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 that do not fall under the mandates of CDR or pCODR
  • Biosimilar Submission Requirements (Non-Oncology Indications Only*)
  • Line extensions
  • Natural Health Products
  • Resubmissions
• Review Process
• 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

1. All submission documents must be provided to each participating province. Inquiries on the submission process can be directed to the contacts provided under the Contact Information for Atlantic Provincial Drug Plans section on this website, orrefer to the individual Atlantic Provincial drug plan websites.  
2. A complete ACDR submission must be sent to the Drug Evaluation Unit (DEU) electronically.
   • A request to submit an ACDR submission can be arranged by emailing deu@nshealth.ca and specifying in the subject line, “REQUEST TO SUBMIT”.  The initial request should not include the submission material.
   • The Drug Evaluation Unit will provide direction to the manufacturer by e-mail on how to send the complete submission.
   • When the complete submission is received, a letter acknowledging receipt will be sent by email to the manufacturer from the Drug Evaluation Unit.

Submission requirements are listed below. Additional information may be requested to support the review of the product, as required.

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New drug products that do not fall under the mandates of CDR or pCODR

1. Cover Letter
   • Specify drug, strength(s), dosage form(s), Drug Identification Number(s) (DINs) and indications included in the submission.
   • Specify the approved indication(s) for each dosage form.
2. Executive Summary
3. Notice of Compliance (NOC)
4. Product Monograph
5. Therapeutic Classifications:
   • American Hospital Formulary Service, Pharmacologic-Therapeutic Classification (PTC)
   • World Health Organization, Anatomical Therapeutic Chemical (ATC) classification
6. Clinical evidence on efficacy, effectiveness and safety
   • Copies of published and unpublished studies that address key clinical issues for the drug under review.
     • Copies of any supplemental appendices associated with published studies.
     • Copies of any errata related to the published studies.
   • A list of all studies submitted in one table and specify the study name, type of study, and citation.
   • Published articles supporting the validity of outcome measures used in the submitted studies (if available).
7. Economic Information
   • A pharmacoeconomic evaluation is required for new chemical entities. Studies should follow current guidelines from the Canadian Agency for Drugs and Technologies in Health (CADTH).
   • Budget Impact Analysis (BIA) for each provincial plan.
     • Include all four BIAs in the submission to the Drug Evaluation Unit.
     • Submissions to the individual Atlantic provincial drug plans only require their own BIA.
8. Pricing and Distribution
   • Current price for all dosage forms, strengths and package sizes. 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).
9. Consent letter authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug plans and
   • other federal, provincial and territorial (F/P/T) drug plans
   • F/P/T health authorities and related facilities
   • Health Canada
   • Patented Medicine Prices Review Board (PMPRB)
   • CADTH

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Biosimilar Submission Requirements (Non-Oncology Indications Only*)

1. Cover Letter
• Specify drug, strength(s), dosage form(s), DIN(s) and indications included in the submission.
• Specify the approved indication(s) for each dosage form.
2. Executive Summary
3. NOC
   For a pre-NOC submission:
   • Submissions will be accepted up to six months (180 days) before the anticipated receipt of Health Canada’s Notice of Compliance (NOC) or Notice of Compliance with conditions (NOC/c).
   • Provide information specifying the anticipated NOC date for the indication(s) being reviewed.
   • A copy of the granted NOC or NOC/c must be provided as soon as it is available (i.e. on the day of, or next business day after, receipt from Health Canada).
   • Submissions are not considered complete until a copy of the NOC or NOC/c is provided.
   • ACDR Recommendations will not be issued prior to a copy of the granted NOC or NOC/c being provided.
4. Product Monograph
   For a pre-NOC submission once the NOC or NOC/c has been issued, the manufacturer must provide the following:
   • Final product monograph, along with a signed letter indicating any wording changes to the Health Canada-approved final product monograph, as compared with the draft product monograph.
5. Budget impact analysis (BIA) for each provincial plan
   • Include all four BIAs in the submission to the Drug Evaluation Unit.
   • Submissions to the individual Atlantic provincial drug plans only require their own BIA.
   • For submissions filed on a pre-NOC basis, if the approved NOC indication differs from the anticipated indication on which the BIA is based, an updated BIA must be provided.
6. Pricing and Distribution
   • Current unit price for all dosage forms, strengths and package sizes.
   • Confirmation that a Notification of Intent to Negotiate a Biosimilar form has been submitted to the pan-Canadian Pharmaceutical Alliance (pCPA).
   • Method of distribution to pharmacies (wholesale, direct or other arrangements).
7. Patient Support Program
   • Specify if a patient support program will be available.
   • Describe details of the services provided. If details are not finalized at the time of submission, they must be provided as soon as available.
8. Consent letter authorizing unrestricted communication and sharing of information regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
   • other F/P/T drug programs
   • F/P/T health authorities and related facilities
   • Health Canada
   • PMPRB
   • CADTH

* The oncology indications for biosimilars will not be reviewed through the Atlantic Common Drug Review Process. For biosimilar oncology indications, please provide submissions to the individual Atlantic provincial drug plans.

