DEVELOPING GLOBAL ROAD MAPS FOR REIMBURSEMENT PROCESSES USED IN HEALTH TECHNOLOGY ASSESSMENT: PHARMACEUTICALS, MEDICAL DEVICES, AND DIAGNOSTICS

Noreen J. Sullivan1, Sheryl L. Szeinbach2, Enrique C. Seoane-Vazquez2, Karl A. Matuszewski3, Kevin W. Mayo4, 5, Stefan Holmstrom6, Geoffrey Wilson7, Annie Chicoye8

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

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.

OBJECTIVE: The purpose of this study was to extend the model for HTA decision-making structures to include reimbursement road maps for several countries.

BACKGROUND

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.

METHODS

Figure 1. HTA Decision and Reimbursement Process Model Template

Table 1. Summary of Reimbursement Processes for HTA in Target Countries

RESULTS

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 decision-making 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.

CONCLUSION

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 Dix-Smith, PhD.

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.

KeyDecision Maker

(Primary & Secondary)

Evaluator/Advisor (Person/Organization)

*Leading Payer Organization

Country

Additional Evaluators/Advisors

Formulary or Approved Products

List

Step 2a

Step 2

Step 1

Step 3

Approved

Not Approved

*Leading Payer Organization: The top 3 payer groups covering the majority of the population.

Step 4

ReimbursementStep 5

CountryPrimary Secondary Primary Secondary Payment

Austria

Federal Ministry of Health, Family & Youth (BNFGJ)

Pricing Committee (PK) & Independent Drug Commission (UHK)

Main Association of Austrian Security Institutions (HBV)

Pharmaceutical Evaluation Board (HEK)

Denmark Danish Medicines Agency (DKMA)

Reimbursment Committee (MTN)

France Ministry of Health & Union for Health Insurance (UNCAM)

Comité Economique des Produits de Santé (CEPS)

High Health Authority (HTA public Agency)

Hospital Committees for medical devices and drugs

Hungary National Health Insurance Fund Administration (NHIFA)

Technology Appraisal Committee (TAC)

Office of Health Technology Assessment (OHTA)

Ireland The Health Services Executive (HSE)

Corporate Pharmaceutical Unit (CPU)

National Centre for Pharmacoeconomics (NCPE)

Spain Central Government Regional Government European Medicines Agency (EMEA); Spanish Medicine Agency (AEMPS)

Ministry of Health (MSC)

Taiwan Bureau of National Health Insurance (BNHI)

Center for Drug Evaluation (CDE)

UK National Institute for Health and Clinical Excellence (NICE)

National Coordinating Centre for HTA (NCCHTA)

100%: Patient copayment capped at 2% of patient annual income

Varies with respect to patient accumulated expenditures

Drugs classified by category

Most products reimbursed at 65%. Products for chronic/severe disease are reimbursed 100 % . 2007 average was 76.77% for retail pharmacy

Key Decision-Makers Evaluator Role Reimbursement

Drugs approved by Community Drug Schemes are100% reimbursed

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

Reimbursed medications are on a national reimbursement list: 100% for hospital pharmaceuticals; 90% for pharmaceuticals used to manage chronic illness; 60% prescription only pharmaceuticals

Branded drug price set by Pharmaceutical Price Regulation Scheme (PPRs) drug is reimbursed by NHS according to manufactuer list price