Charlie McConalogue (Donegal, Fianna Fail)
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567. To ask the Minister for Health if the HSE has received an application for acarizax to be added to the reimbursement list; and if he will make a statement on the matter. [8581/20]

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

In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, the company must submit an application to the HSE to have the new medicine added to the reimbursement list.

Reimbursement is for licenced indications which have been granted market authorisation by the European Medicines Agency or the Health Products Regulatory Authority.

I am advised by the HSE that it has received two applications for the reimbursement of House Dust Mite extract (Acarizax®):

1) House Dust Mite Extract (Acarizax®) for Allergic Asthma

In March 2020, the HSE commissioned the National Centre for Pharmacoeconomics (NCPE) to complete a rapid review on this medicine.  The NCPE recommended a full health technology assessment (HTA) to assess the clinical effectiveness and cost effectiveness of HDM extract (Acarizax ®) for allergic asthma compared with the current standard of care.  On 07 May 2020 the HSE commissioned the NCPE to undertake a full pharmacoeconomic assessment for this indication.

2) House Dust Mite Extract (Acarizax®) for Allergic Rhinitis

In March 2020, the HSE commissioned the NCPE to complete a rapid review.  The NCPE has recommended that a  full HTA is required to assess the clinical effectiveness and cost effectiveness of HDM extract (Acarizax ®) compared with the current standard of care.