AQW 19096/17-22

Mr Stewart Dickson
Alliance Party
East Antrim

Tabled Date: 19/05/2021
Answered On Date: 01/06/2021
Priority Written: No

Question:
To ask the Minister of Health how he will ensure easy availability of Tagrisso (Osimertinib) under compassionate use to benefit patients.

Answer:

Medicines can be provided to patients on compassionate use grounds through various routes, including as agreed with the pharmaceutical company on a named patient basis; post closure of a clinical trial; and the Early Access to Medicines Scheme (EAMS) operated by the Medicines and Healthcare products Regulatory Agency (MHRA).

To avoid a delay for Northern Ireland patients accessing osimertinib (Tagrisso) while differences in regulatory processes are being resolved, prescribing will be at the oncologist’s discretion, on an ‘off label’ basis (i.e. a medicine that is being used in a way that is different to that described in the licence). Doctors are allowed to prescribe medicines outside of the label in areas of unmet medical need and the General Medical Council provides clear recommendations to physicians on ‘off label’ prescribing.