CADTH Drug Portfolio Information Session Pharmaceutical Manufacturers, Industry Associations, and Consultants OCTOBER 14, 2015
Welcome ROBYN OSGOOD MODERATOR
Presenters • Dr. Brian O’Rourke President and Chief Executive Officer, CADTH • Mr. Brent Fraser Vice-President, Pharmaceutical Reviews, CADTH • Dr. Chander Sehgal Director, CADTH Common Drug Review and Optimal Use • Dr. Mona Sabharwal Executive Director, CADTH pan-Canadian Oncology Drug Review • Dr. Michelle Mujoomdar Director, Scientific Affairs, CADTH • Mr. Ken Bond Director, Strategic Initiatives, CADTH 3
Overview of the Agenda TOPIC LEAD Welcome Robyn Osgood Introductory Remarks Brian O’Rourke CADTH Scientific Advice Program Michelle Mujoomdar Evolving Patient Engagement Processes Ken Bond CADTH Drug Portfolio Updates Brent Fraser pCODR Consultations and Updates Mona Sabharwal CDR and Optimal Use Consultations and Chander Sehgal Updates CDR/pCODR Alignment – Consultations and Brent Fraser Updates Open Forum Robyn Osgood
Principles for the meeting • Open, respectful discussion • Let’s listen • Loop back to address outcomes/unanswered questions 5
Introductory Remarks DR. BRIAN O’ROURKE PRESIDENT AND CHIEF EXECUTIVE OFFICER
Session Objectives 1. Outline CADTH’s Scientific Advice Program 2. Outline CADTH’s Patient Engagement Strategy 3. Provide program updates from the CADTH drug portfolio 4. Provide an update on CDR-pCODR alignment activities, including progress to date and key priority areas 5. Answer questions and discuss key issues 7
CADTH Scientific Advice Program MICHELLE MUJOOMDAR, PhD. DIRECTOR, SCIENTIFIC AFFAIRS
About the CADTH Scientific Advice Program • Voluntary, fee-for-service consultation for pharmaceutical companies • Advice on early drug development plans from a health technology assessment (HTA) perspective • Advice at an early point in the drug development process 9
Why Scientific Advice at CADTH? • Industry interest (requests since 2008) • CADTH Pilot • Comparable International Programs: • NICE (UK) • EUnetHTA (Europe) • AIFA(Italian Medicines Agency) • G-BA (Germany) • EMA-HTA Joint Advice
Development of a CADTH Program Guiding Principles • Voluntary • Non-binding • Fee-for-service based on cost recovery • Will not detract or divert resources from other CADTH programs Our Approach to Developing the Program • Engagement with Industry • Learn from existing programs at leading HTA agencies • Adapt and build on the strengths of CADTH
Eligibility • New drug products • Existing drug products with new indications • Drugs for rare diseases • Subsequent entry biologics (SEBs) • Oncology products 12
Types of questions asked • Patient population • Comparator • Outcomes • Follow-up • Analyses • Health Economic-related 13
Features of a Scientific Advice program General • Face-to-face meeting with open, candid exchange • Written record of advice • Value in experts attending meeting; all participants must be knowledgeable Nature of the advice • Relevant, timely, constructive, and actionable with a specific point of view provided • Balance between covering all issue and discussing key issues in depth
Patient Involvement Two approaches: 1. Information provided by company 2. Patient interview 15
Potential Benefits • Early input in drug development process • Recommendations based on better evidence • Reduced uncertainty • Test new development strategies • Advice in context 16
www.cadth.ca/scientificadvice scientificadvice@cadth.ca requests@cadth.ca 17
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Evolving Patient Involvement Processes KEN BOND DIRECTOR, STRATEGIC INITIATIVES
Opportunities for Input • Submissions from individual patients and caregivers • Therapeutic Review feedback and process revisions
Enhancing Input and Feedback Assessments: • Use of patient group input in CDR • Letters of appreciation
Medical Devices and Procedures • Explicit consideration of patient values and preferences • Systematic review of patient preferences and values • Patient interviews to validate key outcomes • Patient groups to comment on draft report and recommendations
Collaboration and Outreach • Patient Community Liaison Forum webpage www.cadth.ca/cadth-patient-community-liaison- forum • HTAi Patient and Citizen Involvement Interest Group Meeting October 18-20 • CADTH 2016 Symposium
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CADTH Drug Portfolio Updates BRENT FRASER VICE-PRESIDENT, PHARMACEUTICAL REVIEWS