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Line Extensions

Submission requirements for line extensions of marketed products that are new dosage forms with the same route of administration and new strengths of the same dosage form that are currently listed on at least one of the Atlantic Provincial Drug Pan formularies:

1. Cover Letter
   • Specify drug, strength(s), dosage form(s), DIN(s) and indications included in the submission.
   • Specify the approved indication(s) for each dosage form.
2. Executive Summary
3. NOC
4. Product Monograph
5. Therapeutic classifications:
   • American Hospital Formulary Service (PTC)
   • World Health Organization (ATC) classification
6. Clinical evidence on efficacy, effectiveness and safety (if applicable)
7. BIAs for each provincial drug plan
   • Include all four BIAs in the submission to the DEU.
   • Submissions to the individual Atlantic provincial drug plans only require their own BIA.
8. Pricing and Distribution
   • Current price for all dosage forms, strengths and package sizes. Manufacturers of generic products must confirm that the price has been submitted to the pCPA Centralized Price Confirmation Process.
   • Method of distribution to pharmacies (wholesale, direct or other arrangements)
9. Consent letter authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
• other F/P/T drug programs
• F/P/T health authorities and related facilities
• Health Canada
• PMPRB
• CADTH

Natural Health Products (NHPs)

A limited number of NHPs have reimbursement status in one or more Atlantic provincial drug plans. These products had historically been assigned a DIN but have been re-classified by Health Canada as 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.

A submission for an NHP will only be considered if the NHP is chemically similar to another product which is currently listed as a benefit on at least one of the Atlantic provincial drug plan formularies. 

Submission requirements:

1. Cover Letter
   • Specify drug, strength(s), dosage form(s), NPN(s), and indications included in the submission.
   • Specify the approved indication(s) for each dosage form.
2. Executive Summary
• The manufacturer must clearly demonstrate how the submitted product is chemically similar to another product which is currently listed on at least one of the Atlantic Provincial Drug Plan Formularies, as well as any advantages (e.g. price, formulation) the submitted product offers. 
3. Evidence of approval from Health Canada, including:
   • Evidence of valid market authorization to sell the NHP in Canada.
     • A copy of the Product License with Product Number issued by Health Canada;
     • A copy of the Site License; and
   • A copy of the product 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 availableupon request of the ACDR.
4. Therapeutic Classifications (if applicable):
   • American Hospital Formulary Service (PTC)
   • World Health Organization's (ATC) classification
5. Relevant clinical evidence on efficacy, effectiveness and safety
6. BIAs for each provincial drug plan.
   • Include all four BIAs in the submission to the DEU.
   • Submissions to the individual Atlantic provincial drug plans only require their own BIA.
7. Pricing and Distribution
   • Current price for all dosage forms, strengths and package sizes. Manufacturers of generic products must confirm that the price has been submitted to the pCPA Centralized Price Confirmation Process
   • Method of distribution to pharmacies (wholesale, direct or other arrangements)
8. Consent letter authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
   • other F/P/T drug programs
   • F/P/T health authorities and related facilities
   • Health Canada
   • PMPRB
   • CADTH

Submissions for NHPs that are not currently listed as a benefit on at least one of the Atlantic Provincial Drug Plan Formularies will not be considered.
However, the AEAC or the Atlantic provincial drug plan managers review committee (APRC) 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 APRC members agree the review should be conducted.

The submission requirements and review process are the same as those for new drug products that do not fall under the mandates of CDR or pCODR. In place of an NOC, ACDR requires the Product License Form.  

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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 considered if they contain new information that was not present in the original or previous submissions.

Resubmission requirements:

1. Cover Letter
   • Specify drug, strength(s), dosage form(s), DIN and indications included in the submission.
   • Specify the approved indication(s) for each dosage form.
   • Specify rationale for resubmission
2. Executive Summary
3. NOC
4. Product Monograph
5. Updated BIAs for each provincial drug plan
   • Include all four BIAs in the submission to the DEU.
   • Submissions to the individual Atlantic provincial drug plans only require their own BIA.
6. Pricing and Distribution
   • Current price for all dosage forms, strengths and package sizes. Manufacturers of generic products must confirm that the price has been submitted to the pCPA Centralized Price Confirmation Process.
   • Method of distribution to pharmacies (wholesale, direct or other arrangements).
7. Consent letter authorizing unrestricted communication regarding the drug product between Nova Scotia, New Brunswick, Prince Edward Island and Newfoundland & Labrador drug programs and
   • Other F/P/T drug programs
   • F/P/T health authorities and related facilities
   • Health Canada
   • PMPRB
   • 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.

• 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.

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@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.