Canadian Organization for Rare Disorders June 22, 2016 Webinar

Pan-Canadian Pharmaceutical Alliance – a Primer

About PCPA Jurisdictions Involved •  All provincial, territorial and federal drug plans

Scope •  pCPA applies mainly / principally to all new drugs coming out

of national HTA review processes (pCODR and CDR) •  Now undertaking (but still a minority):

•  Re-negotiations •  Class negotiations •  Unsolicited manufacturer-initiated negotiations

Lead Jurisdictions •  ON and NS governments are “lead jurisdictions” for brand •  SK and NS governments are “leads” for generics

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National Health Technology Assessment

Recommendation

Office of pCPA review & pCPA teleconference

decision

Negotiations

Letter of Intent Signed

Provincial listings

Individual consideration by

plans No negotiations

pCPA process for new drugs

Separate process for brands/generics

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Innovative medicines Negotiate product listing agreements (PLAs)

•  Closed/Completed: 107 (101 LOIs; 6 no agrmts)

•  Underway: 27 •  No negotiations: 37 •  P/T negotiations: 13 As of May 31, 2016

Generic medicines Value Price Initiative caps generic medicines:

•  Range in prices from 85% of innovator version to 25% depending on number of marketed versions

•  18% of innovative medicine for 18 additional multi-source generics

pCPA

As of March 31, 2015: estimated savings of $490 million (based on 63 completed joint negotiations and generic tiered pricing initiative)

pCPA impact: more listings and greater consistency

14

20 25

32

20

33

11

22

6

21

27

53 56

71

60 59

73 69

54

72

0

10

20

30

40

50

60

70

80

BC AB SK MB ON QC NB NS PE NL

2006 (out of 103 drugs) 2015 (out of 195 drugs)

Source: IMS Brogan; PRA Quarterly; data represents the previous two years of listing decisions

Number of New Medicines Added to Provincial Formularies

(2006 vs. 2015)

Percentage of new medicines reimbursed

(2006 vs. 2015)

14%

19%

24%

31%

19%

31%

11%

21%

6%

20% 14%

27% 29%

36%

31% 30%

37% 35%

28%

37%

0%

5%

10%

15%

20%

25%

30%

35%

40%

45%

50%

BC AB SK MB ON QC NB NS PE NL

2006 2015

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Total Provincial Gov’t Health Expenditures on Prescribed Medicines 2006-2013 (Actual) and 2014-2015 (Forecast), $ Billions

Source: CIHI – National Health Expenditure Trends (C Series)

$8.17 B $8.67 B

$9.16 B $9.86 B $10.06 B $10.30 B $10.28 B $10.29 B $10.44 B $10.66 B

$0

$2

$4

$6

$8

$10

$12

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

$ B

illio

ns

% of total health

spending 8.5 % 8.4 % 8.2 % 8.3 % 8.0 % 7.9 % 7.6 % 7.5 % 7.3 % 7.4 %

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Total provincial government spend flat from 2011-15

pCPA evolution •  pCPA announced (2010) •  pCPA first product negotiated (2011) •  IBM review (2012-13) •  Website (February 2014) •  Changed pCPA from “pricing” to “pharmaceutical” (Sept 2014) •  Announcement that pCPA Office to be established and IBM

report released (October 2014) •  Stakeholder consultation sessions (June 2015) •  pCPA Office functional (September 2015) •  Quebec joins (October 2015) •  Backlog / slowdown begins to appear (October 2015) •  Federal government joins (February 2016) •  First principles for biosimilars released (April 2016) •  Developing guidelines / procedure – consulting with

stakeholders (today!)

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Guiding principles for pCPA process •  Holistic: consideration of value from multiple perspectives •  Predictable: communication of process, timelines,

participation, decision making •  Consistent: consistent process & approach, recognizing

unique nature of negotiations •  Transparent: timely and regular public reporting •  Efficient & Effective: reduce duplication and align with

current national HTA review •  Collaborative and representative: cross-jurisdictional

engagement with stakeholders •  Respectful: Recognition of different perspectives and needs

amongst stakeholders •  Ethical: reflect ethical principles such as validity, veracity and

autonomy •  Value-driven: achieving value for the health care system

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Themes for engagement / questions •  Deals for all Canadians: what is the level of commitment for all

participating provinces to reimburse after an agreement is reached? •  Scope of deals: what is subject to negotiation? Clinical criteria?

