Summary of CADTH Drug Portfolio Information Session
Date: Thursday, November 1, 2018
Time: 1:30 pm to 4:00 pm
Presenters: Brian O’Rourke, Brent Fraser, Alex Chambers, Trevor Richter, Heather Logan, Tarry Ahuja, Michelle Mujoomdar, Harindra Wijeysundera
Purpose: An opportunity for all interested stakeholders to get the latest information about priority initiatives and process changes from CADTH’s pharmaceutical reviews portfolio, including the CADTH Common Drug Review (CDR), the CADTH pan-Canadian Oncology Drug Review (pCODR), and Therapeutic Reviews. Updates on other relevant CADTH initiatives will also be provided.
MORSE’s Key Takeaways
CADTH presented information on their performance metrics, their new strategic plan, initiatives focused on increasing alignment with pan-Canadian partners and improving engagement across multiple stakeholders. There was a collective spirit of collaboration, engagement and excitement on the progress that has been made that came across from the speakers as well as the participants within the audience. Particularly encouraging is the commitment to moving to action on appropriate use of real world evidence, and stronger stakeholder engagement within drug reviews and across broader programs. There was an underlying theme of supporting the public drug plans with implementation of reimbursement recommendations, through CDIAC’s transition from CAPCA to CADTH, development of clinician panels and consideration regarding reimbursement criteria and the proposed supplemental process for highly specialized/complex drugs.
Agenda
- Welcome and Strategic Overview – Presented by Brian O’Rourke
- Pharmaceutical Reviews Portfolio (Overview and Program Updates from CDR and pCODR) – Presented by Brent Fraser, Alexandra Chambers & Trevor Richter
- New Initiatives (Consultations on Complex/Highly Specialized Therapies, Implementation Advice – Canadian Drug Implementation Advisory Committee Transition, CAR T-Cell Therapies, Real World Evidence) – Presented by Heather Logan and Tarry Ahuja
- Scientific Advice – Presented by Michelle Mujoomdar
- Stakeholder Engagement (Patients and Patient Groups, Clinicians and Clinical Societies, Industry) – Presented by Michelle Mujoomdar, Harindra Wijeysundera, Brian O’Rourke
1. Welcome and Strategic Overview
- CADTH Annual drug portfolio information session
- Session has been combined this year (industry, patients & clinicians together)
- Medical devices portfolio meeting was held on November 1st in the morning
- CADTH overview – Not for profit corporation that provides Canada’s health care decision makers with objective evidence about the optimal use of drugs and medical devices
- Two main portfolios:
- Medical devices, procedures, clinical interventions etc. (i.e. not a drug)
- Pharmaceutical portfolio
- Strategy – HTA is the science of what CADTH does (compare clinical & cost effectiveness)
- The philosophy of the new method is to better manage health technologies in support of health and value (determine what is important to patients)
- Two main portfolios:
- HTM – the philosophy of health technology management
- Focus is shifting from assessment at the point of adoption to evaluation across the life cycle of a drug or health technology (Increased emphasis on implementation support)
- Involved in the pre-space, launch and reassessment in post/exit
- Strengthened engagement with stakeholders
- An approach that better supports access, appropriate use, and affordability
- Better supports early and equitable access
- Focus is shifting from assessment at the point of adoption to evaluation across the life cycle of a drug or health technology (Increased emphasis on implementation support)
- New strategic plan – based on that HTM philosophy (includes updated values)
- Goal is to close the gap between evidence, policy and practice, adopt a life cycle approach and anticipate health system/technology trends to develop agile management strategies (get ahead of the technology curve)
- Also working on transparency particularly, with blacked out recommendations
- Pan Canadian Health Organization Implementation Steering Group
- Federal health minister requested review of 8 pan Canadian organizations
- Final report expected to be presented to the government of Canada by mid-December
- From a CADTH perspective, it seems that Implementing the new strategy will be the main change (but the report could also recommend restructuring)
- Federal health minister requested review of 8 pan Canadian organizations
- Advisory Council on the Implementation of National Pharmacare
- Consulting across Canada, has lots of questions on the work CADTH does
- Report will be produced in June 2019
- Health and Biosciences Economic Strategy Table – created by the federal government
- Promote innovation and business in Canada
- Consulting across Canada, has lots of questions on the work CADTH does
2. Pharmaceutical Reviews Portfolio (Overview and Program Updates from CDR and pCODR)
- Pharmaceutical Overview – Discuss stats on reviews, transparency and alignment work
- Timeline performance – Increasing number of reviews each year
- 100% of reviews were done within the 180-day timeframe
- Jurisdictions adopt recommendations almost completely (94% – CDR, 98% – pCODR)
- Negotiation issues (often from budget constraints) are outside CADTH mandate
