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

I thank the Deputies for raising this important 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 Pharmacoeconomics, NCPE. The NCPE conducts health technology assessment of pharmaceutical products for the HSE and can make recommendations on reimbursement to assist the HSE in its decision-making and negotiation process. 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. It is appropriate that these decisions be scientific and that an evidence-based approach be taken to determining the extent to which patients would benefit from treatment with expensive new drugs, whether the drug is effective and what a fair price would be.

As the Deputies will be aware, ivacaftor and lumacaftor, marketed as Orkambi, is a combination drug for the treatment of CF in patients with two copies of a specific CF gene mutation. The drug was approved by the US Food and Drug Administration in July 2015 and by the European Medicines Agency less than a month ago on 19 November 2015. I am not aware of any public health service that currently reimburses it.

Orkambi's manufacturer, Vertex Pharmaceuticals, submitted a rapid review application to the NCPE on 26 November. This rapid review represents the first step in a pricing and reimbursement application. The company is expected to submit a full pricing and reimbursement application to the HSE's primary care reimbursement service in the very near future, although it has not yet done so. Based on pricing details in the rapid review file, the HSE estimates that reimbursement could cost approximately €90 million per year. Given the considerable budget impact, the NCPE is likely to require that a full health technology assessment of the drug be carried out before a recommendation is made. This is the normal process for approving expensive new technologies or medicines, and Orkambi will be assessed fairly and in the same way as other such drugs or technologies. As part of this work, the scientific evidence will be assessed independently and objectively to see if the suggested benefits in terms of life expectancy, quality of life, improved lung function and reduced hospital admissions stack up and, if so, to what extent.

Since early 2013, the HSE has reimbursed more than €60 million for CF patients receiving ivacaftor, marketed as Kalydeco, and there are now approximately 140 patients being treated with this drug. Over the next decade, the HSE expects to spend well over €200 million on this patient group alone. The HSE has also invested in other CF services. The Lieben building at Limerick University Hospital has been developed and commenced operations in November, providing a dedicated outpatient facility and nine isolation rooms. The HSE has made a total of €9 million available in 2015-16 for this facility, of which almost €2 million relates to the CF facility itself. A new CF facility also opened in the last couple of weeks at Cork University Hospital, funded through the voluntary Build for Life programme to the tune of €2 million and a further almost €1 million from HSE.

While I appreciate that some may take the view that the taxpayer should reimburse every licensed medicine for whatever price the drug company demands, the interests of the public, the health service and all patients require that we only reimburse the most effective medicines, and do so at a fair price. In the past, the carrying out of health technology assessments and subsequent informed discussions with manufacturers have ensured that the best value was achieved and health funding was used in the most effective way. In the last 18 months, this system has resulted in savings against the initial price submissions by companies of €19 million a year, and that saving is ongoing and recurs every year. The interests of neither patients nor the taxpayer are best served by just agreeing to whatever price a manufacturer deems appropriate on whatever evidence it happens to put forward. The opportunity cost is enormous, and overpaying for any new drug cost lives in itself, as the money thus used could have gone into other services such as ambulances, which would save lives, maternity services, which would save lives and prevent disabilities, and cancer screening, which would save lives, to give just three examples. I could equally give examples from the two Topical Issue debates prior to this. Deputy Dowds made a very strong case for greater investment in early supported discharge in cases of stroke, which would save lives and prevent disability. Before that, Deputy Stanton made the case for more investment in heart failure treatment, which would benefit many people at a very modest cost.

I appreciate and fully understand that people suffering from cystic fibrosis will be anxious for an early and positive decision in regard to reimbursement for this drug. However, it would not be appropriate for me to appear to prejudge decisions that are matters for the HSE in the first instance, under legislation passed by the Oireachtas in 2013. I trust the Deputies will understand my position on the matter.

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