Written answers

Tuesday, 26 September 2017

Department of Health

Medicinal Products Availability

Photo of Catherine MartinCatherine Martin (Dublin Rathdown, Green Party)
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283. To ask the Minister for Health the steps being taken to provide pre-exposure prophylaxis medication here, in particular, for groups that are at high risk of HIV infection; and if he will make a statement on the matter. [40221/17]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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One of the priority actions identified under the Sexual Health Strategy 2015-2020 was to 'Prioritise, develop and implement guidance to support clinical decision making for STI testing, screening and treatment and on the appropriate use of antiretroviral therapy in HIV prevention’.

As part of this action, a multisectoral PrEP (HIV pre-exposure prophylaxis) working group, with a wide range of professional and community representation, was established by the HSE Sexual Health and Crisis Pregnancy Programme in 2016. The terms of reference of this multisectoral group includes the development of clinical guidance documents and recommendations in relation to the use of HIV PrEP in Ireland. The Working Group is exploring questions in relation to the feasibility, acceptability and uptake of HIV PrEP in Ireland and work has commenced on identifying how these priority questions can be answered through a project within existing clinical infrastructures. In addition the Working Group had explored the possibility of running a ‘demonstration project’ in Ireland with the support of a manufacturer of a relevant authorised product, however, I understand that the demonstration project is not being pursued at this juncture as the window of opportunity has now closed. The Working Group has also progressed work on the development of standards for PrEP service provision and other issues relevant to any future ‘model of care’ and implementation of a PrEP clinical service within a HIV prevention programme to people who would meet determined eligibility criteria and in services meeting agreed standards.

A pharmaceutical manufacturer has submitted a rapid review dossier to the HSE and a rapid review has been formally commissioned from the NCPE (National Centre for Pharmacoeconomics). This is in line with the standard process under the Health (Pricing and Supply of Medical Goods) Act 2013. The outcome of the four week rapid review process has recommended that a full pharmacoeconomic evaluation be undertaken. Following receipt of a further submission from Gilead (which may take between 3 and 6 months) the NCPE starts the 90 day clock on/clock off timeframe for completing the evaluation. This could take between 3 and 6 months to complete at which time the NCPE will make a recommendation to the HSE Leadership team.

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