getting to access: time to access: too fast, too slow, or just right?

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Time to Access: 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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Time to Access: 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

InnomarConsulting™

§  Innomar Strategies acquired Wyatt Health (Dec.‘16)

- Formed InnomarCounsulting™

§ Plus Innomar Strategies offers:

- Regulatory Support

- 3rd Party Logistics

- Pharmacy Services and Networks

- HealthForward Payer Services

- Nursing and Clinics

- Patient Support Programs, and more

Full Canadian Reimbursement Services

Full Service Solutions

3/29/17 CONFIDENTIAL 2

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 CONFIDENTIAL 3

Median Days: NOC to CDR Submission

3/29/17 CONFIDENTIAL 4

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

Day

s (M

edia

n)

All DRD

Median Days: CDR Submission to CDR Recommendation

3/29/17 CONFIDENTIAL 5

181 187 180

212 202 194 193 202181

202

301

232

189201195 189

167182

210

160

202 203 197

262

362

215 207

0

50

100

150

200

250

300

350

400

Days(M

edian)

All DRD

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

3/29/17 CONFIDENTIAL 6

3/29/17 CONFIDENTIAL 7

Median Days: CDR Recommendation to Active pCPA

3/29/17 CONFIDENTIAL 8

7975

0

10

20

30

40

50

60

70

80

90

All DRD

Days(M

edian)

Median Days: Active pCPA to pCPA Completion

3/29/17 CONFIDENTIAL 9

152

184

0

20

40

60

80

100

120

140

160

180

200

All DRD

Days(M

edian)

pCPATotal=259days

pCPA Total = 231 days

Median Days: CDR Recommendation to Reimbursement

3/29/17 CONFIDENTIAL 10

293

219

307341 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/oQC)

QC AVG

Days(M

edian)

All DRD

Poster at 2010 CADTH

Symposium

3/29/17 CONFIDENTIAL 11

Median Days: CDR Recommendation to Reimbursement

3/29/17 CONFIDENTIAL 12

2004-2009 – Extracted from Poster Presented at CADTH Symposium – April 2010

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

3/29/17 CONFIDENTIAL 13