The Health Information and Quality Authority (HIQA) has commenced work on a health technology assessment (HTA) of a Pre-Exposure Prophylaxis (PrEP) programme for populations at substantial risk of sexual acquisition of HIV. The aim of the HTA is to establish the clinical- and cost-effectiveness of providing a PrEP programme in Ireland.

PrEP is a form of HIV prevention whereby HIV medications (most commonly two antiretrovirals used in combination: tenofovir and emtricitabine) are taken by HIV-negative individuals to prevent infection. In their latest guidelines, the World Health Organization (WHO) recommends that PrEP containing tenofovir should be offered as part of HIV prevention programmes to people at ‘substantial risk of HIV infection’.

HIQA’s Director of Health Technology Assessment and Deputy Chief Executive, Dr Máirín Ryan, said: “HIV infection remains a significant public health concern. In 2017, over 500 new HIV infections were reported to the Health Protection Surveillance Centre (HPSC) in Ireland. In fact, the years 2016 and 2017 witnessed the highest number of new HIV notifications ever reported to the HPSC. Approximately half of all new notifications were in males who have sex with males (MSM). Since 2006, there has been a threefold increase in new infections in the MSM community.”

Dr Ryan continued “HIQA’s assessment will look at the clinical- and cost-effectiveness of funding a PrEP programme. In addition to providing PrEP free of charge, such a programme would also monitor patients through regular testing and provide counselling and advice. The assessment will also look at the budget impact of introducing a PrEP programme and assess the organisational and resource implications of such a service.”

HIQA is establishing an expert advisory group comprising representatives from key stakeholder groups who will advise the HTA evaluation team during the course of this assessment.

Ends.

Further Information:

Marty Whelan, Head of Communications and Stakeholder Engagement, HIQA

01 814 7480 / 086 2447 623, mwhelan@hiqa.ie

Read a background document here

Notes to Editor:

• HIQA agreed to undertake the HTA following a formal request from the HSE’s National Clinical Lead for Sexual Health Services and endorsed by the Department of Health.
•  There were 508 new HIV notifications in Ireland in 2016, representing a rate of 10.7 per 100,000 population. Preliminary data for 2017 indicates a similar rate.
• Of the 508 new diagnoses, just over half (51%) were among men who have sex with men (MSM). This was the largest number of diagnoses ever reported in MSM. The majority of these men (63%) were born abroad, with the highest number from Latin America. Between 2006 and 2016, HIV diagnoses increased by 44% overall and 193% in the MSM group.
• Heterosexual transmission accounted for 28% of diagnoses, with 64% of heterosexual cases born in sub-Saharan Africa.
• There were 21 diagnoses among people who inject drugs, a decrease from the numbers in 2014 and 2015, when there was an outbreak of HIV in Dublin among homeless drug users.
• Overall, it is estimated that the total number of people living with HIV in Ireland is approximately 7,200.
• Policy provision for PrEP is contained in the National Sexual Health Strategy 2015–2020.
• In the US, the FDA approved Truvada (combination of tenofovir and emtricitabine) for PrEP to reduce the risk of sexually-acquired HIV-1 infection in 2012, while the European Commission granted marketing authorisation for Truvada throughout the EU in August 2016 for the same indication.
• Patients who take PrEP must be monitored closely. This includes regular testing for HIV and other STIs and monitoring for side-effects of PrEP.
• Eleven countries currently fund PrEP through national programmes. In 2015, France became the first European country to reimburse PrEP through its public health system. A number of other EU countries have subsequently announced that they would fund a PrEP programme, including Belgium, Norway and Scotland, and many others are in the process of implementing national PrEP programmes.

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.