Incorporating Patient Preferences Into the HTA Deliberative Framework: The Patient Values Project: Filomena Servidio-Italiano (Colorectal Cancer Association of Canada)
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Incorporating Patient Preferences Into the HTA Deliberative Framework: The Patient Values Project: Filomena Servidio-Italiano (Colorectal Cancer Association of Canada)
1. Incorporating Patient Preferences Into
the HTA Deliberative Framework:
The Patient Values Project
Filomena Servidio-Italiano
Colorectal Cancer Association of Canada
Canadian Expert Patients in Health Technology
November 7- 8, 2016
Toronto
1
2. HTA for Oncology Drugs in
Canada
HTA
process
for
cancer
drugs
has
evolved
in
Canada
as
a
consequence
of
the
pan
Canadian
Oncology
Drug
Review
(pCODR/
CADTH)
process
pCODR
invites
accredited
pa@ent
groups
to
provide
input
as
part
of
the
criteria
to
be
evaluated
by
expert
commiDees
when
deciding
on
whether
or
not
to
recommend
the
reimbursement
of
new
cancer
therapies
to
Provincial/Territorial
Health
Ministries
Pa@ent
Values
are
inherent
to
the
Pa@ent
Group
Submission
in
the
pCODR
process,
primarily
from
an
experien@al
point
of
view
2
3. In Canada, the cancer PATIENT GROUP INPUT is reviewed by pERC
(pCODR Expert Review Committee) as part of the deliberative framework
when assessing a cancer drug for reimbursement.
Cancer Patient Group Input
CLINICAL
BENEFIT
ECONOMIC
EVALUATION
ADOPTION
FEASIBILITY
PATIENT-‐
BASED
VALUES
pERC’s
Delibera@ve
Framework
for
drug
funding
recommenda@ons
focuses
on
4
main
criteria:
3
4. The Role of Patient Groups in
Providing Input on “Value”
“Pa@ent
Values”
go
to
the
heart
of
quality
of
care
and
are
of
paramount
importance
to
pa@ent
groups
providing
input
in
the
HTA
process
It’s
essen@al
the
pa@ent’s
voice
be
clear
&
impacZul,
based
on
well-‐
planned
and
structured
research
showing
sources
and
methods
u@lized
that
led
to
the
findings
But…costly
for
pa@ent
groups,
for
it
includes:
-‐
Development
and
execu@on
of
surveys
-‐
Analysis
of
Pa@ent
Reported
Outcomes
(PROs)
-‐
Dra_ing
of
HTA
Submission
in
the
context
of
changing
rules
from
regulatory
authori@es
4
5. § Completing the Patient Group Submission involves
contacting and researching patients on a national and
sometimes international level when clinical trials have
not been conducted in Canada
§ It is a skill that is honed over time and continues to
evolve based on the decisions rendered by HTA
authorities
§ But….the biggest challenge identified to date in
respect of the patient group submission……….
The Role of Patient Groups in Providing
Input on Value
5
6. Unfortunately, patient views are often
interpreted subjectively and may
only be used to add qualitative
information if cost effectiveness is
confirmed for the cancer drug under
review
The Greatest Challenge..
6
7. Patient Evidence
Experien@al
Evidence
in
respect
of:
Living
with
Illness
Nature
of
Illness
Needs
&
Expecta@ons
of
Treatment
Limita@ons
that
illness/
Tx
imposes
on
Pt,
family
or
caregiver
Compiling patient/caregiver
information on patient preferences
and what is of value to them in the
context of assessing a particular
drug is not an easy task, but may
impact drug approval and
reimbursement
7
9. Cancer Patient Group Submission Process
Steps
Undertaken
by
Pa@ent
Group
(i.e.
CCAC)
-‐
Create
survey
Ques@ons
-‐
Send
survey
to
cohort
of
recruited
pa@ents/
caregivers
-‐
Analyze
data
internally
-‐
Interview
1-‐3
pa@ents
with
experience
with
drug
in
ques@on
(if
possible)
-‐
Complete
submission
Sec@ons
to
be
Completed
in
pCODR
Submission
-‐
Info
re:
Pa@ent
Group
-‐
Experience
pa@ents
have
with
their
type
of
cancer
-‐
Pa@ents’
experience
with
current
therapy
-‐
Impact
on
Caregivers
-‐
Expecta@ons
for
the
news
drug
under
review
Experiences
pa@ents
had
to
date
with
the
drug
under
review
-‐
Conflict
of
interest
declara@ons
6
W
E
E
K
S
9
10. The CCAC has embarked on the Patient Values Project (PVP)
to better define, measure and weigh patient values in cancer
treatment.
The Patient Values Project
10
11. Patient Values Project Co-Chairs
Dr. Mary Jane Esplen
Psychosocial Oncologist
Dr. Deborah Marshall
HTA Expert
Dr. Judith Glennie
HTA Expert
Dr. Winson Cheung
Medical Oncologist
Dr. Feng Xie
Health
Economics
Clinical
Epidemiology
and
Biosta@s@cs
11
12. Steering Committee
Jennifer Bell: Bioethicist, Psychosocial Oncology, Palliative Care, Princess Margaret , UHN
Martin Chasen: Oncologist Ottawa Hospital Director palliative care U of Ottawa
Winson Cheung: Medical Oncologist, British Columbia Cancer Agency
Tammy Clifford: CADTH
John Michael Daly: Surgeon Temple - Fox Chase Cancer Centre
Mary Jane Esplen: Executive Director, de Souza Institute
Karen Facey: HTA, U.K.
