The price of global health drug pricing strategies to balance patient access and the funding of innovation, 2 edition

Ed Schoonveld does an extraordinary job of making one of the most complex and vital
topics in the industry intelligible to both new and experienced audiences. Best of all, he
leverages case studies and straightforward frameworks to provide a pragmatic approach
for mastering the theory of global pricing and access. I keep his book in easy reach for
my own reference or to share with others.
Susanne Laningham, Executive Director
Global Value Access & Policy, Amgen
This book gives a great overview and offers several perspectives on drug pricing issues.
It provides comprehensive new insights such as the need to take benefits assessments
of pharmaceuticals into consideration during all steps of drug development and
market access. The mix of theory, in the form of underlying arguments and analytical
frameworks, along with practical and up-to-date real-world solutions, makes this book
an outstanding reference.
Thomas Mueller, Head of Pharmaceutical Department
Gemeinsamer Bundesausschuss (Federal Joint Committee), Germany
The Price of Global Health is the most informative and comprehensive book I have
read on the topic of global pharmaceutical pricing and market access. Ed is able to
distill complex topics into simplified and pragmatic frameworks, including insightful
perspectives on market segmentation, communicating value, and pricing. The final
section provides a useful reference, describing how key global healthcare systems are
structured and their approach for assessing value. I have recommended this book for
members of my team as part of their initial training.
David Kaplan, Senior Advisor
Global Payer Market Research, Eli Lilly
Ed’s book has been a huge addition to the global pharmaceutical pricing educational
process. I have used the book to teach pharmaceutical pricing since the book first arrived
on the market. It fills a huge unmet need. The students find that Ed’s book transforms
the complex global pricing environment and the factors that influence the pricing
process into an understandable and manageable entity. The book takes a lot of data
and transforms the information into key concepts. I can’t imagine teaching global

pharmaceutical pricing without Ed’s book.
Richard Truex Ph.D., Adjunct Professor
St. Joseph’s University, Philadelphia


The Price of Global Health is a rare book in pharmaceutical market access strategy
that develops an understandable strategic perspective. It is based on considerable
real-world experience and has been updated as the dynamics of the global pharma
market have evolved. We used it as an important part of our onboarding process for all
junior market access staff. Highly recommended.
Keith Hendricks, Vice President,
Decision Support Group, Corporate Strategic Planning, AbbVie
This book should be on the shelves of every pharmaceutical company executive—in
whatever discipline—and will prove invaluable to anyone interested in providing and
financing modern healthcare.
Joe Zammit-Lucia, President and CEO
Cambridge Pharma Consultancy
This book is fantastic! … People will love it. It’s very well suited for a broad audience
from student to professionals to non experts and will hopefully be useful to demystify
the subject a little. … THE pharma pricing book!
Ulf Staginnus, Executive Director,
Head Market Access & Pricing Europe at Endocyte
The Price of Global Health is a compelling and holistic introduction into the art and
science of pricing.
Andreas Altemark, Head of Global Pricing & MACS Reporting
Bayer HealthCare Pharmaceuticals


The Price of Global Health

To my wife, Hana:
my love and true partner in life


The Price of Global
Health
Drug Pricing Strategies to Balance
Patient Access and the Funding of
Innovation
Second Edition
Ed Schoonveld


© Ed Schoonveld 2015
All rights reserved. No part of this publication may be reproduced, stored in a retrieval
system or transmitted in any form or by any means, electronic, mechanical, photocopying,
recording or otherwise without the prior permission of the publisher.
Ed Schoonveld has asserted his right under the Copyright, Designs and Patents Act, 1988, to
be identified as the author of this work.
Published by
Gower Publishing Limited
Gower Publishing Company
Wey Court East
110 Cherry Street
Union RoadSuite 3-1
FarnhamBurlington, VT 05401-3818
Surrey, GU9 7PTUSA
England
www.gowerpublishing.com

