Neale Richmond (Dublin Rathdown, Fine Gael)
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1303. To ask the Minister for Health when the asthma drug benralizumab will be approved; and if he will make a statement on the matter. [20534/20]

Stephen Donnelly (Wicklow, Fianna Fail)
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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.  

In line with the 2013 Act and the national framework agreed with industry, a company must submit an application to the HSE to have a 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.

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 conducts health technology assessments (HTAs) for the HSE and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention.

The HSE has confirmed that Benralizumab is approved for hospital use only at this time.

I am advised by the HSE that it has received an application for the reimbursement of a Benralizumab autoinjector under the High Tech Arrangements.

In March 2020, a Rapid Review was commissioned by the HSE.  On 28 April 2020, this review was completed with the NCPE recommending that Benralizumab not be considered for reimbursement under high tech drug arrangements at the submitted price.

Commercial discussions are ongoing with the applicant. Strict criteria for use are applied within the hospital setting and these must also be taken into consideration in any proposed transition to the community setting.

The application remains under consideration with the HSE.