Pan-Canadian Pharmaceutical Alliance – a Primer June 22, 2016 Webinar Slides from Up Close and Personal with pCPA

1. Canadian Organization for Rare Disorders
June 22, 2016
Webinar
Pan-Canadian
Pharmaceutical Alliance
– a Primer

2. 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
2

3. 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

4. Separate process for brands/generics
4
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)

5. 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
5

6. 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
$Billions
% of total
health
spending
8.5 % 8.4 % 8.2 % 8.3 % 8.0 % 7.9 % 7.6 % 7.5 % 7.3 % 7.4 %
6
Total provincial government spend flat from 2011-15

7. 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!)
7

8. 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
8

9. 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?
9

10. Patients’ Perceptions of
panCanadian
Pharmaceutical Alliance
Durhane Wong-Rieger, PhD
Consumer Advocare Network

11. 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
11

12. 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%)
12

13. Reliance on Public Drug Plan
13
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

14. Patient Familiarity with pCPA
14
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

15. 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
15

16. 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
16

17. 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
17

18. 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

19. 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