Kathleen Lynch (Cork North Central, Labour) | Oireachtas source

I know a little bit about this issue because a very close friend of mine has cystic fibrosis and has benefited greatly from the drug Kalydeco which I and the former Minister for Health, Deputy James Reilly, approved and which approval we announced approximately two years ago. I am aware of the effects that very specialised drugs can have on relatively rare conditions. Cystic fibrosis is a relatively rare disease, although it is not so rare in Ireland, particularly in the south of the country.I thank the Senator for raising this matter. Decisions on which medicines are licensed for use in Ireland and 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 the health technology assessment of 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 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 is appropriate that there should be no political or ministerial decisions and that a scientific and evidence-based approach is taken to determining the extent to which patients can benefit from treatment with expensive new drugs.

As the Senator may be aware, Orkambi is a combination drug for the treatment of cystic fibrosis, 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 the European Medicines Agency on 19 November 2015. In other words, Orkambi has only been licensed for use in the European Union within the past few months. Its manufacturer, Vertex Pharmaceuticals, submitted a rapid review application to the NCPE on 26 November 2015. This rapid review represents the first step in a pricing and reimbursement application. The NCPE has completed the rapid review and recommended a full health technology assessment of the drug.

Based on pricing details in the rapid review file, the HSE estimates that reimbursement would cost approximately €90 million per year. However, the company has yet to submit a full pricing and reimbursement application to the HSE’s primary care reimbursement service. Since early 2013, the HSE has reimbursed more than €60 million for CF patients receiving Kalydeco and there are approximately 140 patients being treated with this drug. In the next decade the HSE expects to spend well over €200 million on this small but unique group of patients.

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. I also appreciate and fully understand people suffering from cystic fibrosis will be most anxious for an early and positive decision on reimbursement for Orkambi. However, it would not be appropriate for me to appear to prejudge decisions which are for the HSE in the first instance under legislation passed by the Oireachtas in 2013. I trust that the Senator will understand the position.