Summary of CADTH Drug Portfolio Information Session
Date: Monday, November 25, 2019
Time: 1:30 pm to 4:00 pm
On November 25, 2019, CADTH hosted two information sessions in Toronto, Ontario for their Medical Device and Drug Portfolios. These annual sessions are an opportunity for stakeholders to get the latest information about priority initiatives and process changes. The summary below is separated into the following sections:
- Welcome and Strategic Overview
- Pharmaceutical Reviews Portfolio – Overview & Program Updates
- Alignment of CDR & pCODR
- Clinician Engagement
- Health Canada Aligned Reviews
- Conflict of Interest
- Program Updates at a Glance
- New Initiatives
- Update on Recent CADTH Consultations
- Pending Revisions to Economics
- Expansion of Tailored Reviews and Therapeutic Reviews
- Plasma Related Reviews
- Gene Therapy Reviews
- Biosimilar Consultation
- Deliberative Frameworks
- Real-World Evidence
- Scientific Advice
- Stakeholder Engagement
Please note, this summary was prepared as a convenient reference based on MORSE’s understanding of the key takeaways. We invite you to please contact CADTH directly for further information on these initiatives.
1. Welcome and Strategic Overview
Presented by Brian O’Rourke
Brian O’Rourke welcomed all stakeholders and set the stage for the information session. He provided an updated on the pending federal government priorities and described the numerous international initiatives that CADTH is involved with; including for example:
- Creating a revised and harmonized definition of HTA with the International Network of Agencies for Health Technology Assessment (INAHTA);
- Discussing deliberative frameworks through the global policy forum with Health Technology Assessment International (HTAi); and
- Collaborating with ICER and NICE on the value and health economic components of curative therapies.
As a result of Brian O’Rourke’s retirement announcement, CADTH’s Board of Directors is currently conducting a search for a new President and CEO and have created a succession plan with the goal of having the individual in place prior to March 31, 2020.
2. Pharmaceutical Reviews Portfolio – Overview & Program Updates
Presented by Brent Fraser & Trevor Richter
Alignment of CDR & pCODR
This portion of the agenda focused on CADTH’s efforts to align the pCODR and CDR drug review programs. A significant amount of this work is focused on internal process pieces to improve efficiencies with respect to administration, technology, conflict of interest, and document management. They addressed numerous issues which have been raised upfront including:
- CADTH will be retaining both CDEC and pERC. Retaining both is paramount to draw on their expertise and address the volume of files entering the process.
- This alignment will not be simply applying the CDR process to pCODR, rather the best practices of both programs will be assessed to create a common look and feel.
- This process is currently still in a consultative phase and the expectation is for implementation to occur sometime in early to mid-2020.
The objective of this initiative is to establish a single drug review process for all eligible products. However, this merger is complex as it requires a major migration of infrastructure and it is difficult to change processes with the current workload. Their current approach to this merger is to leverage best practices from existing processes considering transparency, efficiency, timeliness and sustainability.
How will the proposed alignment impact patient engagement?
The objective is for patient groups to comment on draft recommendations for all reviews and in the new single drug process the window for patient engagement is to be extended to 35 business days (increased from within 10 business days of the pCODR program receiving a Submission to align with the CDR procedure) with a single coordinated contact point: The Patient Engagement Team.
How will the proposed alignment impact sponsor engagement?
As currently proposed, sponsors will have the opportunity to review and comment on CADTH’s draft review reports prior to the committee meeting in the single drug review process. There are some differences in terms of the frequency of reconsideration requests between the pCODR and CDR processes. The intention will be to consider the reasons for this and identify ways to manage accordingly. Reconsideration meetings will be lengthened (current CDR teleconference: 45 minutes) and offered for all review streams. They are also considering opportunities to potentially include committee members in reconsideration engagement.
The checkpoint meetings will likely be replaced with more rapid and frequent communications from CADTH staff. Sponsors will continue to have the opportunity to engage in a pre-submission meeting – these meetings will become more important and there is consideration about how to improve their value.
Will the recommendation format be changed?
The aligned recommendation framework was introduced in April 2016 and this will not be changed. However, documents between CDR and pCODR vary greatly. Therefore, the goal is to create a consistent format and content of the recommendation documents. CADTH is also seeking to begin posting draft recommendations for all single drug reviews. They are also considering allowing files to be discussed by the committees prior to NOC issuance (potentially for those who participate in the Health Canada aligned review process).
With regard to the reconsideration process, CADTH is contemplating allowing a second feedback period in the event the reconsideration has changed substantially from the initial recommendation. Furthermore, sponsors will be allowed to engage with CADTH to discuss their request for reconsideration for all files and the format and template will be increased from 3 to 10 pages.
The next steps for this process are as follows:
- Internal consolidation of processes (being finalized).
- Discussion with the newly formed Pharmaceutical Advisory Committee;
- The Pharmaceutical Advisory Committee has been created to provide strategic advice on drug related issues and topics to CADTH. It is a merger of DPAC and PAC for the oncology and non-oncology portfolios.
- Consultation with external stakeholders.
- Refinement and finalization of procedures.
- Launch of aligned single drug processes.
CADTH has indicated that the timelines will be communicated in a future update, however the target is to have the procedures finalized by April 2020.
Clinical experts are involved in all phases of the review process and all review teams include at least one clinical specialist with expertise in the diagnosis and management of the condition relevant to the drug under review. CADTH selects experts based on expertise, conflict of interest declaration, availability to commit to timelines and regional representation. They are also seeking opportunities to collaborate with INESSS for joint engagement with clinical experts.
CADTH is considering a new clinician engagement strategy that would focus on input from groups and associations of health care professionals.
