Noel Grealish (Galway West, Independent)
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174. To ask the Minister for Health the status of the review of nivolumab; if this drug will be licensed here; the timeframe for completion of the review of the cost effectiveness of this drug in view of the fact that the manufacturer discontinued a compassionate access programme on 30 June 2016; and if he will make a statement on the matter. [8873/17]

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.

Under the HSE assessment process the National Centre for Pharmacoeconomics conducts health technology assessments of pharmaceutical products and can make recommendations on reimbursement to assist the HSE in its decision-making process.

Nivolumab is subject to separate health technology assessments for a number of different indications and as a combination therapy with Ipilimumab for cancer. The health technology assessments completed by the National Centre for Pharmacoeconomics to date have not recommended reimbursement; evaluations for the other indications are still ongoing.

The statutory assessment process is ongoing.