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Abstract

Clinical effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV acquisition in men who have sex with men (MSM) at high HIV risk is established. A static decision analytical model was constructed to inform policy prioritisation in England around cost-effectiveness and budgetary impact of a PrEP programme covering 5,000 MSM during an initial high-risk period. National genitourinary medicine clinic surveillance data informed key HIV risk assumptions. Pragmatic large-scale implementation scenarios were explored. At 86% effectiveness, PrEP given to 5,000 MSM at 3.3 per 100 person-years annual HIV incidence, assuming risk compensation (20% HIV incidence increase), averted 118 HIV infections over remaining lifetimes and was cost saving. Lower effectiveness (64%) gave an incremental cost-effectiveness ratio of + GBP 23,500 (EUR 32,000) per quality-adjusted life year (QALY) gained. Investment of GBP 26.9 million (EUR 36.6 million) in year-1 breaks even anywhere from year-23 (86% effectiveness) to year-33 (64% effectiveness). PrEP cost-effectiveness was highly sensitive to year-1 HIV incidence, PrEP adherence/effectiveness, and antiretroviral drug costs. There is much uncertainty around HIV incidence in those given PrEP and adherence/effectiveness, especially under programme scale-up. Substantially reduced PrEP drug costs are needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size.

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/content/10.2807/1560-7917.ES.2017.22.42.17-00192
2017-10-19
2024-11-27
http://instance.metastore.ingenta.com/content/10.2807/1560-7917.ES.2017.22.42.17-00192
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References

  1. Public Health England (PHE). HIV in the UK Report [Internet]. London: PHE; 2016. Available from: https://www.gov.uk/government/publications/hiv-in-the-united-kingdom
  2. McCormack S, Dunn DT, Desai M, Dolling DI, Gafos M, Gilson R, et al. Pre-exposure prophylaxis to prevent the acquisition of HIV-1 infection (PROUD): effectiveness results from the pilot phase of a pragmatic open-label randomised trial. Lancet. 2016;387(10013):53-60.  https://doi.org/10.1016/S0140-6736(15)00056-2  PMID: 26364263 
  3. Grant RM, Lama JR, Anderson PL, McMahan V, Liu AY, Vargas L, et al. iPrEx Study Team. Preexposure chemoprophylaxis for HIV prevention in men who have sex with men. N Engl J Med. 2010;363(27):2587-99.  https://doi.org/10.1056/NEJMoa1011205  PMID: 21091279 
  4. Molina J-M, Capitant C, Spire B, Pialoux G, Cotte L, Charreau I, et al. ANRS IPERGAY Study Group. On-Demand Preexposure Prophylaxis in Men at High Risk for HIV-1 Infection. N Engl J Med. 2015;373(23):2237-46.  https://doi.org/10.1056/NEJMoa1506273  PMID: 26624850 
  5. National Health Service (NHS) England Specialised Services Clinical Reference Group for HIV. Clinical Commissioning Policy Proposition: Pre-exposure prophylaxis (PrEP) to prevent the acquisition of HIV in adults - NHS England F03X06 Public Consultation. London: NHS; 2016. Available from: https://www.engage.england.nhs.uk/consultation/specialised-services/user_uploads/f03x06-policy-proposition.pdf
  6. National Health Service (NHS) England. Commissioning Operations, Specialised Commissioning. Developing a method to assist investment decisions in specialised commissioning : next steps Consultation Guide [Internet]. London: NHS; 2016. Available from: https://www.engage.england.nhs.uk/consultation/investment-decisions/supporting_documents/consultationguide.pdf
  7. National Institute for Health and Care Excellence (NICE). Guide to the methods of technology appraisal 2013. London: NICE; 2013.
