Стоимость производства препаратов для лечения ВИЧ и гепатита С

1. Dr Andrew Hill,
Pharmacology and Therapeutics,
Liverpool University,
UK
Treatment of HIV and
Hepatitis C: branded versus
generic medicines

2. Africa, 1999: mass treatment
for HIV/AIDS is not feasible 2

3. A key moment in the history of HIV
“My generics company
can manufacture
HIV antiretrovirals for
a dollar per day”
Dr Yussef Hamied
Cipla,
G8 summit,
2000
3

4. Russia and UNAIDS 90-90-90:
How many people would be on treatment for HIV?
Ref: The Joint United Nations Programme on HIV/AIDS. 90-90-90 An ambitious treatment target to help end the AIDS epidemic. 2014; JC2684
(Numbers as of March 2015) How Aids Changed Everything. Fact Sheet. UNAIDS 2015. MDG 6: 15 YEARS, 15 LESSONS OF HOPE FROM THE AIDS
RESPONSE July 2015.
Target 1:
90% of HIV+ people
diagnosed
Target 2:
90% of diagnosed
people on ART
Target 3:
90% of people on
ART with HIV
RNA suppression

5. Cascade of HIV care – Russia 2013
Ref: Pokrovskaya, A., et al The cascade of HIV care in Russia, 2011–2013. Journal of the International AIDS
Society 2014;17(4). http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4224814/pdf/JIAS-17-19506.pdf

6. Minimum Costs of ARV treatments:
HIV
GREEN – FULLY GENERIC WORLDWIDE IN 2017/8
RED – STILL PATENTED TO 2025+ : VOLUNTARY LICENSES
______________________________________________________________
Combination Estimated price / year
______________________________________________________________
TDF/3TC/ATV/r $279
TDF/FTC/ELV/c $184
ABC/3TC/DTG $179
TDF/FTC/EFV600 $144
TDF/3TC/EFV600 $130
TDF/3TC/EFV400 $100
TAF/3TC/DTG $60
DTG/3TC $46
_______________________________________________________

7. HIV Patent Expiry dates: 2015-2029
11 years (2015-2026) when many drugs are available as individual
generics, but co-formulated versions are still on patent
2014: ZDV, 3TC, NVP, EFV, RTV – already generic
2016: ABC, LPV/r
2017: TDF, ATV/r, DRV/r
2019: ABC/3TC (Kivexa)
2021: ETR
2024: TDF/FTC (Truvada)
2025: Raltegravir
2026: TDF/3TC/EFV (Atripla), TDF/FTC/RPV (Complera),
2029: ABC/3TC/DTG (Triumeq), TAF/FTC/ELV/c
Ref: Medecins Sans Frontieres 2014: Untangling the web of ARV price reductions

8. Voluntary licenses
Some pharmaceutical companies allow cheap
generics to be sold in certain low and middle income
countries, with voluntary licenses
Russia and Eastern European countries are not
included in most of these agreements
As a result, prices in Russia and Eastern Europe can
be unaffordable

9. DOLUTEGRAVIR VOLUNTARY LICENSE COVERAGE

10. ATAZANAVIR VOLUNTARY LICENSE COVERAGE

11. DARUNAVIR VOLUNTARY LICENSE COVERAGE

12. PRICING: DARUNAVIR INSIDE & OUTSIDE SUB-SAHARAN AFRICA
Dosage strength: DRV 600mg and 300mg.

13. Drug
Russian price
(US $)
Access price
(US $)
Price
difference
Basic patent expiry
(Russia)
Lamivudine $286 $29 +886% 2010
Abacavir $778 $140 +456% 2010
Darunavir $4695 $737 +537% 2013
Efavirenz $135 $46 +193% 2013
Ritonavir $310 $91 +241% 2014
Atazanavir/r $1204 $201 +499% 2017
Prices in Russia from Государственный реестр лекарственных средств http://grls.rosminzdrav.ru/PriceLims.aspx (TDF, 3TC, r, RAL) and ITPCru
http://itpcru.org/2015/12/01/analiz-gosudarstvennyh-zakupok-arv-preparatov-pereboi-yanvar-noyabr-2015/ (TDF/FTC, ABC, ATV/r, LPV/r, DRV, DTG, EFV).
All global lowest prices from Clinton Health Access Initiative Reference Price List 2015, except: darunavir (South African Medicine Prices Registry), raltegravir
(MSF Untangling The Web 17th
Edition), dolutegravir (launch price in South Africa). ‘Basic patent’ refers to the composition of matter patent. Additional patent
expiry dates of interest given in brackets. Patent expiry dates: Medicines Patent Pool.

14. Drug
Russian price
(US $)
Access price
(US $)
Price
difference
Basic patent expiry
(Russia)
Lopinavir/r $1434 $256 +460% 2017
Tenofovir DF $1172 $49 +2292% 2018
Raltegravir $6424 $675 +852% 2022
Tenofovir/FTC $2313 $68 +3301% 2024
Dolutegravir $4940 $600 ($38) +723% 2026
Prices in Russia from Государственный реестр лекарственных средств http://grls.rosminzdrav.ru/PriceLims.aspx (TDF, 3TC, r, RAL) and ITPCru
http://itpcru.org/2015/12/01/analiz-gosudarstvennyh-zakupok-arv-preparatov-pereboi-yanvar-noyabr-2015/ (TDF/FTC, ABC, ATV/r, LPV/r, DRV, DTG, EFV).
All global lowest prices from Clinton Health Access Initiative Reference Price List 2015, except: darunavir (South African Medicine Prices Registry), raltegravir
(MSF Untangling The Web 17th
Edition), dolutegravir (launch price in South Africa). ‘Basic patent’ refers to the composition of matter patent. Additional patent
expiry dates of interest given in brackets. Patent expiry dates: Medicines Patent Pool.

