Richard Boyd Barrett (Dún Laoghaire, People Before Profit Alliance)
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613. To ask the Minister for Health if will ensure access to cysteamine bitartrate, otherwise known as procysbi, to all patients here; the stage at which the process is at and the efforts he and HSE is making to be proactive in order to expedite the matter; and if he will make a statement on the matter. [11911/17]

Simon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for decisions on pricing and reimbursement of medicines in 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 information submitted by the company) and will take into account such expert opinions and recommendations which it may have sought at its sole discretion, for example, from the National Centre for Pharmacoeconomics (NCPE).

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 eats a condition than existing therapies).

9. The resources available to the HSE.

I am informed that the manufacturer has submitted an application to the HSE for reimbursement of Procysbi. As far back as December 2015, the manufacturer was requested to submit a dossier for a health technology assessment to assist in decision making. That dossier is awaited.

The NCPE recommendation in relation to the need for a full health technology assessment is published online at: .

The NCPE reviewed the medicine again in January 2017, following some revisions by the manufacturer, and recommended that a HTA dossier would still be required to assist decision making.

The HSE informed the manufacturer of this ongoing requirement again on 31 January 2017.