Atlantic Common Drug Review

Atlantic Common Drug Review

The Atlantic Common Drug Review (ACDR) assesses the clinical and cost effectiveness of drugs that do not fall under the mandates of the National Common Drug Review (CDR) or the Pan Canadian Oncology Drug Review (pCODR), and provides formulary listing recommendations to the provincially funded drug plans in Atlantic Canada.

Drugs reviewed by ACDR include:

  • New single source products that do not fall under the CDR mandate
  • Line extensions
  • Resubmissions for products not previously reviewed by CDR
  • Currently listed drugs
  • Drug classes

Please click the following options for more information:

Contact Information

Please direct all ACDR correspondence to:

Drug Evaluation Unit
c/o Pharmacy Department
Rm 2416 Halifax Infirmary
1796 Summer Street
Halifax, Nova Scotia B3H 3A7
DEU@cdha.nshealth.ca


Contact Information for Atlantic Provincial Drug Plans

Kathleen Coleman
Director, Formulary and Clinical Practice
Nova Scotia Department of Health and Wellness
1894 Barrington Street
3rd Floor Barrington Tower
PO Box 488
Halifax, NS B3J 2A8
Tel: 902-424-4837
Fax: 902-428-3400
E-Mail: Kathleen.Coleman@novascotia.ca

Leanne Jardine
Executive Director
Pharmaceutical Services
Department of Health
PO Box 5100
520 King Street, 6th Floor
Fredericton, NB E3B 5G8
Tel: 506-453-3884
Fax: 506-453-3893
E-mail: leanne.jardine@gnb.ca

Roy Cairns
Pharmacy Consultant
Health System Planning and Development
Department of Health and Wellness
20 Fitzroy Street
Charlottetown, Prince Edward Island, C1A 7N8
Tel:  902-368-4907
Fax:  902-368-4905
E-Mail:  brcairns@gov.pe.ca

Colleen Ryan
Clinical Pharmacist II, Supervisor
Department of Health and Community Services
45 Major’s Path
PO Box 8700
St. John's, NL A1B 4J6
Phone: 709-729-1645 
Fax: 709-729-2851
E-mail: colleenryan@gov.nl.ca

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Flow Chart of Process

A flow chart has been developed to better illustrate how drugs are reviewed for formulary decisions as well as the specific role of the Common Drug Review and the Atlantic Common Drug Review.

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Requirements for Manufacturers' Submissions

  • All documents must be provided to each participating province in electronic format on compact disc accompanied by a cover letter.
  • One complete hard copy submission, along with a full submission in electronic format on compact disc, must be sent to the Drug Evaluation Unit, at the address listed above.
  • Receipt of submissions is acknowledged by the Drug Evaluation Unit by e-mail. Please include a contact e-mail address in the submission.

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New drug products not eligible for review by CDR or pCODR

  1. Executive Summary
  2. Notice of Compliance (NOC)
  3. Product Monograph
  4. Therapeutic classifications:
    • American Hospital Formulary Service, Pharmacologic-Therapeutic Classification (PTC)
    • World Health Organization's Anatomical Therapeutic Chemical (ATC) classification
  5. Clinical evidence on efficacy, effectiveness and safety
    • Double-blind, randomized, controlled trials (RCTs) published in peer-reviewed journals are given the most weight
    • If unpublished/abstract data is submitted, it must be indicated why it is unpublished
    • List all studies submitted in one table and specify the study name, date, authors and whether it is published or unpublished
    • Published articles supporting the validity of outcome measures in studies (if available)
  6. Economic Information
    • A pharmacoeconomic evaluation is required for most new chemical entities. Studies should follow current guidelines from the Canadian Agency for Drugs and Technologies in Health (CADTH)
    • Budget impact analysis for each province plan (Include all four budget impact analyses in the submission to the ACDR coordinator. Submissions to the individual Atlantic provincial drug plans only require their own budget impact analysis).
  7. Pricing and Distribution
    • Current price for all strengths and dosage forms. Manufacturers of generic products must confirm that the price has been submitted to the pan-Canadian Pharmaceutical Alliance (pCPA) Centralized Price Confirmation Process.
    • Method of distribution to pharmacies (wholesale, direct or other arrangements)
  8. Consent letter (MS Word) authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
    • Other federal, provincial and territorial (F/P/T) drug programs
    • F/P/T health authorities and related facilities
    • Health Canada
    • Patented Medicine Prices Review Board (PMPRB)
    • Canadian Agency for Drugs and Technologies in Health (CADTH)

