Paddy Burke (Fine Gael)
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I welcome the Minister for Health, Deputy James Reilly.

Colm Burke (Fine Gael)
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This Adjournment matter concerns the drug Fampyra which is used by multiple sclerosis patients. It has been brought to my attention by a patient using the drug on a trial basis with positive effects that it is not covered by the GMS or drugs payment scheme. The patient's consultant, Dr. Brian Sweeney in Cork, has recommended that she continue using the drug, but it is costing her approximately €250 per month. She does not qualify for a refund and the expense is causing her problems. The advantage of the drug is that it improves mobility and reduces fatigue, although it does not work for everyone. That said, it works for a large number of patients and many consultants have recommended its use. It is recognised in many other European countries and I ask the Minister to consider recognising it here, too, in the GMS, the long-term illness scheme and the drugs payment scheme.

James Reilly (Dublin North, Fine Gael)
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I ask for guidance from the Chair. I will respond to Senator Colm Burke. When he has responded to me, will I have a further opportunity to respond?

Michael Mullins (Fine Gael)
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Yes.

James Reilly (Dublin North, Fine Gael)
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That is fine. I actually dealt with this issue earlier today but thank Senator Colm Burke for raising it in this House.

The HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products under the community drug schemes in accordance with the provisions of the Health (Pricing and Supply of Medical Goods) Act 2013. The executive received an application for the inclusion of Fampridine or Fampyra in the GMS and community drugs schemes. The application was considered in line with the procedures and timescales agreed by my Department and the HSE with the Irish Pharmaceutical Healthcare Association, IPHA, for the assessment of new medicines. In accordance with these procedures, the National Centre for Pharmacoeconomics, NCPE, conducted a pharmaco-economic evaluation of Fampridine and concluded that, as the manufacturer was unable to demonstrate its cost-effectiveness in the Irish health care setting, it was unable to recommend reimbursement of the product. The report is available on the NCPE's website. The HSE assessment process is intended to arrive at a decision on the funding of new medicines that is clinically appropriate, fair, consistent and sustainable. In these circumstances, the HSE has not approved the reimbursement of Fampridine under the community drug schemes.

I understand studies are ongoing to assess the wider impact of Fampridine on both walking and quality of life for persons diagnosed with multiple sclerosis. The results of these studies will contribute to the evidence base demonstrating the clinical effectiveness of Fampridine which can be used to support future applications for its inclusion in the lists of reimbursable items supplied under the community drug schemes. In this context, it is open to the manufacturer, at any time, to submit a new application to the HSE for the inclusion of Fampridine in the community drug schemes. The manufacturer has indicated to the HSE that it intends to submit a revised application for Fampridine and it is my understanding the company may actually have done so this morning.

The HSE and I fully understand patients are very anxious that this product be made available under the community drug schemes. Therefore, the HSE will reconsider the application on receipt, in line with the agreed procedures and timescales for the assessment of new medicines, in order that the matter will be addressed and dealt with as quickly as possible.

Colm Burke (Fine Gael)
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I thank the Minister for his comprehensive reply. I fully understand the position of the HSE and the Department on this issue and accept that pricing is important in the context of drugs being accepted for inclusion in the community drug schemes. In this case the drug has already received approval in a number of other European countries and evidence to support its effectiveness is available, although I am open to correction on this. The patient to whom I referred is responding well to the drug and experiencing obvious beneficial effects, particularly a reduction in fatigue. She contacted me because the drug was proving so successful. She will probably continue to use it, but because it has not received HSE and departmental approval, she will have to fund the treatment herself.

James Reilly (Dublin North, Fine Gael)
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This particular drug costs approximately €6,000 per year. As I understand it, many of the people who are using it are being supplied by the manufacturer on a trial basis. Approximately 7,000 people in this country have multiple sclerosis, which would equate to a bill of €42 million per annum. Fampridine does not work in all cases - far from it. It is estimated that it will only be effective for 20% to 25% of multiple sclerosis sufferers. Admittedly, for those patients for whom it does work, the effects can be dramatic, with the ability to carry out the activities of daily living greatly improved to the point where they can go to work and lead a much more normal life. We would dearly love to be able to provide the drug for them, but we cannot do so at its current costing. We have a limited pot of money available and €42 million would be an enormous sum to take out of it. What other items would we sacrifice to do this? The price of the drug must be more realistic.

I call on the pharmaceutical industry, as I did earlier in Dáil Éireann, to enter into risk sharing with the Government, on behalf of the taxpayer, for whom we are trying to provide services and medication. There is no risk sharing. For example, there is no arrangement whereby we could agree and pay a certain price for those patients for whom the drug is working. In the first instance, we must demonstrate that the drug works, as it clearly does for some. We also need to have a sense of the type of patient for whom it is likely to work and limit its prescribing to such patients.

I am acutely aware, therefore, of the impact on families and the stress caused for them. He was a smoker and a doctor.

We have made great progress. The principle underlying health policy is that patients should be treated at the lowest level of complexity that is safe, timely, efficient, and as near to home as possible. Early intervention is part of this to allow for better outcomes for the patient and more treatment nearer to home. We need to develop stroke rehabilitation services in the context of primary care. I have opened many health centres in the past three years. We have opened them at a rate of one a month. Many of them have physiotherapy and occupational therapy facilities; therefore, the service is evolving. I look forward to us continuing to improve outcomes for patients. However, the Senator is correct that prevention is better than cure and in moving from hospital-centric services to primary care we also have to move resources. There is only one pot of money which is constrained, but we continue to move as much of the service as possible out of the hospital into the community where it is more cost effective and convenient for patients to use it.