The list of reimbursed drugs, which will apply from January 1, includes immunosuppressive drugs for which patients pay a flat fee, the Ministry of Health reported on Monday, in response to concerns signaled by the communities of patients after transplantation.
The ministry explains that the new list includes generic drugs containing the same active substances (in the same form and quantity) that patients were treated so far. In the information provided to PAP, the Ministry of Health indicated that these are: Ceglar (a medicine containing the active substance valganciclovir) and Envarsus (a medicine containing the active substance tacrolimus).
The resort reminds that the equivalents are authorized on the basis of comparative clinical trials, during which it must be proven that they are absorbed at the same time and achieve the same concentration in the blood of patients as the previously registered innovative drug. The equivalents differ under the trade name under which they are sold, have different packaging, sometimes a different shape or color of the tablets, but contain exactly the same active ingredient. The Ministry of Health emphasizes that the standards of research on bioequivalence are the same, e.g. in the European Union, USA or Japan.
Patient communities, which associate people after transplantation, have expressed concern in recent days, claiming that in connection with the announcement of the “list of reimbursed drugs, foodstuffs for particular nutritional uses and medical devices”, which will come into force on 23 January next year, there have been significant adverse changes in the reimbursement of commonly used immunosuppressive and antiviral drugs for people after organ transplants.