Denis Naughten (Roscommon-Galway, Independent)
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989. To ask the Minister for Health when an assessment (details supplied) will be completed; the status of same; and if he will make a statement on the matter. [16754/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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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 Health 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.

In making a relevant reimbursement decision, the HSE is required under the Act to have regard to a number of criteria including efficacy, the health needs of the public, cost effectiveness and potential or actual budget impact.

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 HSE received an application on 22 November 2018 for the reimbursement of Burosumab (Crysvita) for the treatment of X-linked hypophosphataemia (XLH) with radiographic evidence of bone disease in children 1 year of age and older and adolescents with growing skeletons.

In February 2021, the HSE Drugs Group considered the reimbursement application for Burosumab and recommended that this medicine be approved for reimbursement for this indication. In doing so, the Drugs Group reviewed the NCPE's HTA report which was completed in March 2020, the subsequent outputs of commercial negotiations, the conclusions of the Rare Disease Technology Review Committee, and the patient group submissions received during the assessment process.

The final decision-making authority in the HSE is the HSE Executive Management Team (EMT). The HSE EMT decides on the basis of all the demands with which it is faced (across all services) whether it can fund a new medicine, or new uses of an existing medicine, from the resources that have been provided to it in line with the 2013 Health Act.

The HSE has advised that, on 9 of March 2021, the HSE EMT supported hospital pricing approval for Burosumab. The applicant company has been notified of the proposed decision and a formal approval letter will now be progressed by the HSE.

The final decision with respect to the reimbursement of Burosumab will be formalised by the HSE in accordance with 2013 Health Act.