CADTH recently released their annual business plan for 2020-2021. In this, the last year of their three-year strategic plan, CADTH aims to deliver on a number of priority initiatives, several of which may have implications for industry, as described below.
1) Operationalize the Life Cycle Approach to Health Technology Assessment (HTA)
Under this priority initiative, CADTH signals their continued commitment to the life cycle approach to HTA via:
- enhancement of the Scientific Advice Program,
- plans for reassessments, condition level reviews, and
- the incorporation of real-world evidence into CADTH reviews.
a) Enhancement of the Scientific Advice Program
Recent enhancements to CADTH’s Scientific Advice program (e.g., the option for parallel advice with Health Canada or the National Institute for Health and Care Excellence [NICE]) may streamline the process of planning trial protocols and/or supportive studies and reduce overall timelines and workload for industry. While the Scientific Advice program is currently on hold due to the COVID-19 situation, a CADTH key performance indicator suggests increased capacity to meet the demand for this service in the future.
b) Reassessments, Condition-level Reviews
Existing pathways have long allowed for reassessments by CADTH, largely based on sponsor-initiated resubmissions, or requests for advice or therapeutic reviews by payors; the proposed reassessment framework amalgamates these processes. Compared with therapeutic reviews, condition level reviews represent a broader perspective which fits within a reassessment framework and CADTH objectives to align with payor priorities to manage sustainability, and advance the appropriate use of drugs. While sponsors cannot request that CADTH conduct therapeutic or conditional level reviews, they may provide evidence to inform reviews undertaken by CADTH. Given the potential for an increased focus on reassessments, sponsors should be alert to, and plan for, opportunities to provide new evidence in support of the value of their products.
c) Incorporation of Real-World Evidence into CADTH Reviews
Within this priority initiative CADTH states their intention to integrate the collection and analysis of real-world evidence into CADTH reviews, however, it is unclear who will have responsibility for collection and analysis. While real-world evidence could potentially inform both initial reviews and reassessments, in the short term real-world evidence is most likely to inform reassessments and be influenced by the work of CanREValue. However, given CADTH, like other regulatory and HTA agencies, has signaled their openness to the integration of real-world evidence in their reviews, industry may wish to take all opportunities to submit real-word evidence that fills an important evidence gap.
2) Advance the Use of Evidence to Improve Access, Affordability, and Appropriate Use of Drugs and Other Health Technologies
Under this priority initiative CADTH aims to:
- strengthen engagement with patients, clinicians, and other stakeholders and
- strengthen partnerships with the Patent Medicine Prices Review Board (PMPRB), pan-Canadian Pharmaceutical Alliance (pCPA), and members of the pan-Canadian HTA Collaborative.
a) Strengthen Engagement with Patients, Clinicians and other Stakeholders
CADTH continues to increase efforts to incorporate broader perspectives in their reviews. The newly announced Patient and Community Advisory Committee is expected to influence how patients and the public are involved in HTA processes at CADTH. The recent introduction of review-phase clinical panels within the Common Drug Review (CDR) has enhanced clinician engagement in the review of complex drugs, resulting in more detailed, directive, and practice-based recommendations, which have the potential to benefit all stakeholders by reducing time to listing and standardizing reimbursement criteria across jurisdictions. Currently, opportunities for patient and clinician involvement differ between the CDR and pan-Canadian Oncology Drug Review (pCODR) programs. CADTH has indicated that the proposed alignment of CADTH single drug reviews will address some of these disparities (e.g., allowing patient groups to comment on draft recommendations), while other possibilities include allowing clinician groups to provide input for all oncology and non-oncology drugs. In addition, as it relates to the appropriate use of drugs and condition-level reviews, enhanced engagement with clinicians may include collaborations to produce clinical practice guidelines.
b) Strengthen partnerships with the PMPRB, pCPA, and members of the pan-Canadian HTA Collaborative.
Given the mandate of CADTH, strengthening partnerships with the above organizations is logical given their similar goals, and could be related to the potential for a national drug agency, as well as the potential use of pharmacoeconomics by the PMPRB. A more integrated approach to drug assessments and negotiations could ultimately reduce time to listing.
3) Improve Transparency of Decision-Making and Organizational Performance
Under this priority initiative CADTH aims to:
- review and harmonize CADTH deliberative frameworks and
- enhance the transparency of CADTH expert committees.
a) Review and Harmonize CADTH Deliberative Frameworks
There are considerable differences in the deliberative frameworks for CADTH’s three expert committees; Canadian Drug Expert Committee (CDEC), pCODR Expert Review Committee (pERC), and Health Technology Expert Review Panel (HTERP). As with CADTH’s intention to “leverage the best practices from existing processes” sponsors may expect to benefit from a harmonized framework that standardizes the consideration of a broad range of issues into the deliberation and development of recommendations for all health technologies.
b) Enhance the Transparency of CADTH Expert Committees
Changes arising from alignment of CDR and pCODR procedures (e.g., posting draft recommendations for all single drug reviews) may be expected to increase transparency of CADTH’s expert committees. However, this initiative could also signal the possibility for expanded stakeholder attendance at expert committee meetings (e.g., representatives from patient groups, most likely as observers, with the potential for a greater role in the future).
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