Glossary

Business day: Any weekday that is not a statutory holiday, when the pCPA is open for business during regular hours.

Calculated unit price: The price of a drug as determined by a pCPA assessment.

Canada’s Drug Agency (CDA-AMC): An independent, not-for-profit organization and health technology assessment (HTA) body informing public drug plan decisions in Canada (except Québec). Its purpose is “to power evidence-driven drug, health technology, and health system decisions.” 

Canadian Drug Expert Committee (CDEC): A CDA-AMC committee “composed of individuals from across Canada with expertise in drug therapy, drug evaluation, and drug utilization, as well as patient representatives”. The committee makes reimbursement recommendations for drugs that aren’t cancer drugs.

Common drug review (CDR): A CDA-AMC process that “evaluates clinical, economic, and patient evidence for drugs and provides reimbursement recommendations and advice to Canada’s federal, provincial, and territorial public drug plans (except Québec)”. Also called a reimbursement review. 

Close letter: A letter the pCPA sends to the manufacturer letting them know that a negotiation won’t take place for a given drug, or that a negotiation has been closed without agreement. 

Canadian reference product (CRP): An original brand-name drug (also called an innovator product) and the standard that generic or biosimilar versions of the drug are evaluated against.

Drug identification number (DIN): A unique number assigned by Health Canada to any prescription or over-the-counter drug that has been approved for sale in Canada. It identifies the drug’s key characteristics, including manufacturer, active ingredients, dosage strength, and how it’s administered (for example, by mouth or injection).

Drug: According to the definition in Canada’s Food and Drugs Act, a drug is any substance or combination of substances used to:

• Diagnose, treat, prevent, or relieve disease symptoms in people or animals
• Change how the body works, such as restoring or improving normal functions
• Disinfect places where food is made, handled, or stored

This includes natural health products but generally excludes medical devices.

Early negotiation process (ENP): An expedited negotiation pathway for cancer drugs that are part of Project Orbis. It begins earlier than the pCPA’s standard negotiation process (when the CDA-AMC or INESSS accept a submission, rather than when a final reimbursement recommendation is published).

Existing drug: A drug that’s already reimbursed by 1 or more public drug plans. It may be brought to the pCPA for review and reassessment if there are changes in the clinical landscape, market conditions, or product listing agreements. When a new indication is approved for an existing drug, it’s treated like a new drug in our negotiation processes. 

Existing generic category: A group of generic drugs with the same active ingredient, dosage strength, and brand reference product, and that has already been created and priced through the tiered pricing framework (TPF). 

Exiting manufacturer: A manufacturer that is removing 1 or more of its products (as identified by its DIN or natural product number (NPN)) from the Canadian market.

Federal drug plans: Participating federal programs that provide benefits for eligible groups, including Non-Insured Health Benefits (NIHB), Correctional Service Canada (CSC), Veterans Affairs Canada (VAC), and the Department of National Defence (DND). 

Formulary Management Expert Committee (FMEC): “An appointed, pan-Canadian advisory body” of the CDA-AMC, “comprising individuals with expertise in drug therapy, drug evaluation, drug utilization, and economics.” The committee makes recommendations for specialized reviews that are distinct from standard HTA processes, as requested by public drug plans. These include non-sponsored single drug reviews, streamlined drug class reviews, and therapeutic reviews. 

Formulary: The list of drugs that a public plan will pay for, including any conditions for coverage, such as eligibility criteria or prescribing requirements. 

Historical products: Generic drugs whose brand-name reference drug is classified as cancelled post-market (meaning it was previously available, but is no longer sold in Canada), as recorded in Health Canada’s Drug Product Database on or before April 1, 2014.

Hold letter: A letter the pCPA sends to the manufacturer letting them know that a negotiation won’t take place for a given drug for a defined period of time. 

Health technology assessment (HTA): A structured review of a drug that looks at clinical evidence, cost-effectiveness, and broader impacts on patients and the healthcare system. Organizations like the CDA-AMC and Institut national d’excellence en santé et en services sociaux (INESSS) use HTAs to make recommendations about whether a drug should be covered by public drug plans, and what conditions should apply.

