cadth - why it is important, and what now?

43
CADTH: Why is it important, & what now? May 5th, 2016

Upload: canadian-cancer-survivor-network

Post on 19-Mar-2017

289 views

Category:

Government & Nonprofit


1 download

TRANSCRIPT

Page 1: CADTH - Why it is important, and what now?

CADTH:Why is it important, & what now?

May 5th, 2016

Page 2: CADTH - Why it is important, and what now?

CADTH Symposium Theme

Evidence for Everyone:Expanding the Reach of Health Technology

Assessment April 10-12 in Ottawa

Page 3: CADTH - Why it is important, and what now?

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

Page 4: CADTH - Why it is important, and what now?

1.

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

Page 5: CADTH - Why it is important, and what now?

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

Page 6: CADTH - Why it is important, and what now?

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

Page 7: CADTH - Why it is important, and what now?

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

Page 8: CADTH - Why it is important, and what now?

WHAT THE HTA PROCESS VALUES

Elizabeth LyeLymphoma Canada

Page 9: CADTH - Why it is important, and what now?

“Better Evidence for Everyone”

ClinicalEcono

micPatient Experience

Page 10: CADTH - Why it is important, and what now?

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

Page 11: CADTH - Why it is important, and what now?

“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

Page 12: CADTH - Why it is important, and what now?

1.

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

Page 13: CADTH - Why it is important, and what now?

CADTH Symposium Report BackNeed for change in HTA???

Sabrina HannaSave Your Skin Foundation

Page 14: CADTH - Why it is important, and what now?

Evidence for Everyone

Expanding the reach of Health Technology Assessment (HTA)

What does this mean and who is everyone?

Page 15: CADTH - Why it is important, and what now?

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?

Page 16: CADTH - Why it is important, and what now?

Is there a need for change?

YES!

Page 17: CADTH - Why it is important, and what now?

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.

Page 18: CADTH - Why it is important, and what now?

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

Page 19: CADTH - Why it is important, and what now?

Better decisions versus Different Decisions

• Patient submissions help expert committees make better decisions not different decisions

• Gap between theory and practice

Page 20: CADTH - Why it is important, and what now?

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

Page 21: CADTH - Why it is important, and what now?
Page 22: CADTH - Why it is important, and what now?

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

Page 23: CADTH - Why it is important, and what now?

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

Page 24: CADTH - Why it is important, and what now?

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

Page 25: CADTH - Why it is important, and what now?

Bigger Picture

• See the bigger picture instead of the smaller picture

Page 26: CADTH - Why it is important, and what now?

Thank YouSabrina Hanna

[email protected]

Page 27: CADTH - Why it is important, and what now?

CADTH AND PATIENT PARTICIPATION

The evidence isn’t in

Mona Forrest

Page 28: CADTH - Why it is important, and what now?

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.

Page 29: CADTH - Why it is important, and what now?

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

Page 30: CADTH - Why it is important, and what now?
Page 31: CADTH - Why it is important, and what now?
Page 32: CADTH - Why it is important, and what now?

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

Page 33: CADTH - Why it is important, and what now?

The Future: best practices internationally

Martine Elias - Myeloma CanadaSlides presented by Louise Binder

Page 34: CADTH - Why it is important, and what now?

1.

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?

Page 35: CADTH - Why it is important, and what now?

1.

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…

Page 36: CADTH - Why it is important, and what now?

1.

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;

Page 37: CADTH - Why it is important, and what now?

1.

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.

Page 38: CADTH - Why it is important, and what now?

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>>>>>

Page 39: CADTH - Why it is important, and what now?

1.

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

Page 40: CADTH - Why it is important, and what now?

A picture is worth a 1000 words…

HTA Producers

HTA evaluators

Patient

Page 41: CADTH - Why it is important, and what now?

1.

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

Page 42: CADTH - Why it is important, and what now?

Questions?

Please type questions in the “questions” box in your GoToWebinar toolbox – right hand side of

the screen!

Page 43: CADTH - Why it is important, and what now?

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/