British Library Cataloguing in Publication Data
A catalogue record for this book is available from the British Library
The Library of Congress has cataloged the printed edition as follows:
Schoonveld, Ed.
The price of global health: drug pricing strategies to balance patient access and the funding
of innovation / by Ed Schoonveld.
pages cm.
Includes bibliographical references and index.
ISBN 978-1-4724-3880-5 (hardback: alk. paper)—ISBN 978-1-4724-3881-2 (ebook)—ISBN
978-1-4724-3882-9 (epub) 1. Drugs—Prices. 2. Pharmaceutical industry—Prices. 3. Medical
care. 4. Globalization. I. Title.
HD9665.5.S364 2014
338.4’36151—dc23

2014018598

ISBN 9781472438805 (hbk)
ISBN 9781472438812 (ebk – ePDF)
ISBN 9781472438829 (ebk – ePUB)

Printed in the United Kingdom by Henry Ling Limited,
at the Dorset Press, Dorchester, DT1 1HD


Contents
List of Figures
List of Tables
List of Abbreviations  
Foreword by Andrea Mantovani  
Acknowledgments  

Preface to the Second Edition  
Preface to First Edition  
About the Author  
Introduction  

xiii
xvii
xix
xxv
xxvii
xxix
xxxi
xxxv
1

Part A

Drug Market Access and Pricing Basics

Chapter 1

The Drug Pricing Challenge  
Drug Pricing  
Market Access  
Regulatory and Other Drug Approval Systems  
Market Access and Pricing Controls – Why?  
Global Pricing Issues  

11
11

13
14
17
28

Chapter 2

Payers  
Global Payer Systems  
The Payer Perspective  
Drug Budget  
Overview of Payer Cost Control Mechanisms  
Similarities and Differences between Payer Systems  

37
37
38
41
42
47

Chapter 3

Fundamentals of Pricing  
Importance of Setting the Right Price  
Pricing in a Free Market Economy  

49
49
50

vi

T h e P r i c e o f G lo ba l H ea lt h

Drug Pricing  
Government Control  
Price Sensitivity under US Managed Care  
Patient Impact  

55
58
60
62

Chapter 4

Reference-Based Pricing  
ATC Classification System  
Problems with Referenced-Based Pricing Systems  
Adoption of RBP-II Systems  

65
65
69
70

Chapter 5

Health Outcomes and Health Economics  
73
What Is It?  
73
Health Outcomes and Quality of Life  
75
Importance of Health Outcomes and Health Economics  76
Role of Health Outcomes and Health Economics 
in MA&P  
82

Chapter 6

Features, Benefits, Value and Price  
Benefits  
Value  
Customer Preferences  
Setting the Right Price  

87
88
90
92
97

Part BStructured Market Access and Pricing
Approaches
Chapter 7

Pricing and Drug Development  

Asset Shaping Stage  
Evidence-Building Stage  
Implementation and Adjustment Stage  

103
107
114
120

Chapter 8

Payer Segmentation  
Segmentation Dimensions and Archetypes   
Global Payer Segmentation  
Competitive Insurance-Based System  
Therapeutic Reference Systems   
Health Economics-Driven Systems  
Emerging Cash Markets  

127
127
130
133
138
141
145


vii

contents

Chapter 9

Key Situation Factors: The PODiUM Approach  
Patient and Treatment Flow  
Promise Options  
Direct Competition  
Unmet Needs  
Money Flow  

147
148
150
152
153
154

Chapter 10

The BEST PRICE Framework to Market Access
and Pricing  
Benefits Analysis  
Assess Evidence Needs  
Payer Value STory  
PRICE Evaluation  

159
160
166

172
174

Chapter 11

Payer Value Story  
Value Dossier  
TEMPLE Framework  

187
188
188

Part C

Developing an Integrated Global Strategy

Chapter 12

Developing a Global Pricing Strategy  
Objective of a Global Pricing Strategy  
Impact of Price Cascading on Profits  
Global Strategy Development  

