec’s public drug plan requires separate formulary submissions, independent of CDR or pCODR. In addition, the province of Ontario has established a Rapid Review Process that is independent of the CDR Process.
The pan-Canadian Oncology Drug Review (pCODR) process (all provinces except Quebec)
Submissions for drug products for active treatment of cancer that may potentially be funded by the participating provincial and territorial drug plans (i.e., federal, provincial and territorial drug plans, except Quebec) are directed to pCODR who will make a listing recommendation. pCODR is a newly established evidence based cancer drug review process with the role of assessing clinical evidence and cost-effectiveness of new cancer drugs. Manufacturers submit a dossier to the pCODR expert review committee, which also takes into account input by patients and clinician-based tumor groups. The precise submission and review process is currently under review and organizations planning to submit a drug for review are encouraged to begin pre-submission planning activities via email (email@example.com).
Ontario’s Rapid Review Process
Ontario is participating in the CDR and the pCODR processes. However, a product may qualify for the Rapid Review Process, which is independent of the CDR, if evidence is submitted showing that the new chemical entity will either fill a significant unmet medical need or that listing will result in significant savings for the drug plan or the Province. Rapid Review submissions can be made before receipt of the Health Canada Notice of Compliance (NOC, but not earlier than 90 days before expected NOC issuance). Rapid Review submissions filed at least 60 days pre-NOC are eligible to receive a listing decision within 30 days of NOC issuance. Listing decisions are made by the Assistant Deputy Minister and Executive Officer, Ontario Public Drug Programs. (Note that the CDR has also recently piloted a pre-NOC rapid review process.)
Quebec’s Régime Public D’Assurance Médicaments (Public Drug Insurance Program) provides drug coverage to seniors, welfare recipients, and residents without private drug insurance. The last are required to join the public plan (universal coverage). About 43 percent of Quebeckers are covered by the public plan.2 To obtain listing on the Quebec formulary (i.e., Liste de Médicaments Assurés) for any potentially covered drug, manufacturers submit a dossier to the Conseil du Médicament, which makes a listing recommendation. The listing decision is made by the Minister of Health and Social Services. The formulary is published three times a year and is available online in a downloadable format.
Hospitals maintain their own formularies through Pharmaceuticals and Therapeutics Committees. Dossiers must be submitted to individual hospitals or hospital consortia.2
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Private payers in Canada may cover all Health Canada approved drugs, establish their own formularies, or follow the public drug plan in their province.2 In Quebec, private insurers are required to cover at least all drugs listed in the provincial formulary.2 Many private drug plans ask for submission dossiers and specific requirements vary by plan.2
REIMBURSEMENT AND PRICING APPROVAL PROCESS
Pricing approval for brand pharmaceuticals in Canada is regulated by the federal government, through the PMPRB. It acts in a regulatory capacity, to ensure that prices charged by patentees for patented medicines sold in Canada are not excessive. The price of non-patented drugs, such as generics, is not regulated by the PMPRB. For each strength of each dosage form of each patented medicine sold in Canada, patentees are required to file price and sales information twice a year for price regulation purposes.6
The reimbursement process in Canada is governed by a combination of federal, provincial and private plans. Through the publically-funded Medicare system, all Canadians and residents have free access to coverage for drugs, procedures, and physician services provided in hospitals.7 Hospital drug formularies are under provincial purview. Outside the hospital setting, drugs are reimbursed to the majority of Canadians by private health insurance plans, either to employees and their families through employer group insurance, or to other persons and their families on an individual basis. Some vulnerable groups, such as seniors, welfare recipients, and native persons, are covered by specific provincial, territorial, or federal plans. Most plans involve copayments and deductibles so that patients contribute to the costs of reimbursed medicines.2
Data requirements are specific to each jurisdiction for which listing status is sought. However there are requirements that are common to all or most jurisdictions; these include:
a) the price to be charged for all dosage forms
b) product characteristics (from the Product Monograph)
c) clinical efficacy and safety data
e) economic evaluation
f) budget impact assessment.
Below specific data requirements are outlined for a CDR submission and for a submission to Quebec’s Conseil du medicament.
