Glossary of Drug Plan Terms

Glossary of Commonly Used Public Drug Plan Terms

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AAC: Actual acquisition cost: AAC is adjusted to reflect the true cost to the pharmacy and is net of any cash discounts, volume discounts, rebates or performance allowances.

ACP: Advisory Committee on Pharmaceuticals.

ACP Member: A member of the Advisory Committee on Pharmaceuticals.

ACP Term of Reference: The Terms of Reference established for the ACP by CADTH's Board of Directors.

Additional Information: Any information (excluding New Information) that is requested by the Review Team, CEDAC or CDR Directorate that is required to complete the review of the Submission or Resubmission or to explain or clarify information related to the Submission or Resubmission. Providing this information does not affect the review queue; however, if there is a delay in providing it or if the quantity and complexity of the requested information is significant, there may be a consequent delay in completion of the review.

Adjudicate: Decide about a claim based on a set of rules or polices. Refer to claims adjustment.

Adjudication Date: The date, as determined by the processor, on which the claim, transaction or request being responded to has been adjudicated.

Adverse Drug Reaction: A negative reaction to a particular drug or excipient. This definition includes allergic reactions to a drug.

AHFS: American Hospital Formulary Service.

Applicant: The person, corporation or entity filing a Submission or Resubmission.

Appropriate comparator(s): Currently accepted therapy.

Benefit: A drug or product defined by a Drug Identification Number (DIN) or Product Identification Number (PIN) which is eligible for full or partial payment by PharmaCare.

Bioequivalence: A high degree of similarity in the rate and extent of absorption into the systemic circulation of two comparable pharmaceutical products from the same dose, that are unlikely to produce clinically relevant differences in therapeutic effects or adverse effects, or both.

Brand Drug Name: A patented medication produced by a brand name drug company.

Budget Impact Analysis or BIA: An analysis of the impact of a new Drug product on Drug Plan Expenditures.

Business Day: Any day, other than a Saturday, Sunday, statutory holiday, or company holiday on which the Canadian Agency for Drugs and Technologies in Health (CADTH) office in Ottawa, ON is open for business during normal business hours.

CADTH: Canadian Agency for Drug and Technologies in Health, a body corporate duly incorporated under the laws of Canada.

CDR: Common Drug Review.

CDR Director: The CADTH staff person appointed as director of the CDR Directorate.

CDR Directorate: The Directorate established within CADTH to support the CDR process.

CDR Nominating Committee: The nominating committee established according to the CEDAC Terms of Reference for recommending candidates for appointment to CEDAC.

CEDAC: Canadian Expect Drug Advisory Committee.

CEDAC BRIEF: A brief prepared by CDR Directorate staff for the members of CEDAC consisting of but not limited to:

• The Manufacturer's Executive Summary of the Submission or Resubmission
• A list of unpublished studies known to the Manufacturer
• The Reviewers' Reports relating to the Submission or Resubmission
• The Manufacturer's written comments about the Reviewers' Reports, if any, and
• The Reviewers' Replies, if any.

CEDAC Member: A member of the Canadian Expert Drug Advisory Committee.

Clarification: A written response, approved by the CEDAC Chair, to a Drug Plan's Request for Clarification of a CEDAC Recommendation.

Claim: A request submitted manually or electronically, for payment of the cost of providing a product or service.

Claim History: A record of claims and expenditure information for each patient.

Class: All the differently named products containing the same amount of the same drug.

CLHIA: Canadian Life and Health Insurance Association: As a trade association, the CLHIA exists to serve its member companies in areas of common need and concern, providing leadership by acting in their best interests and those of the public.

Client Registry: Information maintained by the Ministry of Health, including databases and access routines, intended to keep track of persons and organizations served by, or providing service to, the Ministry. The client Registry is the control point for issuing of new Personal Health Numbers.

Clinical Benefit: Outcomes that have an overall positive impact on the treatment of a disease.

Clinical Review: The review of published and unpublished information about the comparative safety, efficacy, effectiveness (when available) and use of a Drug in the management of a disease or condition.

Clinical Reviewer: A Reviewer who conducts a Clinical Review.

Code of Conduct: The code of conduct for CADTH committees approved by CADTH's Board of Directors.

Common Technical Document (CTD): A common international format that may be used by drug sponsors to submit information supporting new drug applications to regulatory authorities for review. The United States, the European Union, Japan, Australia and now Canada all use this format.

Conflict of Interest Guidelines or COI Guidelines: The conflict of interest guidelines adopted by CADTH's Broad of Directors for CEDAC, Reviewers and external experts.

