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

Published byJody Alicia Booker Modified over 9 years ago

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Presentation on theme: "ADAP ADVOCACY ASSOCIATION 2013 HIV/HCV CO-INFECTION SUMMIT Lynda Dee Fair Pricing Coalition DRUG DEVELOPMENT & PRICING."— Presentation transcript:

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 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

4 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

5 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

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: 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

8 GSK NEW DRUGS IN DEVELOPMENT  GSK 2336805 (NS5A) + Simeprevir (PI)  GSK 2336805 + 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 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

11 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

12 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)

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 Total after 24 wks Total after 36 wks Total after 48 wks Total after 12 wks Total after 24 wks Total after 36 wks Total after 48 wks Peg- Intron $7,858$15,717$23,575$31,434 Peg- Intron $11,312$22,625$33,937$45,250 Pegasus$8,338$16,676$25,014$33,352Pegasus$14,969$29,939$44,908$59,878

23 HCV DRUG TREATMENT COSTS Incivek Current WAC Price 2nd Price Increases Since Approval in 2011 = 12.3% 12 Weeks24 Weeks36 Weeks48 Weeks Total Incivek Pegasus Ribavirin (generic) Total after 12 wks Pegasus+ Ribavirin (generic) Total after 24 wks Pegasus+ Ribavirin (generic) Total after 32 wks Pegasus+ Ribavirin (generic) Total after 48 wks $55,228$8,083$255$63,566$8,338$71,904$8,338$80,242$8,338$88,580$55,228

24 HCV DRUG TREATMENT COSTS Victrelis Current WAC Price 2nd Price Increases Since Approval in 2011 = 14.5% 4 Weeks24 Weeks36 Weeks48 Weeks Peg- Intron + Ribavarin (generic) Victrelis Peg- Intron + Ribavarin (generic) Total after 24 wks Victrelis Peg- Intron + Ribavarin (generic) Total after 36 wks Victrelis Peg- Intron + Ribavarin (generic) Total after 48 wks Total Victrelis $2,619$25,185$13,097$40,902$15,111$7,858$63,871$15,111$7,858$86,841$55,407

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 Paul AronsBruce Burkett Jeff Berry Ryan ClaryLanny CrossLynda DeeDavid Evans Murray PennerMichael Ninburg Murray Penner Lorren Sandt

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