CADTH Pharmaceutical Reviews Update — Issue 2

Details

Project Line:
Reimbursement Review
Project Sub Line:
Pharmaceutical Review Update
Final Biosimilar Summary Dossier Issued:

Updates for Patients and Communities

If you missed today’s webinar “Ensuring Patient Voices Are Heard: How Patients Can Contribute to the Canada's Drug Agency Symposium,” it will also be available in Events Archives.

Thank you for the many ideas offered by members of the Canada's Drug Agency Patient Community Liaison Forum, patient and public members of the Canada's Drug Agency expert committees, and directors of Canada's Drug Agency programs, on our patient engagement framework and plans for a patient and community advisory group. We’re now directly reaching out to a wide range of patient and community groups to listen to their ideas on these initiatives. If you’re interested in being involved, please contact [email protected].

Canada's Drug Agency Program Updates

Pan-Canadian Oncology Drug Review (pCODR)

1. New and Outgoing pERC Members

Canada's Drug Agency is pleased to welcome the following new members to the pCODR Expert Review Committee (pERC):

  • Dr. Christian Kollmannsberger, Oncologist
  • Dr. Henry Conter, Oncologist
  • Dominika Wranik, Health Economist
  • Daryl Bell, Patient Member

Canada's Drug Agency thanks the following outgoing members of pERC for their hard work and dedication through the years:

  • Carole McMahon, Patient Member
  • Dr. Craig Earle, Oncologist

2. New PAC and PAG Members

Canada's Drug Agency is also pleased to welcome the following new members to the Canada's Drug Agency pCODR Advisory Committee (PAC) and the Provincial Advisory Group (PAG):

  • Joanne Houlihan, Pharmacist, Systemic Therapy Program, Nova Scotia Cancer Care Program (PAC)
  • Evan Ulmer, Director of Cancer Services and EMS, Saskatchewan Ministry of Health (PAC)
  • Piotr Czaykowski, Chief Medical Officer, CancerCare Manitoba (PAC)
  • Andrea Nagle, Pharmaceutical and Health Benefits, Alberta Health (PAG)
  • Melanie Varughese, Pharmacy Manager, Cross Cancer Institute, Alberta Health Services (PAG)

Common Drug Review (CDR)

1. Joint Canada's Drug Agency-INESSS Engagement of Clinical Specialists

Canada's Drug Agency and the Institut national d’excellence en santé et en services sociaux (INESSS) are pleased to announce the details of a new pilot project to jointly engage with clinical specialists on selected drug product reviews.

  • CADTH-INESSS Clinical Engagement Pilot

2. New CDEC Members Appointed

Canada's Drug Agency is pleased to welcome three new members to its Canadian Drug Expert Committee (CDEC): Heather Neville, Dr. Rakesh Patel, and Dr. Emily Reynen. Canada's Drug Agency would like to thank outgoing members Dr. Kerry Mansell and Dr. Silvia Alessi-Severini for their valuable service and many contributions.

3. Posting Requests for Clarification

Effectively immediately, Canada's Drug Agency will post the details of any requests for clarification that are received during the CDR review process. This will include the questions filed by the jurisdictions and CDEC’s responses to the questions. Posting on the Canada's Drug Agency website will typically occur at the same time the CDEC Final Recommendation is posted. In accordance with the Canada's Drug Agency Common Drug Review Confidentiality Guidelines, manufacturers will have the opportunity to request the redaction of any confidential information prior to posting on the Canada's Drug Agency website.

Other Announcements and Initiatives

1. Webinar on Aligned Review Process

Health Canada, Canada's Drug Agency, and l’Institut national d’excellence en santé et en services sociaux (INESSS) have scheduled a webinar to describe the aligned review process in more detail, and answer questions about the initiative. The webinar is scheduled for September 26, 2018, from 10:00 AM to 12:00 PM EDT and is open to all interested stakeholders. To participate, please send your name and email address to [email protected]. You may also send questions in advance to be answered by Health Canada, Canada's Drug Agency, and INESSS during the session. Participants will receive a confirmation email containing log-in information and an agenda.