Colm Burke (Fine Gael)
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I welcome the Minister of State to the House. I am raising the issue of Xolair - I hope I have pronounced it right - which is a drug for people with severe asthma. I am raising it as severe asthma is associated with a significant morbidity and health care resource. Some 10% of patients with asthma have severe asthma and these patients have a disproportionate economic burden. The main cost drivers are the frequency and expense of treatment failure, including asthma exacerbation, associated with unscheduled hospitalisations. Annual health care costs are higher for patients with poor asthma control. A study carried out by Professor Costello found that if this drug were to be made available there would be a 67% reduction in hospitalisations, a 68% reduction in bed days, a 61% reduction in asthma exacerbations, a 62% reduction in courses of oral drugs and a 90% reduction in workdays lost.

This drug has a proven track record yet it is not available under the drugs repayment scheme. Approximately 310 patients currently receive the drug but they are receiving it because it is being funded by hospitals from their own budgets, which will not continue forever. The matter needs to be clarified. Submissions were made in 2014 but, unfortunately, they were rejected. The issue needs to be given priority at this stage.

Jimmy Deenihan (Kerry North-West Limerick, Fine Gael)
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I thank the Senator for raising this issue. Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmocoeconomics, also known as the NCPE. The NCPE is a team of clinicians, a pharmacist, a pharmacologist and statisticians who evaluate the benefits and costs of medical technologies and provide advice to the HSE. The NCPE conducts health technology assessments on pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making process.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drugs schemes in accordance with the provisions of the Health Act 2013. It is appropriate that these should not be political or ministerial decisions and that a scientific and evidence-based approach is taken to determining the extent to which patients would benefit from treatment with expensive new drugs and whether this represents cost effectiveness for the health service and the taxpayer.

In August 2014, the HSE medicines management programme asked the NCPE to carry out an assessment of the clinical and economic dossiers submitted by Novartis Ireland on the cost-effectiveness of the company's drug, Xolair, for the treatment of severe allergic asthma. Novartis proposed that the drug be reimbursed as a hospital-only drug, as it must be administered in a hospital setting. Following its assessment of the manufacturer's dossier, the NCPE did not recommend Xolair for reimbursement as it did not consider the drug to be cost effective for the indicated treatment at the submitted price. The HSE accepted the NCPE's recommendation and the drug is not currently reimbursed under any HSE scheme.

While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price a drug company demands, the interests of the health service as a whole require that we only reimburse the most effective medicines and only at a fair price. In this way, we can ensure the most appropriate and cost-effective expenditure of the drug budget available to the HSE each year.

Colm Burke (Fine Gael)
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I did not get a copy of the written reply and am wondering if it could be made available to me. If I could go back to what I said, the research shows that there would be a 67% reduction in hospitalisations, a 68% reduction in bed days, a 61% reduction in exacerbations, a 62% reduction in courses of oral corticosteroids and a 90% reduction in workdays lost. Economically, it shows that the drug is effective and the research is there. I accept that sometimes there is a difficulty getting a realistic price or quote from the drug companies for a drug but this matter should be reopened. There is a huge cost to the State in not having this available. At the moment hospitals are providing it to more than 300 patients but they are providing it from their own budgets. This matter should be re-examined.

Jimmy Deenihan (Kerry North-West Limerick, Fine Gael)
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I will convey the Senator's concerns and his suggestions to the Minister. I am sure the Senator will also write directly to the Minister on this matter as well.