Gerry Adams (Louth, Sinn Fein)
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53. To ask the Minister for Health the status of the HSE negotiations with the pharmaceutical company responsible for the production of the cystic fibrosis drug Kalydeco in respect of the effort to secure significant price reductions for the drug; when the process is due to conclude; and if he will make a statement on the matter. [37868/16]

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 line with the 2013 Act, if a Company would like a medicine to be reimbursed by the HSE pursuant to the Community Drug Schemes or as a hospital medicine, the Company must first submit an application to the HSE to have the new medicine added to the Reimbursement List or to be priced as a hospital medicine. The Company must submit a separate application to extend a treatment to a new cohort of patients. Each application is considered separately on its merits and in line with the 2013 Act.

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 Ivacaftor, brand name Kalydeco, for the treatment of cystic fibrosis patients aged 2 years and older weighing less than 25kg. In March of this year the HSE asked the NCPE to carry out a health technology assessment of the applicant’s economic dossier on the cost effectiveness of this treatment.

The NCPE completed its assessment and made a recommendation in October 2016. The NCPE determined that the manufacturer failed to demonstrate cost-effectiveness of the drug for its intended cohort of patients and did not recommend that it should be reimbursed for this indication at the submitted price. In the economic dossier submitted to the NCPE the manufacturer estimates that there are 18 patients eligible for early ivacaftor treatment.

A summary of the health technology assessment has been published on the NCPE website and is available at:.

As the HSE is responsible for the negotiations with manufacturers I have asked them to reply to the Deputy directly in relation to the status of negotiations with the manufacturer.

I understand how patients and their families must feel in these circumstances as they await the decisions by the HSE in relation to reimbursement. However as with all new drugs developed, the HSE must follow a process, as set out in the 2013 Act.