Date post: | 22-Jan-2017 |
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Dr Andrew Hill, Pharmacology and Therapeutics, Liverpool University, UK
Treatment of HIV and Hepatitis C: branded versus
generic medicines
Africa, 1999: mass treatment for HIV/AIDS is not feasible
2
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
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
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
Minimum Costs of ARV treatments: HIVGREEN – 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
_______________________________________________________
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/r2017: TDF, ATV/r, DRV/r
2019: ABC/3TC (Kivexa)2021: ETR2024: TDF/FTC (Truvada)2025: Raltegravir2026: 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
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
DOLUTEGRAVIR VOLUNTARY LICENSE COVERAGE
ATAZANAVIR VOLUNTARY LICENSE COVERAGE
DARUNAVIR VOLUNTARY LICENSE COVERAGE
PRICING: DARUNAVIR INSIDE & OUTSIDE SUB-SAHARAN AFRICA
Dosage strength: DRV 600mg and 300mg.
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.
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.
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
_______________________________________________________
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
_______________________________________________________
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/r2017: TDF, ATV/r, DRV/r
2019: ABC/3TC (Kivexa)2021: ETR2024: TDF/FTC (Truvada)2025: Raltegravir2026: 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
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 pillOver $3000/year
Generic pills< $300/year
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.
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
Entecavir for Hepatitis Bone year’s supply (0.2g)
Entecavir for Hepatitis Bcost per person/year by country
Entecavir (Baraclude)
US price: $15,111
Cost price: $36
Prices for Hepatitis C DAAsDrug 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 - -
Current costs of sofosbuvir, per person (12 weeks)
USA USA* UK Spain Brazil LMICs Generic Mini
*discount
Cos
t (U
S $
)
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
_______________________________________________________
Patented vs Generic DAAs in the UK
Harvoni45,000 Euros
Generic SOF/DCV900 Euros
SOFOSBUVIR VOLUNTARY LICENSE & REGISTRATION
Data: Gilead License Factsheet, Aug 2015. Gilead Sovaldi registration, May 2015.
No voluntary license
Voluntary license, registered
Voluntary license, not registeredVoluntary license, registration pending/filed
Gilead sales and profits
Cumulative sales of sofosbuvir and Harvoni to end 2015: $31.5 billion
Profits in 2015: $18 billion
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
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.