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Common Drug Review - CADTH

The Canadian Agency for Drugs and Technologies in Health has released:

• Technology Report Issue 111: Octreotide for Endocrine, Oncologic, and Gastrointestinal Disorders: Systematic Review and Budget Impact Analysis.

• Technology Overview Issue 45: Octreotide for Endocrine, Oncologic, and Gastrointestinal Disorders: Systematic Review and Budget Impact Analysis.

The Canadian Agency for Drugs and Technologies in Health has released:

The Canadian Agency for Drugs and Technologies in Health has released Technology Overview Issue 44: Overview of Short-Acting Agents for Procedural Sedation and Analgesia in Canadian Emergency Departments.
 

The Canadian Agency for Drugs and Technologies in Health has released Technology Report Issue 110 and Technology Overview Issue 43: Management of Neovascular Age-related Macular Degeneration: Systematic Drug Class Review and Economic Evaluation.
 
The Common Drug Review (CDR) has released CDR Update – Issue 46. This Update announces the release of two new documents for the drug Humira for its use in Crohn’s disease. These are the first documents to be released under the CDR’s new transparency initiative. The Update also announces that templates for CDR Review Reports have been updated.

CDR has also released CDR Update – Issue 47. This Update announces revisions to two documents: the Submission Guidelines for Manufacturers and the Procedure for CDR.
 

The Canadian Agency for Drugs and Technologies in Health has released Compus Communiqué Volume 4, Number 5. Highlights of this edition include the posting of an additional report in the series of optimal therapy reports on the insulin analogues component of the diabetes management topic area.
 
The Canadian Agency for Drugs and Technologies in Health has released Technology Report:
  • Issue 107: Octaplas Compared with Fresh Frozen Plasma to Reduce the Risk of Transmitting Lipid-Enveloped Viruses: An Economic Analysis and Budget Impact Analysis.
  • Issue 108: Polyclonal Intravenous Immunoglobulin in Patients with Immune Thrombocytopenic Purpura: Clinical Systematic Review.
  • Issue 109: Short-Acting Agents for Procedural Sedation and Analgesia in Canadian Emergency Departments: A Review of Clinical Outcomes and Economic Evaluation.

CADTH has released Compus Communiqué Volume 4, Number 4. Highlights of this edition include the insulin analogues component of the diabetes management topic area.
 

The Canadian Agency for Drugs and Technologies in Health has released the following reports:

The Canadian Agency for Drugs and Technologies in Health has released COMPUS Communiqué Volume 4, Number 2. This issue includes the Diabetes Management Topic Area and Next Steps for the Insulin Analogue Projects.
 

The Canadian Agency for Drugs and Technologies in Health has released:

  • Technology Report Issue 102: Minimally Invasive Arthroplasty in the Management of Hip Arthritic Disease: Systematic Review and Economic Evaluation.
     
  • Technology Overview Issue 39: Systematic Review and Economic Evaluation of Minimally Invasive Techniques for Total Hip Replacement.
     
  • Issues in Emerging Health Technologies Issue 113: Continuous Erythropoietin Receptor Activator (Mircera®) for Renal Anemia.
     
  • Issues in Emerging Health Technologies Issue 114: Milnacipran for Fibromyalgia.

The Canadian Agency for Drugs and Technologies in Health has released COMPUS Communiqué Volume 4, Number 1. Highlights of this issue include improved access to proton pump inhibitors in Nova Scotia. CADTH has also released:

  • Technology Report Issue 100: Real-Time (Synchronous) Telehealth in Primary Care: Systematic Review of Systematic Reviews.
  • Technology Report Issue 101: Asynchronous Telehealth: Systematic Review of Analytic Studies and Environmental Scan of Relevant Initiatives.
  • Issues in Emerging Health Technologies Issue 112: Rotigotine Transdermal Patches (Neupro®) for the Treatment of Parkinson’s Disease.
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released the CDR Update – Issue 45. The update announces recent recommendations issued through CADTH’s Common Drug Review program from October 1 to December 31, 2007.
 

The Canadian Agency for Drugs and Technologies in Health has released the following Technology Reports:

  • Issue 98: Subcutaneous Versus Intravenous Immunoglobulin for Primary Immunodeficiencies: Systematic Review and Economic Evaluation.
     
  • Issue 99: Telehealth for Acute Stroke Management (Telestroke): Systematic Review of Analytic Studies and Environmental Scan of Relevant Initiatives.

