Mattie McGrath (Tipperary, Independent)
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1729. To ask the Minister for Health if HIQA has or plans on re-examining the emerging evidence regarding the efficacy of ivermectin as a prophylactic and treatment for Covid-19; and if he will make a statement on the matter. [18818/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I wish to advise the Deputy that the HIQA provides evidence-based advice in response to requests from the NPHET.

The HIQA previously undertook an evidence review Interventions in an ambulatory setting to prevent progression to severe disease in patients with COVID-19which is published on www.hiqa.ie. This review included a number of studies of ivermectin.

For the Deputy's information, the HIQA’s overall finding was that there is currently insufficient evidence of either effectiveness or safety to support the use of any pharmaceutical intervention in the community setting to reduce the risk of progression to severe disease in patients who have been diagnosed with COVID-19 unless as part of an ongoing monitored clinical trial. Furthermore, no evidence was identified for the effectiveness or safety of any non-pharmaceutical intervention in the community setting.

As confirmed by the HIQA’s COVID-19 Expert Advisory Group: (), evidence regarding the effectiveness of pharmaceutical treatments intended for systemic use, must be subject to the highest standards of rigour. Where a pharmaceutical intervention is recommended in the absence of appropriate supportive evidence, there is a significant potential for harm to the patient. Whereas this risk of harm may be justified in certain circumstances (e.g. the intervention poses minimal risk, or the setting involves patients with high potential to gain due to almost certain risk of severe adverse consequences in absence of any intervention) this is less likely to be the case in the setting of mild disease, where a great number of otherwise well patients would potentially receive the intervention.

The HIQA has also advised my Department that several international health technology assessment or guideline development organisations have specifically reviewed the evidence to date on ivermectin in COVID-19 and have cautioned or advised against the use of ivermectin outside the setting of clinical trials on the basis of the current evidence. The HIQA has also advised that the pharmaceutical company MSD (Merck, USA), which holds a license in the USA for the use of ivermectin as an antiparasitic agent, on 4th February 2021 published a statement including the following:

“It is important to note that, to-date, our analysis has identified:

- No scientific basis for a potential therapeutic effect against COVID-19 from pre-clinical studies;

- No meaningful evidence for clinical activity or clinical efficacy in patients with COVID-19 disease, and;

- A concerning lack of safety data in the majority of studies.

We do not believe that the data available support the safety and efficacy of ivermectin beyond the doses and populations indicated in the regulatory agency-approved prescribing information.”

An update of the above-mentioned evidence review is not planned at this time.

However, the Deputy may wish to note that the HIQA is currently undertaking an evidence review entitled COVID-19 - Interventions and lifestyle factors that prevent infection or minimise progression to severe disease. Any studies of ivermectin that meet the inclusion criteria outlined in the protocol published at www.hiqa.ie will be included. The HIQA is due to provide the evidence review and associated advice to the NPHET at its meeting on the 6th May 2021.