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ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
Drug Approvals Process in Canada:
The Common Drug Review
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
1.The Common Drug Review
2.CTAC’s history of Patient Group Input
3.The CTAC Method for Patient Group Input
4.Reform of The Common Drug Review
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
https://www.youtube.com/watch?v=fXsC-gfhuKM
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
The Common Drug Review
-Health Canada has said YES or is considering (Notice of Compliance)
-once HC says yes, then it’s available on the market
-but to get a drug listed on public insurance involves more steps
-Common Drug Review: is there social value in this drug over other drugs? Should this drug be listed on public insurance plans?
-Common Drug Review: asks patients and Canadians what they think of the drug
-CDEC (Canadian Drug Experts Committee) is the body that deliberates and makes a recommendation
-Public member of CDEC reads and presents the patient input at the deliberation
https://www.youtube.com/user/ctactalks
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
We provide a lot of inputCTAC IS IN THE TOP 15% OF MOST PROLIFIC PROVIDERS OF PATIENT INPUT IN CANADAJune 2015 - CADTH recognizes 17 (of 114) Patient Groups that have provided more than 5 input submissions since 2010.-CTAC is in the top 15% of Patient Groups regularly submitting input.-8 patient input submissions and 2 therapeutic review responses in 2015 alone!
...and the input we do provide is well-regardedCADTH SEEKS CTAC INPUT ON THE CDR; CTAC RECOGNIZED AS ONE OF THE TOP 4% HIGH-CAPACITY PROVIDERS OF PATIENT INPUT IN CANADAApr 2015 – CADTH conducts informant interviews with its 5 (of 114) most prolific and capable Patient Input submitters. Policy Researcher Adam Cook was interviewed by CADTH’s Impact and Evaluations Advisor, Andrew Dzuba.
CTAC and Patient Inputwe do this a lot...
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
2003 - CDR Developed
2007 – CTAC Position Paper on CDR and Reform
2010 – Patient Input becomes a part of CDR Protocol
April 2014 – CTAC urges for longer submission period for Patient Input
June 2014 – CDR adopts longer submission period for Patient Input
2015 – CTAC begins research on large-scale reforms to CDR
CTAC and Patient Inputand we have been working on this for a long time
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
So how do we do it?
RESEARCH
PRESENT
SURVEY
REPORT
Trial data, Drug Info
Webinar, presentation, meeting
CADTH template
Online survey, consultations
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
So how do we do it?
RESEARCHReview clinical trial data and research for submitted drug
PRESENTShare this data and research with stakeholders and community
SURVEYSolicit feedback from stakeholders, community, and patients
REPORTComplete Patient Group Input report and submit to CADTH for review
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
-This model is replicable.
-Cost Effective
-Agencies are already using it (HepC BC, Pacific Hepatitis C Network, etc)
-CTAC completed 8 Consultations and Reports in 2015 using this design
-We must allow reasonable time for groups to engage
-We must increase capacity of groups to participate
-We must increase visibility and transparency in the process
Patient Input Model
Why don’t more groups participate?
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
Are we speaking the same language?Product monograph vs patient anecdotes
Are we weighing evidence equitably?Public Member vs Health Economist
My Lived Experience versus Your Clinical DataMaking a defensible statement about the best treatment for the most people
Points of Tension in Patient Input Review
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
“...MANY [PATIENT-GROUPS] DO NOT KNOW WHAT’S ACTUALLY BEING ASKED OF THEM.” CDEC MEMBER
“...IF WE CONSIDER OUR ULTIMATE GOAL TO HAVE DECISIONS THAT ARE REFLECTIVE OF THE VALUES OF THE GENERAL
PUBLIC, THEN IT IS FINE TO HAVE THE PUBLIC INFORM THOSE DECISIONS. BUT IF WE CONSIDER OUR OBJECTIVE TO
BE...DECISIONS THAT ARE AS...FAIR AND EQUITABLE, ETHICAL AS POSSIBLE, THEN IT’S NOT NECESSARILY GOING TO BE THE CASE THAT THE PUBLIC IS GOING TO GIVE US THE BEST ANSWERS.” –
CDEC MEMBER
PATIENT INPUT – According to CDEC
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
“YOU INVITE PATIENTS (IN GROUPS) TO PROVIDE ANY INFORMATION THEY WANT TO REGARDING LIVING WITH THEIR CONDITION, BUT IT MUST BE IN 6 PAGES ONLY (11 POINT FONT) – NO PAGE BEYOND 6
WILL BE READ AND THIS MUST BE DONE WITHIN 15 BUSINESS DAYS...THEY [PGI TEMPLATE GUIDES] READ AS CURMUDGEONLY FINGER WAVING AT PATIENTS WHO ARE PRONE...TO TAKING TOO
MUCH TIME TO TELL THEIR LONG-WINDED STORIES OF SUFFERING. YOU’RE BUSY PEOPLE. YOU DON’T HAVE TIME FOR THAT SORT OF
PATIENT INPUT.”
– 2010 RESPONSE TO PGI BY THE MOOD DISORDERS SOCIETY OF CANADA
PATIENT INPUT – According to a Patient Group
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
Opportunities for ReformCADTH and the CDR are designed to be reformed!
-Issue Updates (over 100 requests for feedback and suggestions since 2003)
-CTAC attends annual CADTH symposiums and CADTH takeover of pCODR consultations
-CTAC offers Patient Input and Therapeutic Reviews
-APR 2014: CTAC reform suggested (Manufacturer notice)
-June 2014: Manufacturer notice reform adopted
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
1. OPEN THE PGI PROCESSRAISING THE VOICETransparency in process; Patient Reps on CDEC; Fixed seats for Ethicist as well as Economist
2. REVISED AND STANDARDIZED PROCEDURE FOR PGI DATA ACCUMULATIONSPEAKING THE LANGUAGE Qualitative data can be represented as themes of frequency and value
3. ENGAGE CDEC AND PATIENT-GROUPSA SEAT AT THE TABLE Open, public meetings (Scotland, NICE)
4. EMPOWER PATIENT-GROUPSA REPEAT ENGAGEMENTIncrease capacity to participate! Resources, workshops, etc.
REFORM of the CDR – According to CTAC
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
Participate in the Process!
Subscribe to CADTH updates!
https://www.cadth.ca/subscribe
Watch CTAC Consultations!
https://www.youtube.com/user/ctactalks/videos
ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.
Questions?Adam Cook
Policy ResearcherCTAC
Phone: 1.877.237.2822 x.224E-mail: adam@ctac.ca
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