2. cdr pres acook

ENGAGE. CONSULT. FIND SOLUTIONS. ACT COLLECTIVELY.

Drug Approvals Process in Canada:

The Common Drug Review


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


https://www.youtube.com/watch?v=fXsC-gfhuKM

https://www.youtube.com/watch?v=fXsC-gfhuKM


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


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...


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


So how do we do it?

RESEARCH

PRESENT

SURVEY

REPORT

Trial data, Drug Info

Webinar, presentation, meeting

CADTH template

Online survey, consultations


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


-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?


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


“...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


“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


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


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


Participate in the Process!

Subscribe to CADTH updates!

https://www.cadth.ca/subscribe

Watch CTAC Consultations!

https://www.youtube.com/user/ctactalks/videos

https://www.cadth.ca/subscribe

https://www.youtube.com/user/ctactalks/videos


Questions?Adam Cook

Policy ResearcherCTAC

Phone: 1.877.237.2822 x.224E-mail: [email protected]

Healthcare

2. cdr pres acook