On December 23rd, 2016 draft Order of the Ministry of Health "On Approval of the Procedure for Determining the Cost of Medicines Reimbursement Amount" was published on the website of the Ministry of Health of Ukraine for public comment.
Cost of medicines included in the list of 21 International Non-Proprietary Names (INPN) for hypertensive diseases, bronchial asthma and diabetes of the second type treatment approved by Resolution of the Cabinet of Ministers of Ukraine No. 863 as of November 9th, 2016 is subject to reimbursement.
The key aspect is the division of all medicinal products that are subject to reimbursement under Resolution of the Cabinet of Ministers of Ukraine No. 863 as of November 9th, 2016 into 2 groups as follows: the cost of which is reimbursed in full and the cost of which is not subject to reimbursement.
The draft stipulates that the price of the medicines, gross wholesale price of which per unit of a form of a prescribed dosage is in the range between the maximum gross wholesale price and the minimum gross wholesale price, will be reimbursed, which is price for the medicines of 1 group.
The minimum gross wholesale price is the cost of one unit of a form of prescribed dosage of a medicinal product included in the INPN List, which is determined in accordance with this procedure based on internal reference pricing excluding supply and sale, and trade (retail) markups.
This maximum gross wholesale price is determined through external referencing. You will recall that the draft of the procedure was also published for public comment, however, it is not yet adopted. The procedure determines that the maximum gross wholesale price is the lowest price in the reference countries.
Thus, if the price of a medicine is between the minimum and maximum gross wholesale price, it will be 100% reimbursed. The rest of the medicines included in the List of 21 INPN, the price of which is beyond these limits, are not subject to reimbursement.
It should be noted that the price subject to reimbursement will be determined per unit of a medicinal product. Full cost of the package subject to reimbursement will be calculated by multiplying the cost of such one unit by the number of units in the package.
In order to include a medicinal product trade name in the Register of Reimbursement, an owner or authorized representative of the owner of the registration certificate for the medicinal product will have to file with the Ministry of Health the documents, the list of which is stipulated in the Procedure and is exhaustive.
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