Paul Murphy (Dublin South West, RISE)
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316. To ask the Minister for Health when zolgensma will be made available for a child (details supplied) given the fact that the sooner the drug is received the better the outcome in cases in which the drug is administered before the child is two years of age. [31681/21]

Donnchadh Ó Laoghaire (Cork South Central, Sinn Fein)
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331. To ask the Minister for Health if his Department has examined a review of the gene therapy medicine zolgensma for use in Ireland; and if he will make a statement on the matter. [31932/21]

Seán Haughey (Dublin Bay North, Fianna Fail)
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335. To ask the Minister for Health if the HSE will approve and make available in Ireland the drug known as zolgensma; and if he will make a statement on the matter. [31963/21]

Martin Browne (Tipperary, Sinn Fein)
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355. To ask the Minister for Health the status of the availability of zolgensma (details supplied); and if he will make a statement on the matter. [32183/21]

Denis Naughten (Roscommon-Galway, Independent)
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356. To ask the Minister for Health when he expects a decision on the approval of a drug (details supplied); and if he will make a statement on the matter. [32184/21]

Pearse Doherty (Donegal, Sinn Fein)
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368. To ask the Minister for Health the status of the reimbursement process for the drug zolgensma for the treatment of spinal muscular atrophy; the progress made to date; and if he will make a statement on the matter. [32364/21]

James O'Connor (Cork East, Fianna Fail)
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370. To ask the Minister for Health if approval will be given for the use of the drug zolgensma in the case of a child (details supplied). [32382/21]

Louise O'Reilly (Dublin Fingal, Sinn Fein)
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375. To ask the Minister for Health the status of talks in relation to the drug zolgensma. [32442/21]

Paul Kehoe (Wexford, Fine Gael)
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414. To ask the Minister for Health when a drug will be approved for use; if an emergency use authorisation can be made for a time sensitive case (details supplied); and if he will make a statement on the matter. [32818/21]

Michael Moynihan (Cork North West, Fianna Fail)
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428. To ask the Minister for Health the status of the reimbursement process for zolgensma; the progress made on this issue to date; and if he will make a statement on the matter. [32926/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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I propose to take Questions Nos. 316, 331, 335, 355, 356, 368, 370, 375, 414 and 428 together.

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, 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 licensed 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).

I am advised by the HSE that, in April 2020, the NCPE received a reimbursement application dossier for Onasemnogene abeparvovec (Zolgensma). On 13 May 2020, the NCPE completed a rapid review with respect to this application and recommended a full Health Technology Assessment (HTA) to assess the clinical effectiveness and cost effectiveness of Zolgensma compared with the current standard of care.

The HTA was undertaken as a part of the Beneluxa collaboration between Ireland, the Netherlands and Belgium, with Austria acting as a reviewer in the Belgian procedure.

The HTA was completed in May 2021 and pricing/reimbursement negotiations have commenced July 2021.

A final decision on the pricing/reimbursement application for Zolgensma will be made in accordance with the 2013 Health Act.

Questions relating to specific individual patients are an operational issue and are therefore a matter for the HSE. Section 6 of the HSE Governance Act 2013 bars me as Minister for Health from directing the HSE to provide a treatment or a personal service to any individual or to confer eligibility on any individual.

However, members of the Oireachtas are advised that the HSE is currently unable to access the information to answer Parliamentary Questions due to the recent cyber-attack, which has required a temporary shut-down of HSE IT systems. The disruption to service is on-going, and the HSE is working hard to restore its IT capacity and resume normal services. Members of the Oireachtas will be advised as soon as the HSE is again in a position to provide responses to PQs and are encouraged to resubmit their Parliamentary Questions at that point.