Billy Kelleher (Cork North Central, Fianna Fail)
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245. To ask the Minister for Health whether, in view of the compassionate extension by a company (details supplied) of Respreeza to persons for the next two months, the HSE will enter into negotiations with the company; if the HSE is setting out to complete the negotiations before the compassionate timeframe expires; and if he will make a statement on the matter. [11119/17]

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 last 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 considers the NCPE assessment, and other expert advice, as part of its decision-making process for reimbursement and is made on objective, scientific and economic grounds by the HSE in line with the 2013 Act.

The HSE has confirmed that the drug Respreeza was considered by HSE Drugs Group which did not make a recommendation for reimbursement on clinical grounds. The HSE Leadership team has accepted the Drugs Group recommendation of non-reimbursement.

Under the HSE statutory assessment process the HSE is required to set out a notice of any proposed decision to an applicant company. The HSE is legally required to provide at least a 28 days period (from the formal written notice of proposal) to enable the pharmaceutical company to consider any such proposal not to reimburse and to make representations to the HSE if it wishes to do so. The HSE is legally required to consider any such representations in advance of a formal decision.

Therefore as the statutory process is still on-going the Company has an opportunity to have further discussions with the HSE.

In relation to the compassionate access scheme operated by the manufacturer, CSL Behring, I note and welcome the decision of the Company to extend the scheme by a further two months. However it is important to point out that the operation of such compassionate schemes is at the discretion of manufacturers. I as Minister for Health have no role in the operation of these schemes. There is no provision in Irish legislation for the approval of compassionate use programmes for specific groups of patients with an unmet medical need.

I have previously said that any attempts by manufacturers to link continued access for patients already being treated with a new medicine with decisions under the statutory reimbursement process is both inappropriate and unethical. Manufacturers should operate such schemes in a compassionate and not a commercially-motivated manner.