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In this webinar:
● Discussion of the CADTH Symposium
● Recommendations for HTA improvements in Canada
● Audience Q&A
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3. Who Pays for Pharmaceuticals in
Canada?
Total 2013 Rx Meds Expenditure
$29.3 B*; 100%
Private Sector
Share
$17.1 B; 58.4% of
total
Public Sector
Share
$12.2 B; 41.6% of
total
Other Publicly Funded Drug
Expenditure;
1.1 B; 3.8% of total;
9.0% of public share
Federal Drug Benefit Plan;
0.6 B; 2.0% of total; 4.9% of
public share
Provincial Drug
Benefit Plan;
10.5 B; 35.8% of
total; 86.1% of
public share
Out-of-Pocket
Contributions;
7.0 B; 23.9% of
total;
40.9% of private
share
Private Insurers;
10.1 B; 34.5% of
total; 59.1% of
private share
* Not including medicines dispensed in
hospitals
Source: Prescribed Drug Spending in Canada 2012
Report, CIHI
4. Complex Pathway to Patient Access
Drug Development
Health Canada
Review
Patented Medicine
Prices Review Board
Health Technology
Assessment
Hospitals
Patient Access
Private Drug
Plans
Provincial
Drug Plans
1.
5. Health Canada
• Considers clinical evidence from clinical trials
to decide if a drug/ biologic is safe and
effective for sale
• If so, the manufacturer can sell
• Monitors therapies post approval for ongoing
safety and effectiveness
6. Canadian Agency For Drugs and
Technologies in Health ( CADTH)
• Federal/provincial/ territorial health technology assessment body with two reimbursement
recommendation programs for provinces/ territories:
Common Drug Review ( CDR) program for non-cancer drugs
• Considers clinical, economic evidence and finally patient input
pan-Canadian Oncology Review ( pCODR) program for oncology drugs
• Considers clinical, economic, patient input and ease of implementation “equally” as its deliberative
framework
•
• Each decides the “value” of the drug relative to others available and relative to opportunity costs of
funding this drug versus other drugs
• Recommends a yes , a yes with conditions usually a pricing reduction or no to provincial funding bodies in
health ministries
INESSSS in Quebec
7. Provincial drug budgets
• Silos with at least one silo for drugs
• Oncology budgets are generally managed through the
cancer agencies in the province
• In Ontario and Atlantic Canada take home oncology drugs
are not paid for by the provinces but other provinces do
cover them
• Ontario has just announced an amalgamation of its Ontario
Pharmaceutical Drug Plans but no details are available yet
8. WHAT THE HTA PROCESS VALUES
Elizabeth Lye
Lymphoma Canada
10. Ethical Considerations
• Identifying values - Canada Health Act : Public
Administration; Comprehensiveness; Universality; Portability; Accessibility
• Developing framework to support identification and
analysis of ethical data to support better-informed,
value-sensitive decisions
• Training, engagement of ethicists in HTA process
• Scarcity of ethical evidence; limited resources and
expertise
11. “More” Evidence
• Incorporation of real-world evidence; patient values
• Quality of life data; lived experience of the disease
• Tools to facilitate indirect comparisons of new and/or
existing therapies
• Network meta-analysis adoption, cross-trial comparisons
• New methods for generating evidence
12. Engagement and Collaboration
• “Patient and public engagement”
• PAG input: Update to the CADTH Guidelines
for Economic Evaluation of Health
Technologies
• Clinician input: pCODR – pilot project
1.
13. CADTH Symposium Report Back
Need for change in HTA???
Sabrina Hanna
Save Your Skin Foundation
15. Evidence for everyone
Initially established as a tool for policy-makers, health
technology assessment (HTA) now supports a much
broader range of decision-makers. Everyone — whether
technology developers in academic settings and industry,
patients, clinicians, regional health authority and hospital
administrators, or private sector insurers — can benefit
from the evidence produced by HTA bodies. Because HTA
wasn’t originally designed with these stakeholders in
mind, do its processes and outputs need to change to
make it easier for clinicians, patients, and other key
stakeholders to integrate evidence into their decision-
making?
17. Numbers versus Words
• Quantitative data versus qualitative date
• Qualitative data gives a voice to the science
• Qualitative data answers the questions
1. what are the unmet needs
2. what are the experiences of the current
treatment
3. what is it like to live with the medical condition.
18. Need for Change
• Quantify qualitative data
• Create a template or guide that will help
patient groups provide input that is
meaningful and relevant
• Scientific Literacy
• Educate patient groups
19. Better decisions versus Different
Decisions
• Patient submissions help expert committees
make better decisions not different decisions
• Gap between theory and practice
20. Need for Change
• Formula/Value system for Quality of Life (QoL)
data
• Educate experts on the role of the Patient
groups
• Provide resources for patient groups to
develop submissions that are professional and
relevant to the patient experience
21.
22. Patient Centricity
• Patients Included
• Patients included charter
– Patients or caregivers actively participate in the design
and planning
– Patients and caregivers attend and participate
– Travel accommodation expenses are paid in full, in
advance. Scholarships are provided
– The disability requirement of participants are
accommodated
– Access for virtual participants is facilitated
23. Efficient HTA in real time
Health technology assessment (HTA) refers to
the systematic evaluation of properties, effects,
and/or impacts of health technology. It is a
multidisciplinary process to evaluate the social,
economic, organizational and ethical issues of a
health intervention or health technology.