205
205
207
210

Chapter 13

Public Policy and Ethical Considerations  
Profit versus Right to Healthcare  
Compulsory Licensing  
Differential or Equity Pricing  
Global Trade versus Social Policy  

227
227
230
231
235

Chapter 14

Oncology and Orphan Drugs  
Oncology is Different … (?)  
Orphan Drugs  

239
239
246

Chapter 15

Payer and Pricing Research  
Research and Payer Understanding  
Qualitative Payer and Pricing Research  
Van Westendorp  
Monadic Testing  

251
251
254
259
264


viii

T h e P r i c e o f G lo ba l H ea lt h

Gabor–Granger  
Conjoint Analysis  
Discrete Choice  
Linked Decision Making  
“Don’t Try This at Home”  

265
267
268
269
273

Part D

Market Access and Pricing Strategy
Implementation

Chapter 16

Corporate Market Access and Pricing Function  
Pricing and Corporate Decision Making  
Pricing and Marketing  
Market Access and Pricing Functions  
MA&P and the Drug Development Process  
Go-to-Market Efforts  
Global Management of Price  
Market Access and Pricing Organization  
Role of Information Systems  

277
277
278
279
280
281
282
283
287

Chapter 17

Market Access and Pricing Negotiations  
Prescription Drugs versus Other Products  
Negotiation Settings  
Payer Perspective  
Understanding the Payer’s Point of View  
Examining our Value Proposition  
Payer Objections  

Price  
Structuring Compromise  

289
289
290
292
293
294
297
297
300

Chapter 18

Risk Sharing and Managed Entry Agreements  
What is Risk Sharing?  
“Alternative Pricing Schemes” Would Have Been 
a Better Name  
Types of Risk Sharing Deals  
Finding the Deal that Makes Sense  
Managed Entry Agreements  
Managed Entry Agreements in Emerging Markets  
Implementation Considerations  
The Future of Risk Sharing   

301
302
302
303

310
312
313
313
314


contents

ix

Part E

Key Healthcare Systems

Chapter 19

United States  
Key Statistics  
Overview  
Pricing  
Private Health Insurance  
Pharmaceuticals  
Medicare  
Medicaid  
Hospital Drugs  
Healthcare Marketplace (Exchanges)   
Hospitals, Provider Organizations and Accountable Care
Organizations  
Implications for List and Net Pricing Strategies  

319
319
319
320
322
324
331
334
335
336

Chapter 20

Canada  
Key Statistics  
Overview  
Pharmaceuticals  
Pricing  
Pan-Canadian Pricing Alliance  
Common Drug Review  
Provincial Formularies  
Private Plans  
Health Economics  
Hospitals  
Outlook  

341
341
341

341
342
344
345
346
346
347
347
347

Chapter 21

France  
349
Key Statistics  
349
Overview  
349
Pharmaceuticals  
350
Market Access  
351
Medical Benefit and Added Medical Benefit Assessment  352
Medico-Economic Assessment  
355
Price Determination  
356
Reimbursement Rate Determination  
358
Hospital Drugs  

358

339
340


x

T h e P r i c e o f G lo ba l H ea lt h

Chapter 22Germany  
Key Statistics  
Overview  
Pharmaceuticals  
Pricing  
Reimbursement  
Price Referencing  
Target Prescribing Volumes  
Prescribing Guidelines and Controls  
Parallel Trade  
Health Economics  
Hospitals  
Future Developments  

361
361
361
362
363
368

369
371
371
372
372
373
373

Chapter 23

Italy  
Key Statistics  
Overview  
Drugs  
Pricing and Reimbursement  
Reimbursement  
Regions  
Hospitals  
Health Economics  
Risk Sharing  
Future  

375
375
375
376
377
379
380
381

381
381
382

Chapter 24Spain  
Key Statistics  
Overview  
Pharmaceuticals  
Pricing and Reimbursement  
Reference Pricing  
Regions  
Health Economics  
Parallel Trade  

