ADOPTION OF NEW TECHNOLOGIES IN TWENTY ESTABLISHED AND EMERGING MARKETS

Author(s)

Hertz D, Marcarelli AD, Patel L, Garfield SGfK Bridgehead, Wayland, MA, USA

OBJECTIVES: The purpose of this analysis was to evaluate drivers affecting market access for new technologies in twenty established and emerging markets (Australia, Belgium, Brazil, Canada, China, Denmark, Finland, France, Germany, Italy, India, Japan, Norway, Poland, Russia, Spain, Turkey, the UK, Sweden, and Switzerland). METHODS: Health care spend, government debt ratio, financing structure and regulatory policy were examined relative to their impact on market access. Comprehensive reviews of publicly available literature, data sources, policies and regulations were performed for each country of interest. RESULTS: Entrants to markets without an official regulatory body face stiff competition from non-standard or counterfeit comparator products. At the other extreme, some countries require substantial country-specific clinical evidence for approval, making them cost-prohibitive for smaller manufacturers . High government debt ratios were found to be predictive of increased austerity measures, which broadly have a negative impact on market access for new technologies, placing pressure on downward pricing in countries that use national fee schedules.  DRG-based systems were found to be more receptive than markets that reimbursed inpatient facilities through annual global payments.  The likelihood of a medical device receiving an HTA in any country is dependent on (1) regulatory requirements for market entry and (2) the existence of device-focused HTAs, which are not as pervasive as HTAs for pharmaceuticals. In countries where inpatient procedures are funded by global payments, hospital level reviews are more likely than a national assessment for medical device technologies.  In countries where fee-for-service dominates device reimbursement methods, HTAs at the national level are more common. CONCLUSIONS: Basic drivers of market access, such as health care spend, financing structure and regulatory policy create both independent and interdependent mechanisms that support access to new device technologies. Consideration of country level conditions and hurdles will inform device manufacturers’ differential strategies to enter established and emerging markets.

Conference/Value in Health Info

2012-11, ISPOR Europe 2012, Berlin, Germany

Value in Health, Vol. 15, No. 7 (November 2012)

Code

PHP195

Topic

Health Policy & Regulatory

Disease

Multiple Diseases

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