  8. Joint Committee on Vaccination and Immunisation. Joint Committee on Vaccination and Immunisation - Code of Practice June 2013; 2013. [Accessed 17 Oct 2017]. Available from: https://www.gov.uk/government/uploads/system/uploads/attachment_data/file/224864/JCVI_Code_of_Practice_revision_2013_-_final.pdf
  9. Pitman R, Fisman D, Zaric GS, Postma M, Kretzschmar M, Edmunds J, et al. ISPOR-SMDM Modeling Good Research Practices Task Force. Dynamic transmission modeling: a report of the ISPOR-SMDM Modeling Good Research Practices Task Force Working Group-5. Med Decis Making. 2012;32(5):712-21.  https://doi.org/10.1177/0272989X12454578  PMID: 22990086 
  10. Molina J-M. Experience with the Implementation of PrEP in France. In: Fast-track the end of AIDS in the EU [Internet]. St Julians, Malta; 2017. Available from: https://www.slideshare.net/ECDC_EU/experience-with-the-implementation-of-prep-in-france
  11. Savage EJ, Mohammed H, Leong G, Duffell S, Hughes G. Improving surveillance of sexually transmitted infections using mandatory electronic clinical reporting: the genitourinary medicine clinic activity dataset, England, 2009 to 2013. Euro Surveill. 2014;19(48):20981.  https://doi.org/10.2807/1560-7917.ES2014.19.48.20981  PMID: 25496573 
  12. London School of Hygiene and Tropical Medicine (LSHTM). Economic evaluation of HIV pre-exposure prophylaxis among men-who-have-sex-with-men in England in 2016. London: LSHTM; 2017. Available from: https://doi.org/10.17037/PUBS.04433707
  13. European Medicines Agency (EMA). Truvada emtricitabine / tenofovir disoproxil [Internet]. Human medicines. London: EMA; 2016. [Accessed 19 Oct 2016]. Available from: http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000594/human_med_001113.jsp&mid=WC0b01ac058001d124
  14. Desai S, Nardone A, Hughes G, Delpech V, Burns F, Hart G, et al. HIV incidence in an open national cohort of men who have sex with men attending sexually transmitted infection clinics in England. HIV Med. 2017;18(9):615-22.  https://doi.org/10.1111/hiv.12498  PMID: 28127837 
  15. Mercer CH, Tanton C, Prah P, Erens B, Sonnenberg P, Clifton S, et al. Changes in sexual attitudes and lifestyles in Britain through the life course and over time: findings from the National Surveys of Sexual Attitudes and Lifestyles (Natsal). Lancet. 2013;382(9907):1781-94.  https://doi.org/10.1016/S0140-6736(13)62035-8  PMID: 24286784 
  16. Beck EJ, Mandalia S, Sangha R, Sharott P, Youle M, Baily G, et al. NPMS-HHC Steering Group. The cost-effectiveness of early access to HIV services and starting cART in the UK 1996-2008. PLoS One. 2011;6(12):e27830.  https://doi.org/10.1371/journal.pone.0027830  PMID: 22194795 
  17. Public Health England (PHE). HIV surveillance systems. London: PHE. Available from: https://www.gov.uk/hiv-surveillance-systems
  18. National Health Service (NHS) England Specialised Commissioning Team. Clinical Commissioning Policy : Treatment as Prevention (TasP) in HIV infected adults. London: NHS; 2015. p. 1-24. Available from: https://www.england.nhs.uk/commissioning/wp-content/uploads/sites/12/2015/10/f03pc-tasp-oct15.pdf