15. Top 10 HIV epidemics worldwide
______________________________________________________________
Country HIV Epidemic Cost of TDF/FTC/EFV
______________________________________________________________
South Africa 6.3 million $110
Nigeria 3.4 million $110
India 2.1 million $300
Zimbabwe 1.6 million $110
Mozambique 1.5 million $110
Uganda 1.5 million $110
Tanzania 1.5 million $110
Kenya 1.4 million $110
Russia 1.4 million $2448
Zambia 1.2 million $110
_______________________________________________________

16. Top 10 HIV epidemics worldwide
______________________________________________________________
Country HIV Epidemic Agreed price: TDF/FTC/DTG
______________________________________________________________
South Africa 6.3 million $110
Nigeria 3.4 million $110
India 2.1 million $300
Zimbabwe 1.6 million $110
Mozambique 1.5 million $110
Uganda 1.5 million $110
Tanzania 1.5 million $110
Kenya 1.4 million $110
Russia 1.4 million $7253
Zambia 1.2 million $110
_______________________________________________________

17. HIV Patent Expiry dates: 2015-2029
11 years (2015-2026) when many drugs are available as individual
generics, but co-formulated versions are still on patent
2014: ZDV, 3TC, NVP, EFV, RTV – already generic
2016: ABC, LPV/r
2017: TDF, ATV/r, DRV/r
2019: ABC/3TC (Kivexa)
2021: ETR
2024: TDF/FTC (Truvada)
2025: Raltegravir
2026: TDF/3TC/EFV (Atripla), TDF/FTC/RPV (Complera),
2029: ABC/3TC/DTG (Triumeq), TAF/FTC/ELV/c
Ref: Medecins Sans Frontieres 2014: Untangling the web of ARV price reductions

18. Prices for co-formulations can be much higher –
switch to single pills
TDF/FTC/EFV
TDF/FTC/RPV
TDF/FTC/ELV/c
ABC/3TC/DTG
Generic TDF or ABC
Generic 3TC
Generic EFV or PI/r
Patented pill
Over $3000/year
Generic pills
< $300/year

19. Russia, Thailand and Brazil
All three countries excluded from voluntary licenses
Thailand and Brazil make their own antiretrovirals
Issue compulsory licenses on pharmaceuticals –
overturned the patents to allow access to medicine.
Thailand and Brazil have among the highest HIV
treatment coverage rates worldwide.

20. How much would it cost to acheive
90-90-90 in Russia?
___________________________________________________________________
1.1 million people Current prices Access prices
__________________________________________________________________
TDF/FTC/EFV $2.7 billion $121 million
184 billion roubles 816 million roubles
TDF/FTC/DTG $8.0 billion $121 million
544 billion roubles 816 million roubles
____________________________________________________________
Assumes current costs:
TDF/FTC/EFV in Russia = $2448 / year, vs access price $110
TDF/FTC/DTG in Russia = $7453/year, vs access price $110

21. Entecavir for Hepatitis B
one year’s supply (0.2g)

22. Entecavir for Hepatitis B
cost per person/year by country
Entecavir (Baraclude)
US price: $15,111
Cost price: $36

23. Prices for Hepatitis C DAAs
Drug Calculated
target price for
12-week
treatment
Current global
lowest
Current Russian
price
Sofosbuvir $95 $300 -
Ledipasvir $136 - -
Daclatasvir $17 $153 $4700
Velpatasvir $119-154 - -

24. Current costs of sofosbuvir, per person
(12 weeks)
USA USA* UK Spain Brazil LMICs Generic Mini
*discount
Cost(US$)

25. Top 10 Hepatitis C epidemics worldwide
______________________________________________________________
Country HCV Epidemic Treatments
______________________________________________________________
China 29.8 million Local production
India 18.2 million Voluntary licenses
Egypt 11.8 million Voluntary licenses
Pakistan 9.7 million Voluntary licenses
Indonesia 9.4 million Voluntary licenses
Russia 5.8 million High prices
USA 5.4 million High prices
DR Congo 4.0 million Voluntary licenses
Nigeria 3.3 million Voluntary licenses
Japan 3.0 million High prices
_______________________________________________________

26. Patented vs Generic DAAs in the
UK
Harvoni
45,000 Euros
Generic SOF/DCV
900 Euros

27. SOFOSBUVIR VOLUNTARY LICENSE & REGISTRATION
Data: Gilead License Factsheet, Aug 2015. Gilead Sovaldi registration, May 2015.
No voluntary license
Voluntary license, registered
Voluntary license, not registered
Voluntary license, registration pending/filed

28. Gilead sales and profits
Cumulative sales of
sofosbuvir and
Harvoni to end
2015:
$31.5 billion
Profits in 2015:
$18 billion

29. The new $90 $90 $90
There could be standard prices for HIV, Hepatitis B
and Hepatitis C worldwide
$90 per year to treat HIV
$90 per year to treat Hepatitis B
$90 for a 12 week course of treatment to cure Hepatitis C

30. Conclusions
To achieve UNAIDS 90-90-90 targets for HIV, and mass treatment for
Hepatitis B and C, Russia would need to become like Thailand and Brazil
- Harder negotiations on drug pricing with pharmaceutical companies
- Compulsory licensing if necessary, imports from India
- Mass Local production of antiretrovirals if necessary
It is possible to treat large numbers of people, but only with huge
reductions in treatment costs.