Timeframes • April 2014: pCODR transfer to CADTH • June 2014: CDR Stakeholder information sessions • Feb 2015: CDR & pCODR Stakeholder engagement sessions • Feb-Sept 2015 o Written stakeholder feedback opportunity o CADTH’s establishes the CDR -pCODR alignment working group to identify areas for alignment and prepare procedural changes o Ongoing consultation with participating jurisdictions (drug plans and cancer agencies) • Sept-Oct 2015: o CADTH drug portfolio information session o Stakeholder consultations of key alignment initiatives o Identification of additional procedural and process items for alignment between the CDR and pCODR programs • January – March 2016: Implementation of the procedural decisions made
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pCODR Consultations and Updates DR. MONA SABHARWAL EXECUTIVE DIRECTOR, CADTH PAN-CANADIAN ONCOLOGY DRUG REVIEW
Patient Engagement & Collaboration New Initiative: • Expanding the CADTH Drug Review Process to Receive Patient Input Submissions From Individual Patients and Caregivers Collaboration Projects (2015): • Illustrating key components of the existing “Guide for Patient Advocacy Groups” through two narrated slide decks • Cancer Drug Pipeline Information for Patient Advocacy Groups 29
Consultation on Enhance Clinician Engagement Proposal: • Develop a mechanism that will increase opportunities for clinicians to participate in the CADTH pCODR process Objectives: • Provide value-added contextual information for Clinical Guidance Panel and pERC • Enable cancer specialists to provide input on value of a particular drug and its place in therapy • Solicit values of broad clinician community • Continue to foster relationships with the clinician community 30
Proposed Approach for Clinician Engagement Estimated 99 – 149 business days 12 business days Variable 5 business days 70-90 business days 10 business days 20 business days 12 business days 2. Prepare & submit Industry/ Tumour Request for Drug Review Group 7.1 Get Feedback from Submitter (and impacted manufacturer) 3.1 Screen 4.1 Submission 7.4 Conduct and Initiate Eligible for Clinical Review Early Review Process 1. Conduct Conversion Pre- ? No Yes Submission Planning 4.1.1/4.2.2 pCODR * 6. Prepare & activities Clarify info 5. 9. Prepare & Publicly Post 7.2 Get 8. Summarize including with Summarize Publicly Post End ‡ Initial Feedback from & Review with getting Submitter & Review Final Recomm Recomm, PAG pERC input from during with pERC & Post Input Post Reviews PAG and review notifying Patient Advocacy Groups 4.2 7.3a Get *Includes pCODR Secretariat, Clinical Conduct Feedback Guidance Panel, Economic Guidance Economic from Patient Panel, pCODR Expert Review Committee Review Advocacy (pERC) and Provincial Advisory Group 3.2a Collect Group (PAG) Patient Patient Advocacy Advocacy ‡ Next steps could include Group Input Groups Recommendation implementation, 7.3b Get Procedural Review or Resubmission Feedback 3.2b Collect from Regsitered Registered Clinician Clinician Input
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CDR and Optimal Use of Drugs – Consultations and Updates DR. CHANDER SEHGAL DIRECTOR, CADTH COMMON DRUG REVIEW AND OPTIMAL USE
Revised voluntary withdrawal process • CADTH has recently seen an increase in the number of submissions that are withdrawn by manufacturers during the embargo period. • In order to be accountable to stakeholders, CADTH has a public responsibility to communicate the outcomes of drug reviews that were considered by CDEC. • CADTH plans to revise the CDR Procedure by only permitting withdrawal of a submission up until 4:00 p.m. EST five business days before CDEC is scheduled to deliberate. • This procedural change would be effective for all submissions targeting the Jan 2016 CDEC meeting or later.
CADTH responses to manufacturer comments • To increase the transparency of the CDR process, CADTH plans to revise the CDR Procedure and provide manufacturers with the CDR review team’s responses to their comments regarding the draft CDR review reports. • This would be effective for all submissions and resubmissions targeting the January 2016 CDEC meeting or later. • Responses will be provided seven business days prior to the CDEC meeting • The responses will be provided for information only and manufacturers should not contact CADTH regarding the content of the response document.
Identification of Topics for Therapeutic Reviews Policy Makers, CDEC, CDR Government Environmental CADTH Staff Scans, Horizon (PDOs, LOs) Scans Topic Identification
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