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How patient groups can have more
say in the drug approval process
Today’s webinar will begin with a sound check and
introduction at 12:55 p.m. EST.
1
Patient Involvement in the Lifecycle of a Medicine
February 2015
What today is about
• UNDERSTAND the lifecycle of a medicine
• HOW are patients currently involved in the various
steps of this lifecycle?
• WHAT are the upcoming opportunities for patients
to help shape how drugs are approved and
reimbursed?
• HOW can the various review processes evolve to
better meet patients’ needs?
3
Drug Development
Health Canada
Review
Patented Medicines
Prices Review Board
Health Technology
Assessment
Hospitals
Patient Access
Private Drug
Plans
Provincial
Drug Plans
First – an overview
of the Canadian
drug review process
Manufacturer clinical trials:
quality, safety and efficacy
Regulatory review:
quality, safety and efficacy
“Pricing” review:
maximum “non-excessive”
price
Funding recommendations:
Comparative safety, efficacy
and cost effectiveness
FUNDING
DECISIONS
Patient criteria
/appropriate use
4
Research and Development
• Participating in clinical trials
• Public registries: ClinicalTrial.gov
and canadiancancertrials.ca
• Getting involved in research
• CIHR’s Strategy for Patient-Oriented Research (SPOR):
• patients provide input on identifying health research priorities and
participate in the design and undertaking of research projects
• Patient and Community Engagement Research (PACER) program:
• joint initiative between Alberta Health Services (AHS) and the Institute
for Public Health at the University of Calgary
• trains patients in research methods so that they can become patient-
engagement researchers and join AHS’ Strategic Clinical Networks in
order to determine how the health system can deliver high-quality,
patient-centred care
5
Health Canada Pilot Project
• Announced by Minister Ambrose in
August 2014
• Targets patient input for approval of orphan drugs
• simulate how input from patients will be gathered and
incorporated into the drug review process once the Orphan Drug
Framework is in effect
• 2 drugs: Hoffmann-La Roche’s drug Gazyva for Chronic
Lymphocytic Leukemia and Hyperion Therapeutics’ drug Ravicti
for Urea Cycle Disorders (UCDs)
• Questions posed to patients:
• how the rare disease affects their ability to manage their day-to-day
lives
• what treatments are currently available
• what therapeutic benefits are most important to them
• their risk tolerance for any new treatments
6
Various HTA Processes
• National processes:
• For MOST meds: Canadian Agency for Drugs and Technologies
in Health’s (CADTH’s) Common Drug Review (CDR)
• For cancer meds: Pan-Canadian Oncology Drug Review
(pCODR) – now transferred to CADTH as of April 2014
• Provincial processes:
• British Columbia: “Your Voice” program
• Ontario: Ontario Public Drug Programs
and ODPRN’s drug class reviews
• Quebec: l’INESSS 30 day feedback
• Hospitals and Private Payers:
• Limited opportunities for patient input
7
National HTA processes
• All provinces participate in CDR and pCODR, except Quebec
8
• Federal drug plans also participate in CDR (not pCDOR)
CDR’s expert committee (CDEC)
makes one of four
recommendations:
pCODR’s expert committee
(pERC) makes one of three
recommendations:
i. List
ii. List with clinical criteria and/or
requirements
iii. Do not list at the submitted price
iv. Do not list
i. Recommend
ii. Consider with conditions
iii. Do not recommend
HTA Expert Committees
• Appointed experts who review the clinical and economic evidence
and patient input
• They are responsible for developing funding recommendations which
are passed on to participating plans
• A typical expert committee is comprised of…
• Pharmacologists / Pharmaco-epidemiologists
• Physicians
• Pharmacists
• Health economists
• Sometimes public/lay voice or patients
9
Provincial Reviews
10
Jurisdictions have their own expert review committees
• some consider the national review again and make a further
recommendation to province
Provinces consider CDR/pCODR recommendation and
account for local circumstances, priorities and budgets
Negotiations on price/criteria of drugs often take place:
• joint negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA),
which includes all provinces except QC - QC recently announced its intention to
join but legislative changes are required first
• individual provincial negotiations
In most cases, the minister of health is the final decision-maker, but
the real decision is delegated to relevant government officials (such
as Ontario’s Executive Director of the Ontario Public Drug Programs)
CDR Patient Input Process (2010)
• Part of the CDR process and fits into review timeframes
• Seeks input via Canadian patient groups
• Guide, you tube videos, on-line submissions
