cadth - why it is important, and what now?
TRANSCRIPT
CADTH:Why is it important, & what now?
May 5th, 2016
CADTH Symposium Theme
Evidence for Everyone:Expanding the Reach of Health Technology
Assessment April 10-12 in Ottawa
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 hospitalsSource: Prescribed Drug Spending in Canada 2012
Report, CIHI
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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
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
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
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
WHAT THE HTA PROCESS VALUES
Elizabeth LyeLymphoma Canada
“Better Evidence for Everyone”
ClinicalEcono
micPatient Experience
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
“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
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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
CADTH Symposium Report BackNeed for change in HTA???
Sabrina HannaSave Your Skin Foundation
Evidence for Everyone
Expanding the reach of Health Technology Assessment (HTA)
What does this mean and who is everyone?
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?
Is there a need for change?
YES!
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.
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
Better decisions versus Different Decisions
• Patient submissions help expert committees make better decisions not different decisions
• Gap between theory and practice
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
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
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
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
Bigger Picture
• See the bigger picture instead of the smaller picture
Thank YouSabrina Hanna
CADTH AND PATIENT PARTICIPATION
The evidence isn’t in
Mona Forrest
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.
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
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
The Future: best practices internationally
Martine Elias - Myeloma CanadaSlides presented by Louise Binder
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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?
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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…
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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;
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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.
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>>>>>
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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
A picture is worth a 1000 words…
HTA Producers
HTA evaluators
Patient
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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_and_why_does_it_matter
Questions?
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network1750 Courtwood Crescent, Suite 210Ottawa, ON K2C 2B5Telephone / Téléphone : 613-898-1871E-mail [email protected] or [email protected] Web site www.survivornet.caBlog: http://jackiemanthornescancerblog.blogspot.com/Twitter: @survivornetcaFacebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/