Antiretrovirals Pricing: The Past, The Present, The Future Janice Lee What did we learn from the past? Price evolution of stavudine /lamivudine /nevirapine >99% decrease 76% decrease Prices of Improved First Line Regimens At Present Middle Income Countries First line, Second line, Third line Prices At Present No competition! Untangling the Web 13th Edition • Yearly MSF publication since 2001 to provide pricing of ARVs in response to lack of transparent and reliable information on pricing of ARVs • Used as lobby advocacy tool, quotes in publication, source of price comparison, patent informations, access issues • One of the most comprehensive pricing information on originator ARVs • We are online: utw.msfaccess.org ARVs Cost Projections • Next slides show price projections in 2014 by Clinton Health Access Initiative (CHAI) • Brazilian study showed that 55-99% of the direct manufacturing costs of drug is represented by the active pharmaceutical ingredient (API)1 • Prices are based on CHAI estimation of the products in a commoditized generic market based on costing model where API contributes 70% of the price. Cost estimate of pipeline drug is based on triple FDC and not indicative of single products. Do not address access related issues other than long term cost in a competitive market • Pipeline drugs are showed for the interest of price comparison and more data is needed to determine its safety and efficacy 1 Pinheiro E, Vasan A, Kim JY, et al., Examining the production costs of antiretroviral drugs. AIDS 2006, 20: 1745-1752 Projected Cost per Patient Per Year for Current and Pipeline NRTI in 2014 (Price estimates courtesy of CHAI) 250 US$ per patient per year 200 200 150 91 100 65 50 24 30 12 6 0 TDF AZT d4T 3TC ABC Elvucitabine Antiretrovirals Elvucitabine is not yet marketed, in Phase II studies - Achillion Projected Cost Per Patient Per Year for Current and Pipeline NNRTI in 2014 (Price estimates courtesy of CHAI) 70 65 US$ per patient per year 60 50 40 37 30 15 20 7 10 0 NVP EFV Rilpivirine Antiretrovirals Rilpivirine is not yet marketed, in Phase III studies - Tibotec Projected Cost Per Patient Per Year for Current and Pipeline PIs and Integrase Inhibitors in 2014 (Price estimates courtesy of CHAI) 692 700 600 475 450 500 400 339 200 300 130 200 120 90 100 R +R TV D V A TV +R TV /r V LP G S lv it e gr av ir+ E E lv it e gr av ir+ rit on av te gr av i R al 93 50 ir 0 r US$ per patient per year 800 Antiretroviral Elvitegravir and GS 9350 (cobicistat) is not yet marketed in Phase III studies – Gilead RAL and DVR pricing estimates are derived using conservative long term estimates on anticipated generic API cost and reflect pricing in a commoditized generic market Potential Savings with Dose Optimization **Cost savings per patient per year in US$ Drug Current dose *Target optimised dose AZT 300mg bid 200mg bid 3TC 300mg bid 150mg od EFV 600mg od 400mg od $ 31 $ 16 $ 23 LPV/r 400/100mg bid 200/150 mg bid $ 171 ATV/r 300/100mg bid 200/100 mg OD $ 85 DVR/r 600/100mg bid 400/50 mg OD (PI naives) RAL 400mg bid 100 mg BID *Source: Andrew Hill, **CHAI estimates $ 252 $ 345 First line with TDF US$176ppy Second line with ATV+RTV US$465ppy Third line with DRV+RTV+ETV+RAL US$3204ppy Drug regimen Dose optimized 3-in-1 pill(s) TDF 300mg+3TC 150mg+EFV 400mg OD AZT 200mg BID+3TC 150mg OD+EFV 400mg OD AZT 200mg BID+3TC 150mg OD+ATV/r 200/100mg OD Dose optimized newer ARVs RAL 100mg BID+ TDF 300mg OD+3TC 150mg OD Elvitegravir 150mg+RTV 100mg+TDF 300mg+3TC 150mg Dose optimized ARV in pipeline TDF 300mg+ elvucitabine 10mg+ rilpivirine 25mg TDF 300mg+ elvucitabine 10mg+EFV 400mg *Price estimates courtesy of CHAI *Price US$ ppy $121 $116 $328 $180 $175 $76 $111 In an ideal world… • • • • Cost optimized drugs Generic competition No intellectual property access barriers Improve process chemistry of production resulting in greater price reduction Is there more to cost? • Cost effectiveness studies are often used as a guide to change a current regimen by measuring the change in cost over the change in health benefits • MSF study in Lesotho analysed 943 patients comparing those started on TDF, AZT and d4T based regimen and the cost associated with treatment, monitoring, hospitalisation, consultations • Results on Oral Late Breaker, Session Room 4, 11.00am-12.30pm tomorrow Thank You Acknowledgement: Alexandra Calmy – University Hospital of Geneva Andrew Hill – Liverpool University David Ripin – Clinton Health Access Initiative Untangling the Web team