• Template for most medications and template for subsequent
subsequent entry biologics (SEBs)
• 35 days deadline for input and CADTH advises that focus should be on
“expectations for the new drug and reporting any patient experiences with the
drug in review”
• Letters of appreciation with feedback on the submission are sent
• Patient input summaries are included in clinical review reports posted online
and patient groups can comment on the summaries before they are finalized
• Entire patient submissions are shared with the expert committee, participating
plans and posted online
• Creation of CADTH Patient Community Liaison Forum
• Patient involvement in Scientific Advice Program
• Pilot project underway to obtain input from individual patients and caregivers in
cases where there is no patient group (until Aug. 3, 2015)
• CADTH is piloting patient input in therapeutic reviews (until Nov. 30, 2015)
11
Expert Committee Deliberation Steps
1. One public member presents summary of patient group input -
stated values and preferences and issues of patients and/or their
caregivers related to the condition for which the medication is
indicated and its treatment
2. Two discussants present their overviews of the clinical and economic
evidence
3. Members provide input; and CDR staff, including clinical and economic
reviewers, and invited experts provide input as required
4. Deliberation on patient group input, clinical and economic evidence,
and formulate a recommendation and provide reasons for it.
5. Members choose one of four recommendation options
6. Secret ballot voting on the recommendation option and the reasons
for the recommendation; decided by majority of votes
12
13
CADTH 2014
Patient Group Participation at CDR
14
CADTH 2013
pCODR Patient Input Process
• Canadian patient groups are invited to provide input:
• Must be registered
• Mandate must pre-date decision to register
• Only one submission per registered group is permitted
• Must be funded by more than one funder and no
funder may provide more than 50% of the group’s funding
• No individual patient submissions are permitted
• Patient groups have two opportunities to provide input:
• at time of review initiation (deadline: 10 business days)
• after an initial recommendation is published (deadline: 10 business days)
• Patients are members of the expert committee – they will summarize
and present the patient input
• this input is one of four considerations within pCODR’s deliberative framework
• pCODR is working with Canadian Cancer Action Network on a Patient
HTA Navigator pilot project
• navigator provides support to patient groups to optimize patient submissions
Patient Group Participation at
pCODR
pCODR Merger with CADTH
• pCODR transferred to CADTH in April 2014
• Steering committee has been established with representation
from drug plans and cancer agencies
• pCODR and CDR to remain independent programs
• CADTH now focusing on aligning both processes:
• adopting one set of common guiding principles for both processes
• aligning CDR and pCODR evaluation criteria
• standardizing the recommendation options
• building on efficiencies and best practices from both programs
• CADTH plans to consult stakeholders on these initiatives in
coming months
17
pCODR CADTH
Engagement Opportunities
• pCODR transfer to CADTH:
• Opportunity in coming months for stakeholders to provide input
on common guiding principle, evaluation criteria and
recommendation options to be established for both processes
• Opportunity to also highlight any best practices that should be incorporated or
improvements that should be in both processes
• CADTH’s evaluation of medical devices:
• Plans to refine its approach to health technology assessment of medical devices
throughout the product life cycle
• Potential opportunity to help shape patient involvement process in this context
• pCPA
• New pCPA office expected to be established in Spring 2015
• Roundtables to engage stakeholders about this new coordinating organization suppose
to be held early 2015 – no details on this has yet been released
• CADTH Symposium
• CADTH has started to offer financial support for patient groups wanting to attend the
annual CADTH symposiums
18
How to Increase Patient Voice in the
Lifecycle of Medicines
• How and at what stage should patients be involved?
• What are the criteria for successful involvement of patients in
regulatory, HTA and reimbursement processes?
• What is the current impact of patient input to HTA and funding
decisions?
19
• How should patients’ perspectives be
evaluated and factored into the formulary
recommendations and, ultimately, coverage
decisions?
• What are some of the current
obstacles/barriers for successful patient
involvement?
• What are strategies/approaches to address
them?
