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The All Wales Medicines Strategy Group conducts health technology assessments to evaluate new and existing medicines for use in NHS Wales. The main aim of this process is to ensure that patients in Wales have timely access to safe, effective, and cost-efficient medicines. This briefing describes the AWMSG appraisal process, which typically follows a structured procedure that involves submission, evaluation, and final recommendations.

The HAS’s structured approach to economic evaluation follows a robust process to ensure transparency, efficiency, and equity in healthcare decision-making. By integrating rigorous analyses with stakeholder engagement, the process balances cost-effectiveness with patient access to innovative treatments. This comprehensive methodology supports the long-term sustainability of the healthcare system while maintaining its commitment to high-quality patient care.

The French National Authority for Health (Haute Autorité de Santé, HAS) has in place a structured action plan issued in 2020 to adopt evaluation processes for innovative medicines. The plan focuses on three core initiatives: issuing conditional opinions for early access, implementing real-world monitoring to confirm efficacy and safety, and streamlining assessments for high-value medicines.

The Haute Autorité de Santé (HAS, National Authority for Health) offers an Early Dialogue scientific advice service to guide pharmaceutical companies in designing pivotal clinical trials for innovative medicinal products. This voluntary and confidential service provides non-binding recommendations to optimise evidence generation for Health Technology Assessments, focusing on unmet medical needs and aligning with national requirements.

The Health Economics Methods Advisory (HEMA) is a collaborative initiative established to enhance the evaluation methods used in health technology assessments (HTAs). It brings together experts three health technology assessment agencies to critically assess and refine health economic methodologies.

The French Health Technology Assessment (HTA) process, overseen by the French National Authority for Health (Haute Autorité de Santé, HAS), is a comprehensive evaluation system designed to assess the medical, economic, and public health value of pharmaceuticals. This process informs decisions regarding the reimbursement and pricing of medications within the French healthcare system.

NICE is a UK public body that provides national guidance and advice to improve health and social care. It conducts comprehensive HTAs to evaluate the clinical efficacy and cost-effectiveness of pharmaceuticals, medical devices, and interventions. These evaluations inform reimbursement decisions and clinical guidelines within the NHS England, aiming to optimise resource allocation and ensure evidence-based patient care. Its guidance is also typically also implemented in Wales and Northern Ireland.

The NICE appraisal process follows a detailed timeline that differs according to the type of appraial and the technology concerned. The steps involved in the process and their timing are set out in this article.

For the submission of medicines in NICE’s Single Technology Appraisal (STA) process, the clinical evidence section is central. Demonstration of the medicine’s effectiveness in relation to its use in the NHS allows NICE to assess the benefits and risks of the technology compared to standard treatment options currently offered. The submission must include robust clinical data, following NICE’s guidelines on the types and quality of evidence.

A dossier submitted for a Single Technology Appraisal to the National Institute for Health and Care Excellence must provide comprehensive evidence regarding the technology’s clinical and cost-effectiveness. We break down the key sections that should be included, summarising the type of data required for each part of the submission.

In NICE’s Single Technology Appraisal (STA) process, health economic modelling plays a central role in the appraisal of the technology for its future adoption by NHS England. We provide an overview of NICE's requirements for the health economic modelling process.

The NICE Single Technology Appraisal process is designed to evaluate the clinical and cost-effectiveness of a single drug or technology for use within the NHS in England. The steps outlined here represent the typical process followed, along with the standard timeline.

The National Institute for Health and Care Excellence (NICE) uses the Highly Specialised Technologies (HST) programme to assess medicines and other interventions intended for ultra-rare and debilitating conditions. The programme is reserved for situations where the clinical and economic evaluation of a technology poses particular challenges due to the small patient population, the lack of treatment options, and the difficulty of conducting conventional trials.

The Scottish Medicines Consortium follows a structured, typically 18-week, timeline in its health technology assessment process. We provide a breakdown of the different phases with associated timeframes.