Dáil Éireann Debate, Wednesday - 15 April 2015
498. Deputy David Stanton asked the Minister for Health if he is aware of cases where patients with serious cardiac conditions who have been prescribed Nadolol are unable to access the drug due to the high cost or lack of availability; the options available to such patients; and if he will make a statement on the matter. [14153/15]
Amharc ar fhreagraThere are currently no products authorised in Ireland containing Nadolol, nor are there any applications pending with the Health Products Regulatory Authority for such products.
Nadolol was previously authorised under the brand name Corgard, however, these authorisations were withdrawn by the marketing authorisation holder Sanofi in 2000. The product is however still authorised in some European countries. The Health Products Regulatory Authority has received notification from wholesalers that products containing Nadolol have been imported into Ireland under the notification scheme for exempt medicinal products.
The Health (Pricing and Supply of Medical Goods) Act 2013 sets out the rules and criteria around reimbursement of medicinal products. Under the Act the HSE can only add items to the reimbursement list which have a marketing authorisation.
In exceptional circumstances the Act authorises the HSE to fund reimbursement of items not on the reimbursable list for individual patients provided the patient requires that item for clinical reasons and that there is no listed item which is a suitable alternative for that item in so far as the patient is concerned.
The HSE has confirmed that it has funded Nadolol for individuals when applications are made which provide evidence which allow the HSE to utilise the exceptional criteria provided under the 2013 Act.