Confidentiality Information: Has the meaning given to it in the Confidentiality Guidelines.

Confidentiality Guidelines: The guidelines respecting confidentiality adopted by the CADTH Board in respect of CDR.

Co-pay or Co-payment: The co-pay is the amount you or your family is required to contribute towards the eligible costs of a prescription.

CPhA: Canadian Pharmacists Association: National voluntary organization of pharmacists self-mandated to promote the profession of pharmacy.

Cost/Benefit Analysis: A numerical evaluation of the actual or proposed value of specific process, including calculating the cost of the program and comparing that to the financial outcomes in the form of savings which can be expected from the program.

Deductible: The amount a family is responsible for prior to assistance for your family in paying for further eligible costs for the remainder of the calendar year.

Demographic Information: Basic, non-clinical information about an individual recorded on PharmaNet, usually including full name, gender, address, postal code, and telephone number.

DIN/GP#: A number assigned to each drug product marketed under the Food and Drug regulations by the Health Protection Branch of Health Canada. The DIN identifies only one product.

Directive: A written directive (an Update) from CADTH amending, interpreting or clarifying any process, procedure, guidelines, terms of reference, code of conduct or document relating to the CDR.

DND: Department of National Defence.

DOB: Date of birth.

Dosette Packaging: Single doses packaged individually, e.g., in blister packs.

Drug: An active substance considered to be a drug under the Canadian Food and Drug Act and Regulations, which is sold for human use.

Drug Cost/ Product Value: Total cost of ingredients in a prescription, or total value of supplies issued.

Drug Identification Number (DIN): A number assigned to each drug product marketed under the Food and Drug regulations by the Health Protection Branch of Health Canada. The DIN identifies only one product.

Drug Monograph: Clinical data that provides a healthcare professional with information on the proper use, side effects, etc., of the medication being dispensed. Often, a monograph contains educational or counseling information intended to be understood by and printed out for a patient.

Drug Plans: The participating publicly funded federal/provincial/territorial drug plans.

EDRDs: Expensive Drugs for Rare Diseases

Effectiveness: Whether a drug achieves its desired effect in the real world.

Embargo Period: Refers to a period of time [ten (10) Business Days following the issuance of the Recommendation and Reasons for Recommendation] during which the Recommendation and Reasons for Recommendation are neither acted on by Drug Plans nor are they publicly available. During this period the Manufacturer may submit a Request for Reconsideration or ACP or Drug Plans may submit a Request for Clarification.

External Expert: An individual with appropriate qualifications and expertise that are required for some aspect of the review of the Submission or Resubmission whose services are obtained on a contract basis as required.

Final Reasons for Recommendation: The Reasons for Recommendation attached to the Notice of Final Recommendation.

Final Recommendation: The applicable Recommendation, or recommendation on Reconsideration, attached to the Notice of Final Recommendation.

Formulary: A list of Drugs that are covered as benefits as determined by each Drug Plan.

F/P/T: Federal, Provincial and Territorial.

Generic Drug: A medication that is chemically equivalent to an existing brand name medication and is manufactured by a generic drug company to compete with the brand name product.

GP#: General product identification number assigned to a drug product by the Health Protection Branch of Health Canada.

Information Specialist: A CADTH staff member who specializes in information retrieval and management in a health science research environment.

Investigational Drug: This is a obsolete term. Refer to special Access Program (SAP) drug.

LCA: Low Cost Alternative (See Low Cost Alternative)

Low Cost Alternative: The alternative with the lowest average price (claimed on PharmaNet) of all products usually in the same generic class.

LTC: Long-term Care

Manufacturer: A Drug manufacturer.

Maximum Days' Supply: The maximum number of days worth of treatment paid for a prescription, which is either 30 days or 100 days depending on various circumstances.

Medical device: Any article or instrument used in the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, and in restoring, correcting or modifying organic functions in humans or animals. Devices also include those used in the prevention, diagnosis and care of pregnancy and do not include a drug.

Medication History: Prescription history for each patient Personal Health Number (PHN).

MHC: Mental Health Centre.

Multi-doctoring: When a patient, having obtained a prescription from a doctor, seeks to obtain a prescription from another doctor for an identical or equivalent drug within a short time period.

New Active Substance:

• A chemical or biological substance not previously approved for sale in Canada as a drug; or
• An isomer, derivative or salt of a chemical substance previously approved for sale as a drug in Canada but differing in properties with regard to safety and efficacy; or
• A biological substance previously approved for sale in Canada as a drug, but differing in molecular structure, nature of the source material or manufacturing process.

