|
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.
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|
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.
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|
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.
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|
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.
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|
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:
- 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.
- 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.
- 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.
- 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.
- 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).
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|
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.
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|
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.
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|
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.
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|
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:
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|
• 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:
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|
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.
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• 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.
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|
The Canadian Agency for Drugs and Technologies in Health has
released the following reports:
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|
• 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.
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•
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.
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•
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.
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•
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:
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|
•
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.
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•
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.
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•
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".
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• 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.
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• 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
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•
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.
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|
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:
-
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.
-
Canadian Expert Drug Advisory Committee (CEDAC) Terms of Reference
-
Procedure for Common Drug Review
-
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.
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|
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
- 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).
- 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.
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|
• 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.
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• The Canadian Coordinating Office of Health Technology Assessment,
CCOHTA, has released the following publications:
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• 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.
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• 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.
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• 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.
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• 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.
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• 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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