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

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

ABBVIE (ABBOTT) HCV DRUGS IN DEVELOPMENT ABT 450/r + ABT 072 + 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

BOEHRINGER INGELHEIM (BI) HCV DRUGS IN DEVELOPMENT BI7335/r (faldaprevir) + INF/RBV (PI) Expected filing date: 2014 BI7127 + INF/RBV (n/nucls polymerase) Expected filing date: 2015

BMS HCV DRUGS IN DEVELOPMENT Daclatasvir (DLV) + INF/RBV (NS5A inhibitor) Asunaprevir + INF/RBV (protease inhibitor) DCV + APR + BMS 791325 (n/ns polymerase) Expected filing date: 2014 INF/Lambda: HBV & HCV - Less side effects Expected filing date: 2015 BMS 986094 (nucleotide NS5B) discontinued

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

GILEAD HCV DRUGS IN DEVELOPMENT Sofosbuvir (7977 nucleotide)+ INF/R or RBV Filed: 4-9-13 (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

GSK NEW DRUGS IN DEVELOPMENT GSK 2336805 (NS5A) + Simeprevir (PI) GSK 2336805 + VX 135 (polymerase) No expected filing date

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

JANSSEN HCV DRUGS IN DEVELOPMENT Simeprevir (TMC 435) + INF/RBV (protease) NDA filed: March 30, 2013 Simeprevir (SPV) + GSK 2336805 (NS5A) SPV + sofosbuvir (Gilead 7977) SPV + TMC 647055 (n/ncs) + IDX 719 (NS5A) +/- RBV No expected filing date Phase 4 trials in the ACTG

MERCK HCV DRUGS IN DEVELOPMENT Victrelis approved 2011 (protease inhibitor) MK 5172 + INF/RBV (protease inhibitor) Expected filing date: 2015 MK 5172 + MK 8742 (NS5A inhibitor) Expected filing date unknown

VERTEX HCV DRUGS IN DEVELOPMENT Incivek approved 2011 (protease inhibitor) VX 222 (VCH 222) (non-nucleoside polymerase) VX 222 + Incivek + RBV VX 135 + simeprevir (Janssen protease) VX 135 + GSK 2336805 (polymerase + NS5A) VX 135 + daclatasvir (BMS NS5A)

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

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

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

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

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%

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%

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

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

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.

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

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

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

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

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

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