CADTH has also released the following Technology Overviews:

  • Issue 36: Overview of Subcutaneous Versus Intravenous Immunoglobulin for Primary Immunodeficiencies: Systematic Review and Economic Analysis.
     
  • Issue 37: Telehealth for Acute Stroke Management (Telestroke): Systematic Review and Environmental Scan.

 

The Canadian Agency for Drugs and Technologies in Health has released the following Technology Reports:

  • Issue 95: Thiazide Diuretics as First-Line Treatment for Hypertension: Meta-Analysis and Economic Evaluation.
  • Issue 96: Recombinant Human Growth Hormone for Treatment of Turner Syndrome: Systematic Review and Economic Evaluation.
  • Issue 97: Adalimumab, alefacept, efalizumab, etanercept, and infliximab for severe psoriasis vulgaris in adults: budget impact analysis and review of comparative clinical- and cost-effectiveness.

CADTH has also released the following Technology Overviews:

  • Issue 34: Overview of Thiazide Diuretics as First-Line Treatment for Hypertension.
  • Issue 35: Overview of Recombinant Human Growth Hormone for Treatment of Turner Syndrome: Systematic Review and Economic Evaluation.
The Canadian Agency for Drugs and Technologies in Health has released issue 110 of Issues in Emerging Health Technologies: Maraviroc (Celsentri®) for Multidrug-Resistant Human Immunodeficiency Virus (HIV)-1. CADTH has also released COMPUS Communiqué Volume 3, Number 16 in which they’ve extended the deadline for feedback on the economic insulin analogues report to January 11.
 

Common Drug Review

The House of Commons Standing Committee on Health has released its report entitled Prescription Drugs – Part I The Common Drug Review: An F/P/T Process. The Committee has been examining the status and progress of the CDR as part of a larger study on prescription drugs in Canada. From April to June 2007, the Committee heard from representatives of the Canadian Drug Agency for Drugs and Technologies (CADTH), along with representatives of federal and provincial governments, the pharmaceutical industry, patient advocacy groups, health professionals, researchers and academics.

The report outlines five recommendations, namely:

  1. The federal government work with its provincial and territorial CDR counterparts to require an independent, external performance evaluation of the CDR within a year, and at five year intervals, and to make them immediately available to the public.
     
  2. The federal government work with its provincial and territorial CDR counterparts to enhance transparency by increasing the level of scientific and price information disclosure through discussions with pharmaceutical manufacturers at the time of submission.
     
  3. The federal government work with its provincial and territorial CDR counterparts to increase the current level of public involvement in the CDR through public attendance at open CEDAC meetings and the creation of a public advisory body.
     
  4. The federal government work with its provincial and territorial CDR counterparts to create a set of specific appeal criteria which, if met, would lead to a new and distinct appeal process for CEDAC recommendations which will;
    • Require a separate group of expert reviewers;
    • Extend requests for appeal beyond manufacturers to the public; and,
    • Establish a clear timeframe for an appeal decision.
       
  5. The federal government work with its provincial and territorial CDR counterparts to urge CADTH to establish a specifically designed approach for the review of drugs for rare disorders and for first-in-class drugs.

CADTH

The Canadian Agency for Drugs and Technologies in Health has released issue 109 of Issues in Emerging Health Technologies: Human Papillomavirus (HPV) Vaccines: A Canadian Update. Also released is the COMPUS Communiqué Volume 3, Number 15 which covers the Diabetes Management Topic Area.
 

The Canadian Agency for Drugs and Technologies in Health has released Technology Report Issue 94: Diagnostic Performance and Cost-Effectiveness of Technologies to Measure Bone Mineral Density in Postmenopausal Women.
 
The Canadian Agency for Drugs and Technologies in Health has released Issue 107 of Issues in Emerging Health Technologies titled: Grazax®: An Oral Vaccine for the Treatment of Grass Pollen Allergy (Hay Fever).
 

The Canadian Agency for Drugs and Technologies in Health has released COMPUS Communiqué Volume 3, Number 14. In this issue, CADTH extends an invitation to participate in a web cast on its Rx for Change Interventions Database.
 

The Canadian Agency for Drugs and Technologies in Health has launched Rx for Change, a publicly accessible interventions database on the effects of behaviour change strategies to help promote optimal prescribing and use of drugs.
 