New Combination: Consists of two or more Drugs that have not been previously marketed in Canada in that combination. It may consist of either two or more New Drugs or two or more previously marketed Drugs or a combination of New Drug(s) and previously marketed Drug(s).

New Drug: A New Active Substance that has not previously been marketed in Canada.

New Information: New clinical information (not previously submitted or published) or new cost information that significantly impacts on the cost-effectiveness of the Drug and which does not form part of the original Submission or Resubmission.

If the New Information is in support of improved efficacy, it must be in the form of a randomized controlled trial. If the New Information is in support of improved safety, case-control or cohort studies will be accepted if randomized controlled trials are unavailable.

NOC or NOC/c: Notice of Compliance or Notice of Compliance with Conditions issued by Health Canada, giving authorization to market a drug in Canada.

Non-Insured Health Benefits (NIHB): Federal government coverage of health benefits provided to First Nations by Health Canada.

Notice of Final Recommendation: The notice issued according to Section 7 of the Procedure for Common Drug Review.

Old Drug: Any drug that is not a New Drug.

On-line Adjudication: Processing of a claim immediately, to determine eligibility (pharmacy, prescriber, practitioner, pharmacist, and drug), the drug cost and professional fee claimed, and the cardholder portion. With on-line adjudication, the claim adjudication result is sent to the pharmacy's system immediately.

OOP: Out of Province.

OTC: Over the counter: medications that can be obtained without a doctor's prescription.

Participants: Unless otherwise stated, CADTH staff, Reviewers, CEDAC Members and any experts retained to assist in the CDR process.

Patent: An instrument issued by the Commissioner of Patents in the form of letters patent for an invention. The patent provides its holder and its holder's legal representatives with the exclusive right to make, construct, use and sell the invention for a designated period.

Patient Record: Information recorded regarding a patient, including PHN, demographic information, medical and clinical information, medication history, and any adverse drug reaction data.

Personal Health Number (PHN): A unique identification number assigned to each health card holder. This number is used to store and retrieve all patient information.

Pharmacoeconomic Review: The critical appraisal of the published and unpublished information about costs and consequences of Drugs and their impact on individuals, health care systems and society (i.e., value for money of Drugs).

Pharmacoeconomic Reviewer: Means a Reviewer who conducts a Pharmacoeconomic Review.

PIN: Product Identification Number.

Practitioner: A person authorized to practice medicine, dentistry, veterinary medicine, or a prescribed health care profession in which a practitioner of that profession is authorized to prescribe drugs or devices.

Practitioner ID: A unique number assigned to practitioner by the practitioner licensing body.

Prescriber: Any health professional authorized to prescribe medications or treatment to a patient.

Priority Review: A preferred status in the review queue and on the CEDAC agenda for drugs meeting the Priority Review Criteria. All steps in the CDR procedure are completed and timelines are not truncated.

Product: An item that may be requested on a prescription and/or claim. A product may or may not be a drug, e.g.., blood glucose monitoring strips.

Product Identification Number: An assigned number for a product or compound that does not have a federally-assigned Drug Identification Number.

Radiopharmaceuticals: A pharmaceutical, biological or drug that contains a radioactive entity. Radiopharmaceuticals are primarily used for various imaging functions but can also be used in a therapeutic capacity.

RDP: Reference Drug Program.

Reasons for Recommendation: The detailed, written reasons given by CEDAC regarding Recommendations, or Recommendations on Reconsideration, made by CEDAC.

Recommendation: An evidence based recommendation, made after consideration of Review Criteria, by CEDAC in response to a Submission or Resubmission made by a Manufacturer, ACP or by one or more Drug Plan.

Recommendation on Reconsideration: The conclusion reached by CEDAC on reconsideration of the Submission or Resubmission as described in Section 6.4.4(a) of the Procedure for Common Drug Review.

Reconsideration Brief: The CEDAC Brief, CEDAC Recommendation, CEDAC Reasons for Recommendation and Request for Reconsideration.

Record of Advice: The detailed advice given by CEDAC in reply to a Request for Advice.

Reference Drug Program: A B.C. PharmaCare program in which coverage is based on the cost of the reference drug (or drugs) in a therapeutic category.

Reply: A response by a Reviewer to a Manufacturer's comments about a Clinical or Pharmacoeconomic Review conducted by that Reviewer.

Report: A report produced by a Reviewer in accordance with Reviewer Guidelines.

Request for Advice: A written request made by ACP or by one or more Drug Plans to CEDAC for advice on specific therapeutic, clinical or pharmacoeconomic issues.

