title: Target prices for mass production of tyrosine kinase inhibitors for global cancer treatment.
abstract: OBJECTIVE
  To calculate sustainable generic prices for 4 tyrosine kinase inhibitors (TKIs).
  
  
  BACKGROUND
  TKIs have proven survival benefits in the treatment of several cancers, including chronic myeloid leukaemia, breast, liver, renal and lung cancer. However, current high prices are a barrier to treatment. Mass production of low-cost generic antiretrovirals has led to over 13 million people being on HIV/AIDS treatment worldwide. This analysis estimates target prices for generic TKIs, assuming similar methods of mass production.
  
  
  METHODS
  Four TKIs with patent expiry dates in the next 5 years were selected for analysis: imatinib, erlotinib, lapatinib and sorafenib. Chemistry, dosing, published data on per-kilogram pricing for commercial transactions of active pharmaceutical ingredient (API), and quotes from manufacturers were used to estimate costs of production. Analysis included costs of excipients, formulation, packaging, shipping and a 50% profit margin. Target prices were compared with current prices. Global numbers of patients eligible for treatment with each TKI were estimated.
  
  
  RESULTS
  API costs per kg were $347-$746 for imatinib, $2470 for erlotinib, $4671 for lapatinib, and $3000 for sorafenib. Basing on annual dose requirements, costs of formulation/packaging and a 50% profit margin, target generic prices per person-year were $128-$216 for imatinib, $240 for erlotinib, $1450 for sorafenib, and $4020 for lapatinib. Over 1 million people would be newly eligible to start treatment with these TKIs annually.
  
  
  CONCLUSIONS
  Mass generic production of several TKIs could achieve treatment prices in the range of $128-$4020 per person-year, versus current US prices of $75161-$139,138. Generic TKIs could allow significant savings and scaling-up of treatment globally, for over 1 million eligible patients.
authors.affiliation: Department of Pharmacology and Therapeutics, University of Liverpool, Liverpool, UK.
authors.forename: Andrew
authors.initials: A
authors.lastname: Hill
authors.affiliation: Faculty of Medicine, Imperial College London, London, UK.
authors.forename: Dzintars
authors.initials: D
authors.lastname: Gotham
authors.affiliation: Chemistry and Pharmaceutical Sciences, Howard University, Washington DC, USA.
authors.forename: Joseph
authors.initials: J
authors.lastname: Fortunak
authors.affiliation: Faculty of Medical Sciences, University College London, London, UK.
authors.forename: Jonathan
authors.initials: J
authors.lastname: Meldrum
authors.affiliation: Faculty of Medicine, Imperial College London, London, UK.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Erbacher
authors.affiliation: Faculty of Medicine, Imperial College London, London, UK.
authors.forename: Manuel
authors.initials: M
authors.lastname: Martin
authors.affiliation: Faculty of Medicine, Imperial College London, London, UK.
authors.forename: Haitham
authors.initials: H
authors.lastname: Shoman
authors.affiliation: Faculty of Medicine, Imperial College London, London, UK.
authors.forename: Jacob
authors.initials: J
authors.lastname: Levi
authors.affiliation: Institute for Public Health, Washington University in St. Louis, St. Louis, Missouri, USA.
authors.forename: William G
authors.initials: WG
authors.lastname: Powderly
authors.affiliation: National Centre for HIV Malignancy, Chelsea & Westminster Hospital, London, UK.
authors.forename: Mark
authors.initials: M
authors.lastname: Bower
mesh_terms: D000970:Antineoplastic Agents / Q000191:economics* / Q000627:therapeutic use; D003132:Commerce; D004345:Drug Industry / Q000191:economics; D000069347:Erlotinib Hydrochloride / Q000191:economics / Q000627:therapeutic use; D014943:Global Health / Q000191:economics*; D006801:Humans; D000068877:Imatinib Mesylate / Q000191:economics / Q000627:therapeutic use; D000077341:Lapatinib; D009369:Neoplasms / Q000188:drug therapy*; D009536:Niacinamide / Q000031:analogs & derivatives / Q000191:economics / Q000627:therapeutic use; D010671:Phenylurea Compounds / Q000191:economics / Q000627:therapeutic use; D047428:Protein Kinase Inhibitors / Q000191:economics* / Q000627:therapeutic use; D011505:Protein-Tyrosine Kinases / Q000037:antagonists & inhibitors*; D011799:Quinazolines / Q000191:economics / Q000627:therapeutic use; D000077157:Sorafenib
chemical_list: D000970:Antineoplastic Agents; D010671:Phenylurea Compounds; D047428:Protein Kinase Inhibitors; D011799:Quinazolines; D000077341:Lapatinib; D009536:Niacinamide; D000068877:Imatinib Mesylate; D000077157:Sorafenib; D000069347:Erlotinib Hydrochloride; D011505:Protein-Tyrosine Kinases
keywords: HEALTH ECONOMICS; ONCOLOGY; PUBLIC HEALTH; THERAPEUTICS
references.citation: J Pharmacol Exp Ther. 2005 Dec;315(3):971-9
references.pmid: 16002463
references.citation: Clin Oncol (R Coll Radiol). 2009 Oct;21(8):610-6
references.pmid: 19695849
references.citation: Expert Rev Pharmacoecon Outcomes Res. 2012 Aug;12(4):465-73
references.pmid: 22971033
references.citation: Nat Rev Clin Oncol. 2013 Jun;10(6):314-22
references.pmid: 23568416
references.citation: J Int AIDS Soc. 2011 Mar 27;14:15
references.pmid: 21439089
references.citation: Ann Oncol. 2014 Jan;25(1):270-6
references.pmid: 24356638
references.citation: Lancet. 2017 Jan 28;389(10067):345-347
references.pmid: 27832873
references.citation: Nat Rev Cancer. 2013 Sep;13(9):663-73
references.pmid: 23949426
references.citation: Clin Infect Dis. 2014 Apr;58(7):928-36
references.pmid: 24399087
references.citation: J Virus Erad. 2015 Apr 01;1(2):103-10
references.pmid: 27482399
references.citation: Br J Cancer. 2013 Aug 20;109(4):888-90
references.pmid: 23880824
references.citation: Blood. 2013 May 30;121(22):4439-42
references.pmid: 23620577