The Canadian Agency for Drugs and Technologies in Health has released COMPUS Communiqué Volume 3, Number 13. This issue features a Notice of Extension on Diabetes Management: Insulin Analogues Reports Consultation. CADTH has also released a new Technology Report titled: Effectiveness of magnetic resonance imaging (MRI) screening for women at high risk of breast cancer.
 

The Canadian Agency for Drugs and Technologies in Health has released Issue 105 of Issues in Emerging Health Technologies titled: Subcutaneous Open-Loop Insulin Delivery for Type 1 Diabetes: Paradigm® Real-Time System. CADTH has also released COMPUS Communiqué Volume 3, Number 12. This issue features a Call for Input on Diabetes Management: Insulin Analogues Reports. They’ve also released Issue 106 of Issues in Emerging Health Technologies titled: Capsule Colonoscopy: PillCam® Colon.
 
The Canadian Agency for Drugs and Technologies in Health has released Issue 92 of the HTA Technology Report titled: Long-Acting Insulin Analogues for Diabetes Mellitus: Meta-analysis of Clinical Outcomes and Assessment of Cost-Effectiveness. CADTH has also released Issue 33 of the HTA Technology Overview titled: Insulin Analogues for Diabetes Mellitus: Review of Clinical Efficacy and Cost-Effectiveness.
 

CADTH has released the CDR Update - Issue 41. CADTH is calling for feedback and comments from its stakeholders as CADTH finalizes the CDR transparency procedure and documents. Feedback must be provided by October 19, 2007 to cdrfeedback@cadth.caa.

CADTH has released the CDR Update - Issue 40. The update announces:

  • Revisions to the CDR Procedures and Submission Guidelines incorporating the changes announced in CDR Update Issue 39;
  • Update to targeted CEDAC meeting dates;
  • CDR Recommendations issued through the Common Drug Review program from July 1 to September 30, 2007; and
  • Employment Opportunities

 

  • The Canadian Agency for Drugs and Technologies in Health has released Technology Report Issue 91 titled: Atypical Antipsychotic Monotherapy for Schizophrenia: Clinical Review and Economic Evaluation of First Year of Treatment. CADTH has also released Technology Overview Issue 32 titled: Overview of Atypical Antipsychotic Monotherapy for Schizophrenia: Clinical Review and Economic Evaluation of First Year of Treatment.
     
  • The Canadian Agency for Drugs and Technologies in Health has released Issue 104 of Issues in Emerging Health Technologies entitled: Pharmacogenomics and Warfarin Therapy.
The Canadian Agency for Drugs and Technologies in Health has released Issues in Emerging Health Technologies Issue 103 dated September 2007. This issue covers Nicotine Vaccines for Smoking Cessation.
 
The Canadian Agency for Drugs and Technologies in Health has released Health Technology Update Issue 7, dated September 2007. In this issue they present an article about a new diagnostic tool that combines the molecular imaging of PET with mammography.
 
The Canadian Agency for Drugs and Technologies in Health has released the following report: Yttrium-90 Microspheres (TheraSphere® and SIR-Spheres®) for the Treatment of Unresectable Hepatocellular Carcinoma.
 
The Canadian Agency for Drugs and Technologies in Health (CADTH) has released Issue 101 in Issues in Emerging Health Technologies: Sipuleucel-T (Provenge®): Active Cellular Immunotherapy for Advanced Prostate Cancer.
 
CADTH has released the CDR Update - Issue 38. The update announces:
  • CDR will accept submissions for drugs with new indications, as of October 1, 2007;
  • Revisions to the CDR Procedures and Submission Guidelines. The new documents are dated July 2007 and are effective October 1, 2007; and
  • CDR consultations regarding three proposed changes to the CDR Procedures and Submission Guidelines.

The Canadian Agency for Drugs and Technologies in Health invites all interested parties to provide feedback on three potential areas for change in the Procedure for Common Drug Review (CDR) and the CDR Submission Guidelines for Manufacturers, by July 31, 2007. Please refer to the CDR website for more information.

 

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released supplemental information on Implantable Cardiac Defibrillators for Primary Prevention of Sudden Cardiac Death in High Risk Patients: A Meta-Analysis of Clinical Efficacy, and a Review of Cost-Effectiveness and Psychosocial Issues.

