Paddy Burke (Fine Gael)
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I welcome the Minister of State, Deputy Kathleen Lynch, to the House.

Colm Burke (Fine Gael)
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I am raising this matter regarding a drug, Fampyra, which is suitable for some MS patients. I accept fully that it is not suitable for all patients. A number of people have been in contact with me about this. They are paying more than €300 a month for medication. They are not entitled to claim under the drugs payment scheme and I know one of these people is on a medical card and is finding the situation extremely difficult. The drug is suitable for this person. It has been recommended by the person's medical consultant and advisers. While it is available for sale in Ireland, it is not included in the drugs payment scheme. I accept that it is not suitable, or the solution, for every MS patient. However, it is extremely beneficial to quite a large number of MS patients. These patients feel they are being sidelined as, even if they did not have a medical card, they are not getting any benefits whatsoever in the sense that they have to pay the first €144 themselves with the balance taken up under the drugs payment scheme. In some areas, pharmacists are charging more than €350 for the drug. Could it be included in the drugs payment scheme?

Kathleen Lynch (Cork North Central, Labour)
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I thank the Senator for raising this issue. As usual, he probably raises the most pressing issues relating to health.

Decisions on which medicines are licensed for use in Ireland and which are reimbursed by the taxpayer are not political or ministerial decisions. These are made on objective, scientific and economic grounds by the HSE on the advice of the National Centre for Pharmacoeconomics. 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. At the outset, I would like to clarify that Fampridine, brand name Fampyra, was never available to multiple sclerosis patients under the GMS and community drugs schemes. I am not suggesting that the Senator is saying that this is or was the case. However, I understand that the manufacturer of Fampridine supplied the drug free of charge to some patients who were prescribed the drug by their clinician. The manufacturer has stopped supplying the drug free of charge, thereby requiring these patients to finance the drug themselves if they wish to continue with this drug treatment.

The HSE received an application for the inclusion of Fampridine in the GMS and community drugs schemes. In accordance with agreed procedures, the National Centre for Pharmacoeconomics conducted a pharmacoeconomic evaluation of the drug. That evaluation published in 2012 concluded that it was unable to recommend reimbursement of the product as the manufacturer was unable to demonstrate sufficient effectiveness and a fair price for Fampridine in the Irish health care setting. On foot of this, 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 manufacturer, Biogen Idee, submitted a new application to the HSE on 25 July last year for the inclusion of Fampridine in the community drug schemes. The HSE's corporate pharmaceutical unit has since been engaging with the company seeking improved commercial offerings and the HSE is now considering the outcome of those commercial engagements. The HSE has also had discussions with clinical experts regarding this drug, the outcome of which is also being considered. I want to assure the House that the HSE and I fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope it is appreciated that the better interests of the health service require that we only reimburse the most effective medicines and only at a fair price.The HSE's corporate pharmaceutical unit has since been engaging with the company seeking improved commercial offerings and the HSE is considering the outcome of those commercial engagements. The HSE has also had discussions with clinical experts on this drug, the outcome of which is also being considered. I assure the House that the HSE and I fully understand the concerns of patients regarding the availability of this drug. While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever the price the drug company demands, I hope it is appreciated that the better interests of the health service require that we only reimburse the most effective medicines and only at a fair price.

Colm Burke (Fine Gael)
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I thank the Minister of State for her comprehensive reply. She said discussions are ongoing. Does the Minister of State have any idea when the discussions might conclude or is it very much a case of what progress is made in the coming weeks? Has there been any indication that there will be some progress on the matter?

Kathleen Lynch (Cork North Central, Labour)
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We cannot pre-empt the outcome of the discussions but the fact that they are ongoing is positive. We already have the results of the investigations on the effectiveness of the drug and the engagement with clinicians. The information is being considered as well. In the past we have agreed to reimburse extraordinarily expensive drugs. It is not always about the price; it is about their effectiveness as well. We are engaging on the matter in the manner outlined. I would not say that all hope is lost. I believe that we will find a solution. As with other drugs, I appeal to manufacturers to be sensible and reasonable about the type of hope drugs can offer people who clearly would be very distressed at getting certain diagnoses. We need to continue to engage with both the manufacturers and the clinicians on the matter. We have not yet concluded the process but I would be hopeful that it will conclude at a very early stage.