incorporating patient preferences into the hta deliberative framework: the patient values project:...
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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
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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
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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:
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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
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§ 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
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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..
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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
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Provincial Advisory Group
Submi<er
Pa>ent Advocacy Group Registered Clinician
Review Team
Registered Clinician Provincial Advisory Group
Pa>ent Advocacy Group
pERC
Submi<er
INPUT
SUBMISSION
REVIEW
DELIBERATIONS
FEEDBACK
Ini>al Recommenda>on
Final Recommenda>on
© CADTH 2016
Overview of pCODR Review Process
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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
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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
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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
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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
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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
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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
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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
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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
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
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.
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International Interest - CPOS
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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
Questions?
Thank You!
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