HOW CAN CANADA’S HEALTH TECHNOLOGY ASSESSMENT (HTA) SYSTEM EVOLVE TO MEET PATIENTS’ NEEDS

May 2014

What today is about• UNDERSTAND Canada’s HTA system

• HOW are patients involved in the HTA system?

• WHAT are the upcoming opportunities for patients to provide their perspectives on the HTA system?

• HOW can the HTA system evolve to better meet patients’ needs?

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Private Drug Plans

Provincial

Drug Plans

First – an overview of the Canadian drug review process

Manufacturer clinical trials:quality, safety and efficacy

Regulatory review:quality, safety and efficacy

“Pricing” review:maximum “non-excessive” price

Funding recommendations: Comparative safety, efficacy and cost effectiveness

FUNDING DECISIONS

Patient criteria /appropriate use

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Our discussionwill focus on this stage

Various HTA Processes

• National processes:• For MOST meds: Canadian Agency for Drugs and Technologies

in Health’s (CADTH’s) Common Drug Review (CDR)• For cancer meds: Pan-Canadian Oncology Drug Review

(pCODR) – now transferred to CADTH as of April 2014

• Provincial processes:• British Columbia: “Your Voice”

program • Ontario: Ontario Public Drug

Programs• Quebec: l’INESSS 30 day feedback

• Hospitals and Private Payers:• Limited opportunities for patient input

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National HTA processes

• All provinces participate in CDR and pCODR, except Quebec

• Federal drug plans also participate in CDR (not pCDOR)

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CDR’s expert committee (CDEC) makes one of four recommendations:• List• List with clinical criteria and/or

requirements• Do not list at the submitted price• Do not list

pCODR’s expert committee (pERC) makes one of three recommendations:• Recommend• Consider with conditions• Do not recommend

HTA Expert Committees

• Appointed experts who review the clinical and economic evidence and patient input

• They are responsible for developing funding recommendations which are passed on to participating plans

• A typical expert committee is comprised of… • Pharmacologists / Pharmaco-epidemiologists• Physicians• Pharmacists• Health economists• Sometimes public/lay voice or patients

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Provincial Reviews• Jurisdictions have their own expert review committees

• some consider the national review again and make a further recommendation to province

• Provinces consider CDR/pCODR recommendation and account for local circumstances, practices, priorities and budgets

• Negotiations on price/criteria of drugs often take place:• joint negotiations through the pan-Canadian Pricing Alliance (PCPA)

– this initiative includes all provinces except QC• individual provincial negotiations

• In most cases, the minister of health is the final decision-maker, but the real decision is delegated to relevant government officials (such as Ontario’s Executive Director of the Ontario Public Drug Programs)

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HOW ARE PATIENTS CURRENTLY INVOLVED IN HTA SYSTEM

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CDR Patient Input Process (2010)• Part of the CDR process and fits into review timeframes

• Seeks input via Canadian patient groups

• Guide, template, online submission

• Templates for subsequent entry biologics (SEBs) and drugs for rare diseases under development

• Invitation for patient input for CDR submissions now delayed because of CDR queue – no indication of when and how the queue will be eliminated

• Letters of appreciation with feedback on the submission are sent

• Patient submissions are shared with participating plans and posted online

• Patient input summaries are included in clinical review reports posted online and patient groups can comment on the summaries before they are finalized

• Creation of CADTH Patient Community Liaison Forum

• Pilot project underway (until August 2014) to obtain input from individual patients and caregivers in cases where there is no patient group input

• CADTH is piloting patient input in therapeutic reviews (until July 2014)

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Expert Committee Deliberation Steps

1. One public member presents summary of patient group input - stated values and preferences and issues of patients and/or their caregivers related to the condition for which the medication is indicated and its treatment

2. Two discussants present their overviews of the clinical and economic evidence

3. Members provide input; and CDR staff, including clinical and economic reviewers, and invited experts provide input as required

4. Deliberation on patient group input, clinical and economic evidence, and formulate a recommendation and provide reasons for it.

