National Commission for Evaluation of Medical Devices and Health Technologies (CNEDiMTS) has been working on amending peripheral vascular implant section of the add-on reimbursement (LPPR) list since 2015.
In March 2016, CNEDiMTS issued the report and opinion, in which the following four new generic categories of peripheral vascular stents were proposed:
- Self-expanding endoprostheses;
- Balloon expandable stents;
- Self-expanding covered stents (stent-grafts);
- Balloon-expandable covered stents (stent-grafts).
CNEDiMTS confirmed that it did not observe any added benefits of one generic category of stents over the others.
Also, the following changes were recommended to already registered stents and stent-grafts:
- Keep endoprostheses for venous lesions under brand name category. Keep Boston Scientific’s Wallstent under the brand name (LPPR code 3120621). Number of characteristics of stents were provided;
- Keep endoprostheses Viatorr under brand name due to its unique design;
- Keep stent-graft Viabahn under brand name due its specific characteristics;
- Keep drug-eluting stents (Zilver PTX, Xience Prime BTK, Promus Element Plus BTK) under brand names with objective to collect complementary data;
- Move brands Xpert/Xpert PRO et Inperia Advance Carbostent under generic category Self-expanding endoprostheses;
- Cancel add-on reimbursement for a number of stents due to commercial unavailability of the products.
CNEDiMTS proposed a new version of the section of the LPPR Nomenclature in the annex to its Opinion.
Since the publication of the original Opinion, a minor amendment was published in September 2016 clarifying that objective for maintaining drug-eluting stents under brand names is monitoring the use of devices.
Recently, 11th of July 2017, CNEDiMTS issued the second amendment to its opinion with the following clarifications:
- Clarification that peripheral drug-eluting stents are not covered within generic stent category and shall be registered by brand names;
- Interventional environment shall be added to the condition for the use of stents,
- Dissection of the vessel shall be deleted from an indication for the procedure on upper extremities for LPPR codes 3131694 and code 3171535 (MTRC did not identify these codes in the LPPR List).
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