SUBMISSION PROCESS

Any supplier wishing to have products listed in the Saskatchewan Formulary, the Hospital Benefit Drug List or the Saskatchewan Cancer Agency Benefit List (interchangeable products) may submit requests for product assessment. The route a submission follows is determined by the indication of the products. There is no deadline date for submissions for listing in the Formulary. In general, submissions are reviewed in order of receipt.

Product Submission Process - Appendix I .

 

CLINICAL DOCUMENTATION

Single-Supplier Product Submissions

New Chemical Entities and New Combination Products

Saskatchewan is participating in the Common Drug Review (CDR) process. As a consequence, submissions for new chemical entities and new combination products should be made directly to CDR Directorate in accordance to the CDR Submission Guidelines as posted on the Canadian Agency for Drug and Technologies in Health (CADTH) website http://www.cadth.ca.

Single Source Products That Do Not Contain New Chemical Entities

Saskatchewan Health will accept submissions of single source products that do not contain new chemical entities or new combinations and that will not fall under the jurisdiction of the CDR process; however, the same submission requirements as per CDR guidelines will apply to this category of products.

Line Extension Products

The following submission requirements pertain to new strengths and formulations or reformulations of drug products that are currently listed in the Saskatchewan Formulary.

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph
4. Justification of the need for the Line Extension
5. Copy of Comprehensive Summary (“Clinical Studies” section only) or other document accepted by Health Canada and copies of critical studies that address key clinical issues relevant to the new strength, formulation or reformulation or evidence of formulation proportionality or bioequivalence data; and evidence of a similar dissolution profile.

Changes to Benefit Status of Listed Single Source Drug Products to a New Indication

The following submission requirements pertain to single source drug products currently listed in the Saskatchewan Formulary that have received a new indication from the Therapeutic Product Directorate (TPD) and where the manufacturer wishes to request expansion of the coverage criteria or a change in benefit status due to the new indication.

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph
4. Justification of the Expanded Coverage Criteria or Change in Benefits Status
5. Copy of Comprehensive Summary (“Clinical Studies” section only) or other document accepted by Health Canada and copies of critical studies that address key clinical issues relevant to the new indication.

Interchangeable Product Submissions

The following submission requirements pertain to multi-source products submitted for listing in an interchangeable grouping in the Saskatchewan Formulary.

A.  Drug products in solid oral dosage forms reviewed by the TPD according to the guidelines, "Conduct and Analysis of Bioavailability and Bioequivalence Studies - Part A and B" and have a Canadian Reference Product on the Notice of Compliance.

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph 

Note: (Bio) studies may be requested on a case-by-case basis.

B.  Drug products in solid oral dosage forms reviewed by the TPD according to the guidelines "Conduct and Analysis of Bioavailability and Bioequivalence Studies - Report C.

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph 
4. Executive summary of comparative bioavailability studies with the reference drug product, including tables of calculated pharmacokinetic (PK) parameters, ratios of geometric means for relevant PK parameters and relative 90% CI, or 95% CI where appropriate, for the measured and for the potency corrected data, mean plasma concentrations vs. time curves (linear and log-transformed) or executive summary of comparative pharmacodynamic studies.

C.  Drug products that are cross-referenced

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph 
4. Letters from both the manufacturer of the submitted product and the manufacturer of the cross-licensed product, confirming that the two products are identical in all aspects, except for embossing and labelling.

D.  Drug products in Aqueous Solutions (e.g. oral, ophthalmics, inhalation, injections) that have a Canadian Reference Product on the Notice of Compliance.

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph 

Note: Comparative (Bio) studies may be requested on a case-by-case basis.

E.  Drug products in semi-solid formulations (e.g. creams, ointments)

1. Copy of NOC
2. Copy of completed Drug Identification Number (DIN) notification form
3. Copy of approved Product Monograph 
4. Executive summary of comparative bioavailability studies with reference drug products, including tables of calculated pharmacokinetic (PK) parameters, ratios of geometric means for relevant PK parameters and relative 90% CI, or 95% CI where approptiate, for the measured and for the potency corrected data, mean plasma concentrations vs. time curves (linear and log-transformed) or surrogate comparisons with the reference drug product (i.e. in vivo or in vitro test methods or a pharmacodynamic or therapeutic equivalence study).

