I propose to take Questions Nos. 386 and 397 together.
In 2017, Orkambi was approved for reimbursement by the HSE. Given the scope of this significant investment by the State in Cystic Fibrosis treatment, a strong management and oversight programme was introduced.
A robust reimbursement protocol was introduced for this expensive medicine, which was agreed with the Cystic Fibrosis programme, and was circulated to all designated specialists and prescribing consultants.
This protocol clearly states that patients must be ordinarily resident in Ireland to qualify for reimbursement of this medicine. In Ireland, medicines are available to persons who are ordinarily resident under the Community Health Care Schemes including GMS, DPS and LTI.
In addition the protocol states that persons will be required to attend their specialist Cystic Fibrosis centre at least every 3 months to ensure that care is managed optimally.
My Department has previously directed that a maximum of 3 months medicines can be supplied to patients to facilitate travel, however, arrangements do not extend to persons who no longer reside in the State.