CADTH has also released the CDR Update - Issue 35. The update:

  • announces that CADTH has received approval and funding to expand the CDR to include new indications for old drugs;

  • provides registration information for the CDR Information Session for Industry on June 8, 2007; and

  • announces that Sandy Pagotto has been promoted from Manager of CDR Reviews to Director of CDR.

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released supplemental information on Triptans for Acute Migraine: Comparative Clinical Effectiveness and Cost-effectiveness. They’ve also released supplemental information on Long-acting B2-agonists (LABA) plus Corticosteroids versus LABA Alone for Chronic Obstructive Pulmonary Disease.
 

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released the following Technology Overview:

CADTH has also released Technology Reports on:

 

The Canadian Agency for Drugs and Technologies in Health (CADTH) has released the following Technology Overviews:

CADTH has also released Technology Reports on:

• CADTH has also released the CDR Update - Issue 34, which includes revisions to the CDR Procedures and CDR Submission Guidelines, effective immediately.

• The Canadian Agency for Drugs and Technologies in Health (CADTH) has released the CDR Update – Issue 33, which provides new guidance for all submissions for oncology products (injectable and oral), effective March 1, 2007.

• The Canadian Agency for Drugs and Technologies in Health has released a Technology Overview entitled Overview of Adjunctive Hyperbaric Oxygen. CADTH has also released technology reports on:

 

The Canadian Agency for Drugs & Technologies in Health (CADTH) has released CDR Update - Issue 32 announcing:

• Queuing of Submissions to the Common Drug Review (CDR) - reminding manufacturers that in periods when the number of new submissions and/or resubmissions significantly exceeds the projected volumes, the CDR places the submissions in a tiered queue. The Update indicates the order in which the CDR reviews submissions.

• Advance Notification of Submissions; Pre-submission Meetings - manufacturers are encouraged to notify the CDR Directorate through e-mail of pending submissions in order to help the CDR plan for upcoming submissions. The CDR Directorate is available for one-hour pre-submission meetings with manufacturers to discuss submission requirements and issues specific to the drug. Please see the Update for contact info for requests for meetings.

• Personnel News – Barb Shea will now focus exclusively on COMPUS, Mike Tierney has been promoted to Vice-President of the CDR, Karen Lee has been promoted to Manager of Health Economics at CDR, and Cheryl Fawcett is now Executive Assistant for the CDR Vice-President.
 

• The Canadian Agency for Drugs and Technologies in Health has released: Lubiprostone for the treatment of chronic idiopathic constipation in adults in issue no. 77 of the Emerging Drug List.
 
• The Canadian Agency for Drugs and Technologies in Health has released: Aliskiren for hypertension in Issue no. 76 of the Emerging Drug List.
 

• The Canadian Agency for Drugs and Technologies in Health has released:

  • Emerging Health Technologies Issue 94: Intra-Articular Hyaluronic Acid (Viscosupplementation) for Knee Osteoarthritis.
  • A technology report on: Sevelamer in Patients with End-stage Renal Disease: A Systematic Review and Economic Evaluation.
  • Emerging Drug List: Vildagliptin.

The Canadian Agency for Drugs and Technologies in Health has released the following reports:

CDR: The Canadian Agency for Drugs & Technologies in Health (CADTH) has released CDR Update Issue 31 announcing:

  • a revised format for CEDAC recommendations
  • updated CEDAC Terms of Reference
  • reminders/clarification regarding filing submissions to the Common Drug Review (CDR)
• The Canadian Agency for Drugs & Technologies in Health (CADTH) has released CDR Update Issue 30 which announces the CADTH appointments to its Canadian Expert Drug Advisory Committee (CEDAC).
 
CADTH: The Canadian Agency for Drugs and Technologies in Health has released: Rituximab for Rheumatoid Arthritis in Issue 89 of Issues in Emerging Health Technologies. As well they have released: Transient Elastography (FibroScan) for Non-invasive Assessment of Liver Fibrosis in Issue 90 of Issues in Emerging Health Technologies. They’ve also released Health Technology Update – Issue 4 dated September 2006.
 
CDR: The Canadian Agency for Drugs & Technologies in Health (CADTH) issued CDR Update Issue 29 which includes a change to Section 4 of the CDR Submission Guidelines for Manufacturers.
 
CADTH: The Canadian Agency for Drugs and Technologies in Health has released: Tacrolimus for Crohn’s Disease in Issue 88 of Issues in Emerging Health Technologies.
 
