ECCO Unexplained rises in UK cancer drug prices ...

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Mesna 400mg. Alliance. £4.29. £13.43. + 213%. Ethinylestradiol 1mg. AAH, Alliance. £2.21. £7.14. + 223%. Melphalan 2mg. Aspen. £55p. £1.82. + 231%.
Abstract 966

Unexplained rises in UK cancer drug prices: 2011-2016 Dr Andrew Hill, PhD Pharmacology and Therapeutics, University of Liverpool, UK Melissa Barber, MPhil London School of Hygiene and Tropical Medicine, London, UK

Disclosures Dr Andrew Hill received consultancy payments from Janssen and Merck in 2016, not connected with this project

Background The National Health Service (NHS) is not approving some new cancer drugs because of high prices; 20% of new treatments with high costs could be rationed by the NHS after launch National budgets to treat cancer are limited in most countries. In most countries, patients will not be treated for certain cancers, if drug prices are too high.

https://www.theguardian.com/society/2016/dec/29/breast-cancer-drug-kadcyla-rejected-for-nhs-use-on-cost-benefit-grounds http://www.telegraph.co.uk/news/2017/01/19/one-five-new-drugs-could-rationed-nhs/

Introduction While drugs are on-patent, high prices allow pharmaceutical companies to profit from their investments in research and development After patents have expired and generic versions are sold, drug prices should fall close to the costs of production. Most generics are manufactured in India. However, some generic companies do not lower prices, or raise prices over time

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http://bmjopen.bmj.com/content/6/1/e009586.full

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Martin Shkreli, Turing Pharmaceuticals: 5000% price rise $750 is a ‘more appropriate’ price for $13 AIDS medicine

Martin Shkreli – Turing Pharmaceuticals

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Methods NHS Indicative Prices were collected from 2011 to 2016 from the British National Formulary, for all medicines with cancer-related indications. Indian prices were collected from the 2016 database: www.drugsupdate.com Prices were cross-checked with Drug Tariff (DT) and Prescription Cost Analysis (PCA) databases, to calculate the additional cost to the NHS budgets from price rises.

Results Of the 190 formulations of 89 cancer medicines in this analysis, 28 formulations of 21 medicines showed price rises from 2011-2016 17/21 cancer medicines with price increases from 2011-2016 were generic in 2016. 20 formulations of 14 generic cancer drugs showed price rises >100% from 2011-2016

Price rises for cancer drugs in the UK, 2011-2016 _____________________________________________________________________________________ Drug / dose Generic Company Price per tablet or injection 2011 2016 % Increase ______________________________________________________________________________________ Ifosfamide 2g vial Alliance, Baxter £89 £180 + 102% Ifosfamide 1g Alliance £43 £91 + 112% Diethylstilbesterol 1mg Teva £1.91 £4.11 + 115% Tamoxifen 40mg Wockhardt £38p 94p* + 147% Mesna 600mg Alliance £6.11 £19.06 + 212% Mesna 400mg Alliance £4.29 £13.43 + 213% Ethinylestradiol 1mg AAH, Alliance £2.21 £7.14 + 223% Melphalan 2mg Aspen £55p £1.82 + 231% Melphalan 50mg vial Aspen £33 £137 + 315% Chlorambucil 2mg Aspen 33p £1.62 + 391% Ethinylestradiol 10µg AAH, Alliance £1.77 £9.52 + 438% Cyclophosphamide 50mg Alliance 20p £1.39 + 595% Tamoxifen 10mg Wockhardt 10p £1.21* + 1110% Busulfan 2mg Aspen 21p £2.61 + 1143% ______________________________________________________________________________________ *tamoxifen 10mg and 40mg – lower prices when sold to UK hospitals – eMIT database

UK versus Indian prices for generic cancer drugs, 2016 _____________________________________________________________________________________ Drug / dose India Company UK Company % Increase ______________________________________________________________________________________ Melphalan 2mg 8p GSK India £1.82 Aspen** + 2,175% Ifosfamide 2g vial £6.95 Celon £180 Alliance, Baxter + 2,490% Chlorambucil 2mg 5p GSK India £1.71 Aspen** + 3,320% Imatinib 400mg* £1.71 Glenmark £65 Novartis + 3,701% Lomustine £1.00 Samarth £37 Medac UK + 3,600% Cyclophosphamide 50mg 2p Khandelwal £1.39 Alliance + 6,850% Mesna 1g vial 16p Cipla £13.41 Alliance + 8,281% Busulfan 2mg 3p GSK India £2.76 Aspen** + 9,100% Ethinylestradiol 1mg 3p Bushnell £7.14 AAH, Alliance + 23,700% ______________________________________________________________________________________ *Imatinib generic in USA, patent expires in Europe in 2017 ** GSK had a large share-holding in Aspen from 2009 until late-2016

Legal Action Italy fined the generic company Aspen €5 million after 1500% rises in cancer drug prices, including melphalan and chlorambucil. Aspen threatened Italy with drug shortages unless higher prices were agreed. Spain: Aspen demanded a 4000% rise in Melphalan prices New Zealand: Melphalan price rose from $68 to $3068 per 50mg vial UK: Pfizer / Flynn Pharma: 2600% increase in phenytoin sodium – £84 million fine UK: Activis – 12,000% rise in price for hydrocortisone sodium http://www.thepharmaletter.com/article/italy-s-ica-imposes-a-5-million-euro-fine-on-aspen-after-1-500-hike-in-cancer-drug-prices http://www.thelocal.es/20140212/cancer-drug-maker-demands-4000-spanish-price-hike https://www.bloomberg.com/news/articles/2016-12-07/pfizer-flynn-pharma-fined-record-106-million-by-u-k-regulator http://www.chemistanddruggist.co.uk/news/actavis-uk-accused-12000-price-hike-hydrocortisone

Conclusions Increases in generic cancer drug prices in the UK suggest that NHS negotiations are failing to contain costs. The overall cost of rises in drug prices to the NHS across all therapeutic areas is at least £380 million per year. This only includes communitybased prescribing in England. The addition of hospital-based prescribing and the rest of the UK will increase this over-spend significantly.

Implications Procuring generics more cheaply could allow more people to be treated with more modern medicines. Some cancer medicines are becoming highly restricted in the UK. Companies which raise drug prices with no clear justification need to be investigated – the Health Services Medical Supplies Bill is passing through the UK Parliament to prevent this happening in the future. Legal action in other countries may be needed. http://services.parliament.uk/bills/2016-17/healthservicemedicalsuppliescosts.html

Implications Prices of cancer drugs in UK and Europe need to be regulated carefully Reductions in the prices of generics could then cause a cascade of cancer drug price reductions – prices of new patented medicines are normally referenced to prices of older generics used in control arms.