Dara Calleary (Mayo, Fianna Fail)
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540. To ask the Minister for Health his views on the national cancer control programme's opinion on the cancer treating drug nivolumab also known as Opdivo; his views on making this drug available on the reimbursement scheme; the number of persons being treated with this drug; the costs associated with treating each person on an annual basis; and if he will make a statement on the matter. [17874/17]

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 and the National Cancer Control Programme).

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.

An application has been made by a manufacturer for Nivolumab for a number of different indications and as a combination therapy with Ipilimumab for cancer. This statutory assessment process is ongoing for each indication.

As part of 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.

The health technology assessments completed to date by the National Centre for Pharmacoeconomics on advanced renal cell carcinoma, classical Hodgkin Lymphoma, melanoma, non-squamous Non-Small-Cell-Lung-Carcinoma, NSCLC and Nivolumab plus ipilimumab have not recommended reimbursement.

A summary of the NCPE Pharmacoeconomic evaluations can be found at the following links:

Renal Cell Carcinoma

Classical Hodgkin Lymphoma

Melanoma

Non-squamous NSCLC

NSCLC

Nivolumab plus ipilimumab

These summaries include details on the cost of treatments, budget impact and the NCPE assessment on the data.

With regard to the number of people currently being treated, as the drug has not been approved for reimbursement, no patients are receiving treatment under the community drug schemes at present.

With regard to any access schemes that may be in place, the operation of such schemes is at the discretion of the manufacturers and the HSE does not collect data on the number of patients participating in these schemes.