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ObjectivesThe size of the population of men who have sex with men (MSM) who may be eligible for HIV pre-exposure prophylaxis (HIV-PrEP) in England remains unknown. To plan for a national PrEP implementation trial, we estimated the number of MSM attending sexual health clinics (SHCs) that may be eligible for HIV-PrEP in England.MethodsSexually transmitted infection (STI) surveillance data from 2010 to 2015 from the GUMCAD surveillance system were used to estimate the annual number of HIV-negative MSM who may be eligible for HIV-PrEP in England. Based on national eligibility criteria, we identified HIV-negative MSM attending SHCs with a HIV-negative test in the past year and used diagnosed bacterial STI (past year) in this group as a proxy for condomless sex and eligibility for HIV-PrEP. We estimated HIV incidence per 100 person-years (py) in these groups in 2014.ResultsDuring 2010–2015, the number of HIV-negative MSM attending SHCs with a HIV-negative test in the past year doubled from 14 643 to 29 023, and HIV incidence in this group was 1.9 (95% CI 1.6 to 2.2) per 100 py in 2014. In the same period, the subgroup with a bacterial STI diagnosis (past year), and therefore considered potentially eligible for HIV-PrEP in this analysis, increased from 4365 (30%) to 10 276 (35%). HIV incidence in this subgroup was 3.3 (95% CI 2.7 to 4.0) per 100 py in 2014.ConclusionsIn 2015, approximately 10 000 HIV-negative MSM were considered potentially eligible for HIV-PrEP based on clinic history in GUMCAD. These data were used to inform the initial recruitment target for the PrEP Impact Trial and will inform future evaluations at a population level.

Background Men who have sex with men require special attention for human papillomavirus vaccination given elevated infection risks and the development of, in particular, anal cancer. Objective Our purpose was to review the cost effectiveness of human papillomavirus vaccination for both currently vaccine-eligible and non-eligible individuals, particularly the men-who-have-sex-with-men population, and synthesize the available evidence. Methods We systematically searched for published articles in two main databases (PubMed and EMBASE). Screening and data extraction were performed by two independent reviewers. The risk of bias was assessed using a validated instrument (Bias in Economic Evaluation, ECOBIAS). Methodological aspects, study results, and sensitivity analyses were extracted and synthesized to generate a consistent overview of the cost effectiveness of human papillomavirus vaccination in the men-who-have-sex-with-men population. Results From 770 identified articles, four met the inclusion criteria. Across the studies, human papillomavirus vaccination showed incremental cost-effectiveness ratios ranging from dominant to US$96,146 and US$14,000 to US$18,200 for tertiary prevention and primary prevention, respectively. The incremental cost-effectiveness ratio seemed most sensitive to vaccine efficacy, vaccine costs, and the incidence of anal cancer in the selected target populations. Conclusion This review presents the human papillomavirus vaccine, both as a primary and adjuvant (tertiary) vaccination, as a potentially cost-effective strategy for preventing mainly-but not limited to only-anal cancer in men-who-have-sex-with-men populations.

Summary Background In the UK, HIV incidence among men who have sex with men (MSM) has remained high for several years, despite widespread use of antiretroviral therapy and high rates of virological suppression. Pre-exposure prophylaxis (PrEP) has been shown to be highly effective in preventing further infections in MSM, but its cost-effectiveness is uncertain. Methods In this modelling study and economic evaluation, we calibrated a dynamic, individual-based stochastic model, the HIV Synthesis Model, to multiple data sources (surveillance data provided by Public Health England and data from a large, nationally representative survey, Natsal-3) on HIV among MSM in the UK. We did a probabilistic sensitivity analysis (sampling 22 key parameters) along with a range of univariate sensitivity analyses to evaluate the introduction of a PrEP programme with sexual event-based use of emtricitabine and tenofovir for MSM who had condomless anal sexual intercourse in the previous 3 months, a negative HIV test at baseline, and a negative HIV test in the preceding year. The main model outcomes were the number of HIV infections, quality-adjusted life-years (QALYs), and costs. Findings Introduction of such a PrEP programme, with around 4000 MSM initiated on PrEP by the end of the first year and almost 40 000 by the end of the 15th year, would result in a total cost saving (£1·0 billion discounted), avert 25% of HIV infections (42% of which would be directly because of PrEP), and lead to a gain of 40 000 discounted QALYs over an 80-year time horizon. This result was particularly sensitive to the time horizon chosen, the cost of antiretroviral drugs (for treatment and PrEP), and the underlying trend in condomless sex. Interpretation This analysis suggests that the introduction of a PrEP programme for MSM in the UK is cost-effective and possibly cost-saving in the long term. A reduction in the cost of antiretroviral drugs (including the drugs used for PrEP) would substantially shorten the time for cost savings to be realised. Funding National Institute for Health Research.

