How Pricing Affects Availability Current Context of EECA Region IAS, Paris, July 26, 2017 Sergey Golovin, ITPCru

Acknowledgements ITPCru monitoring team Sergey Kondratyuk, All-Ukrainian Network of People Living with HIV Sergey Biryukov, Antihepatitis C, Kazakhstan Alexandrs Molokovskis, HIV.LV, Latvia Lyudmila Untura, League of People Living with HIV, Moldova

Patients Protests Against High Prices

Impact of Price – Treatment Access Perspective In the context of limited resources, high prices can make medicines unaffordable and inaccessible for many patients in need “High” can be defined as the level of price leading to limited access High prices lead to treatment deficit and stock-outs

Roots of High Prices High prices traditionally emerge as a result of monopoly, when there is no or limited competition History of HIV treatment shows dramatic prices decreases when competition is in place

How Do High Prices Limit Access? High prices prevent the government or the patients from buying the drug itself High prices prevent the government from buying more drugs and covering more people with life-saving treatment, leading to treatment deficit High prices can make governments and patients switch to inferior treatment options

Effect of Pricing Policies Inequalities in access to treatment both in terms of geographical coverage and within countries, creating treatment gaps, when key populations are usually the first to be left out

Price Differences for SOF-based regimens in EECA *Data taken from the report “Hepatitis C in EECA. Epidemic and Response” by the Alliance of Public Health and ITPCru monitoring project

Situation 1. Cases Russia Kazakhstan No access to TDF/FTC FDC due to the price and absence in the EML (the price reaches around 2700 USD ppy) None of the novel DAAs for treating HCV were included in the Essential Medicines List due to high prices (price range – up to 15,000 USD per course of all-oral treatment) Kazakhstan The government is not providing access to SOF/LDV due to the price ($20 229 per 12 weeks)

Situation 1. Cases, continued EU DAA treatment initiation rationing due to limited resources Latvia SOF not included in the reimbursement programme due to the price (EUR41,400 per 12 weeks) SOF/LDV not included in the reimbursement programme due to the price (EUR46,462 per 12 weeks)

Situation 2. Cases Russia Ukraine LPV/r – 27% of the entire ARV budget in 2016; Average price – around 1500 USD ppy for LPV/r 200/50 mg in 2016 (exchange rate 60RUB/USF end of 2016) Large budget deficit – currently, the number of patients needs to be at least doubled ( approx. 250,000 patients) Ukraine LPV/r monopoly price – 60,80USD per pack Approximate generic price – 20USD per pack Achieving the generic price could allow to have 47,000 patients more on treatment, which could cover the existing treatment gap

Situation 3. Cases Russia High prices for DAA-based therapy Government justifying the use of PEG-IFN or even standard interferon in the context of limited resources HIV treatment regimen optimization based on lower prices

Tackling High Prices In order to tackle high prices, we first of all need to tackle monopolies The history shows that competition involving several players is key to significant price reduction

Generics vs No Generics - 1

Generics vs No Generics - 2 * The price of 3TC/AZT experienced a slight increase in 2014 due to provisions in the law giving preferences to local producers and thus limiting competition

Price Decrease for TDF in Russia Over the course of 3 years (2014 – 2016), the average price for tenofovir fell by more than 30 times This happened due to generic competitions and possibly due to threats to issue CL for other ARVs (TDF/FTC and LPV/r) The number of patients on TDF increased by 10 times over 2 years (from 3709 in 2015 to 37 448 in 2016), whereas the expenses for the drugs decreased by two times

Tackling High Prices One way to reduce prices is to conduct price-volume negotiations with the company A number of other instruments are in place compliant with TRIPS flexibilities, for example: Compulsory licensing Patent opposition Parallel importation

Civil Society Role Thorough monitoring of prices, comparing prices in different countries, pricing trends; Pushing for the implementation of TRIPS flexibilities; Making the issue of high prices discussed at the level of government bodies and drawing public attention to it using the media; Direct actions – patent oppositions, which are already making an impact in certain countries (Argentina, Brazil, China, Ukraine, Russia, Moldova, Thailand etc.)

Final Remarks We have to continue disproving the idea that prices are something to be taken for granted! The role of civil society in many cases has been critical to help drive prices down Only constant pressure and commitment of all interested parties will help us overcome the high pricing as a major barrier to achieving the 90/90/90

Final remarks Pricing is a major yet just one of the other barriers to treatment access we need to tackle Price decreases and other market characteristics are sort of “surrogate endpoints” in terms of the patient benefit The ultimate goal is to have as many people as possible receiving quality treatment which meets the current standards