383
383
383
384
384
385
385
386
386

Chapter 25

387
387
387
388

UK  
Key Statistics  
Overview  
Drugs  


contents

xi

Pricing  
Reimbursement  
Patient Co-payments  
Health Economics  
Clinical Commissioning Groups  
Risk Sharing Deals and Patient Access Schemes  
Value-Based Assessment  
Early Access to Medicines Scheme  
Future Developments  

388
389
389
390
391
391
392
393
394

Chapter 26

Japan  
Key Statistics  
Overview  
Drugs  
Pricing for New Drugs  
Pricing Adjustments for Listed Drugs  
Outlook  

395
395
395
396
396
399
400

Chapter 27

Australia  
Key Statistics  
Overview  
Drugs  
Reimbursement Approval  
Therapeutic Referencing  
Health Economics  
Therapeutic Group Premium  
Risk Sharing  

401
401
401
402
402
402
403
404
404

Chapter 28

Brazil  
Key Statistics  
Overview  
SUS  
Pharmaceuticals  
Pricing  
Reimbursement  
Compulsory Licensing  
Productive Development Partnerships  
Outlook  

405
405
405
406
406
407

407
408
409
409


xii

T h e P r i c e o f G lo ba l H ea lt h

Chapter 29

China  
Key Statistics  
Overview  
Drugs  
Outlook  

411
411
411
412
413

Chapter 30

India  
Key Statistics  
Overview  
Drugs  

Patient Access Programs  
Compulsory Licensing  
Outlook  

415
415
415
416
416
417
417

Chapter 31South Korea  
Key Statistics  
Overview  
Drugs  

419
419
419
419

References  
Index  

423
427


List of Figures

1.1
Key global pricing and market access players
1.2
“Dinner for three” analogy
1.3
Drug industry cost structure implications
1.4
Global Big Mac prices
1.5
Global iPad prices
1.6
Global prices indexed to the US for iPad and Big Mac
1.7
International price referencing in some key countries
1.8
Global price referencing network
3.1
Price and profit
3.2
General supply and demand relationships
3.3
Price elasticity of demand
3.4
Example of a price–volume relationship
3.5
Profit maximization: example A
3.6
Profit maximization: example B
3.7

Elasticity under multiple indications
3.8
Profitability under multiple indications
3.9
Price elasticity under price controls
3.10
Price elasticity in US Managed Care 
3.11
Co-pay impact on market share – high co-pay sensitivity
3.12
Co-pay impact on market share – low co-pay sensitivity
4.1
WHO ATC classification of drugs
5.1
Domains in health outcomes and economics research
5.2
Cost-effectiveness plane
6.1
The payer benefit pyramid
6.2
The negotiating triangle
6.3
Sample questions to evaluate perspectives and likely
behavior of key players in the negotiating triangle
7.1
Challenges of the drug development expedition
7.2
Drug development sequence

16

22
24
29
29
30
32
32
50
51
52
53
54
55
56
57
59
61
61
62
66
74
82
88
97
98
104
105


xiv

7.3
7.4
7.5
7.6
7.7
7.8
7.9
8.1
8.2
8.3
8.4
8.5
9.1
9.2
9.3
10.1
10.2
10.3

10.4
10.5
10.6
10.7
10.8
10.9
10.10
10.11
11.1
11.2

11.3
12.1
12.2
12.3
12.4
12.5
12.6
12.7
13.1
13.2
13.3

T h e P r i c e o f G lo ba l H ea lt h

Updated drug development sequence
MA&P management stages
Asset shaping stage
Evidence building stage
Identifying key payer messages
Implementation and adjustment stage
Key steps to MA&P approval
Global payer segments
Global payer segments by sales and population
Examples of impact of co-pay on market share
Normalized impact of co-pay on market share
TR markets: price premium vs. innovation rating
The PODiUM approach
Example of a diabetes treatment algorithm
Example of a simple money flow evaluation
BEST PRICE Framework