Drug Products Without a Canadian Reference Product

The following submission requirements pertain to products submitted for listing in an interchangeable grouping where the active ingredient is designated as an “old drug” by the TPD and the drug product is approved on the basis of DIN application (i.e. an NOC is not issued) or is issued a Notice of Compliance without a Canadian Reference Product.

A.  Drug products in solid dosage forms.

1. Copy of completed Drug Identification Number (DIN) notification form
2. Copy of approved Product Monograph or Prescribing Information
3. Executive summary of comparative bioavailability study or pharmacodynamic study or studies conducted in accordance with the TPD guidelines, "Conduct and Analysis of Bioavailability and Bioequivalence studies - Part A and B and Report C. 

B.  Drug products Not in solid oral dosage forms.

1. Copy of completed Drug Identification Number (DIN) notification form
2. Copy of approved Product Monograph or Prescribing Information
3. Executive summary of comparative bioavailability study or pharmacodynamic study or studies conducted in accordance with the TPD guidelines or surrogate comparisons with the reference drug product (i.e. in vivo or vitro test methods or a pharmacodynamic or therapeutic equivalence study).

C.  Drug products that are cross-referenced

1. Copy of completed Drug Identification Number (DIN) notification form
2. Copy of approved Product Monograph or Prescribing Information
3. Letters from both the manufacturer of the submitted product and the manufacturer of the cross-licensed product, confirming that the two products are identical in all aspects, except for embossing and labelling.

Clinical documentation in support of products to be reviewed may be submitted at any time. The committees meet on a regular basis and will review submission as quickly as possible upon receipt. Details of the criteria for product listings are published in each edition of the Formulary and in the quarterly updates to the Formulary.

Notification is required whenever there is a change in formulation or in the clinical information published in the product monograph, for any listed product as well as for any product under review.

MANUFACTURING DOCUMENTATION

A copy of completed and approved Certified Product Information Document (C.P.I.D.) should be submitted with the clinical documentation if possible,  but will be accepted at a later date.  

ECONOMIC EVALUATION

Price information including catalogue or estimated prices should be provided at the time of product submission.

Submission of pharmacoeconomic analyses are encouraged. The National Pharmacoeconomic Guidelines serve as a guide. The Formulary Committee will routinely consider direct "medical" costs such as:

impact on laboratory test for monitoring, evaluation or diagnosis

impact on physician office visits

impact on hospitalization or institutionalization

impact on surgical procedures

increased or decreased incidence and severity of side effects.

The availability of quality-of-life analyses is encouraged.

Additional Documentation Required:

• A letter authorizing unrestricted communication regarding the drug product between the Saskatchewan Prescription Drug Plan and:

1. Participating federal/provincial/territorial (F/P/T) drug plans
2. F/P/T governments, including their agencies and departments 
3. F/P/T health authorities (including regional authorities and related facilities)
4. Health Canada
5. Patented Medicine Prices Review Board (PMPRB)
6. Canadian Agency for Drug and Technologies in Health (CADTH)

• Expected market share information is requested to allow for an accurate projection of the impact of a new product. 
• Product patent expiration date is requested to allow for consideration of the potential long-term economic impact of the product.
• Copies of the initial product launch material, and any subsequent promotional material sent to physicians and pharmacists.
• Ability to supply product

SUBMISSION PROCEDURE

Requests for product assessment, together with supporting clinical (including notice of compliance and product monograph) and manufacturing documentation should be sent to:

Dr. Lorne Davis, Pharmacologist
Department of Pharmacology, College of Medicine
University of Saskatchewan, 107 Wiggins Road
Saskatoon, Saskatchewan S7N 5E5

E-mail Dr. Davis  

Copies of the covering letter, the product monograph, notice of compliance, pricing information and economic analysis should be sent to: