This document summarizes timelines for drug reimbursement in Canada. It finds that the median time from a positive recommendation by the Canadian Drug Review (CDR) to reimbursement has increased from under 200 days in 2004-2009 to 280-290 days currently, and 422-438 days for rare disease drugs. The increase is partly due to the additional time spent in price negotiations between the pCPA and pharmaceutical companies. Delays in reimbursement can negatively impact patients in need.

1. Time toAccess:
Too fast, too slow, or just right?
Presented by George Wyatt, Executive Senior Consultant
Data Analysis by Dr. Eric Siu, Senior Manager
March 29, 2017

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3/29/17 CONFIDENTIAL2

3. The Parties and Responsibilities
Time Frame Who’s Responsible
1. Regulatory Period (prior to NOC) Pharmaceutical Company
2. Reimbursement Evaluation HTA Body (CDR, pCODR, INESSS)
Private Payers
3. “Price/Value” negotiations pCPA & Pharmaceutical Company
4. Reimbursement Decision Public and Private Payers
3/29/17 CONFIDENTIAL3

4. Median Days: NOC to CDR Submission
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11
37 32
55
31
91
64
52
61 55
41
27
5
-61
36
43
8
126
202
222
72
97
52
42
116
83
37
70
-100
-50
0
50
100
150
200
250
Days(Median)
All DRD

5. Median Days: CDR Submission to CDR Recommendation
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181 187 180
212
202 194 193
202
181
202
301
232
189
201 195 189
167
182
210
160
202 203 197
262
362
215 207
0
50
100
150
200
250
300
350
400
Days (Median)
All DRD

6. CDR not afraid to change
§ 24th edition of Submission Guidelines
- Changes every year, except 2012 – when CDEC codes changes
§ 17th edition of CDR Procedures
§ 120 CDR Updates
§ Nearly 500 submissions
§ Over 400 recommendations
- Positive type recommendations increasing
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7. 3/29/17 CONFIDENTIAL7

8. Median Days: CDR Recommendation to Active pCPA
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79
75
0
10
20
30
40
50
60
70
80
90
All DRD
Days (Median)

9. Median Days: Active pCPA to pCPA Completion
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152
184
0
20
40
60
80
100
120
140
160
180
200
All DRD
Days (Median)
pCPA Total = 259 days
pCPA Total = 231 days

10. Median Days: CDR Recommendation to Reimbursement
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293
219
307
341
319 320
219
355
290 290
-47
280
466
719
429 443
351
456
386
0
455 438
-104
422
-200
-100
0
100
200
300
400
500
600
700
800
AB BC MB NB NL NS ON PEI SK AVG
(w/o
QC)
QC AVG
Days (Median)
All DRD

11. Poster at 2010
CADTH
Symposium
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12. Median Days: CDR Recommendation to Reimbursement
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2004-2009 – Extracted from Poster Presented at CADTH Symposium – April 2010

13. What’s happening & What does it mean for patients
§ Time from Recommendation to Reimbursement is Increasing
- Too slow for many patients
- <200 days (2004-2009) to 280-290 days (2004-2017) = 9+ months
- Drugs for Rare Diseases is now 422-438 days = 14+ months
§ pCPA process has added Time
- Responsibility: pCPA and Pharmaceutical Companies
> Strong preparation is very important
§ More Warning Clouds
- pCPA (drug plans) may not negotiate when drug receives HTA Recommendation with
Clinical Criteria and/or Conditions
> Perceived no unmet medical need
> Payers may not have resources
§ Every delay can hurt a deserving patient
- We can’t relax – we need to be persistent with our message
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