One key requirement for a CDR submission is evidence for the efficacy, effectiveness and safety of a product.5 Copies of published and unpublished key clinical trials are required, as well as, for ongoing studies, new data generated after marketing authorization was obtained. In addition, a list of all completed and ongoing published and unpublished clinical trials needs to be provided.5
Submission of an appropriate economic evaluation, following the most recent CADTH guidelines,8 is another key requirement of the CDR process. 5 The type of evaluation to be performed depends on the product.5
Cost-effectiveness or cost-utility analyses are required if the drug: a) is the first available (no other products listed) to treat a disease or disorder or has established a new therapeutic class; b) has demonstrated differences in safety or efficacy versus comparators in head-to-head randomized controlled trials; or c) in the absence of head-to-head trials, the manufacturer assumes that such differences exist. (Evidence to support this claim must be provided.) Cost-effectiveness or cost-utility analyses must be based on final outcomes, such as life-years, QALYs or important events (e.g., fracture, stroke, or myocardial infarction), or validated surrogate outcomes.
Products demonstrating benefits in other outcomes (e.g. patient-reported, non-clinical, or surrogate) only require cost-consequence analyses. For all other products, only detailed price comparison and cost tables are to be submitted.5
Budget impact analyses (BIAs) are also required for CDR submissions for most of the participating drug plans.5 Unless a priority review is requested, BIAs don’t need to be included with the initial submission package, but must follow it within 20 business days.5 Each BIA must meet the specifications of its respective drug plan, and be supported by current market data and regional information. Product information approved by Health Canada, local epidemiological data (prevalence or incidence) where available, and detailed pricing information are also required.5
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With regard to evidence of clinical efficacy and safety, Quebec stipulates that a maximum of five clinical studies can be submitted, including at least one randomized controlled trial published or accepted for publication in a peer-reviewed biomedical journal. In addition to a economic evaluation according to CADTH guidelines,8 Quebec’s Conseil du médicament requires a detailed price justification.9 Information about the disease of interest — including duration, progression and stages — and the projected impact of the product on the healthcare system also needs to be included in the dossier.9
- BIA: Budget Impact Analysis
- CADTH: Canadian Agency for Drugs and Technologies in Health
- CCO: Cancer Care Ontario
- CCHOTA: Canadian Coordinating Office for Health Technology Assessment
- CDR: Common Drug Review
- CED: Committee to Evaluate Drugs
- CEDAC: Canadian Expert Drug Advisory Committee
- pCODR: Pan-Canadian Oncology Drug Review
- NOC: Notice of Compliance
- PMPRB: Patented Medicine Prices Review Board
- QALY: Quality-adjusted life-year
Please refer to references below.
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- National Geographic Society. Canada Facts. 2011. http://travel.nationalgeographic.com/travel/countries/canada-facts/. (Accessed 17 Feb 2011).
- Paris V and Docteur E. Pharmaceutical pricing and reimbursement policies in Canada. 2007. http://www.oecd.org/document/57/0,3343,en_2649_37407_35715449_1_1_1_1,00.html. (Accessed 2 Feb 2010).
- Ontario Ministry of Health and Long-Term Care. Ontario guidelines for economic analysis of pharmaceutical products. 1994. http://www.health.gov.on.ca/english/providers/pub/pub_menus/pub_drugs.html. (Accessed 14 Feb 2006).
- Canadian Coordinating Office for Health Technology Assessment. Guidelines for economic evaluation of pharmaceuticals: Canada. Ottawa, ON: Canadian Coordinating Office for Health Technology Assessment - CCOHTA, 1994.
- Canadian Agency for Drugs and Technologies in Health. Common Drug Review Submission Guidelines for Manufacturers. 2009. http://cadth.ca/index.php/en/cdr/filing-submission. (Accessed 23 Dec 2009).
- Mandate. 2010. http://www.pmprb-cepmb.gc.ca/english/View.asp?x=1440.
- Canada's Health Care System (Medicare). 2010. http://www.hc-sc.gc.ca/hcs-sss/medi-assur/index-eng.php.
- Canadian Agency for Drugs and Technologies in Health. Guidelines for the economic evaluation of health technologies: Canada. 2006. http://www.cadth.ca. (Accessed 23 Dec 2009).
- Conseil du Médicament Québec. Éléments requis pour les demandes d'inscription. 2008. http://www.cdm.gouv.qc.ca/site/fr_liste_demandes_inscription.phtml. (Accessed 30 Oct 2009).
AUTHORS & CONTRIBUTORS
Hanane Khoury PhD, Bill O’Neil PhD, Monika Wagner PhD and Sharon Welner PhD, BioMedCom Consultants Inc, Montreal, Quebec, Canada
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