CADTH Pharmaceutical Reviews Update — Issue 6

Updates for Patients and Communities

We received 85 nominations to the Canada's Drug Agency new Patient and Community Advisory Committee. Patients, caregivers, and community members from Prince Edward Island, New Brunswick, Nova Scotia, Quebec, Ontario, Manitoba, Saskatchewan, Alberta, British Columbia, and Yukon expressed interest. All Statements of Interest were blinded, read and ranked by at least two individuals, and deliberated upon to create a shortlist for interviews. Interviews are being set-up now, and we hope to confirm the 12 members of the advisory committee by the end of April 2019.

We would like to thank all the nominees for bravely describing lived experiences with addiction, cancer, chronic illness, rare disease, and mental health issues; and how they have built on their health experiences to drive change. Nominees also shared experiences of working with, or being members of, First Nations, LGBTQ, and rural communities.

Canada's Drug Agency Program Updates

Applications Fees

Canada's Drug Agency has implemented new Guidelines on Application Fees for Canada's Drug Agency Pharmaceutical Reviews. The updated document includes the annual fee adjustment based on the Consumer Price Index. Application fees supplement existing federal, provincial, and territorial funding and are used to help finance an increase in the number of drugs Canada's Drug Agency reviews annually.

August 2018 Stakeholder Consultations

Canada's Drug Agency initiated stakeholder consultations in August 2018 on three proposed initiatives for our CDR and pCODR processes:

• Addressing non-submissions by manufacturers.
• Strengthening the process for establishing reimbursement criteria in CDR recommendations.
• Posting of Canada's Drug Agency responses to manufacturer feedback received for draft CDR review reports.

A summary of the stakeholder feedback and the Canada's Drug Agency responses has been posted. Based on feedback, Canada's Drug Agency has decided on the following next steps:

• Canada's Drug Agency is proceeding with the proposed process for addressing non-submissions by manufacturers. The details of this new process have been incorporated into updated versions of the Procedures and Submission Guidelines for the Canada's Drug Agency Common Drug Review and the pCODR Procedures.
• Canada's Drug Agency has adopted a phased implementation approach for the proposal related to strengthening the process for establishing reimbursement criteria in CDR recommendations. Canada's Drug Agency has begun integrating clinical expert panels into the CDR review process and is currently reviewing options regarding the other aspects of the consultation (e.g., manufacturer submitted criteria). The details of the clinical panel processes have been incorporated into the Procedures and Submission Guidelines for the Canada's Drug Agency Common Drug Review.
• Canada's Drug Agency believes that the proposed revision to begin posting comments and responses may be problematic to implement at this time and will engage in further discussion with stakeholders on this issue in the future.

Canada's Drug Agency would like to thank all stakeholders who responded to these consultations. If you have questions regarding the above noted revisions, contact Canada's Drug Agency at [email protected].

Pan-Canadian Oncology Drug Review (pCODR)

2019 Oncology Drugs in Pipeline — Survey

Canada's Drug Agency would like to thank everyone who responded to its 2019 Oncology Drugs in Pipeline survey. The survey was distributed in February 2019 to collect information from participating pharmaceutical manufacturers on upcoming cancer drug submissions in Canada. If you have not had the opportunity to respond to the survey, responses are still welcome.

Common Drug Review (CDR)

Updated CDR Procedure and Guidelines

The Procedure and Submission Guidelines for the Canada's Drug Agency Common Drug Review has been updated. A summary of key revisions is available here. The new document contains a number of procedural improvements and revisions to the submission requirements, and includes all previous procedural amendments announced through Pharmaceutical Review Updates. Applicants who have questions about specific requirements may contact Canada's Drug Agency for guidance on submission preparations by emailing [email protected].

Updated Canadian Drug Expert Committee (CDEC) Meeting Schedule

The CDEC Meeting Schedule has been updated. In response to requests from industry, Canada's Drug Agency will be updating the CDEC meeting schedule on a quarterly basis going forward.

Optimal Use of Drugs

New Canada's Drug Agency Advisory Committee

Canada's Drug Agency has conducted an internal review of its Optimal Use (OU) of Drugs program to identify efficiencies and opportunities to increase timeliness, relevance, and impact of OU projects. This review included an examination of the role and mandate of the Canada's Drug Agency advisory committees in the OU process. Canada's Drug Agency noted that the OU program would benefit from greater emphasis on issues related to drug policy within the jurisdictions and closer linkages with the existing DPAC Formulary Working Group. As such, Canada's Drug Agency has established the DPAC Formulary Working Group for Health Technology Assessments (FWG-HTA), a new advisory committee composed of jurisdictional representatives with a greater role in drug policy decision-making. The new FWG-HTA has been enacted and replaces the DPAC Optimal Use Working Group (OUWG). Canada's Drug Agency wishes to thank all jurisdictional representatives who served on the OUWG.

Other Announcements and Initiatives

Call for Nominations

Canada's Drug Agency is seeking nominations for its advisory and expert committees.

We are recruiting six new members with significant expertise in the Canadian health care system; a range of education, experience, and skill sets; and an interest in helping support health care decision-makers in making informed choices about health technologies.

This is an exciting opportunity to help ensure that the Canadian health care system is the best it can be.

We are inviting nominations for the following Canada's Drug Agency committees and advisory groups:

• Device Advisory Group (DAC): procurement professional and health care practitioner.
• CDEC: multiple positions.
• Health Technology Expert Review Panel (HTERP): health care practitioner.
• pCODR Expert Review Committee (pERC): hematologist-oncologist.

Full details about each role, who is eligible to submit a nomination, the nomination process, time commitments, and honorarium eligibility are available on our website at www.cadth.ca/nominations.

We are pleased to offer an online nomination process for the first time. Interested individuals are invited to submit nominations through our online form no later than 4:00 p.m. EDT, Friday, April 26, 2019.