Judith Glennie: HTA, J. L. Glennie Consulting Inc.
Johanne Hebert: Department of Nursing Psychosocial Université du Québec à Rimouski
Filomena Servidio–Italiano: Education CCAC
Luiza R. Grazziotin Lago: University of Calgary
Karen (Pykerman) MacDonald: Research Associate University of Calgary
Deborah Marshall: Canada Research Chair Health Services and Systems Research U of
Calgary
Celestina Martopullo: Tom Baker Cancer Centre (Psychosocial)
Rebecca Mercer: Canadian Centre for Applied Research in Cancer Control (ARCC),
Jean Mossman: HTA Scotland
Barry D. Stein: President CCAC
Jiahui Wong: Scientist de Souza Institute
Feng Xie: McMaster
Reiner Banken: Senior Fellow at ICER 12
13. Project Objectives
Develop
a
beDer
defini@on
of
Pa@ent
Values
Determine
appropriate
metrics
to
measure
Pa@ent
Values
Generate
an
assignable
weight
to
the
measured
Pa@ent
Values
Empower
Pa@ent
Groups
to
beDer
provide
research-‐
based
input
to
assist
in
HTA
process
Include
beDer
understanding
of
the
pa@ent
perspec@ve
in
the
pa@ent
group
submission
Allow
for
more
reasoned
and
balanced
ra@onale
in
the
assessment
of
new
cancer
drugs
by
pERC
Provide
more
OBJECTIVE
and
QUANTIFIABLE-‐
based
input
on
pa@ent
values
generated
from
validated
research
techniques
13
14. The Patient Values Project aims to better
define, measure and incorporate a
colorectal cancer preferences weight into
the evaluative HTA framework for cancer
drug approval. The Project can then be
applied to other disease sites both in
Canada and in other countries.
Project Description & Purpose
14
15. 3 Phases to the Patient Values Project
Phase
I
• Develop
and
execute
Pa@ent
Preferences
and
Values
Survey
Phase
II
• Develop
key
metrics/indicators
to
measure
values
captured
in
survey
data
Phase
III
• Generate/assign
a
weight
to
pa@ent
values
to
become
part
of
the
Pa@ent
Group
submission
to
pERC
Patient
Values
Project
15
16. PVP Research Questions
Phase 1 (Survey):
1a. How do colorectal cancer patients (early stage and metastatic) value different aspects of treatment* when weighing the associated benefits and
risks?
1b. How do values differ based on patients’ demographics, quality of life, stage of cancer and experiences?
1c. What are the relative quantitative weights for the benefits and risks of treatment decisions?
*Treatment refers to drugs and medications specifically and does not include surgery or other cancer treatment options.
APPROACH: Survey
Phase 2 (Development of key metrics/indicators to measure values captured in survey data):
2a. What combination of attributes in treatment decisions provide colorectal cancer patients with the greatest personal utility?
2b. How can we apply the attributes to inform a framework for drug reimbursement decisions?
APPROACH: Consultation with experts to develop Patient Values Framework
Phase 3 (Generate/assign a weight to patient values to become part of the patient group submission to pERC (PCODR
expert review committee)):
3a. How could these patient values be explicitly incorporated into the current HTA Agency evaluative process for new (colorectal cancer) drug
treatments?
3b. What weight (or proportion) based on the Patient Values metric should be allocated for the Patient Values Submission of the reimbursement
decision for oncology drugs?
3c. How does including Patient Values as developed in our study impact drug reimbursement decisions?
APPROACH: Consultation with experts to develop framework, focus groups and interviews
16
17. Phase I: Patient Values Survey
Quality
of
Life
&
General
Informa@on
Ques@ons
-‐
Background
Ques@ons
-‐
Demographic
Ques@ons
-‐
Experience
Ques@ons
-‐
Lit
Review
performed
comparing
alterna@ve
QoL
instruments
-‐
Contains
Quality
of
Life
Assessment
Tools
(EORTC
QLQ-‐
C30,
QLQ-‐CR38,
EQ-‐5D)
Discrete
Choice
Experiment
(DCE)
Quan@ta@ve
method
used
to
elicit
pa@ent
preferences
and
u@lity
for
various
health
states
DCE
will
explore
what
aspects
of
treatments
pa@ents
value
most
and
what
pa@ents
are
willing
to
trade
off
in
terms
of
benefits
and
harms
17
18. Patient Values Interviews
• Record anecdotal stories from interviews of patients and
caregivers (with their photographs) with their responses to
short questions on what they value or are looking for in their
cancer treatments.
• Developing a set of questions designed around issues,
insights and desired treatment outcomes characterized by
topic such as Health status achieved or retained, Progress of
recovery and Sustainability of health, for assessment in
chronic conditions as well as advanced cancer conditions.
• Groups participating internationally:
i. Adapt the crc survey in other countries (UK, US, EU, Australia).
ii. Adapt the survey to other cancer sites.
iii. Add anecdotal interviews with accompanying photos worldwide.
iv. Combine all the information on one site and compare differences between countries.18
20. Project Steps
Determine
what
(CRC)
pa@ents
Value
through
use
of
a
Validated
Assessment
Tool/
DCE
SURVEY
and
anecdotal
interviews
(Publish)
Develop
metrics
to
measure
the
Values
captured
in
the
SURVEY
Assign
Weight
to
the
Values
so
a
more
objec@ve
input
may
be
submiDed
to
expert
commiDees
Adapt
the
SURVEY
to
other
cancer
sites
Develop
Consensus
Statement
For
Publica@on
20