Core Markets
Why global markets matter:
All major medical device manufacturers recognize the significance of International markets outside of the United States for future growth and early product launch. Hull Associates specializes in helping its clients navigate the market access and reimbursement challenges of the major markets outside of the United States – whether it’s a breakthrough product launch by a major manufacturer, or a second market entrant by a start-up firm, we understand medical devices and the challenges they face in securing reimbursement.
Australia: Australia was among the early adopters of a case mix system of reimbursement for hospital care, but it also maintains pricing controls for a range of implantable medical device products in the private hospital sector. At the same time, home use and disposable products sometimes struggle to achieve premium pricing as a result of inadequate reimbursement systems in the community sector.
Belgium: The centralized INAMI/RISIV committees in Belgium control market introduction and pricing for the majority of innovative medical device products. Navigating this process requires a true “insiders” knowledge of the INAMI/RISIV timetables and perspectives, in addition to substantial evidence of incremental benefit.
Brazil: Brazil remains a dynamic, and increasingly challenging market for medical device products. Though private insurers have long played a role in covering high-tech medical devices, the emerging policies of ANVISA may soon impose price controls, based on multiple overseas market prices, on the Brazilian market. Companies entering this market will require sophisticated pricing strategies, in addition to the right distributor relationships, often at a regional level.
China: Chinese healthcare is in the midst of a major transition, and the oversight and control of medical device prices is among the issues slated for revisions. While a majority of products are paid outside of fixed reimbursement for hospital care, recent proposals have been tabled for national price listings, in addition to similar activities of the major urban areas.
France: With the largest healthcare deficit in Europe, and among the most centralized processes for reimbursement, France poses some of the hardest challenges for introduces innovative products. The listing of novel physician procedures is known to suffer from very lengthy delays, in some cases of 5 years or more. Companies navigating the French landscape must understand the internal views of decisionmakers in multiple committees and be prepared to offer them targeted evidence.
Germany: Europe’s most efficient DRG payment system, combined with well organized buying groups, has produced extreme pressure for many product categories in German hospitals. At the same time, mechanisms for supplemental payment for innovative technologies have been bolstered by recent legislation, so that innovative devices that fit certain criteria can receive supplemental payments, based on locally negotiated prices.
Italy: The Italian hospital DRG system, which is based on the US Medicare DRGs, is adapted locally by each of Italy’s 21 autonomous regions. The addition of supplemental payments, and new ICD-9 procedure codes, is possible in each region, though only about half the regions actually exercise this authority. As a result, there are few prospects for additional reimbursement at a national level – and locally-tailored campaigns must be deployed.
Japan: The Japanese by-function system of product categories tightly controls the reimbursement pricing available to a broad range of medical device products. Every two years, this category system is reviewed, and prices are adjusted, to eliminate excess profits by hospitals and clinics. In addition, Japan also applies a framework of foreign reference pricing, which may result in drastic cuts to existing product categories and adjustments of payments for new products.
Spain: One of Europe’s most pluralistic markets, the rise of private insurers in Spain can play an important role in the introduction of novel technologies. At the same time, Spain’s autonomous regional health authorities each may take different approaches toward a new technology – so local strategies are essential. In most regions, hospital funding is capped with fixed, annual budgets. In others, supplemental payments are offered for selected technologies.
United Kingdom: From the NICE review process to the workings of the Payment by Results reimbursement system, companies must understand a full range of evidence requirements, time lines for coding requests, and support of local pass-through arrangements for hospital products.