OBJECTIVES: Reliable and timely HIV care cost estimates are important for policy option appraisals of HIV treatment and prevention strategies. As HIV clinical management and outcomes have changed, we aimed to update profiles of antiretroviral (ARV) usage pattern, patent/market exclusivity details and management costs in adults (≥ 18 years old) accessing HIV specialist care in England.METHODS: The data reported quarterly to the HIV and AIDS Reporting System in England was used to identify ARV usage pattern, and were combined with British National Formulary (BNF) prices, non-ARV care costs and patent/market exclusivity information to generate average survival-adjusted lifetime care costs. The cumulative budget impact from 2018 to the year in which all current ARVs were expected to lose market exclusivity was calculated for a hypothetical 85 000 (± 5000) person cohort, which provided an illustration of potential financial savings afforded by bioequivalent generic switches. Price scenarios explored BNF70 (September 2015) prices and generics at 10/20/30/50% of proprietary prices. The analyses took National Health Service (NHS) England's perspective (as the payer), and results are presented in 2016/2017 British pounds.RESULTS: By 2033, most currently available ARVs would lose market exclusivity; that is, generics could be available. Average per person lifetime HIV cost was ~£200 000 (3.5% annual discount) or ~£400 000 (undiscounted), reducing to ~£70 000 (3.5% annual discount; ~£120 000 undiscounted) with the use of generics (assuming that generics cost 10% of proprietary prices). The cumulative budget to cover 85 000 (± 5000) persons for 16 years (2018-2033) was £10.5 (± 0.6) billion, reducing to £3.6 (± 0.2) billion with the use of generics.CONCLUSIONS: HIV management costs are high but financial efficiency could be improved by optimizing generic use for treatment and prevention to mitigate the high cost of lifelong HIV treatment. Earlier implementation of generics as they become available offers the potential to maximize the scale of the financial savings.

Opportunities exist to improve public health prevention of new HIV and HPV infections. This thesis used different economic analytical methods, including cost-effectiveness, budget impact analyses, and systematic reviews, to address some of the key policy questions around commissioning of public health HIV and HPV control programmes in England. The main interventions studied included HIV pre-exposure prophylaxis (PrEP), HIV screening, and HPV vaccination.A public health PrEP programme could be cost-effective when given to high-risk persons. High intervention cost and coverage needed pose an affordability challenge. Evaluation of new HIV-related interventions involve comparison with current care, where many existing antiretrovirals are beginning to lose market exclusivity. Current lifetime cost could reduce from ~£200,000 per person to ~£70,000 with generic availability. Besides primary prevention, secondary HIV prevention could be considered, including population screening, which was estimated to cost less in hospital admissions compared with general practices, cost per reactive test being most sensitive to staff cost and prevalence.HPV vaccination of men who have sex with men (MSM) up to 40 years is likely cost-effective. Systematic review of different models found results most sensitive to assumed vaccination efficacy and price. Substantial differences exist in cost and utility estimates for HPV-related outcomes, attributable to different disease sites, stages and management, warranting careful consideration of background economic assumptions.Key learnings include that cost-effectiveness should not be considered independently of budget impact and affordability considerations. Health economists need to be mindful of the evolving and dynamic disease management landscape, which affects cost of treatment.

