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Although the European Union’s medical device approval process applies uniformly across all member states, obtaining reimbursement for a medical device varies from country to country. Whether a medical device qualifies for reimbursement depends largely upon the health care policies of a particular government. Sometimes the reimbursement process varies within a country. England’s reimbursement process differs from that of Wales, Scotland and Northern Ireland – all part of the UK.
As part of the broader UK territory, England represents one of Europe’s largest medical device markets. Breaking into the UK market means not only a successful CE Marking effort, quality system compliance and adequate distribution network, but also the ability to meet the requirements of the country’s reimbursement system.
The United Kingdom’s National Health System (NHS) oversees most of England’s health care system. The NHS is made up of smaller trusts that manage health care on a regional level. Another entity indirectly involved in the reimbursement process is the National Institute for Health and Clinical Excellence (NICE), which among other services provides health technology purchasing recommendations based upon clinical performance and cost-effectiveness.
Emergo Group’s consultants in Europe can fully support you in obtaining the maximum reimbursement level possible under England’s regulatory system. We can assist you in two ways as shown below.
Emergo Group’s Reimbursement Roadmap service is available for clients unfamiliar with England’s reimbursement system. Our Reimbursement Roadmap offers a review of England’s health care reimbursement process, as well as how national and regional health policies can affect reimbursement schedules and rates. The following components make up our Reimbursement Roadmap service:
Our Reimbursement Assessment service is designed for clients who are already somewhat familiar with England’s reimbursement process and are ready to develop medical device reimbursement strategies. Emergo Group can customize this service to align with your specific requirements. Reimbursement Assessment packages typically include:
Emergo Group’s European consultants are well-versed in negotiating the complexities of England’s medical device reimbursement system, and can assist you in meeting requirements and obtaining reimbursement for your device quickly.
Emergo Group can also conduct literature reviews of English HTAs as well as other health care policies and procedures related to the English market’s reimbursement processes. This service includes reviews of existing clinical literature that can be used to support your effort to obtain appropriate reimbursement by highlighting how the NHS reimburses manufacturers of similar devices. Along with England, Emergo Group can also support your reimbursement efforts in France, the Netherlands, Germany, Norway, Denmark and Sweden.