Economic criteria? (explore opportunity for managed access programs and patient involvement throughout)

•  Timeliness and current delays: what are the target timeframes for each step? What are the plans to address current backlog?

•  Patient involvement and communications: how can patients stay involved and be kept informed?

•  Transparency: how can patients know which provinces have signed on to which deals or are leading negotiations?

•  Drugs for Rare Disorders: •  pCPA negotiation of drugs for rare disorders – are orphan drugs a priority? •  How is pCPA collaborating with other government working groups (e.g., FPT

working group on drugs for rare diseases)? •  What has pCPA Office and negotiators learned about drugs for rare disorders

and how is it applying those lessons to improve the process? •  Governance: how is pCPA accountable to citizens/stakeholders?

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Patients’ Perceptions of panCanadian

Pharmaceutical Alliance

Durhane Wong-Rieger, PhD Consumer Advocare Network

Patient Survey on pCPA

§ WHAT are ways to engage patients and public? § Health Canada: transparency on drugs under review § CADTH: patient input, feedback, and posting §  pCPA: no process for engagement

§ WHY were patients surveyed about pCPA? §  pCPA newly created agency with new mandate §  pCPA including all provinces (Quebec pending) and federal govt §  pCPA producing of “pathway” for patient clarification & feedback

§ HOW will learning from survey be used to inform stakeholders? § Comparison to familiarity with other drug review entities § Perceptions of when and how to be engaged

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How was Survey Implemented

§ Canada-wide Web-based survey § Conducted by Advocare and Canadian Organization for Rare

Disorders § Directed to existing patient cohort of 2,000+ § Secondary distribution to patient organizations and umbrella

associations § Promoted through Facebook and Twitter

§ Patient characteristics (Preliminary May-June 2016) § Respondents = 182 § Conditions = blood disorders, cardiovascular, inflammatory, immune-

related, diabetes, cancers, multi-systemic, rare disorders (lysosomal storage)

§ Public drug plan users/caregivers (50%) patient advocates (30%)

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Reliance on Public Drug Plan

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Public Drug Plan User,

35.2%

Caregiver Public Plan,

15.9%

Patient Advocate,

29.5%

Manufacturer, 8.0%

Healthcare Professional,

5.7%

Preliminary results Web-based survey (May - June 2016) n = 182

Patient Familiarity with pCPA

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Not at all familiar, 38.6%

Mostly unfamiliar,

9.6% Neither, 7.2%

Somewhat familiar, 32.5%

Very familiar, 12.0%

Prior to survey, how familiar were you with the pCPA? n=160

Familiarity with All Drug Agencies

46% 42% 27%

50% 36%

38% 28%

40%

35% 45%

16% 30% 33%

15% 19%

HC TPD/BGTD

CADTH PT Drug Plans pCPA Ind Access Plans

Not familiar Know but no Interaction Some Input

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Preference re: Patient Engagement

0% 20% 40% 60% 80% 100%

HC TPD/BGTD

HC Post Market

CADTH

pCPA

PT Drug Plans

Individual Request

How should patients be engaged steps of drug review process?

No input Consult as needed

Info to Patients Regular Input

Feedback on Recommend

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Summary Perceptions

§ About half of respondents reliant on public drug plans

§ About half not familiar with pCPA and slightly less than half were familiar

§ About one-third had some input or consultation with CADTH and/or PT Drug Programmes

§ More than half prefer regular input to all agencies in drug review process

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Final HTA Reco.

pCPA Consideration

Open Negotiation? Engagement Letter Issued To

Manufacturer

Manufacturer Proposal/ Counter

pCPA Proposal/Counter

Terms Reached?

Letter of Intent (LOI)

PLA by Jurisdiction Funding

pCPA Brand Process Flow

Unsolicited Manufacturer Proposal

pCPAO

pCPA Office Notification to Manufacturer

Manufacturer Clarification

Active Negotiation

Review of Existing Drugs

Yes No

Yes No

HTA Review

Patient Group Input

DRAFT pCPA Brand Guidelines Outline A.  Expectations

•  Best practises re. engagement for all stakeholders •  ‘Code of Conduct’ for all stakeholders

B.  Process Stages •  Description of each stage in process flow chart •  Information re. communication at each stage

o Correspondence o Meetings

•  High-level timeline estimates for each stage •  Factors that affect timelines

C. Special Cases •  Overview of the types of files that may not follow the regular process

D. FAQs