The agreement provides for clearly documented procedures and timelines for the assessment of new medicines in as timely a fashion as possible.
The HSE has confirmed that it has received an application for inclusion of Kalydeco (generic name: Ivacaftor) under the community drugs schemes. The application will be considered in line with the agreed procedures. In accordance with these procedures, the National Centre for Pharmacoeconomics (NCPE) will initially conduct a Health Technology Assessment (HTA) which will provide detailed information to the HSE and Department on the potential budget impact of the medicine and will consider if the medicine is cost effective at the price offered to the HSE.
The HTA report will be an important input to assist decision making and is required to be available to assist the HSE in ensuring that the most appropriate decision is made. No further comment is possible at this time as the assessment process is ongoing.