BackgroundMany economic evaluations of human papillomavirus vaccination should ideally consider multiple disease outcomes, including anogenital warts, respiratory papillomatosis and non-cervical cancers (eg, anal, oropharyngeal, penile, vulvar and vaginal cancers). However, published economic evaluations largely relied on estimates from single studies or informal rapid literature reviews.MethodsWe conducted a systematic review of articles up to June 2016 to identify costs and utility estimates admissible for an economic evaluation from a single-payer healthcare provider’s perspective. Meta-analyses were performed for studies that used same utility elicitation tools for similar diseases. Costs were adjusted to 2016/2017 US$.ResultsSixty-one papers (35 costs; 24 utilities; 2 costs and utilities) were selected from 10 742 initial records. Cost per case ranges were US$124–US$883 (anogenital warts), US$6912–US$52 579 (head and neck cancers), US$12 936–US$51 571 (anal cancer), US$17 524–34 258 (vaginal cancer), US$14 686–US$28 502 (vulvar cancer) and US$9975–US$27 629 (penile cancer). The total cost for 14 adult patients with recurrent respiratory papillomatosis was US$137 601 (one paper).Utility per warts episode ranged from 0.651 to 1 (12 papers, various utility elicitation methods), with pooled mean EQ-5D and EQ-VAS of 0.86 (95% CI 0.85 to 0.87) and 0.74 (95% CI 0.74 to 0.75), respectively. Fifteen papers reported utilities in head and neck cancers with range 0.29 (95% CI 0.0 to 0.76) to 0.94 (95% CI 0.3 to 1.0). Mean utility reported ranged from 0.5 (95% CI 0.4 to 0.61) to 0.65 (95% CI 0.45 to 0.75) (anal cancer), 0.59 (95% CI 0.54 to 0.64) (vaginal cancer), 0.65 (95% CI 0.60 to 0.70) (vulvar cancer) and 0.79 (95% CI 0.74 to 0.84) (penile cancer).ConclusionsDifferences in values reported from each paper reflect variations in cancer site, disease stages, study population, treatment modality/setting and utility elicitation methods used. As patient management changes over time, corresponding effects on both costs and utility need to be considered to ensure health economic assumptions are up-to-date and closely reflect the case mix of patients.

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.

Objectives Following national guidelines to expand HIV testing in high-prevalence areas in England, a number of pilot studies were conducted in acute general medical admission units (ACUs) and general practices (GPs) to assess the feasibility and acceptability of testing in these settings. The aim of this study was to estimate the cost per HIV infection diagnosed through routine HIV testing in these settings. Methods Resource use data from four 2009/2010 Department of Health pilot studies (two ACUs; two GPs) were analysed. Data from the pilots were validated and supplemented with information from other sources. We constructed possible scenarios to estimate the cost per test carried out through expanded HIV testing in ACUs and GPs, and the cost per diagnosis. Results In the pilots, cost per test ranged from £8.55 to £13.50, and offer time and patient uptake were 2 minutes and 90% in ACUs, and 5 minutes and 60% in GPs, respectively. In scenario analyses we fixed offer time, diagnostic test cost and uptake rate at 2 minutes, £6 and 80% for ACUs, and 5 minutes, £9.60 and 40% for GPs, respectively. The cost per new HIV diagnosis at a positivity of 2/1000 tests conducted was £3230 in ACUs and £7930 in GPs for tests performed by a Band 3 staff member, and £5940 in ACUs and £18 800 in GPs for tests performed by either hospital consultants or GPs. Conclusions Expanded HIV testing may be more cost-efficient in ACUs than in GPs as a consequence of a shorter offer time, higher patient uptake, higher HIV positivity and lower diagnostic test costs. As cost per new HIV diagnosis reduces at higher HIV positivity, expanded HIV testing should be promoted in high HIV prevalence areas.

Introduction To inform public health planning for a large-scale PrEP trial in England, we estimated the need for HIV pre-exposure prophylaxis (PrEP) among men who have sex with men (MSM) attending sexual health clinics. Methods National STI surveillance data from the genitourinary medicine clinic activity dataset (GUMCADv2) were used to estimate the annual number of HIV-negative MSM who had a HIV test in the past year (which will be a criterion for accessing PrEP in England), for 2010–2015. To estimate the number and proportion of all MSM needing PrEP, we used bacterial STI diagnosis in the past year as a proxy for high-risk behaviour, and estimated HIV incidence (per 100 person-years) in both groups. We used these data to understand the likely geographical distribution of MSM who might need PrEP within the 152 English counties. Results The number of HIV-negative MSM attending sexual health clinics increased by 68% from 69 392 in 2010 to 1 16 546 in 2015, and the number of HIV-negative MSM with a prior HIV test nearly doubled from 14 643 to 29 023 in the same period. Among HIV-negative MSM with a prior HIV test, the number with a recorded bacterial STI (past year) increased from 4365 (30%) in 2010 to 10,276 (35%) in 2015 (33% on average). HIV incidence among MSM with a prior HIV test was 1.9 (95% CI 1.6–2.2) per 100py compared to 3.3 (2.7–4.0) per 100py in MSM with a prior HIV test and history of bacterial STI. The number of MSM in need of PrEP (according to bacterial STI history) was 200 men in 4% (6/152) of counties. Conclusion We estimated that the need for PrEP among MSM in England in 2015 might be around 10 000 individuals with an annual HIV incidence of 3%. Need for PrEP was highly concentrated; in most English counties, the number of MSM with a prior HIV test was small, and only 33% of these men might be clinically assessed as eligible for PrEP. These data illustrate how the population need for PrEP might be estimated in advance of a national trial, and will inform future evaluations at a population level.

