The Health Information and Quality Authority (HIQA) has published a health technology assessment recommending the introduction of a pre-exposure prophylaxis (PrEP) programme for populations at substantial risk of sexual acquisition of HIV. HIQA has advised the Minister for Health that the HTA found that the successful implementation of a national PrEP programme in Ireland would be safe, effective and cost-saving.

Following a public consultation, the Health technology assessment of a PrEP programme for populations at substantial risk of sexual acquisition of HIV was approved by the Board of HIQA this week and has been submitted to the Minister for Health for his consideration.

HIQA’s Director of Health Technology Assessment and Deputy Chief Executive, Dr Máirín Ryan, said: “HIV infection remains a significant public health concern. There were 492 diagnoses of HIV notified in Ireland in 2017. Just over half of all notifications were in men who have sex with men.”

PrEP is the most recent development in the field of HIV prevention, involving the pre-emptive use of oral antiretroviral therapy in HIV negative people to prevent infection. PrEP consists of a fixed dose combination of oral tenofovir/emtricitabine and has been licensed for use in Ireland since 2016. A ‘PrEP programme’ provides PrEP as part of a holistic service that includes frequent monitoring for adherence and side effects, testing for HIV and other STIs, and counselling and advice on safer sex practices.

Dr Ryan continued “From reviewing the evidence, HIQA has found that PrEP is safe and highly effective at preventing HIV in people at substantial risk. Additionally, implementing a PrEP programme would be considered cost saving compared with standard care. The effectiveness of PrEP is strongly linked with taking the medication correctly, and PrEP must not be taken by individuals with an unrecognised HIV infection as drug resistance mutations may develop. This means that it is important that people taking part in a PrEP programme should receive advice on taking the medication appropriately and undergo frequent HIV testing.”

Dr Ryan concluded “The primary barriers to introducing a PrEP programme in public STI clinics in Ireland relate to staffing and infrastructural issues. A significant investment in STI services is required for a national PrEP programme to ensure a safe, sustainable and equitable service.”

The HTA is available from the link below and includes an executive summary and a plain English summary.

Ends.

Further Information:
Marty Whelan, Head of Communications and Stakeholder Engagement, HIQA
01 814 7480 / 086 2447 623, mwhelan@hiqa.ie

Notes to Editor:

• The Health technology assessment of a PrEP programme for populations at substantial risk of sexual acquisition of HIV can be read at www.hiqa.ie  
• HIQA agreed to undertake the HTA following a formal request from the HSE’s Clinical Lead in Sexual Health and endorsed by the Department of Health.
• Policy provision for PrEP is contained in the National Sexual Health Strategy 2015–2020.
• HIV is a notifiable disease in Ireland. All new diagnoses notified in Ireland are reported nationally by the Health Protection Surveillance Centre (HPSC).
• The Joint United Nations Programme on HIV and AIDS (UNAIDS), in conjunction with the HPSC, estimated that the total number of people living with HIV in Ireland is approximately 7,200.
• Of the 492 new diagnoses in 2017, just over half (53%) were among men who have sex with men (MSM). Heterosexuals accounted for 33% of diagnoses and people who inject drugs accounted for 4%.
• Once daily oral tenofovir/emtricitabine as a fixed dose combination tablet has been licensed and available for use as PrEP in Ireland since 2016. While licensed, it is not reimbursed through the Primary Care Reimbursement Service. Therefore, currently individuals with a valid prescription for PrEP must pay out-of-pocket.
• PrEP is available in at least 49 countries worldwide with eleven countries providing PrEP through national programmes. European countries with national programmes in place include Belgium, France, Norway, Portugal and Scotland.
• A HIQA systematic review and meta-analysis of international randomised controlled trials that involved 25,051 participants found that PrEP is highly effective at preventing HIV infection. The greatest volume of evidence was retrieved on the MSM population; PrEP is up to 86% effective at preventing HIV infection in this group when taken appropriately.
• An economic model was developed to estimate the costs and consequences of providing a PrEP programme to individuals at substantial risk of infection. PrEP was found to be more effective and less costly than not providing PrEP.
• The incremental budget impact of a national PrEP programme is €1.5m in the first year and €5.4m over five years. Extending the budget impact assessment beyond five years, the yearly incremental budget impact becomes cost saving by Year 8 and the aggregate budget impact becomes cost saving (‘break even’ point) by Year 14.
• In the base case analysis, 173 HIV infections are estimated to be averted over the course of the first five years.
• The primary barriers to introducing a PrEP programme in public STI clinics are staffing and infrastructural issues. Staff shortages were cited by all 18 public STI clinics in a recent survey with many services also limited due to the lack of availability of clinic space and time.

The Terms of Reference of the HTA are to:

• describe the epidemiology of HIV infection in Ireland.
• examine the clinical effectiveness and safety of oral pre-exposure prophylaxis (PrEP) to reduce sexual acquisition of HIV in individuals at substantial risk of infection.
• review the evidence of the cost-effectiveness of PrEP.
• evaluate the cost-effectiveness and budget impact of introducing a PrEP programme in Ireland.
• estimate the organisational and resource implications of a PrEP programme in Ireland.
• consider the wider ethical or societal implications that the introduction of PrEP may have for patients, the general public or the health care system.