Health Canada Aligned Reviews
CADTH is collaborating with Health Canada and INESSS on aligned reviews and information sharing. This process allows Health Canada to upload key documents directly to the HTA agencies and helps avoid potential delays in reviews. Currently, 47% (26/55) of all eligible submissions have opted into the information sharing and CADTH would like to see these numbers increase in the future. CADTH introduced a new temporary suspension process whereby sponsors that receive a Notice of Deficiency (NOD) or Notice of Non-compliance (NON) may be permitted to remain in CADTH’s process rather than face a mandatory withdrawal.
Conflict of Interest
As of January 2, 2020 CADTH, will no longer be redacting conflict of interest information from patient or clinician groups for drugs being reviewed through the pCODR process
Program Updates at a Glance
3. New Initiatives
Presented by Trevor Richter, Heather Logan & Nicole Mittmann
Update on Recent CADTH Consultations
28 responses from industry and government were received and the detailed summary and next steps will be communicated at a later date. The consultations commenced in August/September 2019 and covered the following topics:
- Changing Category 1 Requirements
- Feedback: Concerns regarding added expense and burden
- Proposed Reassessment Framework
- Feedback: Potential for conditional listing based on RWE development and concerns about increased uncertainty for industry
- Enhanced Transparency of CADTH’s Reports
- Feedback: Support from jurisdictions and considerable opposition from industry
Pending Revisions to Economics
Revisions to economic requirements are projected for approximately February 3, 2020. These changes include:
- Base case must reflect the Health Canada approved indication for all submissions
- Pan-Canadian BIA for all submissions
- Economic models must be programmed in excel
- Economic models must have a run time of < 8 hours
- Probabilistic analysis must be stable over multiple runs
CADTH will provide advance notification to allow time for sponsors to plan accordingly.
Expansion of Tailored Reviews and Therapeutic Reviews
CADTH has created a revised form and new simplified submission template for tailored reviews which now includes selected additional drug products such as new formulations of existing drugs that are eligible for review by CADTH. The decision to conduct a tailored review will be made by CADTH on a case-by-case basis.
Therapeutic Reviews have also been expanded to include oncology topics as well.
Plasma Related Reviews
CADTH has implemented an interim process for the review of plasma protein products while the provinces and territories complete a review of formulary processes in collaboration with Canadian Blood Services (CBS), CADTH and other key stakeholders. The objective is to promote efficiency by seeking alignment of procedures, guidelines and timelines. The initial guidance document has been released and a new subcommittee, the Canadian Plasma-Related Product Expert Committee (CPEC) will issue recommendations for plasma protein products.
Gene Therapy Reviews
The gene therapies reviewed to date were processed through the medical devices and clinical interventions program and the recommendation given by the Health Technology Expert Review Panel (HTERP) was released simultaneously with INESSS.
Going forward these products will be reviewed through a single drug review process. CADTH will however make the determination if it is not well suited to the existing process based on the improved eligibility request form.
They have established new additional requirements and review process which could facilitate faster access, including a new template outlining the sponsor’s plan for implementing the product in Canada. The new fees for this type of review are under Schedule E and are $108,000.
The next steps are to release the process documents, fee schedule, and eligibility form. Manufacturer which may have a therapy filed in the near future should reach out to CADTH.
The Biosimilar Consultation was initiated by the pCPA in summer 2018 and the agreement to proceed provided to CADTH July 2019. It provided a mechanism for stakeholders to provide input to jurisdictions that may be exploring biosimilar policy options, there is however no implementation plan.
CADTH is in the process of writing the report now and there will be an online consultation from December 9, 2019 to January 8, 2020. The stakeholder input will be consolidated and submitted to pCPA and the jurisdictions by January 31, 2020.
CADTH has 3 expert review committees who deliberate at key meetings and develop reimbursement recommendations. Discussions are guided by deliberative processes and frameworks. They share many similarities and some differences, so CADTH is assessing the processes and frameworks that are in place to identify opportunities for improvement and alignment. They are also looking at best practices internationally and working with the Centre for Innovation in Regulatory Science (CIRS) to conduct a quality assessment.
- Current: Review of frameworks at CADTH, other HTAs and Quality work
- January 2020: HTAI Global Policy Forum
- February/March 2020: CIRS Quality of Decision-Making Study Results
- February/March 2020: Completion of literature review and discussions with external organizations and experts
- April 2020: Recommendations
There is an ongoing collaboration between CADTH, INESSS and Health Canada to produce a strategy for use of RWE across the lifecycle and create guidance documents for use of RWE for drugs. The RWE Core Action Team (CAT) includes HTA and regulators with an objective of addressing common barriers and improving transparency and awareness.
CADTH is also involved in the CanREValue Collaboration which is working to develop a framework for Canadian provinces to generate and use RWE for cancer drug funding decisions.
Next steps include:
- Continuing collaboration between stakeholders to provide guidance and framework;
- Continuing collaboration with industry and data stewards to produce “appropriate” RWD;
- Improve capacity and skill across HTA and payers
- “Dive-in” with pilots
4. Scientific Advice
Presented by Nicole Mittmann
This program provides advice to pharmaceutical companies on clinical trial design and economic evaluation plans several years before market authorization. It is a voluntary, non-binding, confidential, fee for service, and cost-recovery program. They offer three services which are accepting applications for 2020 meetings:
- Parallel scientific advice between CADTH and Health Canada (including INESSS initially in an observer role)
- Parallel scientific advice with NICE
- Scientific advice from CADTH only
5. Stakeholder Engagement
Presented by Nicole Mittmann and Brent Fraser
CADTH has implemented the Patient and Community Advisory Committee to provide patient and public perspectives in the development of initiatives to improve the appropriate use of drugs and devices across the life cycle of health technologies across all programs.