Andrew Doyle (Wicklow, Fine Gael)
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465. To ask the Minister for Health if a review will be carried out of PKU products on the long-term illness card that have been assessed and are waiting to be assessed; when the products currently waiting to be assessed will be assessed by the HSE; if consultations will take place with persons in need regarding the products available; and if he will make a statement on the matter. [8486/17]

Andrew Doyle (Wicklow, Fine Gael)
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478. To ask the Minister for Health the long-term illness card budget spend on PKU products year on year; the person or body responsible for maintaining the list of PKU products; the frequency with which they meet and the criteria used in the assessment of new products for inclusion; and if he will make a statement on the matter. [8598/17]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 465 and 478 together.

Under the Health (Pricing and Supply of Medical Goods) Act 2013, the HSE has statutory responsibility for the administration of the community drug schemes; therefore, the matter has been referred to the HSE for attention and direct reply.

Robert Troy (Longford-Westmeath, Fianna Fail)
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466. To ask the Minister for Health the status of funding for the drug Respreeza for patients suffering from emphysema caused by Alpha-1. (details supplied). [8487/17]

Simon Harris (Wicklow, Fine Gael)
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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 reaching its decision, the HSE examines all the evidence which may be relevant in its view for the decision (including the information /dossier submitted by the Company) and will take into account such expert opinions and recommendations which may have been sought by the HSE at its sole discretion (for example, from the National Centre for Pharmacoeconomics).

In considering an application, the HSE will also have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Act. Part 3 requires the HSE to have regard to the following criteria:

1. the health needs of the public;

2. the cost-effectiveness of meeting health needs by supplying the item concerned rather than providing other health services;

3. the availability and suitability of items for supply or reimbursement;

4. the proposed costs, benefits and risks of the item or listed item relative to therapeutically similar items or listed items provided in other health service settings and the level of certainty in relation to the evidence of those costs, benefits and risks;

5. the potential or actual budget impact of the item or listed item;

6. the clinical need for the item or listed item;

7. the appropriate level of clinical supervision required in relation to the item to ensure patient safety;

8. the efficacy (performance in trial), effectiveness (performance in real situations) and added therapeutic benefit against existing standards of treatment (how much better it treats a condition than existing therapies); and

9. the resources available to the HSE.

I am informed that the HSE received a request and economic dossier from the manufacturer of Respreeza for maintenance treatment of emphysema in adults with documented severe alpha1-proteinase inhibitor deficiency.

In June of this year the HSE asked the NCPE to carry out a health technology assessment on the cost effectiveness of this treatment. The NCPE completed its assessment and made a recommendation on 9 December 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug and did not recommend it for reimbursement.

A summary of the health technology assessment has been published on the NCPE website and is available at:

.

The HSE considers the NCPE assessment, and other expert advice, as part of its decision-making process for reimbursement. This decision will be made on objective, scientific and economic grounds by the HSE in line with the 2013 Act.

In keeping with the drug assessment process, the recommendation of the HSE Drugs Group regarding the reimbursement of Respreeza was considered by the HSE Leadership team. The HSE has informed that the statutory assessment process is ongoing.