Billy Kelleher (Cork North Central, Fianna Fail)
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526. To ask the Minister for Health the reason the ten Irish sufferers of MPS IVA morquio disease cannot receive the medication Vimizin for treatment through local hospital based care or home care, similar to children in the UK with this condition and many others on mainland Europe. [11490/17]

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). It 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.

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 8 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 statutory process is on-going.