Background Current evidence suggests that chlamydia screening programmes can be cost-effective, conditional on assumptions within mathematical models. We explored differences in cost estimates used in published economic evaluations of chlamydia screening from seven countries (four papers each from UK and the Netherlands, two each from Sweden and Australia, and one each from Ireland, Canada and Denmark). Methods From these studies, we extracted management cost estimates for seven major chlamydia sequelae. In order to compare the influence of different sequelae considered in each paper and their corresponding management costs on the total cost per case of untreated chlamydia, we applied reported unit sequelae management costs considered in each paper to a set of untreated infection to sequela progression probabilities. All costs were adjusted to 2013/2014 Great British Pound (GBP) values. Results Sequelae management costs ranged from £171 to £3635 (pelvic inflammatory disease); £953 to £3615 (ectopic pregnancy); £546 to £6752 (tubal factor infertility); £159 to £3341 (chronic pelvic pain); £22 to £1008 (epididymitis); £11 to £1459 (neonatal conjunctivitis) and £433 to £3992 (neonatal pneumonia). Total cost of sequelae per case of untreated chlamydia ranged from £37 to £412. Conclusions There was substantial variation in cost per case of chlamydia sequelae used in published chlamydia screening economic evaluations, which likely arose from different assumptions about disease management pathways and the country perspectives taken. In light of this, when interpreting these studies, the reader should be satisfied that the cost estimates used sufficiently reflect the perspective taken and current disease management for their respective context.

Objectives: The aim of this study was to analyze the experience of the National Institute for Health and Care Excellence (NICE) in identifying new procedures entering the United Kingdom (UK) healthcare system, for assessment and publication of recommendations on their use. This system is designed to provide guidance in an area where regulation is lacking worldwide.Methods: Retrospective analysis of all procedures notified to the Interventional Procedures Programme (NICE) between 2002 and 2012. Notifications were analyzed year by year for their source (who notified them), clinical specialties involved, and whether guidance was subsequently published.Results: A total of 1,094 procedures were notified by clinicians (51 percent), and by others, including hospitals (6 percent), horizon scanners (5 percent), patients (4 percent), private health insurers (4 percent), and medical device manufacturers (3 percent). Guidance was published on 44 percent of procedures notified to the program. There was a decrease in the numbers of procedures notified during 2003–2012 (p = .049). There were notifications across all specialties, with the largest numbers in general surgery (125), urology (104), orthopedics (99), interventional radiology (93), cardiology (82), and obstetrics and gynecology (82).Conclusions: The “open” NICE Web portal allows anyone to notify new procedures, aiming to maximize the opportunity of identifying all those procedures entering clinical practice. This has resulted in identification of large numbers of procedures from across the whole range of medical specialties. The fact that similar proportions of procedures notified from diverse sources have been selected for assessment and publication of practice recommendations suggests that this inclusive approach is worthwhile.

Summary Offering human papillomavirus (HPV) vaccination to men who have sex with men up to age 40 years via genitourinary clinics will have a large impact on HPV-related diseases and is likely to be cost-effective., Background. Men who have sex with men (MSM) have a high lifetime risk of anogenital warts and cancers related to infection with human papillomavirus (HPV). They also benefit less from herd protection than heterosexual males in settings with female-only HPV vaccination. Methods. We evaluated the potential health impact and cost-effectiveness of offering vaccination to MSM who visit genitourinary medicine (GUM) clinics. We used a mathematical model of HPV 6/11/16/18 sexual transmission within an MSM population in England, parameterized with sexual behaviour, GUM attendance, HPV prevalence, HIV prevalence, warts, and cancer incidence data. Interventions considered were offering HPV vaccination to either HIV-positive MSM or MSM regardless of HIV status, for age bands 16–25, 16–30, 16–35, and 16–40 years. Results. Substantial declines in anogenital warts and male HPV-related cancer incidence are projected to occur following an offer of vaccination to MSM. MSM not attending GUM clinics will partially benefit from herd protection. Offering vaccination to HIV-positive MSM up to age 40 is likely to be cost-effective if vaccine procurement and administration costs are below £96.50 a dose. At £48 a dose, offering vaccination to all MSM up to age 40 is likely to be cost-effective. Conclusions. Quadrivalent HPV vaccination of MSM via GUM clinics is likely to be an effective and cost-effective way of reducing the burden of HPV-related disease in MSM.

