Pat Buckley (Cork East, Sinn Fein)
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469. To ask the Minister for Health his plans to provide funding for alpha-1 patients to receive treatment with Respreeza or Zemaira; if he will reimburse those that have already started treatment; and if he will make a statement on the matter. [39791/16]

Brendan Griffin (Kerry, Fine Gael)
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516. To ask the Minister for Health his views on a matter (details supplied) regarding the drug Respreeza; and if he will make a statement on the matter. [40043/16]

Mattie McGrath (Tipperary, Independent)
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530. To ask the Minister for Health if he will support urgent funding for the Respreeza or Zemaira drug for alpha-1 patients; and if he will make a statement on the matter. [40094/16]

Alan Kelly (Tipperary, Labour)
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533. To ask the Minister for Health the status of the situation with the Respreeza drug; and if he will deal with this urgent situation immediately (details supplied); and if he will make a statement on the matter. [40160/16]

Simon Harris (Wicklow, Fine Gael)
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I propose to take Questions Nos. 469, 516, 530 and 533 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.

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 alpha-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: www.ncpe.ie/wp-content/uploads/2016/02/NCPE-website-summary_Final.pdf .

The HSE will 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.

I understand that the NCPE is arranging to meet the patient representative group, the Alpha One Foundation, as soon as possible to provide them with an update in relation to the recommendation of the NCPE.

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 these schemes is at the discretion of manufacturers. My Department has asked the NCPE to contact the company to seek clarification for those patients currently receiving this drug.