Jack Chambers (Dublin West, Fianna Fail)
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92. To ask the Minister for Health the status of plans to publicly fund the treatment Spinraza for persons with spinal muscular atrophy here; and if he will make a statement on the matter. [37922/18]

Paul Murphy (Dublin South West, Solidarity)
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104. To ask the Minister for Health when persons suffering with spinal muscular atrophy can expect to have the drug nusinersen approved for reimbursement; and if he will make a statement on the matter. [37948/18]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 92 and 104 together.

The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

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 HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.

Nusinersen (Spinraza) is for the treatment of 5q spinal muscular atrophy (SMA).

An application for the reimbursement of Nusinersen (Spinraza) is currently being processed by the HSE. No decision has been arrived at as yet as the statutory assessment process is still ongoing.

Mary Butler (Waterford, Fianna Fail)
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93. To ask the Minister for Health when funding will be approved for Spinraza in line with the BeNeLuxA initiative; and if he will make a statement on the matter. [37928/18]

Simon Harris (Wicklow, Fine Gael)
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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. The Act specifies the criteria for decisions on the reimbursement of medicines.  

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 HSE strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an on-going basis. This can lead to a protracted deliberation process.

Nusinersen (Spinraza) is for the treatment of 5q spinal muscular atrophy (SMA).  

An application for the reimbursement of Nusinersen (Spinraza) is currently being processed by the HSE. No decision has been arrived at as yet as the statutory assessment process is still ongoing.

Two members of the Beneluxa Initiative (Belgium and the Netherlands) completed a joint negotiation for the reimbursement of Spinraza in July 2018. This process began before Ireland joined the collaboration and Ireland was not party to these negotiations.

Mary Butler (Waterford, Fianna Fail)
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94. To ask the Minister for Health if he has agreed to or plans to engage with an organistaion (details supplied) and the pharmaceutical industry to ensure new medicines are available for persons with MS; and if he will make a statement on the matter. [37929/18]

Simon Harris (Wicklow, Fine Gael)
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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. The Act specifies the criteria for decisions on the reimbursement of medicines. As Minister for Health, I do not have any statutory power or function in relation to reimbursement of medicines.

Under the 2013 Act, if a company wishes to have a medicine reimbursed through the community drugs schemes, it must submit an application to the HSE to have the medicine added to the Reimbursement List.

As outlined in the 2016 Framework Agreement on the Supply and Pricing of Medicines, and in line with the 2013 Act, the HSE will decide, within 180 days of receiving the application (or a longer period if further information is sought from the company), to add the medicine to the reimbursement list, agree to reimburse it as a hospital medicine or refuse to reimburse it.

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 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 strives to reach a decision in as timely a manner as possible. However, because of the significant monies involved, it must ensure that the best price is achieved, as these commitments are often multi-million euro investments on an ongoing basis. This can lead to a protracted deliberation process.

I am keen to explore ways in which new medicines might be more easily available for public patients in Ireland, but innovative approaches must be compatible with the statutory provisions in place and must also recognise fundamental pricing and funding issues, in the context of finite Exchequer resources. 

Owing to scheduling difficulties, it was not possible for me to meet with MS Ireland in June. However, I am willing to meet with MS Ireland on a mutually convenient date.