5. bayoumi cadth ctac presenetation 2016

Patient Group Input:

The CDEC Perspective

Ahmed Bayoumi

[email protected]

@AMBayoumi

Introduction• I am:

○ A physician who works in the HIV clinic at St. Michael’s Hospital

○ A researcher with training in health services research and economic

evaluation

○ A member of the Canadian Drug Expert Committee

• I will present

○ Experiences

○ Conceptual Issues

○ Some research results, collaboration with Dr. Zahava Rosenberg-

Yunger

○ More questions than answers!

Overview

• The process

• Why do we have patient and public input?

• Does the process work?

Introduction• In 2013, Canadians spent $29.3 billion on prescription drugs

• 14% of total health expenditures

• Rate of change in drug spending in 2013: 2.3%

• Second-lowest point in >20 years

• Several new, expensive drugs on the horizon

• Including hepatitis C therapies

Public, 42%Private

insurers, 35%

Out-of-pocket,

24%

Prescribed Drug Spending in Canada, 2012: A Focus on Public Drug Programs, CIHI 2014

The Process

Drug

Approval

(Health

Canada)

Drug

Pricing

(PMPRB)

Common

Drug

Review

pan-Canadian Oncology

Drug Review

INESSS

(Quebec)

Drug

Advisory

Committee

Minister or

Senior

Bureaucrat

PMPRB=Patent Medicine Price Review Board

INESSS=L'Institut national d'excellence en santé et en services sociaux

2 Types of Reviews

• Individual drug reviews

○ Most common

○ Evaluate a single agent only

○ Driven by manufacturer

• Therapeutic reviews

○ Evaluate drugs for a specific indication

○ For example, new oral anticoagulants

○ Driven by drug plans

The Canadian Drug Expert Committee

Patient / Public

Input

CADTH Review

and Independent

Appraisal

Clinical Evidence

Economic

Evidence

CDEC

Recommendation

Manufacturer

Submission

What Happens at the Provincial Level?

• Provinces make own decisions

• Also consider budget impact

• 90% of the time, participating plans agree with

CDEC recommendation

• In 2006, Ontario passed legislation allowing price

negotiations

• Estimated savings of >$600M by 2009

• Similar initiative in BC

• Smaller provinces lacked negotiating power

The Pan-Canadian Pharmaceutical

Alliance for New Drugs• Established in 2010

• Provinces receive recommendation

• Decide whether should negotiate collectively,

individually, or not at all

• List on website

• Also addressing cost of generic drugs

• As of December 31, 2014

○ 49 completed joint negotiations on brand name drugs

○ price reductions on 14 generic drug

○ >$315 million saved annually

Committee MembersYukon

Manitoba

Alberta

AtlanticProvinces

Federal

QuebecSaskatchewan

CDEC

p-CODR

Ontario

BritishColumbia

Non-Patient

Public / Patient

Patient and Public Input

• Sometimes individual testimonials

• Sometimes informal surveys of patients

• Rarely systematic input

• Groups need to declare conflicts and funding

• Some submissions have no patient or public input

Process

Overview

• The process



Why have Patient / Public Representatives?

• To reflect the patient’s voice

• To ensure patient’s values are heard

• To ensure public values are heard

• To make the process more legitimate

• To make the process more democratic

• To provide context to the decisions

Why do we have patient / public input?

The Role of Representatives

“It depends on what we consider our ultimate goal

to be, if we consider our ultimate goal to have

decisions that are reflective of the values of the

general public, then it is fine to have the public

inform those decisions. But if we consider our

objective to be, to decisions that are as, shall we

say, fair and equitable, ethical as possible, then

it’s not necessarily going to be the case, that the

public is going to give us the best answers.”


Which Values?

“Societal values, patient values, ethical values...They’re not

all the same thing...We usually deal with patient values,

which is specific to a patient with a disease based on

what, what treatment is available out there, how much it

costs, what’s the burden of illness. As opposed to

societal values that might say, you know, maybe we only

want to treat the diseases that have X amount of people

with them, or maybe we want to always treat the rare

diseases...”


Some Contextual Issues

• Which outcomes matter?

• What is the context of the decision?

• Who benefits?

• Does everybody have equal access?

• Are there other equity concerns?


Overview

• The process



Some Process Issues• Support

• Representation

• Legitimacy

• Opportunities for participation in

discussion and decisions

• Effect on decisions

Does the process work?

Support

• “Many [patient groups] do not understand

what’s actually being asked of them”

• Subjective information “Rigorous” data?

• Many groups do not have the resources to

do this effectively

• Committee representatives may lack

expertise to participate fully

• Communication and education essential


Representation

• Who gets selected as a committee

member and how?

• Whom are they representing?

• “Co-opt” patients to be part of the

committee?

• Whom do patients represent?


Legitimacy

• Some questions, some cynicism

• Balanced submissions?

• “Astroturf” organizations – seem to be

grassroots but really representing

manufacturers

• Some committees keep names

confidential


Participation

• Are patient / public members fully integrated?

Issues of power / expertise?

• Should terms and honoraria be equal?

• Ontario also has a citizen’s council

○ To address broader conceptual issues

• Participation at other points in the process?

• Full voting members

○ Confidential votes?

• Recognition that requires greater resources


Effect on Decisions

• Does including patient / public members

change the decisions?

• Does public input change the way

committees deliberate?

• “Better” decisions, “different” decisions, or

both?

• Very challenging to measure


How Transparent is the Process?Transparency Criteria:

1. Are member names available online?

2. Are member selection criteria available online?

3. Are “no” decision available online?

4. Is there stakeholder input prior to a

recommendation?

5. Is there an appeals process?

6. Are rationales available online?

7. Are members’ conflict of interest disclosures

available online?Rationale Support Representation Fairness LegitimacyOpportunity for Participation Degree of Participation Effect on Decisions Resources

Rosenberg-Yunger and Bayoumi Health Policy 118:255–263

Transparency Criteria by Committees

BC, Ontario, CDEC, pCODR

Quebec

Atlantic, Saskatchewan

Alberta, NIHB

Yukon, Manitoba

Rationale Support Representation Fairness LegitimacyOpportunity for Participation Degree of Participation Effect on Decisions Resources

Rosenberg-Yunger and Bayoumi Health Policy 118:255–263

CDEC, pCODR

Ontario, BC

Quebec

Saskatchewan, Atlantic

Alberta, NIHB

Yukon, Manitoba

7

6

5

4

3

2

1

0

Number of Criteria

Concluding Thoughts

1. How to incorporate patient and public voice continues to evolve.

2. Issues of representation and autonomy of the patient and public voice are key.

3. Two areas where patient/public input are central:

1. Defining which outcomes are important.

2. Determining how evidence is interpreted.

4. Critical evaluations greatly increase trust in the process – positive and negative

5. bayoumi cadth ctac presenetation 2016

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