Background The efficacy and effectiveness of pre-exposure prophylaxis (PrEP) for preventing HIV infection acquisition by high-risk men who have sex with men (MSM) is established. We estimated the cost and cost-effectiveness of a proposed daily oral PrEP programme covering 10 000 high-risk MSM attending genitourinary medicine clinics in England. Methods From the perspective of public providers, a static decision analytical model was used to investigate lifetime HIV infections, treatment costs, and quality-adjusted-life-year (QALY) losses associated with daily PrEP given for 1 year, beginning in 2016, compared with no intervention. A cohort of MSM who were not known to be HIV positive at their first attendance in 2012 and had tested HIV negative between 42 and 365 days previously was identified. These men were followed up from the date of their earliest negative HIV test in 2012 for up to 1 year either until they seroconverted or until their last attendance. HIV incidence was calculated as the number of seroconversions (new HIV diagnoses) per 100 person-years. Data sources including genitourinary medicine clinic activity data were used to estimate HIV incidence in year 1 and thereafter. Costs were updated to 2013–14 values and both future costs and QALYs were discounted at 3·5%. Budgetary impact was undiscounted. Findings At 86% effectiveness, delivery of PrEP to 10 000 high-risk MSM in the first year (target population with an HIV incidence of 2·4 per 100 person-years in year 1) resulted in 178 fewer lifetime HIV infections, 28 delayed infections, and an incremental cost-effectiveness ratio (ICER) of £26 300, compared with no PrEP. More conservative assumptions of 64% PrEP effectiveness gave an ICER of £54 500, compared with no PrEP. ICER was highly sensitive to year 1 HIV incidence (eg, with HIV incidence of 3·3 per 100 person-years and at 86% PrEP effectiveness, ICER was £4170), PrEP effectiveness, PrEP drug costs, and potential changes in antiretroviral treatment cost upon patent expiry. An investment of £54 million in year 1 breaks even anywhere from year 42 (86% PrEP effectiveness) to beyond year 61 (64% PrEP effectiveness). Interpretation The model shows that the estimated cost-effectiveness of PrEP is very sensitive to key variables (eg, year 1 HIV incidence and patient adherence), about which there is much uncertainty, especially if programme scale-up occurs. A substantial reduction in the price of antiretroviral drugs, when used for PrEP, is needed to give the necessary assurance of cost-effectiveness, and for an affordable public health programme of sufficient size. Funding None.

Background Economic evaluations of chlamydia screening programmes do not consistently show that widespread chlamydia screening is cost-effective, which shows uncertainty in some of the assumptions incorporated into the models used. We explored differences in cost estimates used in published cost-effectiveness analyses. Methods Studies were identified from a systematic review of cost-effectiveness analyses of chlamydia screening commissioned by the European Centre for Disease Prevention and Control (2014). We included studies from developed countries that took a national health service or statutory health insurance system perspective for comparison with the English setting (n=14; England, Scotland, the Netherlands, Sweden, Ireland, Denmark, Canada, and Australia). Management costs for seven major sequelae of chlamydia infection (pelvic inflammatory disease, ectopic pregnancy, tubal factor infertility, chronic pelvic pain, epididymitis, neonatal conjunctivitis, and neonatal pneumonia) were extracted from each paper. We adjusted costs to 2013–14 pounds sterling using the Hospital & Community Health Services index and historical Bank of England foreign currency exchange rates. We assessed the effect of considering different sequelae, management costs, or both on the estimated cost-effectiveness of chlamydia screening by applying unit costs of sequelae included in each paper to one set of literature-derived progression probabilities to estimate an overall cost of sequelae per chlamydia infection. Findings Only half of the studies included all seven major chlamydia sequelae. Papers commonly referred to one previously published source that mostly included older estimates (>10 years old). Sequelae management costs per case ranged from £171 to £3635 (pelvic inflammatory disease), £953 to £3615 (ectopic pregnancy), £546 to £6752 (tubal factor infertility), £159 to £3341 (chronic pelvic pain), £22 to £1008 (epididymitis), £11 to £1459 (neonatal conjunctivitis), and £433 to £3992 (neonatal pneumonia). Total cost of sequelae per case of chlamydia using a standard set of progression probabilities ranged from £37 to £412. Interpretation The large disparities in estimated unit costs of chlamydia sequelae considered in existing cost-effectiveness analyses can be attributed to different assumptions about disease management pathways and costs from different country perspectives. Therefore, updated cost-estimates for chlamydia sequelae specific to the English setting are needed to inform future economic evaluations of chlamydia control programmes in England. Funding None.