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The Early Access to Medicines Scheme (EAMS) is a UK initiative established by the Medicines and Healthcare products Regulatory Agency (MHRA) to provide patients with life-threatening or seriously debilitating conditions access to medicines that do not yet have a marketing authorisation but address unmet medical needs. 

The Innovative Licensing and Access Pathway was launched in January 2021 by the MHRA to speed up the development and delivery of innovative medicines, and it is due to be relaunched in March 2025. It provides a collaborative framework among the MHRA, the national HTA bodies of the UK and, in the revised ILAP, the National Health Service (NHS). The scheme is designed to streamline access to new therapies that meet unmet medical needs, ensuring transformative treatments reach patients more swiftly.

The National Institute for Health and Care Excellence (NICE) offers a comprehensive advisory service aimed at helping pharmaceutical and health technology companies enter the NHS market. This service supports companies in generating evidence, refining economic models, and preparing for engagement with NHS payers and commissioners. The goal is to ensure that innovative treatments can be successfully introduced into the 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.

The National Institute for health and Care Excellence uses real-world evidence to fill gaps in knowledge and support decision-making in health and social care. This evidence is derived from data collected outside of controlled clinical trials, often referred to as real-world data. NICE has developed a framework to guide the generation and use of this type of evidence, aiming to increase its quality and transparency.

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.

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.

NICE operates a Managed Access Programme to provide patients with early access to promising new treatments while additional evidence is collected to address uncertainties about their clinical or cost-effectiveness. This approach is particularly beneficial for treatments that show potential but lack comprehensive data to support routine NHS use.

Patient Access Schemes in England aim to improve the affordability and accessibility of high-cost treatments provided to NHS England patients, especially those treatments that may not initially meet cost-effectiveness standards set by the National Institute for Health and Care Excellence (NICE).