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Medicinal Products

Dáil Éireann Debate, Tuesday - 12 October 2021

Tuesday, 12 October 2021

Questions (575, 578)

Brendan Griffin

Question:

575. Deputy Brendan Griffin asked the Minister for Health if consideration is being given to providing additional funding for new medicines specifically orphan medicinal products in the context of budget 2022; and if he will make a statement on the matter. [49577/21]

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Brendan Griffin

Question:

578. Deputy Brendan Griffin asked the Minister for Health if he has given consideration to changes to Ireland's reimbursement process specifically for orphan medicinal products given that Ireland continually lags behind other European countries for delivery of therapies to persons living with rare diseases; and if he will make a statement on the matter. [49581/21]

View answer

Written answers

I propose to take Questions Nos. 575 and 578 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.

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).

"League tables" comparing speed of reimbursement in Ireland with that of other countries are often misleading, as several countries have quite different and often less rigorous statutory assessment arrangements than Ireland. Furthermore, new products being licenced can fall well short of cost-effectiveness thresholds, with limited clinical benefits.

While the 2013 Health Act does not include provision for a different ruleset when assessing orphan drugs, the criteria that apply to the evaluation process allow sufficient scope for the HSE to take on board the particular circumstances that pertain to orphan drugs and rare diseases, and this can be observed in the profile of pricing/reimbursement approvals in recent years.

The allocation of €50m for new medicines in Budget 2021 has enabled the HSE to approve 43 new medicines/expanded uses of existing medicines to date this year, as of 7 October. Approximately 15 of these approvals are for the treatment of rare diseases.

The HSE have provided the following summary in relation to orphan drugs recommendations from July 2016 to May 2021:

- 34% (46/134) of drugs had orphan designation at the time of Drugs Group review.

- 78% (36/46) of these orphan-designated drugs received a positive Drugs Group recommendation.

Therefore, such products continue to be approved for reimbursement when applications are accompanied by robust clinical evidence that an unmet need would be addressed, in accordance with the 2013 Act.

Any funding allocation for new medicines in 2022 will be considered in the context of Budget 2022.

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