Request for Clarification: A written request from a Drug Plan for clarification of a CEDAC Recommendation.

Request for Reconsideration: A written request from Manufacturers to have a CEDAC Recommendation reconsidered.

Request for Withdrawal: A written request by an Applicant to withdraw a CDR Submission or Resubmission from the review process.

Resubmission: The request by a Manufacturer, Drug Plan or the ACP to have an original Submission, that is under review or has received a Notice of Final Recommendation, reviewed again through the CDR process on the basis of New Information that was not provided in the original Submission or considered by CEDAC. The Resubmission goes to the end of the review queue.

Review Criteria: The following criteria are considered by CEDAC in making a listing recommendation:

• Clinical studies, which assess safety and/or efficacy of the Drug in Appropriate populations. (note: when available, effectiveness data will be compared with accepted therapy.)
• Therapeutic advantages and disadvantages relative to accepted therapy.
• Cost effectiveness relative to current accepted therapy.

Review Team: A team of individuals, including CDR Staff Reviewers, Contracted Reviewers and External Experts (clinical expects, methodologists, or other experts) with appropriate qualifications and expertise, assembled by the CDR Directorate to undertake the review of a Submission or Resubmission or to prepare a Report in response to a Request for Advice.

Review Template: A template developed by the CDR Directorate for use by Reviewers to prepare Reviewer Guidelines established by the CDR Directorate.

Reviewer: An expert selected to conduct a Clinical or Pharmacoeconomic Review in accordance with Reviewer Guidelines established by the CDR Directorate.

Reviewer Guidelines: The CADTH guidelines adopted by the CDR Directorate that set out how a Reviewer must conduct, and report on, a Clinical Review or a Pharmacoeconomic Review.

Rules of Procedure: The rules of procedure established by CADTH's Board of Directors for CADTH's committees.

SA: Special Authority

SAP: Special Access Programme.

Significant Improvement: Statistically significant and clinically relevant improvement identified through well controlled clinical trials.

Special Access Programme: This programme, administered by the Therapeutic Products Directorate of Health Canada, is responsible for authorizing the sale of pharmaceutical, biological, and radio-pharmaceutical products that are not for sale in Canada. The programme may occasionally allow physicians to treat patients with drugs not approved for sale in Canada in cases of serious or life-threatening illness when conventional therapies have failed, are unsuitable, are unavailable or offer limited options.

Special Authority: An exemption that makes a particular drug eligible for full or partial benefits.

Special authorization: A process where a drug plan or drug benefit program makes a prescriber request coverage for a specific drug (request can be a letter or form detailing the patient's condition, providing specific clinical information and reasons why the medication is necessary) before approval can be granted for reimbursement of the cost of the medication. In some cases there are specific criteria associated with the use of a drug that must be met before approval is granted.

Submission: A submission to the CDR consisting of:

• A written application made by a Manufacturer, together with supporting documentation, to have a Drug listed on the Drug Plans' formularies; or
• A written request made by ACP or by one or more Drug Plans, together with supporting documentation, if any, to consider the listing status of Drugs already on formularies, to conduct Drug class reviews or to undertake any other Drug-related review(s) as required.

Submission Guidelines: The guidelines adopted by CADTH that outline how Submissions from Manufacturers must be prepared and submitted.

Submission Requirements: Information that is required by the CRD Directorate to undertake the Clinical and Pharmacoeconomic Reviews of Drugs and other information that is required by Drug Plans in making listing decisions. The Submission Requirements consolidate the requirements for the CDR and the Drug Plans. The Requirements apply to Submissions and Resubmissions.

Surrogate Markers: Parameters that when measured directly are reasonably likely, based on available evidence, to predict an effect of a drug on recognized clinical outcomes such as morbidity and mortality. A validated surrogate marker is predictive of the clinical benefit of a drug.

Systematic Review: Involves a review of a clearly formulated question using systematic and explicit methods to identify, critically appraise and summarize relevant studies (published and unpublished) according to predetermined criteria. Reported outcomes can be synthesized either quantitatively or narratively to summarize the results of included studies.

TPD: Therapeutic Products Directorate of Health Canada.

Trial Drug: A drug that is initially dispensed in a trial quantity (14 days supply) under a Trial Prescription Program.

Trial Prescription Program: A PharmaCare program that pays the dispensing fee associated with providing a small initial quantity of a drug to a consumer who has not used the drug before, in order to determine whether use of the drug is effective of subject to adverse side effects.

User ID: The name or alphanumeric code by which the user is identified and gains access to a computer system or network.

VAC: Veterans Affairs Canada. Formerly call Department of Veterans.