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

Elvucitabine is not yet marketed, in Phase II studies - Achillion

Projected Cost per Patient Per Year for Current and Pipeline NRTI in 2014 (Price estimates courtesy of CHAI)

200

3024

91

65

6

12

0

50

100

150

200

250

TDF AZT d4T 3TC ABC Elvucitabine

Antiretrovirals

US

$ pe

r pa

tient

per

yea

r

Rilpivirine is not yet marketed, in Phase III studies - Tibotec

Projected Cost Per Patient Per Year for Current and Pipeline NNRTI in 2014 (Price estimates courtesy of CHAI)

7

37

65

15

0

10

20

30

40

50

60

70

NVP EFV Rilpivirine

Antiretrovirals

US

$ pe

r pa

tient

per

yea

r

Elvitegravir and GS 9350 (cobicistat) is not yet marketed in Phase III studies – GileadRAL and DVR pricing estimates are derived using conservative long term estimates on anticipated generic API cost and reflect pricing in a commoditized generic market

Projected Cost Per Patient Per Year for Current and Pipeline PIs and Integrase Inhibitors in 2014 (Price estimates courtesy of CHAI)

692

339

475

12090

450

200

130

0

100

200

300

400

500

600

700

800

Antiretroviral

US

$ p

er

pati

en

t p

er

year

Potential Savings with Dose Optimization

Drug Current dose*Target optimised

dose

**Cost savings per patient per year in

US$

AZT 300mg bid 200mg bid $ 31

3TC 300mg bid 150mg od $ 16

EFV 600mg od 400mg od $ 23

LPV/r400/100mg

bid 200/150 mg bid $ 171

ATV/r300/100mg

bid 200/100 mg OD $ 85

DVR/r600/100mg

bid400/50 mg OD (PI

naives) $ 252

RAL 400mg bid 100 mg BID $ 345

*Source: Andrew Hill, **CHAI estimates

Drug regimen *Price US$ ppy

Dose optimized 3-in-1 pill(s)TDF 300mg+3TC 150mg+EFV 400mg ODAZT 200mg BID+3TC 150mg OD+EFV 400mg ODAZT 200mg BID+3TC 150mg OD+ATV/r 200/100mg OD

$121$116$328

Dose optimized newer ARVsRAL 100mg BID+ TDF 300mg OD+3TC 150mg ODElvitegravir 150mg+RTV 100mg+TDF 300mg+3TC 150mg

$180$175

Dose optimized ARV in pipelineTDF 300mg+ elvucitabine 10mg+ rilpivirine 25mgTDF 300mg+ elvucitabine 10mg+EFV 400mg

$76$111

*Price estimates courtesy of CHAI

First line with TDFUS$176ppy Second line with ATV+RTV

US$465ppy Third line with DRV+RTV+ETV+RAL

US$3204ppy

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 GenevaAndrew Hill – Liverpool UniversityDavid Ripin – Clinton Health Access InitiativeUntangling the Web team