Dáil Éireann Debate, Wednesday - 22 February 2017
189. Deputy Louise O'Reilly asked the Minister for Health the reason a decision was made not to reimburse Respreeza; the grounds on which this decision was made; if the HSE will be re-entering negotiations with the drug company (details supplied); the outcome for those persons who had been on a compassionate based programme of this drug; his plans to assist those persons; and if he will make a statement on the matter. [8916/17]
Amharc ar fhreagra196. Deputy Clare Daly asked the Minister for Health further to the decision by the HSE new drugs group not to reimburse Respreeza, if he will intervene such that persons suffering with alpha-1 antitrypsin deficiency do not lose access to this life-changing drug. [8944/17]
Amharc ar fhreagraI propose to take Questions Nos. 189 and 196 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 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: www.ncpe.ie/wp-content/uploads/2016/02/NCPE-website-summary_Final.pdf.
The HSE considers 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 keeping with the drug assessment process, the recommendation of the HSE Drugs Group regarding the reimbursement of Respreeza was considered by the HSE Leadership team. The HSE has informed that the statutory assessment process is ongoing.
