Formulary - Saskatchewan

1 Saskatchewan Ministry of Health Formulary Sixty-Second Edition July 1, 2012 - March 31, 2013 Drug Plan Inquiries should be directed to: Pharmaceutical Services Drug Plan & Extended Benefits Branch Saskatchewan Health 2nd Floor, 3475 Albert Street Regina, Saskatchewan S4S 6X6 Website Address: Telephone inquiries should be directed as follows: Consumer .. 1-800-667-7581 (306) 787-3317 Pharmacy .. 1-800-667-7578 (306) 787-3315 Special Support Program .. 1-800-667-7581 (306) 787-3317 EDS, Palliative Care, "No Substitution" (306) 787-8744 EDS Requests (24-hour message system)..Toll 1-800-667-2549 Profile Release .. 1-888-798-8083 (306) 798-8083 Pricing, Contract (306) 787-3420 Product Submission (306) 933-5599 Research and Utilization (306) 787-3307 Hospital Benefit List (306) 787-3420 Facsimile numbers: EDS Unit Fax (EDS requests, Palliative Care forms and "No Substitution" requests only).

2 General Fax .. (306) 798-1089 (306) 787-8679 Saskatchewan Drug Information Service: Healthcare .. Website Address: 1-800-667-3425 (306) 966-6340 1-800-665-3784 (306) 966-6378 Copyright - 2012 Her Majesty the Queen in right of the Dominion of Canada, as represented by the Minister of Health of the Province of Saskatchewan Ministry of Health Government of Saskatchewan The Honourable Dustin Duncan Minister of Health ISSN 1929-5022 (Online) Produced in Canada TABLE OF CONTENTSMEMBERSHIP OF DRUG ADVISORY COMMITTEE OF .. iiiPRODUCT SUBMISSION . ivREQUEST FOR PRODUCT . vNOTES CONCERNING THE .. xviPHARMACOLOGICAL - THERAPEUTIC CLASSIFICATION OF DRUGS 08:00 ANTI-INFECTIVE . 210:00 ANTINEOPLASTIC . 2612:00 AUTONOMIC . 2820:00 BLOOD FORMATION AND . 4024:00 CARDIOVASCULAR . 4828:00 CENTRAL NERVOUS SYSTEM . 9236:00 DIAGNOSTIC.

3 14240:00 ELECTROLYTIC, CALORIC AND WATER . 14648:00 ANTITUSSIVES, EXPECTORANTS AND MUCOLYTIC . 15052:00 EYE, EAR, NOSE AND THROAT . 15256:00 GASTROINTESTINAL . 16260:00 GOLD . 17264:00 HEAVY METAL . 17468:00 HORMONES AND SYNTHETIC . 17684:00 SKIN AND MUCOUS MEMBRANE . 19886:00 SMOOTH MUSCLE . 21288:00 . 21692:00 UNCLASSIFIED THERAPEUTIC . 22094:00 DIABETIC . 234 APPENDICESAPPENDIX A - EXCEPTION DRUG STATUS . 242 APPENDIX B - ONLINE CRITERIA . 295 APPENDIX C - SPECIAL . 298 APPENDIX D - Saskatchewan MS DRUGS . 299 INDICESINDEX A - THERAPEUTIC CLASSIFICATION . 304 INDEX B - ALPHABETICAL LIST OF PHARMACEUTICAL PRODUCT . 306 62nd EDITIONINTRODUCTIONThe Saskatchewan Formulary isupdated AnnuallyUpdates will be providedPeriodically COMMITTEE DRUG ADVISORY COMMITTEE OF Saskatchewan (DACS) Dr. Dennis Gorecki Chair Pharmacist, Professor of Pharmacy Dr.

4 Shahid Ahmed Physician - Medical Oncologist Clinical Associate Professor of Medicine Dr. Rob Basi Physician - Internal Medicine Clinical Assistant Professor of Medicine Dr. Marilyn Caughlin Family Physician and Pharmacist Dr. Adam Gruszczynski Family Physician Assistant Professor of Medicine Dr. Derek Jorgenson Pharmacist Associate Professor of Pharmacy Ms. Namarta Kochar Public Representative Director, Major Projects Refresh Inc. STAFF ASSISTANCE Ms. Donna Herbert/ Ms. Arlene Kuntz Pharmacist, Pharmaceutical Services Drug Plan & Extended Benefits Branch Dr. Lorne Davis Pharmacologist, Pharmaceutical Services Drug Plan & Extended Benefits Branch Mr. Allen Lefebvre Public Representative Project Coordinator Dr. Anne PausJenssen Physician - Internal Medicine Professor of Medicine Dr. Nazmi Sari Health Economist Associate Professor of Economics Dr. William Semchuk Clinical Pharmacist Assistant Clinical Professor of Pharmacy and Medicine Dr.