• CDA-AMC reimbursement recommendations help inform pCPA negotiations and listing decisions by public drug plans throughout Canada, except Québec. 
• INESSS recommendations help inform pCPA negotiations and listing decisions by Québec’s public drug plan.
• Federal drug plans, with beneficiaries across Canada, primarily use CDA-AMC reimbursement recommendations as a guide but also consider INESSS’ recommendations. 

Indication: The approved use of a drug, meaning the specific disease, conditions, or symptoms it’s intended to treat, prevent, or diagnose. Some drugs have multiple indications.

Institut national d’excellence en santé et en services sociaux (INESSS): An independent governmental agency and the main HTA body informing public drug plan decisions in Québec. Its mission is “to promote clinical excellence and the efficient use of resources in the health and social services sector.”

Jurisdiction: A participating public drug plan in Canada that takes part in pCPA negotiations and makes its own decisions about drug coverage. Our member jurisdictions include public drug plans in all provinces and territories and the Government of Canada.

Lead: Representative identified to act on behalf of the pCPA during a negotiation. Some negotiations are led by pCPA staff, while others are led in partnership by the pCPA and a drug plan. In all cases, the work is done on behalf of the collective.

Letter of acknowledgement (LOA): A letter the pCPA sends to the manufacturer to confirm we’re aware an HTA reimbursement recommendation has been issued, or that one of its expedited negotiation processes has been initiated.

Letter of engagement (LOE): A letter the pCPA sends to the manufacturer letting them know that we’ll engage in negotiation for a drug. This letter identifies the public drug plans that will participate in the negotiation, and who will lead the negotiation on behalf of the pCPA.

Letter of intent (LOI): A document detailing the negotiated terms and conditions of an agreement between the pCPA and a manufacturer (such as price and patient eligibility) at the end of a successful negotiation. These terms must then be reflected in a product listing agreement (PLA) between a public drug plan and the manufacturer before the drug can be listed. 

Line extension: A new version of an existing drug that uses the same active ingredient in a higher or lower dosage strength, an alternative dosage form (for example, tablet, liquid, or cream), or a different route of administration (for example, by mouth, injection, or inhalation).

Manufacturer: A pharmaceutical company that submits or resubmits a proposal to the pCPA for a drug to be negotiated. For simplicity, we also use this term to include companies that sell a drug in Canada on behalf of the original manufacturer. 

Market entrant: A new generic drug (with a DIN or NPN) entering the Canadian market or seeking public drug plan coverage.

Market entry assessment: A review of a new generic drug entering the market. It looks at how the new drug may affect pricing, including a change in pricing tier or adjustments to the prices of drugs in the same generic category.

Market exit assessment: A review that happens when a generic drug leaves the Canadian market (on or after April 1, 2018). It looks at how the exit may affect pricing, including a possible change in pricing tier or adjustments to the prices of remaining drugs in the same generic category.

Market exit: When a generic drug leaves the Canadian market. This can happen if its DIN or NPN is cancelled, becomes dormant (inactive), or the drug is discontinued and no longer available.

Natural product number (NPN): A unique number assigned by Health Canada to approved natural health products, such as vitamins, minerals, and herbal remedies. 

Negotiation: The meetings, discussions, and activities that take place between lead(s) from the pCPA and the manufacturer after the pCPA sends a letter of engagement, until either an agreement is reached and terms are reflected in an LOI, or the pCPA sends a close letter indicating negotiations concluded without an agreement. 

New drug: A drug that has received a new final HTA reimbursement recommendation. 

New generic category: A group of generic drugs with the same active ingredient, dosage strength, and brand reference product that’s being created and priced for the first time through the TPF. This typically happens when a generic version of a drug becomes available and no existing category applies.

