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
• Flow Chart of Process
• Requirements for Manufacturers' Submissions
  • New drug products not eligible for review by CDR
  • Line extensions
  • Resubmissions
• Prioritization of Reviews
• Atlantic Expert Advisory Committee
• Drug Plan Decisions
• Review of Benefit Status

Contact Information

Please direct all ACDR correspondence to:

Contact Information for Atlantic Provincial Drug Plans

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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.

• Flow chart (PDF)

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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 must be sent to the ACDR coordinator.
• Receipt of submissions is acknowledged by the ACDR secretariat 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

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   • If unpublished/abstract data is submitted, it must be indicated why it is unpublished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 availability
   • Current price for all strengths and dosage forms
   • Method of distribution to pharmacies (wholesale, direct or other arrangements)
   • Evidence of ability to supply anticipated demand
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)
9. A letter specifying the current or intended Compendium of Pharmaceuticals and Specialties (CPS) listing status
10. A copy of the Pharmaceutical Advertising Advisory Board (PAAB) approved promotional materials

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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 availability
   • Current price for all strengths and dosage forms
   • Method of distribution to pharmacies (wholesale, direct or other arrangements)
   • Evidence of ability to supply anticipated demand
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)
9. A letter specifying the current or intended Compendium of Pharmaceuticals and Specialties (CPS) listing status
10. A copy of the Pharmaceutical Advertising Advisory Board (PAAB) approved promotional materials

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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 availability
   • Current price for all strengths and dosage forms
   • Method of distribution to pharmacies (wholesale, direct or other arrangements)
   • Evidence of ability to supply anticipated demand
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)
8. A letter specifying the current or intended Compendium of Pharmaceuticals and Specialties (CPS) listing status
9. A copy of the Pharmaceutical Advertising Advisory Board (PAAB) approved promotional materials

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Prioritization of Reviews

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.

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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.

• Terms of Reference (PDF)
• Members (PDF)

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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. The timeframe for receipt of information will be 60 days.

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.

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