5 Yvonne Shevchuk Clinical Pharmacist Professor of Pharmacy Associate Dean, College of Pharmacy and Nutrition Dr. Lilian Thorpe Physician - Psychiatry and Geriatric Psychiatry Professor of Medicine and Community Health and Epidemiology Dr. Thomas W. Wilson Internal Medicine/Clinical Pharmacology Professor, Department of Medicine University of Saskatchewan Ms. Kathy Gesy Pharmacy Leader, Oncology Pharmacist Saskatchewan Cancer Agency Ms. Tracey Smith Director, Pharmaceutical Services Drug Plan & Extended Benefits Branch Mr. Kevin Wilson Executive Director, Drug Plan & Extended Benefits Branch ii PREFACE OBJECTIVES The Drug Plan has been established to: provide coverage to Saskatchewan residents for quality pharmaceutical products of proven therapeutic effectiveness; reduce the direct cost of prescription drugs to Saskatchewan residents; reduce the cost of drug materials; encourage the rational use of prescription drugs.

6 THE Formulary The Saskatchewan Formulary is a listing of the therapeutically effective drugs of proven high quality that have been approved for coverage under the Drug Plan. It is compiled by the Minister of Health with the advice of the Drug Advisory Committee of Saskatchewan (DACS) and is published annually, with regular updates. The members of the DACS are appointed by the Minister of Health and provide independent, specialized advice on drug-related matters. The membership on the DACS is composed of two public representatives as well as clinical specialists in the areas of medicine, pharmacology, pharmacy, and economics. The ongoing work of the DACS includes the evaluation of new products, as well as the re-evaluation of products as required. The goal is to list a range and variety of drugs that will enable prescribers to select an effective course of therapy for most patients.

7 THE DRUG REVIEW PROCESS Saskatchewan is participating in the Common Drug Review (CDR). The CDR helps support and inform drug plan decisions about drugs by providing: systematic reviews of the clinical evidence reviews of the pharmacoeconomic information detailed recommendations by the Canadian Drug Expert Committee (CDEC). The Drug Plan continues to make final benefit-listing and coverage decisions, based on CDEC recommendations, and jurisdictional factors, such as plan mandates, priorities, and resources. For more information about the CDR and CDEC, visit: Upon receipt of the CDEC recommendation, the DACS will begin Saskatchewan s review. Using this information, along with additional details of anticipated cost and impact on patterns of practice, the DACS makes a recommendation to the Minister of Health. These recommendations reflect the "Policy for Inclusion of Products in the Saskatchewan Formulary " (see pages ix - xi).

8 Iii 1 The DACS provides independent, specialized advice on drug-related matters to the Minister of All products listed in the Saskatchewan Formulary are benefits when used in the hospital setting.* The majority of submissions for interchangeable generic drugs do not require committee review as the Executive Director of the Drug Plan has the authority to approve these products for coverage. More complex interchangeable drug submissions are reviewed by the drug review SUBMISSION PROCESS *MANUFACTURERSUBMISSIONDRUG ADVISORY COMMITTEE of Saskatchewan (DACS) 1 Saskatchewan Formulary Saskatchewan CANCER AGENCYDRUG FORMULARYHOSPITAL BENEFIT DRUG LIST 2 RECOMMENDATION TO THE MINISTRY OF HEALTHONCOLOGY INDICATIONvia the Pan Canadian Oncology Drug Review (for pCODR eligible products)Common Drug Review (CDR) Process (for CDR eligible products)All other medicationsivREQUEST FOR PRODUCT ASSESSMENT 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 may submit requests for product assessment.

9 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. Clinical Documentation Single-Supplier Product Submissions New Chemical Entities, New Combination Products and New Indications for Listed Products. Saskatchewan is participating in the Common Drug Review (CDR) process. As a consequence, submissions for new chemical entities, new combination products and new indications for listed products should be made directly to CDR Directorate in accordance to the CDR Submission Guidelines as posted on the Canadian Agency for Drugs and Technologies in Health website 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.

10 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. Clinical documentation in support of products to be reviewed may be submitted at any time. The committee meets on a regular basis and will review submission as quickly as possible upon receipt.