Not/non-assessable product: A generic drug that isn’t eligible for a TPF assessment. This applies to drugs listed on a public plan before April 1, 2014 that aren’t part of an existing generic category. Instead of a full assessment, the pCPA provides a suggested submitted price. 

Non-formulary: Drugs that aren’t on a drug plan’s formulary, or list of covered drugs. 

Non-formulary benefits: A way for patients to get coverage for a drug that isn’t usually covered, such as the Ontario Exceptional Access Program (EAP).

Notice of Compliance (NOC): An official approval issued by Health Canada after reviewing a drug’s safety, efficacy, and quality. Once an NOC is granted, the drug can be marketed and sold in Canada.

Notice of Compliance with Conditions (NOC/c): A conditional approval issued by Health Canada that allows a drug to be sold in Canada while more evidence is gathered. This applies to promising drugs that address serious conditions, where early access is important. Conditions include requirements to collect additional data to confirm the drug’s benefits and safety.

pCPA temporary access process (pTAP): An expedited negotiation pathway for drugs with an NOC/c approved through the CDA-AMC’s time-limited recommendation (TLR) pathway. It enables early, temporary public coverage for promising drugs while confirmatory evidence is being gathered.

Participating jurisdiction: A public drug plan participating in a negotiation, as identified in the LOE.

pan-Canadian Pharmaceutical Alliance (pCPA): A stand-alone, not-for-profit organization that negotiates drug prices with manufacturers on behalf of public drug plans in Canada. 

pan-Canadian Oncology Drug Expert Review Committee (pERC): A CDA-AMC committee made up of “individuals from across Canada with expertise in cancer drug therapy, drug evaluation, and drug utilization, as well as patient representatives.” The committee makes reimbursement recommendations for cancer drugs. 

Pharmaceuticals with anticipated comparable efficacy and safety (PACES): One of the CDA-AMC’s tailored review processes, for drugs that already have strong evidence or a well-understood therapeutic area or are clearly comparable to other drugs already on the market. It’s a flexible and streamlined HTA approach that enables faster reimbursement recommendations. 

Patented Medicine Prices Review Board (PMPRB): A federal agency that regulates the introductory prices of patented medicines sold in Canada to ensure they’re not excessive. 

Product distribution: The availability of a generic drug for sale and distribution through a provincial wholesaler. 

Product listing agreement (PLA): An agreement between a drug manufacturer and a public drug plan that sets the terms and conditions for public coverage of a drug, consistent with the LOI. 

Project Orbis: “An international partnership designed to give cancer patients faster access to promising cancer treatments.”

Proposal: An offer the manufacturer submits during a negotiation outlining the proposed terms for funding a drug in the participating jurisdictions. 

Submitting manufacturer: The manufacturer that submits a market entry or market exit request for pCPA assessment.

Subsequent entry biologic (SEB): Former term for biosimilar drugs. A biologic drug approved by Health Canada after the original reference biologic. Learn more the Drugs we negotiate page.

Suggested submitted price: The lowest price for the same generic drug (with a DIN or NPN) that’s publicly listed anywhere in Canada.

Targeted negotiation process (TNP): An expedited negotiation pathway that streamlines non-complex negotiations, including those for drugs that are comparable to others already available in the market. 

Time-limited recommendation (TLR): A CDA-AMC “recommendation to publicly fund a drug or drug regimen for a certain period of time on the condition the manufacturer will conduct ongoing clinical studies that address uncertainty in the evidence.” TLRs apply to promising drugs approved by Health Canada with a NOC/c and are subject to future reassessment by the CDA-AMC.

Unmet need: According to the CDA-AMC, this refers to situations where current treatments don’t adequately address a health condition, either because no effective treatment exists, or existing treatments have significant limitations, such as poor effectiveness, safety concerns, or low acceptability to patients.

Unsolicited offer: A proposal submitted by a manufacturer to the pCPA outside of active negotiations, including before an LOE is issued, or to indicate interest in reinitiating negotiations after a file closed without an agreement. Unsolicited offers may also be used for some line extensions, or to introduce an existing drug to new jurisdictions.