The latest edition of the CADTH Newsletter details a new “Issues in Emerging Health Technologies” bulletin, covering the drug Febuxostat for Prevention of Gout Attacks.
 
CADTH Update: The Canadian Agency for Drugs and Technologies in Health (CADTH) recently updated a previous issue of their latest Emerging Drug List publication. The January 2006 Issue discussing Vaccines for Herpes Zoster  was amended in May.
 
CADTH Update: The Canadian Agency for Drugs and Technologies in Health (CADTH) recently released their latest Issues in Emerging Health Technologies publication. The May 2006 Issue discussing Chondroitin Sulfate for Interstitial Cystitis is now available for download from the CADTH website.
 
CDR Update: The Canadian Agency for Drugs & Technologies in Health (CADTH) issued CDR Update Issue 27 which includes revised CDR Procedures and Submission Guidelines to take effect September 1, 2006.
 
Common Drug Review/CADTH: As of April 3, 2006, the Canadian Coordinating Office for Health Technology Assessment (CCOHTA) will formally become known as the Canadian Agency for Drugs and Technologies in Health (CADTH). CADTH is an independent, not-for-profit agency funded by Canadian federal, provincial, and territorial governments to provide credible, impartial advice and evidence-based information about the effectiveness of drugs and other health technologies to Canadian health care decision makers. CADTH provides information through three programs: Health Technology Assessment (HTA), the Common Drug Review (CDR) and Canadian Optimal Medication Prescribing and Utilization Service (COMPUS). For more information visit the CADTH website at: www.cadth.ca.
 
Common Drug Review / CCOHTA: The Canadian Coordinating Office for Health Technology Assessment has released CDR Update No. 25, dated Feb. 3, 2006.
 

CCOHTA Emerging Drug Lists: The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) has released Emerging Drug Lists on:

CCOHTA is inviting stake holders to provide their input regarding selected evidence grading systems and quality assessment tools to be used by the Canadian Optima Medication and Prescribing Utilization System (COMPUS). A series of tools have been pre-selected at CCOHTA with the assistance of internationally recognized methodological experts, with a view to meeting the unique needs of the COMPUS program. These pre-selected evaluation tools may be viewed and feedback can be submitted online through CCOHTA's website. Comments must be received on or before December 13, 2005.

The opportunity for public comment on the draft document COMPUS Procedures: Evidence-Based Best Practice Recommendations has been extended to December 2, 2005. Comments may be submitted through the CCOHTA website.

The Medication Prescribing and Use Project (MPUP) collection has been updated as of November 28th. A full listing of completed and ongoing investigations can be viewed here.

The Proton Pump Inhibitor interim report is expected in early 2006. The document will be made publicly available for feedback, before being reviewed by clinical experts.
 

CCOHTA Emerging Drug Publication: The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) has released an Emerging Drug List publication: Bexxar for Non-Hodgkins Lymphoma.
 

CDR Evaluation Released:

The Evaluation of the First Year of Operation for the Common Drug Review has been released. The full report can be found on the CCOHTA web site with a document outlining CCOHTA’s response to the recommendations contained in the report.

Feedback Requested on Proposed CDR Changes:

Revised versions of the Procedure for Common Drug Review and the CDR Submission Guidelines for Manufacturers targeted for early 2006. Updated documents, titled DRAFT Procedure for Common Drug Review and DRAFT Pharmacoeconomic Submission Requirements for Common Drug Review have been posted on CCOHTA’s web site. CCOHTA is requesting feedback to cdrfeedback@ccohta.ca by November 11, 2004.
 

• New CCOHTA Bulletin: The Canadian Coordinating Office of Health Technology Assessment (CCOHTA) has announced the release of the COMPUS Communiqué, an e-bulletin about the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS). This bulletin was created to keep subscribers up-to-date on program activities. To subscribe visit the CCOHTA website under "my CCOHTA subscription".
 
CDR Industry Information Session: The CDR Directorate of CCOHTA will be hosting an information session on Friday October 21, 2005 in Ottawa for members of the pharmaceutical industry. The session will provide updates on the Common Drug Review program and submission process, provide a report on the results of CDR Evaluation and hear a perspective from Dr. Andreas Laupacis, Chairman of CEDAC. For more information please visit the CCOTHA website.
 