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Line Extensions

Submission requirements for new strengths, new formulations, or reformulations of drug products that are currently listed on at least one of the Atlantic Provincial Drug Plan Formularies:

  1. Executive Summary
  2. Notice of Compliance (NOC)
  3. Product Monograph
  4. Therapeutic classifications:
    • American Hospital Formulary Service, Pharmacologic-Therapeutic Classification (PTC)
    • World Health Organization's Anatomical Therapeutic Chemical (ATC) classification
  5. Clinical evidence on efficacy, effectiveness and safety (if applicable)
  6. Economic Information
    • Budget impact analysis for each drug plan (Include all four budget impact analyses in the submission to the ACDR coordinator. Submissions to the individual Atlantic provincial drug plans only require their own budget impact analysis).
  7. Pricing and Distribution
    • Current price for all strengths and dosage forms. Manufacturers of generic products must confirm that the price has been submitted to the pan-Canadian Pharmaceutical Alliance (pCPA) Centralized Price Confirmation Process.
    • Method of distribution to pharmacies (wholesale, direct or other arrangements)
  8. Consent letter (MS Word) authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
    • Other federal, provincial and territorial (F/P/T) drug programs
    • F/P/T health authorities and related facilities
    • Health Canada
    • Patented Medicine Prices Review Board (PMPRB)
    • Canadian Agency for Drugs and Technologies in Health (CADTH)

Natural Health Products (NHPs)

The Natural Health Products Regulations came into effect on January 1, 2004.

A limited number of NHPs are currently listed as benefits on Atlantic Provincial Drug Plan Formularies.  These products were originally assigned a Drug Identification Number (DIN) but have been re-classified by Health Canada as Natural Health Products (NHPs) and assigned a Natural Product Number (NPN). 

Some of these products may have continued to be listed as benefits if the manufacturer submitted a letter confirming the following information:

  • Health Canada approved the transition from a DIN to NPN.
  • There was no change in the master formulation.
  • The price remained the same.

Submissions for Listed NHP Entities

A submission for a NHP will only be considered if the NHP is chemically similar to another product which is currently listed as a benefit in the Formulary. 

Submission requirements:

  1. Executive Summary
    • The manufacturer must clearly demonstrate how the submitted product is chemically similar to another product currently listed in the Formulary, as well as any advantages (i.e. price or otherwise) the submitted product offers. 
  2. Evidence of approval from Health Canada, including:
    • Evidence of valid market authorization to sell the NHP in Canada
      1. A copy of the Product License with Product Number issued by Health Canada;
      2. A copy of the Site License; and
    • A copy of the monograph
      Note:  A copy of the completed, dated, and signed Product License Application Form approved by Health Canada is not required in the submission, but must be made available upon request of the ACDR.
  3. Therapeutic classifications:
    • American Hospital Formulary Service, Pharmacologic-Therapeutic Classification (PTC)
    • World Health Organization's Anatomical Therapeutic Chemical (ATC) classification
  4. Relevant clinical evidence on efficacy, effectiveness and safety
  5. Economic Information
    • Budget impact analysis for each drug plan (Include all four budget impact analyses in the submission to the ACDR coordinator. Submissions to the individual Atlantic provincial drug plans only require their own budget impact analysis).
  6. Pricing and Distribution
    • Current price for all strengths and dosage forms. Manufacturers of generic products must confirm that the price has been submitted to the pan-Canadian Pharmaceutical Alliance (pCPA) Centralized Price Confirmation Process
    • Method of distribution to pharmacies (wholesale, direct or other arrangements)
  7. Consent letter (MS Word) authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
    • Other federal, provincial and territorial (F/P/T) drug programs
    • F/P/T health authorities and related facilities
    • Health Canada
    • Patented Medicine Prices Review Board (PMPRB)
    • Canadian Agency for Drugs and Technologies in Health (CADTH)

Submissions for New NHP Entities

Submissions for new NHP entities will not be considered.

However, the Atlantic Expert Advisory Committee (AEAC) or the Atlantic Provincial drug plan managers may consider initiating a review for a new NHP. Criteria for initiating a review of a new NHP entity include, but are not limited to:

  • There is a significant unmet medical need for which the NPH provides a treatment option,
  • There is published evidence available to critically evaluate the NHP, and
  • All participating drug plans agree the review should be conducted.

The submission requirements and review process are the same as those for new drug products.  In place of a Notice of Compliance, ACDR will require evidence of approval from Health Canada, including evidence of valid market authorization to sell the NHP in Canada. 