Examples of product benefits
Bottom-up and top-down approach with the
payer benefit pyramid
Illustrative example of a detailed benefits assessment
Role of evidence in market access
Template for qualitative evaluation of trial options
Price impact on US Managed Care tier status
Scenarios for impact of tier placement on prescribing
Price–revenue relationship
The French ASMR Innovativeness Rating System
Impact of French reimbursement on prescribing
TEMPLE Framework
Example of a payer value story
Examples of prime customer perspectives in some markets
Optimal price by country: a characteristic example
Price cascading due to international referencing and trade
Simplified example of global pricing trade-offs
Typical examples of locally optimal prices
Global price referencing network
Example of EU-5 pricing strategy options
Typical global sales distribution for prescription drugs
WHO definition of essential medicines
Compassionate pricing simplicity: the new divide
The conflicting worlds of social fairness and trade 

105
106
108
115
119

121
122
131
132
136
137
141
148
149
156
160
162
163
164
167
173
175
176
177
178
179
189
192
195
206
207
208
211
212
220

225
232
233
237


L i s t o f F i g u r es

xv

14.1
Benefits analysis for a typical oncology drug
244
15.1
Payer research stimuli development
258
15.2
Van Westendorp approach
259
15.3
Graphic representation of Van Westendorp research results
260
15.4
Modified Van Westendorp approach
262
15.5
Van Westendorp results for an Orphan drug with a
sub-optimal value proposition
263
15.6

Van Westendorp results for a typical drug situation
263
15.7
Pitfalls of the Gabor–Granger research methodology
266
15.8
Dinner for Three with its influencers
270
15.9
Interlinked US pricing model
270
15.10
Interlinked pricing model variations
272
16.1
MA&P activity phases over a drug’s life cycle
280
16.2
Global and regional floor examples
283
16.3
MA&P team option in functional global structure
284
16.4
Example of a MA&P team structure
285
16.5
MA&P teams in a business unit structure
286
18.1

Risk sharing deal categories304
18.2
Looking for the win-win
311
19.1
US population by payer segment
320
19.2
US health insurance market share by premiums
322
19.3
Private employer-sponsored plan evolution 2000–2013
326
19.4
Private employer-sponsored plan co-pay development
327
19.5
Private employer-sponsored plan co-insurance development
327
19.6
Impact of patient co-payment on prescription abandonment
328
19.7
Standard Medicare Part D benefit design (2014 limits) 
332
19.8
Income eligibility level for Medicaid/CHIP coverage
334
19.9
US state participation with ACA Medicaid expansion

336
19.10
State health insurance Marketplace decisions
337
19.11
US Price optimization modeling across decision makers
338
20.1
PMPRB drug classification system
344
21.1
SMR ratings through March 2012
353
21.2
ASMR ratings through March 2012
354
21.3
ASMR Improvement Ratings 2001–2012
355
22.1
AMNOG Process
364
22.2
Highest assigned benefit category by drug under

AMNOG through February 20, 2014
366
23.1
AIFA pricing and reimbursement approval process
378

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List of Tables

5.1
5.2
5.3
8.1
12.1

12.2
12.3

12.4

12.5

15.1
19.1
19.2
19.3
19.4
21.1
21.2
21.3
23.1
24.1
26.1
28.1

NIH Definitions
Examples of clinical and long-term patient health outcomes
Health economic perspectives
Global payer archetypes
Case Study: Optimal local price without international
referencing
Case Study: Prices adjusted with international referencing
Case Study: Prices adjusted with international referencing;
UK price increased to qualify for FPA in Japan
Evaluation of options related to parallel trade avoidance
Slightly modified parallel trade case with smaller
Italian market
Van Westendorp’s key intersections
US drug pricing definitions
Four-tier and Five-tier formulary designs