• The Common Drug Review (CDR) Directorate has issued the latest CDR Update, No. 20, dated July 26, 2005, announcing updates to the CDR Submission Guidelines for Manufacturers as well as to the Procedure for the Common Drug Review.
 
• The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) has released a new Connection newsletter. Connection 18: CCOHTA symposium major stepping stone for HTA in Canada.
 
• The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) has released an Emerging Drug List publication: Prasugrel for Patients with Acute Coronary Syndrome Undergoing Balloon Angioplasty.
 
• The Common Drug Review (CDR) Directorate has issued the latest CDR Update, No. 19, dated June 9, 2005, announcing the release of the CDR Evaluation Stakeholder Survey and providing instructions on how to access the survey online.
 
CDR Update: The Common Drug Review (CDR) Directorate has issued the latest CDR Update, No. 18, dated May 25, 2005, announcing the evaluation of the Common Drug Review’s first year of operations available at: www.ccohta.ca

CCOHTA Consultation Session: The Canadian Coordinating Office for Health Technology Assessment (CCOHTA) is hosting a consultation session on June 10th, 2005 in Ottawa about the approach to evaluation methodology proposed by its Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) program to assess evidence for best practices. The deadline for registration is June 3, 2005. For more information: www.ccohta.ca
 

• The Common Drug Review (CDR) Directorate has issued CDRUpdate, No. 17, dated April 29, 2005, outlining staff additions and transitions at CDR.
 
• The Common Drug Review Directorate has issued CDR Update No. 16, dated April 18, 2005 - meeting dates have been changed for three of the Canadian Expert Drug Advisory Committee meetings scheduled for 2005.
 
• CCOHTA has released the Winter 2004 issue of Connection: CCOHTA reaches out with new liaisons.
 

CDR Update No. 15 - CCOHTA Committees Merge / Submission Status Updates

The Common Drug Review has issued the latest update No. 15 effective February 1st, 2005 with the following announcements:

Merger of Two CCOHTA Committees

The Common Drug Review Committee (CDRC) and the Pharmaceutical Advisory Committee (PAC) have merged to form the Advisory Committee on Pharmaceuticals (ACP). PAC has existed for a number of years, providing advice to the Health Technology Assessment (HTA) Directorate, while the CDRC was struck more recently to focus on CDR specifically. Since the mandates of both these committees relate to pharmaceuticals, it has been agreed that they should be combined. The ACP will provide advice to the CCOHTA Board and to the CDR and HTA Directorates to enable them to meet their goals and objectives.

CDR Documents Revised to Reflect the Merged Committee

The following CDR documents have been revised, with references to the Common Drug Review Committee (CDRC) replaced by the Advisory Committee on Pharmaceuticals (ACP). Related pages on the CCOHTA website have also been updated to reflect this change. Please note that no changes have been made to the procedure or submission requirements. The revised documents become effective immediately and are posted on the CDR section of the CCOHTA website:

  1. Advisory Committee on Pharmaceuticals (ACP) Terms of Reference – Replaces both the Common Drug Review Committee (CRDC) and the Pharmaceutical Advisory Committee (PAC) Terms of Reference.
  2. Canadian Expert Drug Advisory Committee (CEDAC) Terms of Reference
  3. Procedure for Common Drug Review
  4. Common Drug Review Submission Guidelines

Change in Date for Submission Status Updates from Wednesdays to Fridays

Effective Friday, February 4, 2005, the CDR Drug Submission Status updates posted weekly to the CCOHTA CDR Submission Status web page will be made every Friday, changing from Wednesday.

The Friday postings will reflect activity to Thursday noon of each week. Postings may be made more frequently as necessary. 
 

Common Drug Review Industry Info Session

CDR presentations which were may by staff of the CDR Directorate at the November 23rd Information Session for Industry are now available under the Outreach link of the CDR section of the CCOHTA website.
 

CDR Submission Guidelines Update

CCOHTA has issued the latest update to the CDR dated December 2, 2004 with the following announcements:

Changes to the CDR Submission Guidelines for Manufacturers and Canadian Expert Drug Advisory Committee Terms of Reference

  1. Common Drug Review Submission Guidelines for Manufacturers
    The Criteria for Resubmissions (Section 1.3.1) on page 16 of the Common Drug Review Submission Guidelines for Manufacturers have been revised. Please note that the second criterion for filing resubmissions now states:
  • New Information becomes available after notice of final CEDAC recommendation not to list has been issued.

