Michael Creed (Cork North West, Fine Gael)
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877. To ask the Minister for Health his views on the gene therapy treatment known as luxturna for the treatment of the early onset of severe retinal dystrophy; and if he will make a statement on the matter. [11627/21]

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 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).

The HSE has advised that on 23 September 2019 an application was received for the reimbursement of Voretigene neparvovec (Luxturna) for the treatment of adult and paediatric patients with vision loss due to inherited retinal dystrophy caused by confirmed biallelic RPE65 mutations and who have sufficient viable retinal cells.

On 29 October 2019, following the completion by the NCPE of a rapid review, the HSE commissioned a full pharmacoeconomic assessment with respect to this indication.

On 3 April 2020, the NCPE received the applicant’s submission for this assessment. On 18 September 2020, the NCPE completed its assessment and recommended that Voretigene neparvovec not be considered for reimbursement unless cost effectiveness could be improved relative to existing treatments.

The HSE engaged in commercial negotiations with the applicant company in November 2020.

The HSE Drugs Group is the national committee which the HSE has in place to make recommendations on the pricing and reimbursement of medicines. The membership of the HSE Drugs Group includes public interest members and clinicians.

The HSE Drugs Group considered Voretigene neparvovec at its February 2021 meeting and has requested patient and clinician Engagement input via the Rare Diseases Technology Review Committee (RDTRC) to assist the group in making its recommendation to the HSE Executive Management Team (EMT) regarding reimbursement of Voretigene neparvovec. The Drugs Group will review the output of the RDTRC as soon as possible with a view to making a reimbursement recommendation.

The HSE EMT is the decision-making body for the reimbursement of medicines under the Health Act 2013 and it will, following receipt of the outcome of the HSE Drugs Group's deliberations, make the decision on whether Voretigene neparvovec will be reimbursed.

Michael Creed (Cork North West, Fine Gael)
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878. To ask the Minister for Health the treatments available in the public health service for persons diagnosed with Leber congenital amaurosis and early onset of severe retinal dystrophy; and if he will make a statement on the matter. [11630/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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As this is a service matter, I have asked the Health Service Executive to respond to the Deputy directly, as soon as possible.

Michael Creed (Cork North West, Fine Gael)
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879. To ask the Minister for Health if he plans to establish a national medicines agency; and if so, the way in which it will interact with the National Centre for Pharmacoeconomics. [11631/21]

Stephen Donnelly (Wicklow, Fianna Fail)
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The Programme for Government includes a commitment to establish a National Medicines Agency, promoting national prescribing to reduce the cost of medicines, including via generic prescription, where appropriate, and to set a fair price for drug reimbursement.

The establishment of a National Medicines Agency would require a significant body of work to be undertaken, to map out an integrated pharmaceutical policy function for the Agency and to consider the resources necessary for its establishment.

That work has yet to commence, with the priority and focus on tackling the Covid-19 pandemic.