 

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Resubmissions

Resubmissions may be made for drugs that have previously been reviewed through the Atlantic Common Drug Review process. Resubmissions will be reviewed if they contain new information that was not present in the original or previous submissions.

  1. Executive Summary clearly outlining the new information contained in resubmission
  2. Notice of Compliance (NOC)
  3. Product Monograph
  4. New clinical evidence on efficacy, effectiveness and safety (if applicable)
  5. Economic Information
    • Updated budget impact analysis for each drug plan (Include all four budget impact analyses in the submission to the ACDR coordinator. Submissions to the individual Atlantic provincial drug plans only require their own budget impact analysis).
  6. Pricing and Distribution
    • Current price for all strengths and dosage forms. Manufacturers of generic products must confirm that the price has been submitted to the pan-Canadian Pharmaceutical Alliance (pCPA) Centralized Price Confirmation Process.
    • Method of distribution to pharmacies (wholesale, direct or other arrangements)
  7. Consent letter (MS Word) authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
    • Other federal, provincial and territorial (F/P/T) drug programs
    • F/P/T health authorities and related facilities
    • Health Canada
    • Patented Medicine Prices Review Board (PMPRB)
    • Canadian Agency for Drugs and Technologies in Health (CADTH)

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Review Process

Submissions are accepted on an on-going basis and there are no deadlines unless specifically stated. In general, submissions are reviewed in order of receipt of complete submissions. However, changes may be made in exceptional cases. Submissions that do not require clinical review (e.g. formulary changes, line extensions) may undergo administrative review.

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Atlantic Expert Advisory Committee

The Atlantic Expert Advisory Committee (AEAC) is an independent advisory group composed of physicians, pharmacists and other persons with expertise in drug therapy and drug use evaluation. The committee makes recommendations to the Atlantic Ministers of Health (or delegate) regarding the listing of drugs on the Atlantic provincial drug plan formularies. The approach is evidence-based and the advice reflects the best available medical and scientific knowledge and current clinical practice.

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Drug plan decisions

Each provincial drug plan makes their own final listing decision based on the AEAC recommendation and jurisdictional factors, such as plan mandates, priorities, and resources. The manner in which the recommendations are processed is up to each drug plan and listing decisions must be approved by the Minister of Health (or delegate). Each drug plan informs pharmaceutical manufacturers of benefit listing decisions in their province.

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Review of Benefit Status

Criteria for Initiating a Review of Benefit Status

Reviews of drugs are conducted to ensure the benefit status and coverage criteria are current and based on the best available evidence.


Criteria for initiation of a review of benefit status include, but are not limited to:

• Changes related to the drug; e.g.

    - Change in scientific evidence on clinical efficacy or safety.

    - Change in regulatory status (e.g., change from prescription to over-the-counter status.)

    - Change in the cost of the drug or comparator drugs which results in altered cost-effectiveness or budget impact.

• Availability of new comparator products which possess clearly demonstrated therapeutic advantages.

Identifying Drugs for Review of Benefit Status

If the drug or drug class meets the criteria, a review of benefit status may be recommended by the Atlantic Expert Advisory Committee (AEAC) or the Atlantic Provincial drug plan managers.

Manufacturer Notification of a Review of Benefit Status

Manufacturers will be notified of the initiation and rationale of a review of benefit status via email. Manufacturers are provided with an opportunity to submit information for consideration in the drug evaluation review process.

All drug submissions and ACDR correspondence should be directed via mail or email to the following address:

Drug Evaluation Unit
c/o Pharmacy Department
Rm 2416 Halifax Infirmary
1796 Summer Street
Halifax, Nova Scotia B3H 3A7
DEU@cdha.nshealth.ca

Pharmaceutical manufacturer representatives are requested to contact drug plan managers for any other communication related to the drug review.

In order to preserve the impartial integrity of drug evaluation reviewers, they will not engage in discussions with pharmaceutical representatives.

Confidentiality of reports

Pharmaceutical manufacturers require that submitted information and data be kept confidential; therefore, any reports containing such information are considered confidential and cannot be shared.

Drug Benefit Recommendation

The AEAC recommendation may or may not result in a change in benefit status.

Pharmaceutical manufacturer notification

• The AEAC recommendation, reasons for the recommendation, and a list of references used to support the decision will be communicated to the manufacturers by the ACDR secretariat within 5 to 7 business days of the AEAC recommendation, effective January 1, 2012.

• Any questions related to the recommendation should be directed to the drug plan managers.

Healthcare professional and public notifications

• Communication of drug benefit decisions to healthcare professionals and the public will be via provincial drug plan bulletins.