Search and filter

The Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA) is a key player in the access landscape, determining which healthcare services, including medicines, are covered, and assesses the comparative benefit provided by new drugs. Medicines showing a comparative benefit are launched at prices set by the manufacturer, who then negotiates the definitive price with the National Association of Statutory Health Insurance Funds, with the price applicable from six months after launch. Those without a comparative benefit are subject to national reference pricing.

Recommendations for a flexible approach to archetypes for making sense of the diversity of national access approaches.

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.

France's healthcare system is centrally coordinated and regionally administered through Agences Régionales de Santé (ARS), ensuring universal coverage and equitable access to services. The Haute Autorité de Santé (HAS) evaluates medical benefits and improvements, informing reimbursement decisions, while the Comité Économique des Produits de Santé (CEPS) negotiates medicine prices. France operates two main early access programmes, the Autorisation d’Accès Précoce (AAP) and Autorisation Compassionnelle (AC) pathways to expedite patient access to innovative treatments.

Horizon scanning is a collaborative and systematic process aimed at identifying new and emerging health technologies, particularly medicines, to ensure the NHS is well-prepared for their introduction, both organisationally and financially. It is carried out separately by the different member nations of the UK - this briefing covers the process followed in England.

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.

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.

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.

In Germany, manufacturers can seek scientific advice separately from the Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte, BfArM), the Federal Institute for Vaccines and Biomedicines (Paul-Ehrlich-Institut, PEI), and the Federal Joint Committee (Gemeinsamer Bundesausschuss, G-BA). Alternatively they may opt for joint scientific advice to integrate regulatory and HTA perspectives. Choosing the right approach can streamline development, reduce risks, and optimise resource allocation.

The United Kingdom comprises four countries: England, Scotland, Wales and Northern Ireland, each with its own devolved government responsible for health policies. The health system is regionally managed through the National Health Service (NHS) in each nation. These bodies determine how care is delivered and which medicines are available, informed by decisions of the regional health technology assessment bodies and, in the case of early access routes to market, in collaboration with the national regulator. The published list price is set in discussion with the Department of Health and Social Care, while any discounted price agreed with the HTA bodies and must be in line with willingness to pay thresholds. Separate funds exist for oncology and other expensive medicines, subject to assessment.

Why a good working understanding of the regulatory approval process is invaluable to the access practitioner.