1. ADAP ADVOCACY ASSOCIATION 2013 HIV/HCV CO-INFECTION SUMMIT
Lynda Dee
Fair Pricing Coalition
DRUG DEVELOPMENT & PRICING

2. OVERVIEW HCV Drug Development by Company
Pricing & Price Increase Factors
Annual Average HIV Price Increases
HCV Price Increases Since Approval
Company Assessments
WAC Prices
Review of Approved HCV Drug Prices
Projections: Janssen, Gilead and Abbott
FPC Members & Contact Information

3. ABBVIE (ABBOTT) HCV DRUGS IN DEVELOPMENT
ABT 450/r + ABT ribavirin (RBV)
ABT 450/r + ABT333 + RBV
ABT 450: Boosted protease inhibitor
ABT 072: N/nucls polymerase inhibitor
ABT 333: N/nucls polymerase inhibitor
Expected filing date: Mid-2014

4. BOEHRINGER INGELHEIM (BI) HCV DRUGS IN DEVELOPMENT
BI7335/r (faldaprevir) + INF/RBV (PI)
Expected filing date: 2014
BI INF/RBV (n/nucls polymerase)
Expected filing date: 2015

5. BMS HCV DRUGS IN DEVELOPMENT
Daclatasvir (DLV) + INF/RBV (NS5A inhibitor)
Asunaprevir + INF/RBV (protease inhibitor)
DCV + APR + BMS (n/ns polymerase)
Expected filing date: 2014
INF/Lambda: HBV & HCV - Less side effects
Expected filing date: 2015
BMS (nucleotide NS5B) discontinued

6. GENENTECH/ROCHE HCV DRUGS IN DEVELOPMENT
Mericitabine (RG7128) + INF/R:
Non-nucleotide polymerase inhibitor
Danoprevir/r (RG7227) + INF/R
Protease inhibitor
Expected filing date: Unknown

7. GILEAD HCV DRUGS IN DEVELOPMENT
Sofosbuvir (7977 nucleotide)+ INF/R or RBV
Filed: (G1, 4, 5, 6 + INF/R, G2, 3 + RBV)
Sofosbuvir + ledipasvir (5885) (NS5A)
Expected filing date: 2014
Sofosbuvir + daclatasvir (BMS NS5A)
Sofosbuvir + simeprevir (Janssen PI)
No expected filing date: ACTG Phase 4

8. GSK NEW DRUGS IN DEVELOPMENT
GSK (NS5A) + Simeprevir (PI)
GSK VX 135 (polymerase)
No expected filing date

9. IDENTIX DISCONTINUED DRUGS
IDX 183 (nucleotide NS5B)
IDX 19368
Effective, but toxic: cardio events

10. JANSSEN HCV DRUGS IN DEVELOPMENT
Simeprevir (TMC 435) + INF/RBV (protease)
NDA filed: March 30, 2013
Simeprevir (SPV) + GSK (NS5A)
SPV + sofosbuvir (Gilead 7977)
SPV + TMC (n/ncs) + IDX 719 (NS5A) +/- RBV
No expected filing date
Phase 4 trials in the ACTG

11. MERCK HCV DRUGS IN DEVELOPMENT
Victrelis approved 2011 (protease inhibitor)
MK INF/RBV (protease inhibitor)
Expected filing date: 2015
MK MK 8742 (NS5A inhibitor)
Expected filing date unknown

12. VERTEX HCV DRUGS IN DEVELOPMENT
Incivek approved 2011 (protease inhibitor)
VX 222 (VCH 222) (non-nucleoside polymerase)
VX Incivek + RBV
VX simeprevir (Janssen protease)
VX GSK (polymerase + NS5A)
VX daclatasvir (BMS NS5A)

13. PRICING FACTORS Better, New and Improved Better Efficacy
Better Side Effect/Resistance Profile
Better Administration: QD, FDC

14. PRICING FACTORS Last approved drug in same class
Expected market share timeframe
Input from payers
Corporate culture and finances
What the market will bear???

15. PRICING FACTORS Persuasive Pricing Factors: Drug Development Costs?
Marketing Costs?
Manufacturing Costs?
Access Program Costs?

