1. Treating 35 million people with ART – where are we?
Andrew Hill
St Stephens AIDS Trust
Chelsea and Westminster Hospital
London, UK

2. Estimating minimum costs of treatment
HIV: Using publicly available databases on costs of treatment in low-income countries (e.g. Clinton Foundation, Medicins Sans Frontieres). HIV
Hepatitis B, TB 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.
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.

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

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

5. Total exported volumes equivalent to 344,000 12-week courses
11573 kg exported in this timeframe
kg per 12-week treatment

6. Estimating minimum costs of sofosbuvir
API needed per person = 34g (400mg x 84 days)
Cost of API =
$1,209/kg
API per 12 weeks = $40
Formulated drug = $56
Packaged drug = $58
Final generic price = $86
Formulation = 40%
Packaging = $0.35/month
Profit margin = 50%

7. Current costs of sofosbuvir, by country 12 week course of treatment
Sofosbuvir (Sovaldi)
US price: $84,000
Cost price: $86

8. Total exported volumes equivalent to 373,000 12-week courses
kg per 12-week treatment
1878 kg exported in this timeframe

9. Estimating minimum costs of daclatasvir
API needed per person = 5g (60mg x 84 days)
Cost of API =
$1,377/kg
API per 12 weeks = $6.9
Formulated drug = $10
Packaged drug = $11
Final generic price = $16
Formulation = 40%
Packaging = $0.35/month
Profit margin = 50%

10. Current costs of daclatasvir, by country 12 week course of treatment
Daclatasvir (Dakinza)
US price: $63,000
Cost price: $16

11. Hepatitis C buyers clubs
There are many companies willing to export generic DAAs into Europe / North America
Generic sofosbuvir can be bought online in 15 minutes, for approx. $1200 per course. Prices falling rapidly.
But what about quality?
We need systems in place to ensure that supplies are from accredited generic manufacturers

12. The FixHepC Buyers Club (www.fixhepc.com)

13. Published SVR12 Results SOF+LDV and SOF+DCV
Dr Andrew Hill aggregated all the clinical trials data we could find for the DAA combinations SOF+LDV and SOF+DCV, and they are presented here.
And if we compare this to the results of generics….

14. REDEMPTION-1 Overall SVR4 Results For Generics
We don’t see a lot of difference.
The 100% results in GT2,4,5,6 are of course pretty meaningless given the tiny numbers, but for GT1 and GT3 the results are in line with expectations.
We do expect a handful of patients who passed SVR4 to fail SVR12 but don’t expect that to cause a huge change and note the confidence intervals are already reasonably narrow.
Note: Some small percentage loss of SVR is expected during the SVR4 to SVR12 period

15. Price of Moxifloxacin by country
US price: $806
Cost price: $6

16. Price of Linezolid by country

17. 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

18. Imatinib (Gleevec)
US price: $106,322
Cost price: $180

19. 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
$79891
Sorafenib
Renal Cell Carcinoma
$1450
$1332
$139,138
Lapatinib
Breast Cancer
$4020
$18,603 (Thailand)
$75161
Cabazitaxel
Metastatic prostate cancer
$666
$30,810 (South Africa)
$120,613
Dasatinib
$15
$1183 (Brazil)
$10,408
Pazopanib
$116
$1463 (Brazil)
$8412
Gefitinib
$16
$139
$6728
Capecitabine
Metastatic Colorectal Cancer
$73
$126 (Latvia)
$1941

20. The new $90 $90 $90
There could be standard prices for HIV, Hepatitis B and Hepatitis C in low/middle income countries. 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

21. 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
– this time, more quickly