Options for affordable pre-exposure prophylaxis (PrEP) in national HIV prevention programmes in Europe

摘要

The successful integration of pre-exposure prophylaxis (PrEP) into comprehensive HIV programmes that include increased testing, the offer of early treatment for infected individuals and combination HIV prevention, is showing signs of contributing to a reduction in new HIV infections [ 1 , 2 ]. Such programmes can enable and motivate people with a high risk of HIV infection to come for testing, encourage those who test negative to consider PrEP, support their effective adherence and deliver collateral benefits such as increased screening and treatment of other sexually transmitted infections (STIs) [ 1 , 3 ]. This promising evidence, in the context of stagnant or rising incidence of HIV in many European countries [ 4 ], has naturally led to intensifying demand for inexpensive and broader provision of PrEP [ 5 ]. The great majority of current PrEP users in Europe and other similar settings are gay and bisexual men and other men who have sex with men (MSM) at high risk of HIV-infection [ 3 , 5 , 6 ]. They are generally well-informed, motivated and supported by civil society and concerned clinicians. However, even in well-established PrEP programmes that engage with less empowered populations, building up to more extensive distribution and uptake of PrEP remains a challenge [ 7 ]. All PrEP programmes need to address persistent barriers and doubts including the need for an estimate of the number of people eligible for PrEP, the price of the PrEP medication, the risk of drug resistance, a potential increase in STI diagnoses via risk compensation and increased testing, achieving effective adherence to PrEP and limited engagement with PrEP by certain members of key populations and certain healthcare providers [ 6 ]. Despite some encouraging experience around meeting these concerns [ 1 , 2 , 6 ] the persistent uncertainty weakens estimates of cost-effectiveness for PrEP and hinders planning for broader implementation. Countries are faced with the dilemma of how to implement and fund effective PrEP programmes at a national scale in a way that addresses need, minimises possible negative impact and remains within the country’s means [ 5 , 6 ]. Secure integration with other sexual health and community services has the potential to bring out the collateral benefits of PrEP access [ 5 ]. The economic evaluation of PrEP in England by Ong et al., published in this edition of Eurosurveillance [ 8 ], explores implications of the first phase of a PrEP programme for MSM at high HIV risk. Despite its limitations, the static decision analytic model that was chosen is attractive due to its simplicity that encourages a broader engagement with cost-effectiveness analyses. The model’s short time relevance reflects the difficulties of projecting PrEP costs and effects very far into the future. Limitations also include that effects beyond the benefit to individuals receiving PrEP could not be modelled using this approach, so the total benefits of PrEP might be underestimated. The results emphasise the high sensitivity of PrEP cost effectiveness to (i) the price of the medicine, (ii) the HIV risk of those taking PrEP and (iii) their level of adherence. This is in line with findings from other modelling studies from high income countries, using various approaches, that indicate that PrEP programmes will become more cost-effective or even cost-saving if PrEP is used by groups (of MSM) who are at the highest risk of HIV infection and when medication costs are reduced, including potential savings through the uptake of on-demand PrEP [ 5 , 6 , 9 - 13 ]. PrEP is evaluated as potentially cost effective in England if taken up with good adherence and correspondingly high clinical effectiveness by groups with a ca 3 per 100 person years’ risk of HIV infection [ 8 ]. The uncertainty around these parameters, and the sensitivity of cost-effectiveness estimates to them, did not allow for stronger conclusions to be drawn. The budgetary impact of a modest programme was considerable: in a single year, a PrEP service for 5,000 PrEP person years costs €36.6M (￡26.9M) at current British National Formulary (BNF) price of the patented drug. Since the price of the PrEP medicine is the main budgetary cost, it is crucial that ways be found to reduce this if PrEP programmes are to go to scale. Different funding models for PrEP have been explored, depending on country health programme frameworks, but the price of the PrEP medicine limits how many people will be offered it whether funding is central, through insurance programmes or private [ 14 ]. We take this opportunity to review various strategies to access affordable antiretrovirals for PrEP. In France, a national programme with subsidised costs has been rolled out since January 2016 [ 5 ]. Norway [ 15 ] and Scotland [ 16 ] have indicated that PrEP will be free to the person using it, and other European countries are taking first steps to roll out PrEP [ 17 ]. Otherwise, a number of potential PrEP users find