16. PRICE INCREASES Medical Inflation Rate from 2-12 to 2-13
Medical Services = 3.9%
Physician Services = 2.5%
Hospital Services = 5.4%
Other company increases

17. ANNUAL AVERAGE HIV PRICE INCREASES
Abbott: Norvir 38% - Kaletra 3.6%
BI: Aptivus 4.3% - Viramune 15.2%
BMS: Sustiva 7.7% - Atripla 9.7%
Gilead: Viread 13.5% - Emtriva 10.2%
Truvada 10.3% - Complera 9.1%

18. ANNUAL AVERAGE HIV PRICE INCREASES
Jenssen: Prezista 8.3%
Intelence 6.5%, Edurant 8.8%
Merck: Isentress 5.9%
ViiV: Combivir 8.1% - Lexiva 9.0%

19. HCV DRUG PRICE INCREASES
Incivek – Vertex = 12.3% since 2011
Victrelis – Merck = 25% since 2011

20. COMPANY ASSESSMENTS Original Pricing Price Increases Access*
AbbVie/Abbott Abbott AbbVie
BI BI Janssen
BMS BMS BMS
Gilead Gilead Gilead
GSK/ViiV ViiV ViiV
Merck (HCV only) Merck (HCV only) Merck
Vertex Vertex Vertex
Merck/Janssen* Merck* *Good Assessment

21. HCV DRUG TREATMENT COSTS
Wholesale Acquisition Cost (WAC):
The price paid by a wholesaler’s supplier, typically the manufacturer of the drug. WAC is the price manufacturers release publicly and is sometimes called the “list price”. Publicly disclosed or listed WAC amounts may not reflect all discounts.

22. HCV DRUG TREATMENT COSTS
Pegylated Interferon + Ribavirin Current WAC Price
With Generic Ribavirin
With Brand (Rebetrol or Copegus)
Total
after
12 wks
24 wks
36 wks
48 wks
Peg-Intron
$7,858
$15,717
$23,575
$31,434
$11,312
$22,625
$33,937
$45,250
Pegasus
$8,338
$16,676
$25,014
$33,352
$14,969
$29,939
$44,908
$59,878 22

23. HCV DRUG TREATMENT COSTS
Incivek Current WAC Price
2nd Price Increases Since Approval in 2011 = 12.3%
12 Weeks
24 Weeks
36 Weeks
48 Weeks
Total
Incivek
Pegasus
Ribavirin
(generic)
after
12 wks
Pegasus+
24 wks
32 wks
48 wks
$55,228
$8,083
$255
$63,566
$8,338
$71,904
$80,242
$88,580 23

24. HCV DRUG TREATMENT COSTS
Victrelis Current WAC Price
2nd Price Increases Since Approval in 2011 = 14.5%
4 Weeks
24 Weeks
36 Weeks
48 Weeks
Peg-
Intron +
Ribavarin
(generic)
Victrelis
Total
after
24 wks
36 wks
48 wks
$2,619
$25,185
$13,097
$40,902
$15,111
$7,858
$63,871
$86,841
$55,407 24

25. HCV DRUG TREATMENT COSTS
BETTER EFFICACY/SIDE EFFECT/ADMINISTRATION
= HIGHER PRICES THAN INF/RBV
+ INCIVEK OR + VICTRELIS ($85,000)
PROJECTIONS:
JANSSEN PI + INF/RBV (12, 24, 48) = $85,000 PLUS?
GS 7977 (NS5B) FOR 12 WEEKS = $55,000 PLUS
GS 5885 (NS5A) FOR 12 WEEKS = $55,000 PLUS
= $110,000 PLUS

26. HCV DRUG TREATMENT COSTS
BETTER EFFICACY/SIDE EFFECT/ADMINISTRATION
= HIGHER PRICES THAN INF/RBV
+ INCIVEK OR + VICTRELIS ($85,000)
PROJECTIONS:
NEW PI FOR 12 WEEKS (AB450/R) = $55,000
PLUS $720 NORVIR + $255 RBV = $55,975
NEW NS5A FOR 12 WEEKS (AB267) = $55,000 PLUS
NEW NON-NUC 12 WEEKS (AB333) = $55,000 PLUS
= $165,975 PLUS

27. FAIR PRICING COALITION fairpricingcoalition.org
Bill Arnold Bill Arnold
Paul Arons Bruce Burkett
Jeff Berry Ryan Clary
Lanny Cross Lanny Cross
Lynda Dee Lynda Dee
David Evans David Evans
Murray Penner Michael Ninburg
Murray Penner
Lorren Sandt