title: Translating PrEP effectiveness into public health impact: key considerations for decision-makers on cost-effectiveness, price, regulatory issues, distributive justice and advocacy for access.
abstract: BACKGROUND
  The extraordinary feat of proving the effectiveness of oral pre-exposure prophylaxis (PrEP) in clinical trials in different populations in a variety of settings may prove to have been easier than ensuring it is used well. Decision-makers must make difficult choices to realize the promise of antiretroviral prophylaxis for their countries. This paper outlines key economic, regulatory and distributive justice issues that must be addressed for effective and acceptable PrEP implementation.
  
  
  CONCLUSIONS
  In considering the role that PrEP can play in combination prevention programmes, decision-makers must determine who can benefit most from PrEP, how PrEP can be provided safely and efficiently, and what kind of health system support will ensure successful implementation. To do this, they need contextualized information on disease burden by population, analyses of how PrEP services might best be delivered, and projections of the human resource and infrastructure requirements for each potential delivery model. There are cost considerations, varying cost-effectiveness results and regulatory challenges. The principles of ethics can inform thorny discussions about who should be prioritized for oral PrEP and how best to introduce it fairly. We describe the cost-effectiveness of PrEP in different populations at higher risk of HIV exposure, its price in low- and middle-income countries, and the current regulatory situation. We explore the principles of ethics that can inform resource allocation decision-making about PrEP anchored in distributive justice, at a time when universal access to antiretroviral treatment remains to be assured. We then highlight the role of advocacy in moving the PrEP agenda forward.
  
  
  CONCLUSIONS
  The time is ripe now for decisions about whether, how and for whom PrEP should be introduced into a country's HIV response. It has the potential to contribute significantly to high impact HIV prevention if it is tailored to those who can most benefit from it and if current regulatory and pricing barriers can be overcome. Advocacy at all levels can help inform decision-making and push the access agenda to avert HIV infections among those at highest risk of HIV exposure. The benefits will accrue beyond the individual level to slow HIV transmission at the population level.
authors.affiliation: Department of Global Health, Academic Medical Center, Amsterdam Institute for Global Health and Development, University of Amsterdam, Amsterdam, The Netherlands.|Department of Infectious Disease Epidemiology, Faculty of Epidemiology and Population Health, London School of Hygiene and Tropical Medicine, London, England; c.hankins@aighd.org; catherine.hankins@lshtm.ac.uk.
authors.forename: Catherine
authors.initials: C
authors.lastname: Hankins
authors.affiliation: Epidemiology & Population Health, Albert Einstein College of Medicine New York, NY, USA.
authors.forename: Ruth
authors.initials: R
authors.lastname: Macklin
authors.affiliation: AVAC New York, NY, USA.
authors.forename: Mitchell
authors.initials: M
authors.lastname: Warren
mesh_terms: D019380:Anti-HIV Agents / Q000627:therapeutic use*; D003362:Cost-Benefit Analysis; D003657:Decision Making; D015658:HIV Infections / Q000517:prevention & control*; D006801:Humans; D065129:Pre-Exposure Prophylaxis / Q000191:economics / Q000941:ethics / Q000331:legislation & jurisprudence; D011634:Public Health; D012935:Social Justice
chemical_list: D019380:Anti-HIV Agents
keywords: HIV prevention; antiretroviral; cost-effectiveness; ethics; pre-exposure prophylaxis; regulatory; resource allocation; tenofovir/emtricitabine