Public consultation on pharmaceutical policy: Learnings and best practices

Public consultation on pharmaceutical policy: Learnings and best practices Presented by: Scott Gavura, Director, Provincial Drug Reimbursement Program...
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Public consultation on pharmaceutical policy: Learnings and best practices Presented by: Scott Gavura, Director, Provincial Drug Reimbursement Programs, CCO Sherry O’Quinn, Senior Pharmacist, Ontario Public Drug Programs, MOHLTC Presented at: CADTH Symposium May 6, 2013

Acknowledgements Brent Fraser Director, Drug Program Services, Ontario Public Drug Programs Lisa Milgram Program Manager, Provincial Drug Reimbursement Programs, CCO Diane McArthur Assistant Deputy Minister and Executive Officer, Ontario Public Drug Programs Dr. Carol Sawka Vice President, Clinical Programs and Quality Initiatives and Co-chair, Clinical Council, Cancer Care Ontario.

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Overview  Why don’t we see more consultation on pharmaceutical policy in Canada?  What’s the experience internationally?  How does Ontario establish and implement pharmaceutical policy?  Why did Ontario establish an Evidence-Building Program?  How was Ontario’s consultation conducted?  What did we learn about policy consultation?  What should pharmaceutical policy-makers consider when contemplating public consultation?

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Background  Health systems are moving from paternalistic, opaque systems to more collaborative, shared-responsibility models.  Despite repeated calls for more public involvement in health-care priority setting, this shift has lagged at the policy-setting table.  Despite the contribution drugs make to health outcomes, public consultation on drug policy is rare.  Drug policy development processes are not transparent:  Traditionally informed by academics, commissioned opinions  Rare to obtain from lay public, or those without a particular advocacy focus  Rare for policies to change on the basis of consultation

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Drug funding issues can be politically charged “Ontario expands coverage for compassionate drug access” – January 21, 2011 “Last-hope prostate drug not funded” – August 23, 2012

“The cost of drugs: breaking the bank to stay alive” - August 23, 2012 “Cancer patient fights Ont. government for at home chemotherapy costs” – March 27, 2013

“[Canadian] Cancer Society demands new drug coverage” April 16, 2013 “Pharmacare helps uninsured mom of cancer patient” April 19, 2013

Why don’t we consult more often? Managing expectations

Complexity of Topic

Perceived Challenges Conflicts of Interest

Ability to obtain truly “lay” input

There’s little published evidence to guide an approach Few examples in the peer-reviewed literature describing public consultation on pharmaceutical policies: • France’s National community Forums (1998) 1 • Israel’s Health Parliament (2002) 2 • Calgary’s citizens’ jury (2008) 3 • California’s Just Coverage project (2006) 4 Unpublished examples: • Department of Health (UK) • NICE’s Patient Involvement Unit • Australia’s Consumer Focus Collaboration References are listed at the end of presentation

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Drug systems reforms in Ontario paved the way • In 2006, the public drug system in Ontario underwent reforms to create a stronger, more effective system in five key areas: o Improving patient access to drugs o Ensuring better value for money o Promoting appropriate use of medications o Investing in innovative health system research o Strengthening the transparency and accountability in the public drug system • Creation of a new position of Executive Officer who has some powers that previously resided with the minister and with cabinet

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Why an Executive Officer? Faster & more responsive decision-making • To patients, prescribers, and manufacturers

Communication of decisions & rationale publicly • Enhancing transparency of funding processes

Improving the listing process for drugs • Partnering with manufacturers

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Ontario’s Citizens Council: Public participation in pharmaceutical policy Why

• Evolved out of drug systems reforms • Commitment for meaningful engagement

How

• Advisory body of 25 Ontarians • Provide values/opinions on drug policy decisions

• Helps EO to understand what public values What • Set tone for our consultative processes 10

Ontario’s new framework offered the opportunity to seek public input in policy and program design

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The drug funding challenge Uncertainty + Do not fund

Collect additional information

Fund as full benefit 0 Negative

Expected Net Benefit

Adapted from: Intl J of Tech Assessment in Health Care 23:4, 2007

Positive

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The evidence-building challenge is not unique to Ontario “Only in Research” “Coverage with Evidence Development” “Field Evaluations” 13

The Approach Program announcement • March 2011

Initial policy analysis • March-May 2011

Implement Herceptin funding • May 2011

Policy release and public consultation • June-August 2011

Policy finalization & consultation published • Fall 2011 14

Preliminary policy work revealed an opportunity for consultation to inform the process Lack of Transparency

Compromises credibility

Reduces collaboration

Limits utility of findings

Best practices lacking

Guidelines

Methodologies

Funding models

Ongoing evaluation critical

Coordinated overall approach

Measure against objectives

Relevance for decisionmakers

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Our consultation templates

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Design of consultation process

Web-based survey open to public

Invited comments from key stakeholders

Draft Policy Posted on CCO website Facilitated Workshops with groups 17

The Final Consultation Package Introduction • Background and rationale for evidence-building programs

Summary of policy work to date • Provide context and limits on scope of consultation

Focused questions for response • Description of components of policy • e.g. Principles, Prioritization, Transparency, Oversight • Specific questions for each component • 28 questions in total 18

Over 140 organizations and individuals contributed feedback in the consultation Oncologists

Researchers

Citizen’s Council

Industry (IOWG)

Disease Site Groups

Pharmacists

Associations & partners 19

What did we learn from the consultation? Where the policy wording was unclear

Perceived limits on scope Priorities for policy expansion Opportunities for stakeholders in program administration How to continue the engagement Transparency expectations 20

What we gained from the process

Improved policy and program Multiple perspectives on policy and approach Highlighted that drug funding policy is complex Gave stakeholders insight into our policy development Knowledge to community in advance of launch 21

Our response to the consultation Copy available at: http://www.cancercare.on.ca/toolb ox/drugs/ebprogram/ Or

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Lessons learned & tentative best practices Tailor consultation to audience • Narrow live sessions to a few key questions, provided in advance

Public engagement is not advocacy engagement • Different expectations and preexisting knowledge base

External facilitators enhance process • Use one with experience in sector

Emphasize and document intent to use feedback • Not just an optics exercise

Don’t underestimate resources required • Significant workload for staff to consult meaningfully 23

Lessons learned & tentative best practices Manage cynicism actively • Commitment to post feedback received

When you say “no”, say “why” • Consultation response, reflecting feedback, essential for credibility • Different expectations and preexisting knowledge base • It’s OK to say “not yet, here’s why…”

Describe how consultation had an effect • Make sure contribution is documented and reflected in comments

This level of transparency creates expectations • Should be part of long-term commitment to transparency and engagement 24

For more information on the Evidence-Building Program: http://cancercare.on.ca/toolbox/drugs/ebprogram/

[email protected] [email protected]

References 1. Lister G, Jakubowski E. Public engagement in health policy: International lessons. Journal of Management & Marketing in Healthcare. 2008;1(2):154–165. 2. Guttman N, Shalev C, Kaplan G, et al. What should be given a priority - costly medications for relatively few people or inexpensive ones for many? The Health Parliament public consultation initiative in Israel. Health Expect. 2008;11(2):177–188. 3. Menon D, Stafinski T. Engaging the public in priority-setting for health technology assessment: findings from a citizens’ jury. Health Expectations. 2008;11(3):282–293. 4. Ginsburg M, Goold SD, Danis M. (De)constructing “Basic” Benefits: Citizens Define The Limits Of Coverage. Health Affairs. 2006;25(6):1648–1655. 26