• Interface of science and policy
24. Need for Change
• Join the digital age
• Share everything. hide nothing. Adapt Often
• Improvement of transparency and
communication
• Take HTA already delivered and adapt to our
setting
• Consult with people who benefit from and use
the work of HTA professionals
• Establish patient/citizen councils
28. CADTH’s Symposium in April was “certified” Patients Included
The evidence: This is a self-certification which any organization can use, providing they
meet criteria listed on the www.patientsincluded.org website.
What was missing:
Very few patients were involved in panels, and few were given scholarships to attend;
what financial support was available had to be divided between students,
preferably those presenting, and patients.
The process was unclear for patients and/or patient groups to participate in planning
the Symposium, including themes, topics and speakers, and in presenting.
There was no recognition or thanks in the program for any participation by patients.
29. CADTH obsessions
• Strong belief that patient groups are in conflict of interest if
they receive pharmaceutical company funding
• Disdainful for patients/patient groups that use Survey
Monkey or similar free or economical web-based tools to
survey patients
• Believe that patient participation is a risk: patients will be
uninformed, will belabour their own experience, will
disrupt professional decision-making
• Belief that patient input for drug reviews is suspect because
not seen as professional; lived experience is not seen as
valid
• Patient groups are questioned about their representivity
and who they report to
30.
31.
32. What is missing
• Transparency about how CADTH is funded - amounts and sources, so
patients may form their own opinions about possible bias
• Genuine understanding and respect for patient participation
• Patient pathways on CADTH website: very difficult to find out who the
patient representatives are (where they exist); how they are picked, and
for how long a term (danger of being co-opted)
• Train researchers and academic experts on value of patient input and
lived experience
• Need for critical mass: more patients, perhaps a panel of patient-experts
to be called upon in turn
• Do away with literature searches as a source of patient experiences and
work with real patients
CADTH Symposium
• Dedicated patient tables at meals and adjacent spaces so patients can
share experiences
• Serious funding to allow more patients to attend
33. The Future: best practices
internationally
Martine Elias - Myeloma Canada
Slides presented by Louise Binder
34. Our challenges are Global:
• Are regulatory decision makers able to change their
decision making paradigm?
• HTA agencies provide information and
recommendations, but then 3rd parties make the
reimbursement decisions
• What flexibility do HTA agencies have to navigate the
reimbursement environment. Will a new model be
required?
• Industry needs to address regulators, HTAs, Clinicians
and patients. Can they satisfy all?
• Bottom line: Can we manage the continuum from
bench to access in a smooth and efficient way?
1.
35. But what does Cancer Care Ontario
want….
• CCO is interested in supporting RWE that
addresses payer needs with the potential to
inform or validate funding decisions
• CCO is committed to expanding its efforts to use
RWE to inform decision making and is
management for cancer funding programs by
collaborating with their cancer partners
• They welcome input on who this could involve.
• WHERE IS THE PATIENT VOICE…
1.
36. What is being done elsewhere to bring patient value
through RWE into the decision process – EU Example
(1)
• GetReal aims to collect RWE data for early adoption in the
pharmaceutical R&D and the healthcare decision making process by:
– Bringing together healthcare decision makers, academics, pharmaceutical
companies, clinicians, and patient stakeholders;
– Proposing innovative trial designs and assessing the value of information;
– Proposing and testing innovative analytical and predictive modelling
approaches;
– Creating new decision making support, and building tools to allow for the
evaluation of development programs and use in the assessment of the
value of introducing new treatments;
– Sharing and discussing deliverables with healthcare decision makers,
academics, pharmaceutical companies, clinicians, and patient
stakeholders;
1.
37. What is being done elsewhere to bring patient value
through RWE into the decision process – EU Example
(2)
is an enabling platform for the coordination of
Medicines Adaptive Pathways to Patients (MAPPs)
activities. MAPPs seeks to foster access to beneficial
treatments for the right patient groups at the earliest
appropriate time in the product life-span in a
sustainable fashion.
1.
38. Our problems will be solved when countries can
find ways to deliver access, and manage their
uncertainty- right drug at the right time for the
right patient…
Innovative schemes to provide reimbursement
Health outcome based:
Rebate for early non-responders or pay for results
Finance disease management programs, education
Response schemes based on RWE data collection eg. Coverage with
evidence development
Provide additional data when available
Non-Outcomes based:
Population level cap
Initiation period costs
Capped duration of treatment
Volume discountIF THERE IS A WILL THERE IS A WAY>>>>>
39. Collaboration required..
• Widespread collaboration of efforts, including on an
international scale, is ideal and would support
evidence generation
• Incorporation of RWE more formally into the R&D
continuum – opportunity for every stakeholder to
cooperate (pharma, regulators, HTA, patients and
clinicians)
• Need for streamlined approach to when and how real
world evidence is considered in decision making
process
• Perhaps the development of collaborative networks
and incentivize problem solving were proposed
solutions…. Worth exploring
1.
40. A picture is worth a 1000 words…
HTA Producers
HTA evaluators
Patient
41. Recommendations from the
Symposium
Find it on the front page of the CCSN website, or
the following link:
http://survivornet.ca/en/news/what_is_cadth_a
nd_why_does_it_matter
1.
43. 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/
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Facebook: www.facebook.com/CanadianSurvivorNet
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