The new version of the Common Drug Review Submission Guidelines for Manufacturers is dated December 1, 2004 and is posted on the CDR section of the CCOHTA website (www.ccohta.ca).

  1. Canadian Expert Drug Advisory Committee (CEDAC) Terms of Reference
    Section 9.5 has been amended to include the Vice President of CDR and Canadian Optimal Medication and Prescribing Utilization Service as a meeting attendee at CEDAC meetings. Section 9.8 has been amended to provide clarity that CEDAC has the authority to make a recommendation for all submissions to CDR.

The revised CEDAC Terms of Reference are dated December 1, 2004 and are posted on the CDR section of the CCOHTA website at: www.ccohta.ca.
 

• CCOHTA has released an updated Emerging Drug List report on Alemtuzumab for B-cell chronic lymphocytic leukemia. This replaces the report originally issued in May, 2004.
 

CDR Industry Information Session
The CDR Directorate of CCOHTA invites members of the pharmaceutical industry to attend an information session on Tuesday, November 23, 2004 in Ottawa.  The session will provide updates on the Common Drug Review program and submission process.  The session is open to pharmaceutical manufacturers and individuals who prepare submissions for new chemical entities and new combination products on their behalf.

More details and registration information is available on CCOHTA's website at www.ccohta.ca
 

• CCOHTA has released an updated Emerging Drug List report on cinacalcet. This replaces the report originally issued in September, 2004.
 
• CCOHTA has released a new Emerging Drug List: Cinacalcet for secondary hyperparathyroidism.
 
• CCOHTA has released a new Emerging Drug List: Duloxetine for major depressive disorder and stress urinary incontinence.
 

• In the latest CDR Update No. 12 dated August 17th, 2004 the Common Drug Review Submission Guidelines for Manufacturers have been updated and posted on the CDR section of CCOHTA’s web site. The new version is dated July 2004. The template letters and product profile required in a manufacturer’s submission have also been updated.

More info available on the CCOHTA website.
 

CCOHTA Appoints Director of COMPUS Program:  In a news release dated July 19th, 2004 CCOHTA announced the appointment of Barbara Wells as Director of COMPUS, effective July 19, 2004. The Canadian Optimal Medication Prescribing and Utilization Service, or COMPUS, is a program for promoting best practices in drug prescribing and use that was launched at CCOHTA in March 2004. As Director of COMPUS, Ms. Wells will be responsible for the development and delivery of the program. Further details are available on the CCOHTA website.
 

• The Canadian Coordinating Office of Health Technology Assessment, CCOHTA, has released the following publications:

• CCOHTA’s CDR has released updated Submission Status Reports (listed alphabetically by product name) effective July 14, 2004:

Active
  • Adderall XR
  • Ciprodex
  • Fabrazyme
  • Forteo
  • Gynazole.1
  • Neulasta
  • Remodulin
  • Pegasys RBV
  • Replagal
  • Teveten Plus
  • Viread
  • Zavesca
Complete
  • Axert
  • Combigan Ophthalmic Solution
  • Evra
  • Iressa
  • Reyataz

For details on these reports please go to the CCOTHA website and look under the Common Drug Review Section -Submission Status.
 

• The Canadian Coordination Office for Health Technology Assessment (CCOHTA) has published the Spring 2004 Connection Newsletter which includes an overview of the Canadian Optimal Medication Prescribing and Utilization Service (COMPUS) and a report on the latest activities of the Common Drug Review.

CCOHTA has also issued an Emerging Drug List Publication on Ranolazine.
 

• CCOHTA’s Common Drug Review has issued the latest CDR update #9 dated April 23rd, 2004 which outlines the first CDR reviews completed, revisions to Appendix 1 of the Submission Guidelines for Manufacturers, the first CDRC Meeting and CDR Directorate’s activities. Details of the update are available under the CDR section of CCOHTA's website.
 
• The Common Drug Review's Submission Status Report which reflects activity up to March 2nd, 2004 lists the following drug products currently under review: Axert, Combigan Ophthalmic Solution, EVRA, Iressa, Replagal, Reyataz, Viread.  For more information refer to CCOHTA's website under Common Drug Review.
 
• Further to the June 25th, 2003 CCOHTA Workshop on "Preparing Submissions for the Common Drug Review", the Presentation is now posted on CCOHTA's website.
 
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