20
DISCUSSION
21
ANNEXES
CDR – How Patient Input is Used
22
CADTH 2014
pCODR Patient Input Process
5.
Summarize
& Review
with pERC
3.2 Collect
Patient
Advocacy
Group
Input
7.3 Get
Feedback from
Patient
Advocacy
Group
8. Summarize
& Review with
pERC
6. Prepare &
Publicly Post
Initial
Recomm,
Post
Reviews
4.2.
Conduct
Economic
Review
4.1.
Conduct
Clinical
Review
9. Prepare &
Publicly Post
Final Recomm
& Post Input
Direct impact of patient
perspective
Indirect impact of patient
perspective
pCODR 2013
Canadian Cancer Survivor Network
Contact Info
Canadian Cancer Survivor Network
1750 Courtwood Crescent, Suite 210
Ottawa, ON K2C 2B5
Telephone / Téléphone : 613-898-1871
E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca
Web site www.survivornet.ca
Blog: http://jackiemanthornescancerblog.blogspot.com/
Twitter: @survivornetca
Facebook: www.facebook.com/CanadianSurvivorNet
Pinterest: http://pinterest.com/survivornetwork/

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How patient groups can have more say in the drug approval process

  • 1. How patient groups can have more say in the drug approval process Today’s webinar will begin with a sound check and introduction at 12:55 p.m. EST. 1
  • 2. Patient Involvement in the Lifecycle of a Medicine February 2015
  • 3. What today is about • UNDERSTAND the lifecycle of a medicine • HOW are patients currently involved in the various steps of this lifecycle? • WHAT are the upcoming opportunities for patients to help shape how drugs are approved and reimbursed? • HOW can the various review processes evolve to better meet patients’ needs? 3
  • 4. Drug Development Health Canada Review Patented Medicines Prices Review Board Health Technology Assessment Hospitals Patient Access Private Drug Plans Provincial Drug Plans First – an overview of the Canadian drug review process Manufacturer clinical trials: quality, safety and efficacy Regulatory review: quality, safety and efficacy “Pricing” review: maximum “non-excessive” price Funding recommendations: Comparative safety, efficacy and cost effectiveness FUNDING DECISIONS Patient criteria /appropriate use 4
  • 5. Research and Development • Participating in clinical trials • Public registries: ClinicalTrial.gov and canadiancancertrials.ca • Getting involved in research • CIHR’s Strategy for Patient-Oriented Research (SPOR): • patients provide input on identifying health research priorities and participate in the design and undertaking of research projects • Patient and Community Engagement Research (PACER) program: • joint initiative between Alberta Health Services (AHS) and the Institute for Public Health at the University of Calgary • trains patients in research methods so that they can become patient- engagement researchers and join AHS’ Strategic Clinical Networks in order to determine how the health system can deliver high-quality, patient-centred care 5
  • 6. Health Canada Pilot Project • Announced by Minister Ambrose in August 2014 • Targets patient input for approval of orphan drugs • simulate how input from patients will be gathered and incorporated into the drug review process once the Orphan Drug Framework is in effect • 2 drugs: Hoffmann-La Roche’s drug Gazyva for Chronic Lymphocytic Leukemia and Hyperion Therapeutics’ drug Ravicti for Urea Cycle Disorders (UCDs) • Questions posed to patients: • how the rare disease affects their ability to manage their day-to-day lives • what treatments are currently available • what therapeutic benefits are most important to them • their risk tolerance for any new treatments 6
  • 7. Various HTA Processes • National processes: • For MOST meds: Canadian Agency for Drugs and Technologies in Health’s (CADTH’s) Common Drug Review (CDR) • For cancer meds: Pan-Canadian Oncology Drug Review (pCODR) – now transferred to CADTH as of April 2014 • Provincial processes: • British Columbia: “Your Voice” program • Ontario: Ontario Public Drug Programs and ODPRN’s drug class reviews • Quebec: l’INESSS 30 day feedback • Hospitals and Private Payers: • Limited opportunities for patient input 7
  • 8. National HTA processes • All provinces participate in CDR and pCODR, except Quebec 8 • Federal drug plans also participate in CDR (not pCDOR) CDR’s expert committee (CDEC) makes one of four recommendations: pCODR’s expert committee (pERC) makes one of three recommendations: i. List ii. List with clinical criteria and/or requirements iii. Do not list at the submitted price iv. Do not list i. Recommend ii. Consider with conditions iii. Do not recommend
  • 9. HTA Expert Committees • Appointed experts who review the clinical and economic evidence and patient input • They are responsible for developing funding recommendations which are passed on to participating plans • A typical expert committee is comprised of… • Pharmacologists / Pharmaco-epidemiologists • Physicians • Pharmacists • Health economists • Sometimes public/lay voice or patients 9
