Could a competent person comment on how these documents relate to the future availability of Elvanse in Poland?
https://bipold.aotm.gov.pl/index.php/zlecenia-mz-2023/1005-materialy-2023/8035-28-2023-zlc
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Olga Sierpniowska Pharmacist, Editor
7 months ago
The linked documents refer to the issue of reimbursement of the price of Elvanse imported from abroad as part of the target import (on the demand of a specific patient through a special procedure):
https://www.gdziepolek.pl/artykuly/import-docelowy-jak-sprowadzic-lek-z-zagranicy
They are not a valuation in preparation for the inclusion of Elvanse in the list of reimbursable medicines and, in my opinion, do not have a direct impact on whether the marketing authorisation holder wants to extend the regular distribution of Elvanse in Polish. A positive opinion on the reimbursement of target imports is, of course, a "plus" if in the future the manufacturer wants to sell its drug in Poland at a discount, but from the company's point of view, business and logistical aspects are undoubtedly important - in particular, the amount of demand for the product, etc.
In the analysis of the economic problem, AOTMiT (the cited documents) stated that "in the period from May 2021 to March 2023, 30 approvals were issued for reimbursement of the medicinal product Elvanse for 11 patients in the evaluated indication, and the total amount of consents for reimbursement amounted to approx. PLN 57 thousand (114 packages were imported)". There is no information on how many patients imported the drug as part of the target import without applying for reimbursement.
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