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Market access for medical technologies in Scotland

A brief overview of key market access pathways and challenges for medical devices, in-vitro diagnostic tests in Scotland

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Key topics

There are two key themes describing market access for medical technologies in Scotland: 

  • Funding: inclusion of services in the List of specialist (national) services
  • Health technology assessment: obtaining recommendations from the Scottish Health Technologies Group (SHTG)

Scotland operates under the global budget principle; there is no reimbursement system in place. However, the HRG system does exist and it is not used for case-by-case reimbursement within the same territory, only for the mobility of patients between Territorial NHS Boards. Scotland uses the same HRG system as England.

Scotland has one innovative payment scheme – the Accelerated National Innovation Adoption (ANIA) pathway.

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Funding

Funding is the key aspect of market access in Scotland. While routine hospital care is organized and provided by NHS Territorial Boards (i.e., on the regional level), specialized services (which cannot be performed locally or regionally) must be specifically included in the List of specialist (national) services by the National Services Division (NSD) of the National Services Scotland (NSS). The specialist services are financed from the national budget, and not from the regional (NHS Territorial Boards) budgets.

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Health technology assessment

HTAs are performed on the national level by the Scottish Health Technologies Group, and their recommendations significantly influence the adoption of novel technologies by the healthcare providers, but also the designation of specialist services.

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Specifics for IVD tests

There is no specific reimbursement framework for in-vitro diagnostic tests. Most IVD tests are funded using a global budget principle as part of the funding of the labs.

Genetic and molecular pathology tests are regulated via the Scottish Strategic Network for Genomic Medicine (SSNGM) directories.

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