  19. National Health Service (NHS) England. Freedom of Information request (Ref: FOI-007334). London: NHS; 2015.
  20. Curtis L. Unit Costs of Health & Social Care 2014. Canterbury: Personal Social Services Research Unit; 2014.
  21. Marcus JL, Hurley LB, Hare CB, Nguyen DP, Phengrasamy T, Silverberg MJ, et al. Preexposure Prophylaxis for HIV Prevention in a Large Integrated Health-Care System: Adherence, Renal Safety, and Discontinuation. J Acquir Immune Defic Syndr. 2016;73(5):540-6.  https://doi.org/10.1097/QAI.0000000000001129  PMID: 27851714 
  22. Aghaizu A, Wayal S, Nardone A, Parsons V, Copas A, Mercey D, et al. Sexual behaviours, HIV testing, and the proportion of men at risk of transmitting and acquiring HIV in London, UK, 2000-13: a serial cross-sectional study. Lancet HIV. 2016;3(9):e431-40.  https://doi.org/10.1016/S2352-3018(16)30037-6  PMID: 27562744 
  23. Revicki DA, Frank L. Pharmacoeconomic evaluation in the real world. Effectiveness versus efficacy studies. Pharmacoeconomics. 1999;15(5):423-34.  https://doi.org/10.2165/00019053-199915050-00001  PMID: 10537960 
  24. Alaei K, Paynter CA, Juan S-C, Alaei A. Using preexposure prophylaxis, losing condoms? Preexposure prophylaxis promotion may undermine safe sex. AIDS. 2016;30(18):2753-6.  https://doi.org/10.1097/QAD.0000000000001262  PMID: 27824624 
  25. Nichols BE, Boucher CAB, van der Valk M, Rijnders BJA, van de Vijver DAMC. Cost-effectiveness analysis of pre-exposure prophylaxis for HIV-1 prevention in the Netherlands: a mathematical modelling study. Lancet Infect Dis. 2016;16(12):1423-9.  https://doi.org/10.1016/S1473-3099(16)30311-5  PMID: 27665989 
  26. Ouellet E, Durand M, Guertin JR, LeLorier J, Tremblay CL. Cost effectiveness of ‘on demand’ HIV pre-exposure prophylaxis for non-injection drug-using men who have sex with men in Canada. Can J Infect Dis Med Microbiol. 2015;26(1):23-9.  https://doi.org/10.1155/2015/964512  PMID: 25798150 
  27. Schneider K, Gray RT, Wilson DP. A cost-effectiveness analysis of HIV preexposure prophylaxis for men who have sex with men in Australia. Clin Infect Dis. 2014;58(7):1027-34.  https://doi.org/10.1093/cid/cit946  PMID: 24385445 
  28. Chen A, Dowdy DW. Clinical effectiveness and cost-effectiveness of HIV pre-exposure prophylaxis in men who have sex with men: risk calculators for real-world decision-making. PLoS One. 2014;9(10):e108742.  https://doi.org/10.1371/journal.pone.0108742  PMID: 25285793 
  29. Birrell PJ, Gill ON, Delpech VC, Brown AE, Desai S, Chadborn TR, et al. HIV incidence in men who have sex with men in England and Wales 2001-10: a nationwide population study. Lancet Infect Dis. 2013;13(4):313-8.  https://doi.org/10.1016/S1473-3099(12)70341-9  PMID: 23375420 
  30. National Health Service (NHS) England. NHS England announces major extension of national HIV prevention programme with Public Health England and funding for ten new specialised treatments [Internet]. News. London: NHS; 2016 [4 Dec 2016]. Available from: https://www.england.nhs.uk/2016/12/hiv-prevention-pregramme/
  31. British Medical Association, Royal Pharmaceutical Society. British National Formulary. 70th ed. London: Published jointly by BMJ Group and Pharmaceutical Press; 2015. p1366.
  32. Pathway Analytics. Integrated Sexual Health Tariff. Available from: http://sexualhealthtariff.pathwayanalytics.com/
  33. Miners A, Phillips A, Kreif N, Rodger A, Speakman A, Fisher M, et al. ASTRA (Antiretrovirals, Sexual Transmission and Attitudes) Study. Health-related quality-of-life of people with HIV in the era of combination antiretroviral treatment: a cross-sectional comparison with the general population. Lancet HIV. 2014;1(1):e32-40.  https://doi.org/10.1016/S2352-3018(14)70018-9  PMID: 26423814 
  34. Kind P, Hardman G, Macran S. EQ5D UK population norms. York: The University of York; 1999. p98.
  35. Sciences G. United States Securities and Exchange Commission 2015 Form 10-K Annual Report pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 for the fiscal year ended December 31, 2015. Gilead Sciences. Delaware; 2015. Available from: http://www.gilead.com/ar2015/assets/img/GileadSciences_10K_20160224.pdf
  36. Churchill D, Waters L, Ahmed N, Angus B, Boffito M, Bower M, et al. British HIV Association guidelines for the treatment of HIV-1- positive adults with antiretroviral therapy, 2015. London: BHIVA;Jul 2012:p1–114. Available from: http://www.bhiva.org/documents/Guidelines/Treatment/2015/2015-treatment-guidelines.pdf
  37. Nakagawa F, Lodwick RK, Smith CJ, Smith R, Cambiano V, Lundgren JD, et al. Projected life expectancy of people with HIV according to timing of diagnosis. AIDS. 2012;26(3):335-43.  https://doi.org/10.1097/QAD.0b013e32834dcec9  PMID: 22089374 
  38. National Institute for Health and Care Excellence (NICE). Pre-exposure prophylaxis of HIV in adults at high risk: Truvada (emtricitabine/tenofovir disoproxil). Evidence summary: new medicine [ESNM78]; 2016. [Accessed 27 Oct 2016]. p. 1–50. Available from: https://www.nice.org.uk/advice/esnm78/chapter/Full-evidence-summary
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