Michael McGrath (Cork South Central, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

1006. To ask the Minister for Health the position regarding making the drug Respreeza available for persons suffering from alpha-1 antitrypsin deficiency; and if he will make a statement on the matter. [41523/16]

Gino Kenny (Dublin Mid West, People Before Profit Alliance)
Link to this: Individually | In context | Oireachtas source

1012. To ask the Minister for Health if he will ensure that the result of the health technology assessment by the NCPE of the human alpha1 proteinase inhibitor drug Respreeza is processed in a timely way, so that it can be promptly reimbursed by the HSE as it is reimbursed in other countries (details supplied); if he will ensure that those persons currently on the drug with beneficial results are guaranteed continued reimbursed use; and if he will make a statement on the matter. [41569/16]

Robert Troy (Longford-Westmeath, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

1053. To ask the Minister for Health if he will support funding for the drug Respreeza for persons suffering from emphysema caused by alpha 1 (details supplied). [41769/16]

Fiona O'Loughlin (Kildare South, Fianna Fail)
Link to this: Individually | In context | Oireachtas source

1118. To ask the Minister for Health his plans to offer reimbursement for the drug Respreeza, which would allow persons suffering from alpha-1 antitrypsin deficiency to continue treatment; and if he will make a statement on the matter. [1012/17]

Simon Harris (Wicklow, Fine Gael)
Link to this: Individually | In context | Oireachtas source

I propose to take Questions Nos. 1006, 1012, 1053 and 1118 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 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 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.

In relation to compassionate access schemes, I have previously asked manufacturers to show compassion and to maintain 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. The manufacturer has informed the NCPE that there are 17 patients in the compassionate programme receiving Respreeza which will continue until the end of January 2017.