Kathleen Lynch (Cork North Central, Labour)
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I am aware that there is concern among cystic fibrosis (CF) sufferers, and families of people who have CF, about this medicine.

Orkambi (lumacaftor/ivacaftor) is a combination drug for the treatment of CF in patients who have two copies of a specific CF gene mutation. The drug was licensed by the US Food and Drug Administration in July 2015 and by the European Medicines Agency in November 2015. To date, it has not been approved for reimbursement by any public health service in Europe.

Each country has its own process for approval. The Irish process is laid down in the Health (Pricing and Supply of Medical Goods) Act 2013. The Act gives the HSE has statutory responsibility for decisions on pricing and reimbursement of medicinal products in the community drugs schemes. It is appropriate that these should not be political decisions and that a scientific and evidence-based approach is taken to determine the extent to which patients would benefit from treatment with expensive new drugs.

Prior to reimbursing any medicine, the HSE considers a range of statutory criteria, including clinical need, cost-effectiveness, and the resources available to the HSE. The process for approval of new high tech drugs in Ireland involves three steps. The first step involves a rapid review, which has been completed for Orkambi. The second involves a full health technology assessment by the National Centre for Pharmacoeconomics (NCPE). This expert assessment is scientific and objective and evaluates whether the claims made for the benefits of a new drug are valid, and to what extent, including its impact, for example, on life expectancy, quality of life, reducing hospital admissions or reduced need for transplants. The NCPE also considers which patient groups might benefit, how the drug compares with existing treatments and if it is cost-effective at the price sought by the manufacturer. I have requested that the NCPE expedite this part of the process. The Centre hopes to be in a position to issue its recommendation to the HSE in early June, and the HSE may, if it decides to proceed, then engage in price negotiations with the manufacturer.

This process is designed to secure the best value for the HSE for investment in new treatments for Irish patients, and any savings that accrue from the process can be used to fund other health service developments, for example isolation rooms for CF and cancer patients, better ambulance services, home supports for the elderly and safer maternity services.

I hope that it will be possible for Orkambi to be approved for patients who may benefit from it, and at a fair price, but it must go through the normal approval procedure first, like all other high-tech medicines.