Pre-Submission Meetings
The NCPE hosts pre-submission meetings with Applicants once the Corporate Pharmaceutical Unit has stated that a Health Technology Assessment (HTA) is required to inform a drug reimbursement decision.
What is the purpose of a pre-submission meeting?
The pre-submission meeting provides an opportunity for the Applicant to meet with the NCPE Review Team prior to finalising their HTA submission. The purpose is to outline the proposed approach to the clinical and cost-effectiveness modelling, and to obtain guidance from the NCPE on what may be the most appropriate approaches to adopt. The aim is to help the Applicant provide the best quality HTA submission possible, in order to avoid challenges later in the assessment process.
The NCPE Pre-Submission Meeting Guidance for Applicants contains all of the information to help Applicant’s plan the pre-submission meeting. Please click on the link below to download a copy.