Leo Varadkar (Dublin West, Fine Gael) | Oireachtas source

I thank the House for giving me the opportunity to discuss this important issue. It is important to state the decisions on which medicines are licensed for use in Ireland and reimbursed by the taxpayer are not political or ministerial. They are made on objective, scientific and economic grounds by the national drugs committee of the Health Service Executive, HSE, on the advice of the National Centre for Pharmacoeconomics.

The HSE has statutory responsibility for decisions on the 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. It received an application for the inclusion of fampridine, which is marketed as Fampyra in the general medical services, GMS, and community drug schemes. It is indicated for the improvement of walking in adult patients with multiple sclerosis with a walking disability. The application was considered in line with the procedures and timescales agreed by the Department of Health 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 conducted a pharmacoeconomic evaluation of fampridine and concluded that, as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for fampridine, it was unable to recommend reimbursement for the product. I will lay this document before the Oireachtas Library today to allow Senators consider it in full. On foot of this decision, the HSE decided that it was not in a position to add the drug to the list of reimbursable Items supplied under the GMS and other community drug schemes. The HSE's decision is in line with that in other European countries that have also decided not to provide the drug under their public health systems. It is open to the manufacturer, at any time, to submit a new application to the HSE with new evidence that demonstrates the effectiveness of the drug by offering a reduced price or both.

A revised application was received by the HSE on 25 July. The HSE's corporate pharmaceutical unit has since been engaging with the company. These engagements have been completed and the HSE is now considering the outcome. Fampridine will be assessed, with a range of other applications, for reimbursement of medicines for multiple sclerosis and other diseases. I assure the House that the HSE and I fully understand the concerns of patients about the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for any price a drug company demands, I hope it is appreciated that the better interests of millions of taxpayers and thousands of patients require that we only reimburse the most effective medicines and only at a fair price.

I will also this afternoon place in the Oireachtas Library the relevant document of the commissioning board of the British National Health Service, NHS. This document has nothing to do with me, my Department or anything in this country - it is an NHS policy statement from April 2013 based on the London New Drugs Group analysis. That group states that "in clinical trials, a statistically significant improvement in walking time was achieved in fewer than half of patients taking fampridine. The clinical significance of this improvement, of 0.3 to 0.8 seconds to walk 25 feet compared with placebo, is questionable". In layman's terms, the drug did not work for more than half of the patients and the other half were enabled to walk 25 feet 0.3 to 0.8 seconds more quickly than they would have had they taken a sugar tablet or a placebo. The group goes on to state it considers the overall clinical benefit of the medicine to be marginal - it supports a recommendation to not routinely fund fampridine. It is not a miracle drug. The group further states fampridine is not a cost-effective use of NHS resources. Senators will know that this is an expensive drug and I will be placing this view of the NHS in the Oireachtas Library this afternoon.

I also have a Dutch study of December 2012 by the medicinal products reimbursement committee which reaches a similar conclusion. The Netherlands has one of the best funded health services in the world. The study highlights the most frequent adverse effects of the drug, including urinary tract infections, insomnia, anxiety, dizziness, headaches, balance disorders, paraesthesia, tremors, dyspnoea, pharyngolaryngeal pain, gastrointestinal disorders, back pain and asthenia. The study states fampridine has a narrow therapeutic window and a relatively small increase in exposure can lead to a large increase in central nervous system, CNS, side effects such as convulsions. It can even have a negative effect on walking. It also states fampridine cannot be administered to patients with epilepsy and that there is a lack of data on its effects on elderly patients and those with cardiovascular disorders. It concludes that fampridine has a lower therapeutic value than exercise or physical therapy in improving the walking ability of patients with multiple sclerosis. The medicine is deemed to be less effective than physical therapy. The study states there is no proven place for fampridine in therapy. I put this study before the House today.

I am not making the decision, but I want to make it clear that, no matter what decision is made, the door is never closed to new medicines. Even if a drug is refused several times, a manufacturer can always come back with new evidence that demonstrates its effectiveness, a reduced price or both. The possibilities of cost and risk sharing arrangements are open too. In such circumstances the HSE would only reimburse the drug for the small number of people for whom it worked, not those for whom it did not.

The HSE national drugs committee has the difficult job of protecting patients from the false claims and health promises of some drug companies, clinicians and advocacy groups. The committee must also protect the taxpayer in order that resources can be used to best effect for the vast majority of patients. Everyone in this House, including me, as Minister, has a duty to support the HSE national drugs committee in its difficult and important work.