Release of clinical, economic and indirect comparison checklists

Clinical, economic and indirect comparison checklists are provided to New Drugs Committee (NDC) members and SMC Committee members before their monthly meetings.

Our assessment team use the clinical and economic checklists to summarise the main points of the company’s submission and highlight the key strengths and weaknesses of the case being presented. Considering information recorded on the checklist allows reviewers to come to a judgement on whether the case for the medicine has been demonstrated.

Indirect comparison checklists are used to assess the quality and validity of any medicine that the submitting medicine is being compared against, confirming the type of analysis, reviewing study selection and methodology and identifying the areas where statistical expertise is required.

Copies of the checklists are provided to the submitting company in confidence and for information only, on request.

In accordance with data protection legislation, all personal information is removed from the checklist before it is released to the submitting company.