- Transparency – More info available internationally (some is sensitive and can’t be shared)
- Redactions raise questions (the goal is to minimize or eliminate redactions)
- Collaboration – Focusing on partnerships
- Canadian Blood Services, pCPA, Canadian Association of Provincial Cancer Agencies, Regulatory Review of Drugs and Devices
- Working with Health Canada through R2D2 and CADTH has heavily been engaged in finding opportunities to gain efficiencies in both sides
- Closer relationship with INESSS
- Alignment – Aligning review processes
- How can we get the information through pre-NOC to do reviews earlier in the process? (Reducing delays to implementing recommendations)
- Plan to re-evaluate after one year to determine how to expand this
- Internal processes – Aligned number of pre-NOC submissions, CADTH Collaborative Workplace, New biosimilar Collaborative Workspace and review process
- Timeline performance – Increasing number of reviews each year
- Program updates – Trying to maintain a reactive aspect to the program (continuously adapting to meet the needs of stakeholders)
- CDEC – 3 members stepped down, 3 new members joined (physicians/pharmacy)
- Volume metrics – 100% compliance with performance metric (< 180 days)
- 41 or 42 CDR reviews (historical range of expected number per year)
- 4 or 5 RFAs coming through this year as well
- Pre-NOC – Uptake >50%, 2018 had 57% (increased uptake)
- CADTH Accepts submissions six months pre-NOC
- Information sharing with Health Canada allows alignment
- Deliver recommendation and NOC at the same time (removing gap)
- New Procedure Document – Will be routinely updated
- Pharmaceutical Reviews Update – One newsletter replaces individual emails
- Enhanced clinical engagement – Clinical expert panels (review phase)
- Plan to target drugs that undergo an accelerated HC review
- More info to be delivered to drug plans, no impact on fees or timelines
- CADTH INESSS Pilot – Clinician engagement panels (implementation phase)
- Launched in September (1st drug is going through this process)
- Issue a call for specialists at the same time as the call for patient input (experienced difficulty in soliciting experts, may expand the pool)
- Reimbursement Criteria – To provide jurisdictions with more detailed advice on reimbursement criteria
- Considering how best to do this
- Enhance clinician engagement
- Manufacturers could provide criteria upon submission which would be considered by the review process
- Non-submissions – Occurs when public drug plans are under pressure to consider funding, but the manufacturer does not intend to submit to CDR
- CADTH prepares the file and solicits a submission from the manufacturer
- If submission is not received, CADTH issues a public statement saying they cannot make a recommendation (cannot act without HTA recommendation)
- Lack of information on the CADTH side on cost-effectiveness
- Posting comments – Transparency
- It was proposed to publicly share info currently only shared with manufacturer and drug plan (feedback they provide on drafts and CADTH feedback)
- Concerns surrounding releasing information that may be sensitive or inaccurate
- 180-day timeline (may be a challenge to review publicly)
- Optimal Use – Goal is to deliver higher number of these new products over the next year
- Updates from pCODR – 4 new pERC members
- New product – Released last spring, to address provincial gaps in single technology reviews (particularly metastatic melanoma, gap analysis was done in ~4 months)
- anticipate more requests moving forward
- Key metrics – Increasing trend as more are coming in for pCODR
- pre-NOC (more uptake, 70% are pre-NOC)
- Recommendation is consistent (Issued 115 notifications as of Sept 30, 2018)
- Patient/clinician input (97% have patient input, 90% have clinician input, 231 clinicians registered to provide input)
- CADTH and Canadian Cancer Action Network collaboration – CCAN has dissolved
- Want to hear patient voice (looking for opportunities to reach out to many patient groups at once and provide cancer drug pipeline information)
- Searchable database of cancer drugs coming (ca/pipeline)
- No pipeline survey this year (will be implemented for the new year)
- Qualitative studies – What is meaningful patient engagement?
- Learn from patients (44 patient groups, 22 participants)
- Themes include: making submission a priority, resourcing/logistics, finding relevant patients, and determine perceived impact of patient input
- pCODR clinician feedback – Allows for broader clinician participation
- Physicians, pharmacists and nurses
- Form with tailored questions for each drug will be in upcoming reviews
- New resource – Collaborative effort with IMC and Lymphoma Canada
- Guide to providing clinician input was launched this week with pCODR
- Reassessments – CADTH Reassessment Working Group
- Look at previous products to see how reassessment reviews are accommodated
- pERC has made recommendations that reference time limited funding
- Can be re-evaluated (exploring RWE in cancer drug funding decisions)
- Will require a series of consultations (won’t be solved by CADTH alone)
- New product – Released last spring, to address provincial gaps in single technology reviews (particularly metastatic melanoma, gap analysis was done in ~4 months)
→ Question: Would CADTH be willing to adopt a new framework for drugs for rare diseases?
