Louise O'Reilly (Dublin Fingal, Sinn Fein)
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152. To ask the Minister for Health when a decision is expected on the drug respreeza zemaira; the status of the assessment by the National Centre for Pharmacoeconomics; the outcome when the compassionate use of the drug to patients runs out at the end of December 2016; and if he will make a statement on the matter. [37989/16]

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. This assessment is still on-going. Once the assessment is completed, a summary report will be published on the NCPE website.

The HSE will then consider 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 relation to compassionate access schemes, I have previously asked manufacturers to show compassion and to maintain access compassionate access schemes for patients during the assessment process by the HSE and this remains the position. However, the operation of compassionate access schemes is at the discretion of manufacturers.