  • 10. Provincial Reviews 10 Jurisdictions have their own expert review committees • some consider the national review again and make a further recommendation to province Provinces consider CDR/pCODR recommendation and account for local circumstances, priorities and budgets Negotiations on price/criteria of drugs often take place: • joint negotiations through the pan-Canadian Pharmaceutical Alliance (pCPA), which includes all provinces except QC - QC recently announced its intention to join but legislative changes are required first • individual provincial negotiations In most cases, the minister of health is the final decision-maker, but the real decision is delegated to relevant government officials (such as Ontario’s Executive Director of the Ontario Public Drug Programs)
  • 11. CDR Patient Input Process (2010) • Part of the CDR process and fits into review timeframes • Seeks input via Canadian patient groups • Guide, you tube videos, on-line submissions • Template for most medications and template for subsequent subsequent entry biologics (SEBs) • 35 days deadline for input and CADTH advises that focus should be on “expectations for the new drug and reporting any patient experiences with the drug in review” • Letters of appreciation with feedback on the submission are sent • Patient input summaries are included in clinical review reports posted online and patient groups can comment on the summaries before they are finalized • Entire patient submissions are shared with the expert committee, participating plans and posted online • Creation of CADTH Patient Community Liaison Forum • Patient involvement in Scientific Advice Program • Pilot project underway to obtain input from individual patients and caregivers in cases where there is no patient group (until Aug. 3, 2015) • CADTH is piloting patient input in therapeutic reviews (until Nov. 30, 2015) 11
  • 12. Expert Committee Deliberation Steps 1. One public member presents summary of patient group input - stated values and preferences and issues of patients and/or their caregivers related to the condition for which the medication is indicated and its treatment 2. Two discussants present their overviews of the clinical and economic evidence 3. Members provide input; and CDR staff, including clinical and economic reviewers, and invited experts provide input as required 4. Deliberation on patient group input, clinical and economic evidence, and formulate a recommendation and provide reasons for it. 5. Members choose one of four recommendation options 6. Secret ballot voting on the recommendation option and the reasons for the recommendation; decided by majority of votes 12
  • 14. Patient Group Participation at CDR 14 CADTH 2013
  • 15. pCODR Patient Input Process • Canadian patient groups are invited to provide input: • Must be registered • Mandate must pre-date decision to register • Only one submission per registered group is permitted • Must be funded by more than one funder and no funder may provide more than 50% of the group’s funding • No individual patient submissions are permitted • Patient groups have two opportunities to provide input: • at time of review initiation (deadline: 10 business days) • after an initial recommendation is published (deadline: 10 business days) • Patients are members of the expert committee – they will summarize and present the patient input • this input is one of four considerations within pCODR’s deliberative framework • pCODR is working with Canadian Cancer Action Network on a Patient HTA Navigator pilot project • navigator provides support to patient groups to optimize patient submissions
  • 17. pCODR Merger with CADTH • pCODR transferred to CADTH in April 2014 • Steering committee has been established with representation from drug plans and cancer agencies • pCODR and CDR to remain independent programs • CADTH now focusing on aligning both processes: • adopting one set of common guiding principles for both processes • aligning CDR and pCODR evaluation criteria • standardizing the recommendation options • building on efficiencies and best practices from both programs • CADTH plans to consult stakeholders on these initiatives in coming months 17 pCODR CADTH
  • 18. Engagement Opportunities • pCODR transfer to CADTH: • Opportunity in coming months for stakeholders to provide input on common guiding principle, evaluation criteria and recommendation options to be established for both processes • Opportunity to also highlight any best practices that should be incorporated or improvements that should be in both processes • CADTH’s evaluation of medical devices: • Plans to refine its approach to health technology assessment of medical devices throughout the product life cycle • Potential opportunity to help shape patient involvement process in this context • pCPA • New pCPA office expected to be established in Spring 2015 • Roundtables to engage stakeholders about this new coordinating organization suppose to be held early 2015 – no details on this has yet been released • CADTH Symposium • CADTH has started to offer financial support for patient groups wanting to attend the annual CADTH symposiums 18
  • 19. How to Increase Patient Voice in the Lifecycle of Medicines • How and at what stage should patients be involved? • What are the criteria for successful involvement of patients in regulatory, HTA and reimbursement processes? • What is the current impact of patient input to HTA and funding decisions? 19 • How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions? • What are some of the current obstacles/barriers for successful patient involvement? • What are strategies/approaches to address them?
