A market access plan for five European countries means five sets of institutions, and the names do not map onto each other. HAS is not the German equivalent of G-BA, and neither of them does quite what NICE does.
Dr Nick Proctor and Megan O'Brien compiled this list for the participants of their course Understanding Pharma Market Access & Payers in Europe. It covers 58 entries across France, Germany, Spain, Italy and the UK, each with its full title and a short description of what the body, system or term actually is:
- France: ANSM, CEPS, HAS and more
- United Kingdom: MHRA, NICE, VPAG and more
- Germany: AMNOG, G-BA, IQWiG and more
- Italy: AIFA, CSE, SSN and more
- Spain: AEMPS, CIPM, SNS and more
Below you will find the comparison table, eight of the entries in full, and the complete index of all 58. The descriptions of every entry are in the download.
Who does what in each of the EU5
Five countries, the same five jobs, five different sets of names. Everything in this table comes from the list.
The pattern is different in every country. France and Italy concentrate the decisions in one or two bodies. Germany separates the assessment from the decision, with IQWiG advising and G-BA deciding. Spain runs price and reimbursement through one commission advised by two others. The UK has three appraisal bodies depending on the nation, and buys at local level through the integrated care boards. A launch sequence that works in one of these markets does not transfer to the next, which is why the names are worth learning rather than translating.
A sample from the list
Eight of the 58 entries, as they appear in the download:
France
ASMR / SMR: Amélioration du service médical rendu / Service médical rendu
The CT is responsible for assessing the actual clinical benefit and the clinical added value of a medicine vs. already marketed competitors. The results are used to determine a medicine's price and level of reimbursement.
CEPS: Comité Economique des Produits de Santé
The Economic Committee for Health Care Products negotiates the price of a drug with its manufacturer. CEPS references a drug's ASMR in this assessment.
Germany
G-BA: Gemeinsamer Bundesausschuss
The Federal Joint Committee. Supreme decision-making body, issuing directives and determining the benefit package of the statutory health insurance (GKV). Responsible for reimbursement decisions in the GKV.
IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
Institute for Quality and Efficiency in Health Care. Independent scientific institute that investigates the benefits of medical interventions for patients.
Italy
AIFA: Agenzia Italiana del Farmaco
National regulator, pricing and reimbursement body.
Spain
CIPM: Comisión Interministerial de Precios de los Medicamentos
Interministerial Commission for Medicines Prices. Makes the final decision on drug price and reimbursement, following advice from the SGF.
United Kingdom
NICE: National Institute for Health and Care Excellence
Appraises selected pharmaceuticals and other health technologies.
ICB: Integrated Care Boards
Plan and buy health services for their local population, replacing Clinical Commissioning Groups (CCGs) in 2022.
All 58 entries, by country
Here is everything the list covers. The description of each entry is in the download.
France (9)
ANSM: Agence nationale de sécurité du médicament et des produits de santé
ARS: Agences Régionales de Santé
ASMR / SMR: Amélioration du service médical rendu / Service médical rendu
CEESP: Commission Evaluation Economique et de Santé Publique
CEPS: Comité Economique des Produits de Santé
CT: Commission de la Transparence
GHS: Groupes Homogènes de Séjour
HAS: Haute Autorité de Santé
T2A: Tarification à l'activité
Germany (14)
AMNOG: Arzneimittelmarktneuordnungsgesetz
AMR: Arzneimittel-Richtlinien
BfArM: Bundesinstitut für Arzneimittel und Medizinprodukte
DRG: Diagnosis Related Groups
EMA: European Medicines Agency
FB: Festbetrag
G-BA: Gemeinsamer Bundesausschuss
GKV: Gesetzliche Krankenversicherung
InEK: Institut für das Entgeltsystem im Krankenhaus
IQWiG: Institut für Qualität und Wirtschaftlichkeit im Gesundheitswesen
KK: Krankenkassen
KV: Kassenärztliche Vereinigungen
NuB: Neue Untersuchungs- und Behandlungsmethoden
ZE: Zusatzentgelt
Spain (10)
AEMPS: Agencia Española de Medicamentos y Productos Sanitarios
CAFPF: Comité Asesor para la Financiación de la Prestación de Servicios Farmacéuticos del SNS
CIPM: Comisión Interministerial de Precios de los Medicamentos
DGCYF: Dirección General de Cartera Común de Servicios del SNS y Farmacia
EMA: European Medicines Agency
INGESA: Instituto Nacional de Gestión Sanitaria
MSC: Ministerio de Sanidad, Servicios Sociales e Igualdad
RHS: Regional Health Service
SGF: Subdirección General de Farmacia
SNS: Sistema Nacional de Salud
Italy (11)
AIFA: Agenzia Italiana del Farmaco
AO: Aziende Ospedaliere
ASL: Azienda Sanitaria Locale
ASR: Azienda Sanitaria Regionale
CPR: Comitato Prezzi e Rimborso
CSE: Commissione Scientifica ed Economica del Farmaco
CTS: Commissione Tecnico-Scientifica
DTP: Diagnostic Therapeutic Pathways
EMA: European Medicines Agency
INN: International Non-proprietary Name
SSN: Servizio Sanitario Nazionale
United Kingdom (14)
ABPI: Association of the British Pharmaceutical Industry
AWMSG: All Wales Medicine Strategy Group
DoH: Department of Health
Foundation Trusts: Hospital groups, part of the NHS
ICB: Integrated Care Boards
ICS: Integrated Care Systems
ILAP: Innovative Licensing and Access Pathway
MHRA: Medicines and Healthcare products Regulatory Agency
NHS: National Health Service
NHSE: NHS England
NICE: National Institute for Health and Care Excellence
QALY: Quality-adjusted Life Years
SMC: Scottish Medicines Consortium
VPAG: Voluntary Scheme for Branded Medicines Pricing, Access and Growth
Download the glossary
Who compiled this list
Dr Nick Proctor and Megan O'Brien are consultants at Access Infinity, specialising in global pricing and market access strategy. They compiled this list for the participants of their course.
Dr Nick Proctor is a Partner at Access Infinity, with more than 25 years leading pricing, reimbursement and market access projects for many of the world's leading pharmaceutical brands. His background is in pricing, evidence synthesis, and health economics and outcomes research, and he has worked with payers across the major developed and emerging health markets. He has been a CELforPharma faculty member since 2015. Participants regularly single out how interactive and practical his training is.
Megan O'Brien is an Associate Director at Access Infinity, with over 10 years in pharmaceutical consultancy. She specialises in pricing and market access, real-world evidence generation and business intelligence, and has led strategic partnerships for major pharmaceutical clients. She has designed and delivered non-interventional RWE studies for both single and multiple sponsors.
Continue your learning from Nick and Megan
If you’d like to learn more from Nick and Megan, CELforPharma also offers a 1-day, hands-on course where you'll:
- Demystify market access concepts and payer decision-making
- Understand payer archetypes and how they differ across countries
- Gain clarity on evidence expectations and access pathways in major EU markets
- Learn how to embed market access into a cross-functional strategic process
Understanding Pharma Market Access & Payers in Europe
With Dr Nick Proctor & Megan O'Brien
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