5. Members choose one of four recommendation options

6. Secret ballot voting on the recommendation option and the reasons for the recommendation; decided by majority of votes

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Patient Group Participation at CDR

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CADTH 2013

CDR – How Patient Input is Used

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CADTH 2014

pCODR Patient Input Process• Canadian patient groups are invited to provide input:

• Must be registered• Only one submission per registered group is permitted• Mandate must pre-date the pCODR review • Must be funded by more than one funder and no

funder may provide more than 50% of the group’s funding• No individual patient submissions are permitted

• Patient groups have two opportunities to provide input: • at time of review initiation • after an initial recommendation is published

• Patients are members of the expert committee – they will summarize and present the patient input• this input is one of four considerations within pCODR’s deliberative

framework

pCODR Patient Input Process

5.Summarize & Review with pERC

3.2 Collect Patient

Advocacy Group Input

7.3 Get Feedback from

Patient Advocacy

Group

8. Summarize & Review with

pERC

6. Prepare & Publicly Post

Initial Recomm,

Post Reviews

4.2.Conduct

Economic Review

4.1.Conduct Clinical Review

9. Prepare & Publicly Post

Final Recomm & Post Input

Direct impact of patient perspective

Indirect impact of patient perspective

pCODR 2013

pCODR Merger with CADTH• pCODR transferred to CADTH in April 2014 to:

• consolidate policy direction across different drug programs

• improve the pCODR governance structure to ensure its long-term viability and sustainability

• Two-phase transfer:• Phase 1 (effective April 1, 2014): staff, processes, funding, and

expertise remain intact as a program, and still based in Toronto but now under the governance of CADTH

• Phase 2 (to commence April 2015): exploration of better alignment of pCODR and CDR evaluation criteria, while taking advantage of best practices of both processes

• CADTH plans to consult stakeholders at different steps of transition

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British Columbia – Your Voice program

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Ontario – Patient Evidence Submission

Quebec – INESSS

Some are going beyond the basics…

• Press release and public posting / memo to patient members to inform them of the opportunity

• Collection and compilation of data and submission

• Press release and posting of input and expectations

• Continued communication with members and public when recommendation becomes public

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Engagement Opportunities• pCODR transfer to CADTH:

• Information session for patient groups on June 9, 2014 to to discuss the progress to date and next steps

• Survey sent by CADTH to stakeholders to be completed by May 21, 2014• Opportunity for patients to provide input on the transfer, including best practices

from pCODR and CDR that should be retained and any other improvements that should be made to the process

• CDR Patient Input Templates and Guide• template for SEBs and drugs for rare diseases under development (CADTH plans

to consult on the SEB template in May 2014)• CADTH plans to write a new guide for patient input

• PCPA• IBM consulted stakeholders in fall 2013 on a formal PCPA process and

governance structure • First draft of IBM report tabled - provinces still waiting to receive final version• Patient groups may want to provide ongoing feedback to provinces and territories

to ensure the provinces have sufficient input to inform policy

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Ideas on Improving the HTA System?

• How and at what stage should patients be involved in HTA processes?

• What are the criteria for successful involvement of patients in HTA processes?

• How should patients’ perspectives be evaluated and factored into the formulary recommendations and, ultimately, coverage decisions?

• What are some of the current obstacles/barriers for successful patient involvement?

• What are strategies/approaches to address them?

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DISCUSSION

APPENDIX A – LIST OF ACRONYMS

Acronym Definition

CADTH Canadian Agency for Drugs and Technologies in Health

CDR Common Drug Review

CED Committee to Evaluate Drugs

HTA Health Technology Assessment

INESSS Institut National d’Excellence en Santé et en Services Sociaux

OPDP Ontario Public Drug Programs

pCODR Pan-Canadian Oncology Drug Review

RAMQ Régie de l’Assurance Maladie du Québec

PCPA Pan-Canadian Pricing Alliance

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How input is referenced

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How input is referenced

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pCODR - How Patient Input is Used

pCODR 2013