Phase-out schedule of donut hole under Medicare Part D
Median 2013 cost sharing for Medicare Part D plans
ASMR ratings of clinical benefit improvement
ASMR rating impact on drug price 
SMR rating and reimbursement
Reimbursement categories
Patient co-payments as of July 1, 2012 
Pharmaceutical price premium requirements (JPMA, 2014)
Price approval requirements for six drug categories

74
76
78
130
213
214
216
221
223
261
321
326
333
333
354
356
358
380
385
397

407


This page has been left blank intentionally


List of Abbreviations
€
Euro Currency
ACA
Patient Protection and Affordable Care Act
AD
Alzheimer’s Disease
AEMPS
Agencia Española de Medicamentos y Productos Sanitarios
(Spain)
AFP
Average Foreign Price (Japan)
AFSSAPS
Agence Française de Securité Sanitaire des Produits de Santé
(France)
AHFS – DI
American Hospital Formulary Service – Drug Information
(US)
AIDS
Acquired Immunodeficiency Syndrome
AIFA
Agencia Italiana del Farmaco (Italy)
AIOCD
All India Organization of Chemists and Druggists (India)

AMCP
Academy of Managed Care Pharmacy (US)
AMNOG
Arzneimittelmarktneuordnungsgesetz (Act on the Reform of

the Market for Medicinal Products; Germany)
AMP
Average Manufacturer Price
ANS
Agência Nacional de Saúde Suplementar (Brazil)
ANSM
Agence Nationale de Sécurité du Médicament et des Produits
de Santé (France)
ANVISA
Agência Nacional de Vigilância Sanitária (Brazil)
AOK
Allgemeine Ortskrankenkasse (Germany)
ASMR
Amélioration du Service Medical Rendu (France)
ASP
Average Selling Price (US)
ATC
Anatomical Therapeutic Classification
AWP
Average Wholesale Price (US)
AZT
Azidothymidine
BEST PRICE Framework: Benefits, Evidence, STory, PRICE
BfArM
Bundesinstitut für Arzneimittel und Medizinprodukte

(Germany)


xx

T h e P r i c e o f G lo ba l H ea lt h

BGTD
Biologics and Genetic Therapies Directorate (Canada)
BHIS
Basic Health Insurance Scheme (China)
BKK
Bundesverband Betriebskrankenkassen (Germany)
BMG
Bundesministerium für Gesundheit (Germany)
BMS
Bristol-Myers Squibb
BRIC
Brazil, Russia, India, China
CADTH
Canadian Agency for Drugs and Technologies in Health
(Canada)
CAP
Competitive Acquisition Program (US)
CCDSM
Collaborating Centre for Drug Statistics Methodology (WHO)
CCG
Clinical Commissioning Group (UK)
CCOHTA
Canadian Coordinating Office for Health Technology

Assessment (now CADTH; Canada)
CDF
Cancer Drug Fund (UK)
CDR
Common Drug Review (Canada)
CED
Coverage with Evidence Development
CEESP
Commission Evaluation Economique et de Santé Publique
CEPS
Comité Economique des Produits de Santé (France)
CGHS
Central Government Health Scheme (India)
CHIP
Children’s Health Insurance Program (US)
CHMP
Committee for Medicinal Products for Human Use (EU)
CIPE
Comitato Interministeriale per la Programmazione Economica
(Italy)
CIPM
Comisión Interministerial de Precios de los Medicamentos
(Spain)
CMED
Câmara de Regulação do Mercado de Medicamentos (Brazil)
CML
Chronic Myelogenous (or Myeloid) Leukemia
CMS
Center for Medicare and Medicaid Services (US)

CODEM
Comité de Evaluacion de los Medicamentos de Uso Humano
(Spain)
COMP
Committee for Orphan Medicinal Products (EU)
CONITEC
Comissao Nacional de Incorporaca de Technologias
COPD
Chronic Obstructive Pulmonary Disease
CPI
Consumer Price Index
CT
Commission de Transparence (France)
CTS
Commissione Tecnico Scientifica (Italy)
CUF
Commissione Unica del Farmaco (Italy)
DBCAC
Drug Benefit Coverage Assessment Committee (S. Korea)
DDD
Daily Defined Dose (WHO)
DH
Department of Health (UK)


