CADTH Pharmaceutical Reviews Update — Issue 5

Updates for Patients and Communities

After spending the fall listening to patient groups and exploring how other organizations have involved patients and families in their organizational governance, we’re excited to announce that Canada's Drug Agency is launching a new Patient and Community Advisory Committee.

We invite those with extensive experience as a patient or family caregiver in Canada and an awareness of others’ views and experiences to apply to join our 12-person committee. 

See our Call for Nominations to the Canada's Drug Agency Patient and Community Advisory Committee.

Canada's Drug Agency Program Updates

Canada's Drug Agency Pan-Canadian Oncology Drug Review (pCODR)

Register for our webinar to learn about an upcoming consultation on a proposal to transition the functions of CAPCA’s Cancer Drug Implementation Advisory Committee to Canada's Drug Agency.

In December 2018, Canada's Drug Agency and the Canadian Association of Provincial Cancer Agencies (CAPCA announced that we would be exploring how some of the implementation functions of the Cancer Drug Implementation Advisory Committee, or CDIAC, could be transferred to Canada's Drug Agency. In collaboration with CAPCA, we will be issuing a consultation document on or before March 1, 2019. The consultation will be open to all stakeholders who may be interested in providing input on the proposal.

As part of this consultation, Canada's Drug Agency and CAPCA will be holding a webinar on Monday, March 4, 2019 from 12:00 p.m. to 1:00 p.m. EDT. Panellists Heather Logan (Senior Advisor, Canada's Drug Agency), Alexandra Chambers (Director, Canada's Drug Agency pan-Canadian Oncology Drug Review), and Erika Brown (Interim Executive Director, CAPCA) will outline key concepts of the proposal. The webinar is open to everyone and will provide an opportunity for participants to engage in a dialogue about this proposal. Advance registration is required, and registration will close on Friday, March 1, 2019 at 5 p.m. EDT.

Register here.

Canada's Drug Agency Common Drug Review (CDR)

1. Clinician Engagement

Strengthening engagement with the clinical community is an important objective of the new Canada's Drug Agency Strategic Plan. With that in mind, Canada's Drug Agency has undertaken several initiatives to enhance clinical engagement in the CDR process.

1.1 Clinical Panels in the Review Phase

In August 2018, Canada's Drug Agency initiated a consultation on Strengthening Process for Establishing Reimbursement Criteria in CDR Recommendations. A key component of this proposal was to expand engagement with clinicians during reviews of complex drugs and conditions that would likely result in challenging deliberations and reimbursement negotiations; specifically, through the formation of clinical panels composed of specialists with experience in the diagnosis and management of the condition for which the drug under review is indicated. Canada's Drug Agency will seek to leverage the expertise of these specialists to better characterize unmet therapeutic needs, assist in characterizing and communicating situations where there are gaps in the evidence that could be addressed through the collection of additional data, promote the early identification of potential implementation challenges, gain further insight into the clinical management of patients living with a condition, and explore the potential place in therapy of the drug.

Stakeholders indicated considerable support for this portion of the proposal and Canada's Drug Agency moved quickly to implement the clinical panel initiative. As noted in the consultation, to promote alignment throughout the health system and increase the efficiency of the approval and reimbursement process, Canada's Drug Agency is planning to establish clinical panels for drugs that are undergoing or have undergone an expedited review by Health Canada for the indication of interest (i.e., priority review or advance consideration under a Notice of Compliance with conditions). As communicated in September 2018, a subset of these panels will be conducted jointly with the INESSS, as part of a newly established pilot project.

Full details regarding the Canada's Drug Agency procedure for the integration of clinical panels into the review phase will be incorporated into an updated procedural document (targeted to be posted in March 2019).

1.2 Clinical Panels in the Implementation Phase

Providing enhanced implementation support for Canada’s publicly funded drug programs is an important part of the Canada's Drug Agency 2018‒2021 Strategic Plan. For certain drugs that have been reviewed through the CDR process, the jurisdictions have indicated that there is a need for additional support from panels of clinical experts to assist in the further development and refinement of reimbursement criteria and conditions required to implement a Canada's Drug Agency recommendation. In response to this request, Canada's Drug Agency has established a process to convene panels of clinical experts to provide further advice to the jurisdictions regarding potential reimbursement criteria and conditions for a funding recommendation. These panels will only be established at the request of the participating drug plans. Complete details regarding the use of clinical panels in the implementation phase will be incorporated into an updated procedural document (targeted to be posted in March 2019).

Health Economics

1. Economic Models

Manufacturers must ensure that economic models submitted to Canada's Drug Agency are free from harmful components and, in particular, that they do not contain any harmful code, such as program routine, device, malware, or other undisclosed feature. This includes, without limitation, a time bomb, virus, software lock, drop dead device, malicious logic, worm, Trojan horse, or trap door that is designed to delete, disable, deactivate, interfere with or otherwise harm the Canada's Drug Agency hardware, data, or other programs, or adversely affect the functionality of Canada's Drug Agency systems.

Other Announcements and Initiatives

Canada's Drug Agency Symposium 2019

Registration is now open for the 2019 Canada's Drug Agency Symposium being held in Edmonton, Alberta, from April 14 to 16, 2019. A preliminary program detailing the planned workshops, concurrent sessions, and breakfast sessions is available here.