Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

The HSE does not require approval or consent from the Minister or Government when making a reimbursement decision.

HSE decisions on which medicines are reimbursed by the taxpayer are made on objective, scientific and economic grounds, on the advice of the National Centre for Pharmacoeconomics (NCPE). The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The NCPE has informed me that a HTA was commissioned by the HSE on Emtricitabine / tenofovir disoproxil fumarate (Truvada) on 19 July 2017. However, to date the manufacturer has not submitted the information necessary to progress the assessment.

In the absence of the company's submission, and in the interest of moving forward, the HSE has asked HIQA to carry out the HTA. I understand that this request is being dealt with at the HIQA board meeting in early July as a priority request.

Once the HTA is complete, the application will be processed in line with the 2013 Act.

Pre-exposure prophylaxis (PrEP) currently has marketing authorisation in the EU and as such is available from pharmacies with a private prescription.