L i s t o f A b b r e v i at i o n s

xxi

DMARD

Disease Modifying Anti-Rheumatic Drug
DoD
Department of Defense
DP
Direct Price
DPCO
Drugs Price Control Order (India)
DRG
Diagnosis-Related Group
DTC
Direct To Consumer (Advertising)
ECJ
European Court of Justice
ECT
Electroconvulsive Therapy
EMA
European Medicines Agency
EMEA
see EMA
EORTC
European Organization for Research and Treatment of Cancer
ESIS
Employee State Insurance Scheme (India)
ESRD
End-Stage Renal Disease
EU
European Union
EU-5
France, Germany, Italy, Spain, UK
FDA

Food and Drug Administration (US)
FPA
Foreign Price Adjustment (Japan)
FSS
Federal Supply Schedule (US)
FUL
Federal Upper Limit (US)
G-BA
Gemeinsamer Bundesausschuss (Germany)
GDP
Gross Domestic Product
GI Gastro-Intestinal
GSK
GlaxoSmithKline
GVS
Geneesmiddelen Vergoedings Systeem (Netherlands)
HAM-D
Hamilton Depression Rating Scale
HAS
Haute Authorité de Santé (France)
HbA1C
Haemoglobin A1C
HE
Health Economics
HEOR
Health Economics and Outcomes Research
HER-2
Human Epidermal growth factor Receptor 2
HHS
(Department of) Health and Human Services (US)

HIPC
Highest International Price Comparison (Canada)
HIRA
Health Insurance Review and Assessment Service (South
Korea)
HIV
Human Immunodeficiency Virus
HMO
Health Maintenance Organization (US)
HO
Health Outcomes
HPFB
Health Products and Food Branch (Canada)
HQ
Headquarters
HTA
Health Technology Assessment


xxii

T h e P r i c e o f G lo ba l H ea lt h

ICP
Internally Calculated Price (Japan)
IKK
Bundesverband der Innungskrankenkassen (Germany)
IPP
Indifference Price Point
IRDA

Insurance Regulatory Development Authority Bill (India)
IQWiG
Institut für Qualität und Wirtschaftlichkeit im
Gesundheitswesen (Germany)
IV Intravenous
GKV
Gesetzliche Krankenversicherung (Spitzenverband Bund der
Krankenkassen; Germany)
KFDA
Korean Food and Drug Administration (S. Korea)
KOL
Key Opinion Leader
LDL
Low Density Lipoprotein
LEEM
Les Enterprises du Médicament (France)
MA
Market Access
MA
Medical Aid (S. Korea)
MA&P
Market Access and Pricing
MAC
Maximum Allowable Cost (US)
MAP
Minimally Acceptable Profile
MBS
Medicare Benefits Schedule (Australia)
MCO
Managed Care Organization (US)

MEA
Managed Entry Agreements
MHRA
Medicines and Healthcare product Regulatory Agency (UK)
MIPC
Median International Price Comparison (Canada)
MLSS
Ministry of Labor and Social Security (China)
MMA
Medicare Modernization Act (US)
MS
Multiple Sclerosis
NCCN
National Comprehensive Cancer Network (US)
NCE
New Chemical Entity
NDRC
National Development and Reform Commission (China)
NEDL
National Essential Drug List (China)
NGO
Non-Governmental Organization
NHI
National Health Insurance (S. Korea, Japan)
NHIC
National Health Insurance Corporation (S. Korea)
NHS
National Health Service (various countries)
NICE
National Institute for Health and Care E xcellence (UK)

NIH
National Institute of Health (US)
NPPA
National Pharmaceutical Pricing Authority (India)
NRCMS
New Rural Cooperative Medical System (China)
OPP
Optimal Price Point
OPPI
Organization of Pharmaceutical Producers of India (India)