Minimum costs to produce treatments for HIV, Hepatitis B/C and cancer. Dr Andrew Hill, Pharmacology and Therapeutics, Liverpool University, UK

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1 Minimum costs to produce treatments for HIV, Hepatitis B/C and cancer Dr Andrew Hill, Pharmacology and Therapeutics, Liverpool University, UK

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,

4 Minimum Costs of ARV treatments: HIV GREEN FULLY GENERIC WORLDWIDE IN 2017 RED STILL PATENTED TO : 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

5 What is the potential, outside HIV/AIDS? 1. Low-cost elimination programmes for major infectious diseases 2. Widespread use of a range of drugs in low and middle income countries 3. Drugs become cost-effective for use in low and middle income countries 4. Test and treat or Universal Access applied to many therapeutic areas

6 How to lower drug prices for any disease? 1. Calculate the minimum price of drug production 2. Make sure the number of patients is large enough to make low-cost production feasible coordinate demand forecasts between national health authorities and donors 3. Where drug is already generic, set up supplies from at least three generic companies 4. Where drug is not generic, negotiate voluntary licenses with pharmaceutical companies these may involve royalty payments

7 Median treatment cost per person-year (US$) PRICING: DARUNAVIR INSIDE & OUTSIDE SUB-SAHARAN AFRICA DRV treatment cost comparison ( transactions) Nigeria Moldova Ukraine Morocco Jamaica Armenia South Africa Egypt Gabon Mauritius Belarus Azerbaijan (GNI ~US$ 5,000) (GNI ~US$ 7,000-8,500) (GNI ~US$ 10,00-13,000) (GNI ~US$ 16,000-18,000) Dosage strength: DRV 600mg and 300mg.

8 HIV Patent Expiry dates: years ( ) 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

9 If outside voluntary license countries, prices can be much higher Patented pill Over $3000/year Generic pills < $300/year TDF/FTC/EFV TDF/FTC/RPV TDF/FTC/ELV/c Generic TDF or ABC Generic 3TC Generic EFV or PI/r ABC/3TC/DTG

10 Estimating minimum costs of treatment Three methods: 1.HIV: Using publicly available databases on costs of treatment in lowincome countries (e.g. Clinton Foundation, Medicins Sans Frontieres). HIV 2.Hepatitis B and Cancer: Tracking import-export databases to find costs of API (Active Pharmaceutical Ingredient drug substance before formulation and packaging). Then add costs of final formulation and profit margin using established methods. 3.Hepatitis C: First principles: evaluating routes of chemical synthesis, retrosynthesis, costing of raw materials (sub-units of drugs). Collaboration with experts in chemical synthesis and mass production of medicines to evaluate prices. Cross-checks using different methods.

11 Total exported volumes equivalent to 344, week courses

12 Total exported volumes equivalent to 373, week courses

13 Daclatasvir: generic prices Cost of API = $1432/kg API needed per person = 5g (60mg x 84 days) API per 12 weeks = $8 Formulation = 40% Formulated drug = $11 Packaged drug = $12 Packaging = $0.35/month Profit margin = 50% Final generic Price = $17 For mid March 2016, Prices falling rapidly

14 Target prices for Hepatitis C DAAs Drug Calculated target price for 12-week treatment Current global lowest Current US price Sofosbuvir $95 $300 $84,000 Ledipasvir $ Daclatasvir $17 $153 $63,000 Velpatasvir $

15 Cost (US $) Current costs of sofosbuvir, per person (12 weeks) $84, $56,000 $53, $27, $8,000 $900 $750 $100 USA USA* UK Spain Brazil LMICs Generic Mini *discount

16 Summary HCV production costs We are already getting to unit cost prices of $95 for SOF/DCV, even when producing volumes for 300,000 people per year. Volumes twenty times higher (i.e. 5 million courses) would be needed to treat 3% of the epidemic each year. Production costs should fall further. - API cost / kg for sofosbuvir should fall below $1000 in Daclatasvir production costs are minimal. At the moment, most API is shipped to Egypt large exports elsewhere? We cannot track the export of final finished product i.e. bottles of SOF/DCV. Also not tracking exports from China / Bangladesh.

17 Treatments for Hepatitis B WHO guidelines recommend first-line treatment with either tenofovir or entecavir. Entecavir is now fully generic in the USA. Tenofovir is on patent until early 2018 Entecavir dosing is 0.5mg/day, which corresponds to 0.18g of drug required for a year s treatment. Entecavir API is being manufactured by Indian generic companies and exported worldwide at low prices. Potential to treat for $36 per person per year as a minimum price.

18 Entecavir for Hepatitis B one year s supply (0.2g)

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

20 Treatments for Cancer Basic 20-year patents on six Tyrosine Kinase Inhibitors (TKIs) expire by 2020: Imatinib Ibrutinib Erlotinib Sorafanib Sunitinib Lapatinib Simple chemical structure, oral dosing, dose range mg/day Import / export API prices used to estimate minimum production costs Compared with quotes from approved suppliers and national prices

21 Price per year (USD) $ $ $ $ Lowest available price for Imatinib (400mg) in selected countries Imatinib (Gleevec) US price: $106,322 $ Cost price: $180 $ $ $ $ $ $ $ 0 $ $ $ $ 790 $ 180

22 Treatments for Cancer production prices Drug Major indication Target price Indian price (or other lowest if Indian not available) US price Imatinib Chronic Myeloid Leukaemia $172 $803 $107,799 Erlotinib Non-Small Cell Lung Cancer $240 $1932 $79,891 Sorafenib Renal Cell Carcinoma $1450 $1332 $139,138 Lapatinib Breast Cancer $4020 $18603 (Thailand) $75,161 Cabazitaxel Metastatic prostate cancer $666 $30810 (South Africa) $120,613 Dasatinib Chronic Myeloid Leukaemia $15 $1183 (Brazil) $10,408 Pazopanib Renal Cell Carcinoma $116 $1463 (Brazil) $8,412 Abiraterone Metastatic prostate cancer $3589 $27,570 (Thailand) $85,877 Gefitinib Non-Small Cell Lung Cancer $16 $139 $6,728 Capecitabin e Metastatic Colorectal Cancer $73 $126 (Latvia) $1,941

23 US (Bayer) US (generic) UK (Bayer) Spain (generic) Thailand (Bayer) South Africa (generic) France (generic) Russia (generic) GDF Catalogue (generic) India (nonsra generic) Low-demand target price High-demand target price price in USD per month Price of Moxifloxacin by country $ $ $106 $86 $82 $62 $38 $19 $12 $7 $9 $3

24 How to lower drug prices Calculation of minimum target prices set a target for generic companies Volume demand needs to be high enough to make low-cost production possible coordination between national health authorities and donors Where drug is already generic, establish set of high quality producers Where drug is still on patent, negotiate voluntary licenses with royalty payments

25 7 point plan for Global Treatment Access 1. Calculate minimum prices for all drugs in the WHO Essential Medicines List, plus Top 20 selling treatments worldwide 2. Show which diseases then become cost-effective to treat at low cost 3. Agree new treatment priorities with Health Authorities. 4. Online warning system to show which generics are sold >5 x production price 5. When low-cost generics introduced, re-calculate cost-effectiveness of any other high-cost drug in the same class 6. Voluntary licenses for most important drugs still on-patent 7. Quality control system for generics - publicly available results

26 Universal access to HIV treatment is one of the greatest success stories in medicine (>15 million treated). This should not stand alone, but be repeated for mass treatment of cancer, viral hepatitis and other diseases 26 this time, more quickly

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