CADTH Pharmaceutical Reviews Update — Issue 4


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

CADTH Program Updates

CADTH pan-Canadian Oncology Drug Review (pCODR)

1. Upcoming Webinar on CADTH/pCODR Clinician Input and Feedback Process

In collaboration with Innovative Medicines Canada’s Joint Oncology Project Team, CADTH is pleased to offer a webinar on the pCODR clinician input and feedback process. The webinar will be held on January 22nd from 12:00 p.m. to 1:00 p.m. EST. The webinar is open to everyone, with a focus on those involved in pCODR submissions and clinician engagement. The webinar will provide an overview of pCODR, detailed information about the clinician input process, and new tools available for clinicians.

Please use the following link to log in to the webinar:

For the audio: (toll-free) 1-877-394-5901; Access code: 7568417.

2. Proposal to Harmonize, Streamline, and Transition the Cancer Drug Implementation Advisory Committee to CADTH

Providing customized implementation support to decision-makers at all levels of the health system is a key objective of the 2018-2021 CADTH Strategic Plan. In support of this objective, CADTH and the Canadian Association of Provincial Cancer Agencies (CAPCA) are exploring how some of the implementation advisory functions of the Cancer Drug Implementation Advisory Committee (or CDIAC) can be transferred to CADTH.

CDIAC was created by CAPCA in 2016 to provide advice and recommendations to the provincial cancer agencies on how new cancer drugs could be integrated into existing treatment pathways to support greater sustainability with the introduction of new and often expensive cancer drugs. Given the potential to streamline and harmonize the work of CDIAC and CADTH’s pCODR program, and the opportunity to enhance the transparency of this work, CAPCA approached CADTH about assuming some of CDIAC’s implementation advisory responsibilities. CADTH’s strong relationships with Canada’s cancer agencies and federal, provincial, and territorial (F/P/T) drug plans, its established drug review processes, and its commitment to providing its customers with customized implementation support make CDIAC’s implementation advisory functions a natural fit for the organization.

Currently, CADTH and CAPCA are in the early phases of exploring how some of CDIAC’s implementation advisory functions might be incorporated into its pharmaceutical review portfolio. As a first step, CADTH has convened a deliberative framework expert panel to provide advice and recommendations for a framework to guide how implementation issues could be deliberated and recommendations formulated. As well, CADTH will be consulting with cancer agencies, F/P/T drug plans, patient groups, clinicians, and industry throughout the transfer to ensure that the implementation advisory functions at CADTH are considered fair and transparent, and that they continue to meet stakeholders’ needs.

To date, no decisions have been made about how these new implementation advisory responsibilities could be operationalized at CADTH; however:

  • It’s not necessarily CADTH’s intention to adopt the committee as is. CADTH will be considering a variety of possible options.
  • Although initially the focus will be on cancer drugs, the new implementation advisory functions may expand over time to include non-cancer drugs.

We will be consulting with all key stakeholders in early 2019. At this time, CDIAC will continue to operate in its current format under CAPCA.

3. Pre-Submission Information

As a reminder, submitters should complete the Pre-submission Information Requirements Form — Submissions to the greatest extent possible in anticipation of a submission, as set out in the pCODR Pre-submission Guidelines. The Pre-submission Information Requirements Form — Submissions outlines the following: submitter/manufacturer information, drug information, companion diagnostic, Health Canada review type, Health Canada consent letter, key date information, pre-submission meeting, Canadian trials and patient access programs, clinical overview, economic overview, and international comparisons.

This information is used in pre-submission planning activities; this preparation includes setting up pCODR supports to assist both submitters and stakeholder groups throughout the review process, obtaining input from the Provincial Advisory Group (PAG), and notifying appropriate stakeholder groups (i.e., patient groups and registered clinicians) of the pending review.

PAG will be notified by the pCODR program of an anticipated submission when a submitter has indicated their intent to make a submission and has provided the pCODR program with pre-submission information. The pCODR program may share pre-submission information with PAG as it prepares its input on the submission. The pre-submission information is also used to inform the new template for clinician input, including customized questions that are more specific to the drug and indication that is under review by the pCODR program.

4. 2019 Oncology Drugs in Pipeline — Survey

pCODR is again undertaking our periodic survey to facilitate consistent and systematic data collection from participating pharmaceutical manufacturers on upcoming cancer drug submissions in Canada. The first survey in 2012 was conducted by Cancer Care Ontario. pCODR has assumed responsibility for maintaining tracking of the pipeline cancer drugs on behalf of the provinces. This survey is to update the information collected in 2017.

The 2019 survey continues to focus on information that should be available in the public domain but may be difficult to find in one source in a consistent manner.

The benefits manufacturers identified from past surveys include:

  1. streamlining and standardizing responses to common requests from provincial drug programs and cancer agencies
  2. reducing redundant inquiries from individual provincial drug programs and cancer agencies
  3. assisting pCODR with resource planning to better accommodate the anticipated volume of submissions.

The target for the 2019 survey to be sent to participating pharmaceutical manufacturers is February 2019.

CADTH Common Drug Review (CDR)

1. Call for Clinical Experts

CADTH will be launching a new initiative to assist in identifying clinical experts who could participate in our review processes. Effective for all CDR submissions and resubmissions filed on or after January 2, 2019, CADTH will be issuing a Call for Clinical Experts for the purpose of recruiting clinical experts who are interested in working with CADTH. This call will be issued at the same time the Call for Patient Input is currently posted (i.e., 20 business days prior to the anticipated date of receipt). Those interested will be asked to register by completing a Web form with contact information and details about their areas of expertise and interest. CADTH will compile a database of registered clinicians and use this information to assist in the recruitment of clinical experts.

2. CDR Project Webpage Updates

CADTH will be updating the CDR project webpages to include the following additional information:

  • whether or not the submission was filed on a pre-NOC basis
  • whether or not the manufacturer elected to participate in the aligned review process with Health Canada.

Other Announcements and Initiatives

1. CADTH Drug Portfolio Information Session

The annual CADTH Drug Portfolio Information Session was held on November 1, 2018. The event was attended online and in person by more than 350 stakeholders and provided attendees with information about priority initiatives and process changes from CADTH’s pharmaceutical reviews portfolio. If you are interested in viewing the slides, the session presentation is available here.

2. Workshop on Real-World Evidence

On October 21, 2018, Health Canada, CADTH, the Institute of Health Economics (IHE), and the Canadian Association for Population Therapeutics (CAPT) held a workshop titled Defining Decision-Grade Real-World Evidence and its Role in the Canadian Context: A Design Sprint. The objections of the workshop were:

  • to identify the value and application of real-world evidence (RWE) in supporting pharmaceutical regulatory and reimbursement decision-making
  • to identify the conditions upon which RWE will be considered of sufficient quality to inform decision-making.

The summary report from the workshop is now available on the IHE website.