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DEVELOPING GLOBAL ROAD MAPS FOR REIMBURSEMENT PROCESSES USED IN HEALTH TECHNOLOGY
ASSESSMENT: PHARMACEUTICALS, MEDICAL DEVICES, AND DIAGNOSTICS
Noreen J.
1
Sullivan ,
2
Szeinbach ,
2
Seoane-Vazquez ,
3
Matuszewski ,
Sheryl L.
Enrique C.
Karl A.
6
7
8
Stefan Holmstrom , Geoffrey Wilson , Annie Chicoye
Kevin W.
4,
5
Mayo ,
1Resonance
Health Analysis Services Pty Ltd, Encinitas, CA, CA, USA, 2Ohio State University, College of Pharmacy, Columbus, OH, USA, 3 Gold Standard/Elsevier, Tampa, FL, USA, 4Bridgehead
International, New York, New York, USA, 5University of the Sciences in Philadelphia, PA, USA, 6Astellas Pharma Europe, HEOR, Leiderdrop, Netherlands, 7GE Healthcare, Buckinghamshire, UK,
8IMS Consulting, Puteaux Cedex, France
Figure 1. HTA Decision and Reimbursement Process Model Template
BACKGROUND
Country
Health technology assessment (HTA) is used to evaluate
health care technologies (e.g., pharmaceuticals, medical
devices, and diagnostics) with respect to cost and their
projected impact on patient outcomes and society.
Currently, there is an ongoing initiative by the International
Society for Pharmacoeconomics and Outcomes Research
(ISPOR) to develop Road Maps that describe the utilization
of HTA in health care. The first part of this project
described the decision makers and the decision-making
process for HTA in several countries. The second part of
this project adds the reimbursement process for products
and devices approved through the HTA process.
*Leading Payer Organization
Step 1
Step 2
OBJECTIVE: The purpose of this study was to extend the
model for HTA decision-making structures to include
reimbursement road maps for several countries.
Step 2a
METHODS
DATA COLLECTION & STRATEGY: Members of the of
the ISPOR Special Interest Group (SIG) contacted key
individuals in several countries including: Austria,
Denmark, France, Hungary, Ireland, Spain, Taiwan, and
UK. Pharmaceuticals, medical devices, and diagnostics
were used as the framework for our research. The
completed decision model template presented in Figure
1 includes the decision maker, the decision-making
process, data requirements, and reimbursement
processes for each country. The criteria used included:
• Decision Maker: Payer (person or organization)
who makes final decision for coverage and payment of
product.
• Evaluator/Advisor: Person or organization who
provides input into the decision-making process via
HTA development and/or review but does not make
final decision for coverage and payment.
• Decision-Making Process: HTA evaluation
process, as defined in the public domain, for new and
emerging technologies.
• Reimbursement Process: Describes the strategy
for coverage and payment of approved
pharmaceuticals, medical devices, and diagnostics.
VALIDATION: Once models were completed, they were
forwarded to a contact affiliated with each Payer
organization to confirm their accuracy.
Key
Decision Maker
(Primary & Secondary)
Evaluator/Advisor
(Person/Organization)
Approved
Step 3
Not
Approved
Formulary or
Approved
Products
Step 4
List
Step 5
Reimbursement
Additional
Evaluators/Advisors
*Leading Payer Organization: The top 3 payer groups covering the majority of the population.
Table 1. Summary of Reimbursement Processes for HTA in Target Countries
Country
Austria
Denmark
France
Hungary
Ireland
Key Decision-Makers
Primary
Secondary
Federal Ministry of
Health, Family & Youth
(BNFGJ)
Danish Medicines
Agency (DKMA)
Ministry of Health &
Union for Health
Insurance (UNCAM)
National Health
Insurance Fund
Administration (NHIFA)
The Health Services
Executive (HSE)
Spain
Central Government
Taiwan
Bureau of National
Health Insurance
(BNHI)
National Institute for
Health and Clinical
Excellence (NICE)
UK
Evaluator Role
Primary
Pricing Committee (PK) Main Association of
& Independent Drug
Austrian Security
Commission (UHK)
Institutions (HBV)
Reimbursment Committee
(MTN)
Comité Economique des High Health Authority (HTA
Produits de Santé
public Agency)
(CEPS)
Technology Appraisal
Committee (TAC)
Secondary
Pharmaceutical
100%: Patient copayment capped at 2% of patient annual income
Evaluation Board (HEK)
Hospital Committees for
medical devices and
drugs
Office of Health
Technology
Assessment (OHTA)
Corporate Pharmaceutical National Centre for
Unit (CPU)
Pharmacoeconomics
(NCPE)
Regional Government European Medicines
Ministry of Health
Agency (EMEA); Spanish (MSC)
Medicine Agency (AEMPS)
Center for Drug Evaluation
(CDE)
National Coordinating
Centre for HTA
(NCCHTA)
Reimbursement
Payment
Varies with respect to patient accumulated expenditures
Most products reimbursed at 65%. Products for chronic/severe
disease are reimbursed 100 % . 2007 average was 76.77% for retail
pharmacy
Drugs classified by category
Drugs approved by Community Drug Schemes are100% reimbursed
Reimbursed medications are on a national reimbursement list: 100%
for hospital pharmaceuticals; 90% for pharmaceuticals used to
manage chronic illness; 60% prescription only pharmaceuticals
Reimbursement determined by 1) listing 2) restrictions for coverage,
and 3) new reimbursement price Patient co-pay is usually less than
18% based on total cost of drug
Branded drug price set by Pharmaceutical Price Regulation Scheme
(PPRs) drug is reimbursed by NHS according to manufactuer list
price
RESULTS
For the most part, reimbursement and payment processes for
new and emerging technologies parallel the overall HTA process.
Key decision makers and Evaluators play an important role in the
reimbursement process for HTA and ultimately, influence Key
Decision Makers in the acceptance of new and emerging
technologies (Table 1). While pathways for reimbursement and
coverage varied across countries, we were able to define key
characteristics that defined the reimbursement process for the
review and approval of new and emerging technologies in
countries around the world.
For these countries, reimbursement and payment decisions were
the responsibility of decision makers who were either closely
connected to the Key Decision Maker or who served as a primary
decision maker for HTA. Reimbursement and payment levels
varied across countries, with levels of reimbursement based on
annual income, co-payment, drug categories, or a pre-determined
percentage.
Other Advisory entities consisted of various
committees and agencies that provided economic evaluations as
part of their responsibilities to the Key Decision Makers or
provided input upon request as an independent or contracted
entity. In summary, the process for reimbursement and coverage
of new and emerging technologies in the countries examined was
fairly centralized and organized within the overall HTA process.
CONCLUSION
This study was designed to characterize and present the
reimbursement process for HTA in several countries with respect
to Key Decision Makers, Evaluators, Advisors and the decisionmaking process. Although the reimbursement processes for HTA
contained features that are common across the countries
examined, the coverage and payment mechanisms varied within
each country. Future research will focus on the addition of other
countries with respect to decision-making and reimbursement
processes and how data are used to determine pricing and
reimbursement levels for new and emerging technologies.
ACKNOWLEDGEMENT
We would like to thank the members of the ISPOR Special
Interest Group for Global Health Care Reimbursement
Systems and Decision Processes with special thanks to
Randa F. Eldessouki, Nadia G. Naaman, and Marilyn DixSmith, PhD.