  • 22. CDR – How Patient Input is Used 22 CADTH 2014
  • 23. pCODR Patient Input Process 5. Summarize & Review with pERC 3.2 Collect Patient Advocacy Group Input 7.3 Get Feedback from Patient Advocacy Group 8. Summarize & Review with pERC 6. Prepare & Publicly Post Initial Recomm, Post Reviews 4.2. Conduct Economic Review 4.1. Conduct Clinical Review 9. Prepare & Publicly Post Final Recomm & Post Input Direct impact of patient perspective Indirect impact of patient perspective pCODR 2013
  • 24. Canadian Cancer Survivor Network Contact Info Canadian Cancer Survivor Network 1750 Courtwood Crescent, Suite 210 Ottawa, ON K2C 2B5 Telephone / Téléphone : 613-898-1871 E-mail jmanthorne@survivornet.ca or mforrest@survivornet.ca Web site www.survivornet.ca Blog: http://jackiemanthornescancerblog.blogspot.com/ Twitter: @survivornetca Facebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/

Editor's Notes

  1. CDR: - As of December 31, 2013, there are 268 CDR recommendations: 52% positive and 48% negative pCODR: - As of December 31, 2013, there were 62 pCODR/JODR recommendations: 73% positive and 27% negative
  2. As soon as CADTH anticipates being able to initiate the review of a queued submission within 35 business days, it will post the invitation for patient input on its website and send out an E-Alert and tweet to subscribers. Patient groups will have up to 35 business days to provide input when notified of the invitation to provide patient input. Posting Patient Input Submission Online: Submitters will be asked to provide permission for CADTH to post their entire patient input submission with all personal information removed. Space is available on the template for the submitter to indicate whether or not permission is granted. If permission is not granted, CADTH will post on its website that a patient submission was received, but it was not posted at the request of the submitter. A summary of all patient input that was received will be included in the CDR Clinical Review Report, which will be posted. CADTH Scientific Advice: - Program will offer advice to pharmaceutical companies on early drug development • Companies will report on patient engagement activities related to clinical trial design • CADTH will interview patient representatives to inform advice to companies
  3. *** CADTH Queue: - Currently, CADTH is queuing the review of drug submissions to CDR. - Products previously in queue have been delayed up to 5 months. Based on our assessment, drugs that are last in queue could face from 7 to 11 months delays, in addition to the std 6 months timeline it takes for products to go through CDR. - This means that the initiation of the review for queued submissions is delayed until further notice. As soon as CADTH anticipates being able to initiate the review of a queued submission within 35 business days, it will post the invitation for patient input on its website and send out an E-Alert and tweet to subscribers. Patient groups will have up to 35 business days to provide input when notified of the invitation to provide patient input. Posting Patient Input Submission Online: Submitters will be asked to provide permission for CADTH to post their entire patient input submission with all personal information removed. Space is available on the template for the submitter to indicate whether or not permission is granted. If permission is not granted, CADTH will post on its website that a patient submission was received, but it was not posted at the request of the submitter. A summary of all patient input that was received will be included in the CDR Clinical Review Report, which will be posted.
  4. Phase 1 (effective April 1, 2014): staff, processes, funding, and expertise remain intact as a program, and still based in Toronto but now under the governance of CADTH Phase 2 (to commence April 2015): exploration of better alignment of pCODR and CDR evaluation criteria, while taking advantage of best practices of both processes
  5. Report will be submitted to senior provincial executives and the Council of the Federation – public comms on the report could be the Council of Federation meeting in August 2014
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