If you are a manufacturer, distributor, or user of medical devices in France, you might have heard of the intra-GHS list. But what is it exactly and how does it affect the market access and reimbursement of medical devices in the country? In this blog post, we will explain the basics of the intra-GHS list, its purpose, its process, and its recent updates.
What is the intra-GHS list?
The intra-GHS list is a list of medical devices that are financed within the hospital tariff (GHS) in France but require an evaluation by the National Authority for Health (HAS) to ensure their safety, effectiveness, and efficiency. Only devices that are on this list can be purchased and used by hospitals. The list is updated regularly and the latest version was published on January 16, 2024. The intra-GHS list covers devices that belong to certain categories of products that are considered invasive or risky for human health. These categories are determined by the ministers of health and social security and include, for example, implantable devices, neurostimulators, cardiac assist devices, and endovascular prostheses. The evaluation by the HAS is based on clinical data, technical specifications, and comparison with alternative treatments. The HAS assesses the devices according to four criteria: safety, clinical benefit, improvement of the quality of life, and efficiency. The HAS also takes into account the opinions of patients, healthcare professionals, and health economists. Based on the evaluation by the HAS, the ministers of health and social security decide whether to include or exclude the devices from the intra-GHS list, by issuing an order published in the Official Journal. The devices that are included on the list are then financed by the hospital tariff, which is a fixed amount paid by the health insurance for each hospital stay, regardless of the actual costs incurred.
Why is the intra-GHS list important?
The intra-GHS list is an important mechanism for the regulation and reimbursement of medical devices in France, as it aims to ensure that only devices that have proven their value are financed by the public health system. The intra-GHS list also provides an incentive for innovation, as it encourages manufacturers to generate clinical evidence and demonstrate the added value of their devices compared to existing alternatives. The intra-GHS list also has implications for the market access and competitiveness of medical devices in France, as it affects the availability and affordability of the devices for hospitals and patients. The devices that are on the intra-GHS list can be purchased and used by hospitals without any additional cost, while the devices that are not on the list have to be funded by other sources, such as hospital budgets, patient co-payments, or private insurance. This can create barriers and inequalities in the access and use of medical devices, especially for those that are innovative, expensive, or rare.
What are the recent updates on the intra-GHS list?
The intra-GHS list is constantly evolving, as new devices are added, removed, or modified, based on the latest evidence and decisions. The most recent version of the intra-GHS list was published on January 16, 2024, and it contains 95 devices, divided into 12 categories. Some of the major changes introduced in this version compared to the previous one of August 2021 are:
- The inclusion of two new devices: PENUMBRA JET 7 MAX (STA012), a revascularization device for acute ischemic stroke, and AXS Infinity LS (STA013), a long sheath for neurovascular access.
- The exclusion of one device: PENUMBRA JET 7 (STA007), a revascularization device for acute ischemic stroke, due to safety concerns and lack of clinical benefit.
- The modification of the reimbursement rates for some devices, such as PENUMBRA ACE60 (STA004), PENUMBRA ACE68 (STA005), PENUMBRA 3MAXC (STA006), PENUMBRA JETD (STA008), PENUMBRA RED62S (STA011), PENUMBRA RED68 (STA011), and PENUMBRA RED72 (STA011), which were increased from 50% to 100% of the hospital tariff.
More changes are expected at the end of March 2024, as some devices are currently undergoing a renewal process of their inclusion on the intra-GHS list. The devices that are subject to this process are:
- AXS Catalyst 5 (STA010), AXS Catalyst 6 (STA010), and AXS CATALYST 7 (STA010), which are aspiration catheters for acute ischemic stroke.
- AXS Vecta (STA009), which is a distal access catheter for neurovascular procedures.
The renewal process involves a re-evaluation by the HAS based on the latest clinical data and the opinions of stakeholders. The HAS will issue its recommendations by the end of February 2024, and the ministers of health and social security will decide whether to renew or not the inclusion of these devices on the intra-GHS list by the end of March 2024.
Conclusion
The intra-GHS list is a key element of the French healthcare system, as it regulates and reimburses the medical devices that are financed within the hospital tariff. The intra-GHS list aims to ensure the quality, safety, and efficiency of the devices, as well as to promote innovation and value-based healthcare. The intra-GHS list also has an impact on the market access and competitiveness of the devices, as it affects their availability and affordability for hospitals and patients. The intra-GHS list is constantly updated, based on the latest evidence and decisions, and it reflects the dynamic and complex nature of the medical device sector in France.