Written answers

Tuesday, 14 May 2019

Department of Health

Medicinal Products Reimbursement

Photo of John CurranJohn Curran (Dublin Mid West, Fianna Fail)
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351. To ask the Minister for Health if he is satisfied that the pricing and reimbursement system of the HSE prioritises use of the most cost-effective medicines; and if he will make a statement on the matter. [20755/19]

Photo of Simon HarrisSimon Harris (Wicklow, Fine Gael)
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The HSE has statutory responsibility for medicine pricing and reimbursement decisions, in accordance with the Health (Pricing and Supply of Medical Goods) Act 2013. The Act specifies the criteria for decisions on the reimbursement of medicines.

Reimbursement is for licensed indications which have been granted market authorisation by the European Medicines Agency (EMA) or the Health Products Regulatory Authority (HPRA).

In line with the 2013 Act and the national framework agreed with industry, if a company would like a medicine to be reimbursed by the HSE, it must apply to have the new medicine added to the reimbursement list.

In considering an application, the HSE must have regard to Part 1 and Part 3 of Schedule 3 of the 2013 Health 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 eats a condition than existing therapies).

9. The resources available to the HSE.

It will take into account such expert opinions and recommendations which it may have sought at its sole discretion, for example from the National Centre for Pharmacoeconomics (NCPE).

The NCPE conducts health technology assessments (HTAs) for the HSE, and makes recommendations on reimbursement to assist HSE decisions. The NCPE uses a decision framework to systematically assess whether a drug is cost-effective as a health intervention. It is through this assessment process that the HSE also seeks to reduce the price of medicines to more affordable prices. There is also an increased level of engagement (commercial negotiations) between the HSE and manufacturers in an effort to reduce the price to affordable levels.

I am satisfied that the 2013 Health Act provides for a fair, transparent and rigorous process for the assessment of all drugs which has delivered tangible results for Irish patients. To date in 2019, 23 new medicines and five new uses of existing medicines have been approved by the HSE, an investment of in excess of €175 million over five years.

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