3. New Initiatives (Consultations on Complex/Highly Specialized Therapies, Implementation Advice – Canadian Drug Implementation Advisory Committee Transition, CAR T-Cell Therapies, Real World Evidence)
- Complex/Highly Specialized Therapies – Proposal for supplemental process drafted
- EDRD was established (in 2014) to explore management of rare disease therapies
- External consultations begin in November
- Written submission process will be confirmed following consultation
- Consulting with patients, clinicians, industry (CADTH is facilitating invitations)
- Survey will be released on November 14 (way to give opinions/ask questions)
- Driven by provinces and CADTH facilitates (BC, AB and ON are leading)
- Not a way to bypass standards of evidence
- Implementation Advice (CDIAC) – Cancer Drug Implementation Advisory Committee
- Introduce new treatments in a more effective/consistent way and provide advice to provinces on implementing the drug based on committee recommendations
- Role of CAPCA is to look at issues of common interest in drug funding and find a solution
- Multi-disciplinary, includes Quebec
- Want to ensure they can continue to provide access to valuable cancer drugs
- Lot of provincial variability in how/when these drugs are implemented
- Helps enhance clinician input and supports consistency in provincial oncology drug listing (without unnecessarily delaying patient access to new therapies)
- Determine how key components can be moved to CADTH due to resource needs
- Can we sustain this work, allowing it to evolve and strengthen?
- Fits into CADTH’s new strategic plan in terms of implementation support
- No decisions have been made about how this would be operationalized
- Would not necessarily adopt CDIAC as is (explore using it more broadly)
- Developed the Deliberative Framework Expert Panel (implementation focused recommendation framework, provides advice about process and operations)
- Goal is to implement this fully by April 2019
- Assessment of CAR T-Cell Therapies
- Device review (not a pharmaceutical, considered a procedure due to complexity)
- Implementation (practice and policy decisions will be made for appropriate use)
- Focusing on HTM and optimal use, recommendation will be to fund or not
- Expert committees are involved (Chair, public member, ethicist, health economist and three health care practitioners and up to five experts)
- Optimal use components (variety of different factors considered to ensure they go through HTERP Deliberative Framework)
- 9 step process takes approximately 9 months
- Clinical, economic, implementation and final reports will be produced
- Real World Evidence – RCT vs. non-RCT sources (filling evidence gaps)
- Different sources will be used to inform different policy and research questions
- Used with the product life cycle approach for both drugs and devices
- Had a summit defining grade RWE and its role in the Canadian context
- Meeting summary will be available by Dec 2018
- Multi-stakeholder RWE
- CADTH, Health Canada, IHE, CAPT, academia, researchers, clinicians, patient representatives, payers, data providers and industry
- Objective is to identify the value and applications of RWE in supporting pharmaceutical regulatory and reimbursement decision making
- Next steps – CADTH developing an RWE action plan
- Working with HC to generate a RWE Framework (Spring 2019)
- Several touchpoints for consultation and stakeholder feedback
4. Scientific Advice
- Canadian Institute for Research – Launched in Jan 2015
- Tammy Clifford departed CADTH last week and Michelle Mujoomdar is now acting VP
- Opportunity for CADTH to give advice to pharmaceutical companies for scientific development plans (to meet the needs of HTA bodies and payers)
- Timeline – Before initiation of pivotal trials Phase II or Phase III
- Flexible/customized timelines available, voluntary and non-binding
- Fee for service program – provided by most other agencies
- Clinical trial design or economic analysis – Outcomes of interest
- Face to face meeting – Draft advice is being provided
- Engage patients and caregivers in the process/advice through interviews
- Led by a patient engagement officer, six in process at this time
- Number of companies come back for a 2nd time
- Joint scientific advice with NICE – Preliminary process
- Exploring CADTH/Health Canada Parallel Scientific Advice – Discuss divergent advice
- Health Canada has observed several advice processes already
5. Stakeholder Engagement (Patients and Patient Groups, Clinicians and Clinical Societies, Industry)
- Patient Engagement Framework – Patient Advisory Committee
- Exercise to understand how to frame next steps (planned for next fiscal year)
- Provide information in an external document developed by consensus
- Chose to map current activities to the values and standards by HTAi
- Values include relevance, fairness, equity, legitimacy, capacity building
- Listening Exercise – Patient community liaison forum (21 patient groups)
- How can CADTH better involve and support patients?
- Greater involvement – Respectful, diverse engagement
- Has to be worthwhile (demonstrate an impact)
- Capacity issues in re-assessment
- Have to remember they have limited resources
- Be supported – Clear guidance on what is helpful or seen as biased
- Advisory group being created to advise CADTH across all programs
- Lived experience highlighted as essential
- Selected by nominations and to meet core competencies
- Greater involvement – Respectful, diverse engagement
- How can CADTH better involve and support patients?
- Exercise to understand how to frame next steps (planned for next fiscal year)
- Clinicians – Strategic overview of clinician and clinical society engagement
- Expert reviewers and panels – Has not been historically consistent across all diseases
- Clinicians are fairly narrowly engaged
- Have clinician input across all stages and implementation
- Needs broader sense of the clinical community – connect with all providers for new ideas
- Clinical/Professional societies – Represents network of peers
- Produce a lot of guidelines (deep influence on clinical care)
- Outreach and consideration of how to engage with these societies is underway
- Industry – Industry liaison forum (important stakeholder to engage)
- Resistance in many countries to engaging with pharmaceutical companies
- Created numerous methods for formal and broader consultation
