HIQA launches public consultation on a PrEP programme to prevent HIV

Date of publication:

The Health Information and Quality Authority (HIQA) has launched a public consultation on a draft health technology assessment (HTA) of a pre-exposure prophylaxis (PrEP) programme for populations at substantial risk of sexual acquisition of HIV.

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.

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.”
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.”

HIQA wants to hear the views of the Irish public on this draft report before it is finalised. Following this, a final report will be prepared for consideration by the HIQA Board before providing advice to the Minister for Health. HIQA invites members of the public to give feedback on the draft report by 28 May 2019. The completed assessment will be submitted to the Minister for Health and the Health Service Executive as advice and published on the HIQA website.

You can read the draft report and take part in the public consultation using the link below.

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

Notes to Editor:

  • 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.
  • 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.
  • There were 492 diagnoses of HIV notified in Ireland in 2017, representing a rate of 10.3 per 100,000 population. An increasing proportion (39%) of diagnoses in Ireland in 2017 was in people known to be previously diagnosed HIV positive abroad.
  • Of the 492 new diagnoses, 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.
  • In the economic analysis, PrEP is cost saving. Providing PrEP is less costly, and more effective (in terms of Quality-Adjusted Life Years [QALYs] gained), than not providing PrEP.
  • Policy provision for PrEP is contained in the National Sexual Health Strategy 2015–2020.

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.