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Medicinal Products

Dáil Éireann Debate, Wednesday - 13 January 2021

Wednesday, 13 January 2021

Questions (862, 864, 869, 883, 1054)

Fergus O'Dowd

Question:

862. Deputy Fergus O'Dowd asked the Minister for Health if matters raised in correspondence by a person (details supplied) on access to Luxturna for persons with degenerative retinal disease will receive a response; and if he will make a statement on the matter. [45088/20]

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Bernard Durkan

Question:

864. Deputy Bernard J. Durkan asked the Minister for Health his plans to offer reimbursement for Luxturna which is essential for treatment of rare retinal disease; and if he will make a statement on the matter. [45093/20]

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Seán Haughey

Question:

869. Deputy Seán Haughey asked the Minister for Health if a gene therapy (details supplied) will receive recognition under the medical card and drug refund schemes; and if he will make a statement on the matter. [45109/20]

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Cian O'Callaghan

Question:

883. Deputy Cian O'Callaghan asked the Minister for Health when the drug Luxturna will become widely available for persons suffering from degenerative retinal disease; and if he will make a statement on the matter. [45145/20]

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Gerald Nash

Question:

1054. Deputy Ged Nash asked the Minister for Health his views on the decision of the National Centre for Pharmacoeconomics to refuse reimbursement for life-changing gene therapy Luxturna for inherited retinal diseases which are rare, serious and life limiting; his plans to support the treatment in view of the commitments made in the programme for Government (details supplied); and if he will make a statement on the matter. [1643/21]

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Written answers

I propose to take Questions Nos. 862, 864, 869, 883 and 1054 together.

As the Deputy will be aware, the Oireachtas put in place a robust legal framework, in the Health (Pricing and Supply of Medical Goods) Act 2013, which gives full statutory powers to the HSE to assess and make decisions on reimbursement of medicines, taking account of a range of objective factors and expert opinion as appropriate.

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 can be improved relative to existing treatments.

The final HTA report will be reviewed by the HSE Drugs Group, along with the outputs of commercial negotiations which took place in November 2020 and the patient group submission received during the HTA process. The HSE advises that Voretigene neparvovec is expected to be included on a Drugs Group agenda in early 2021.

The HSE Executive Management Team 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 Drugs Group's deliberations, make the decision on whether Voretigene neparvovec will be reimbursed.

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