For MZ SR:
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state Secretary Doc. MUDr. Andrea Kalavská, PhD., MHA
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director-General of the Pharmacy and Drug Policy Section Dr Adam Hlôška
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director of the Division of Classification, Pricing and Medicine PharmDr. Rastislav Pullmann
For Izomedact, s.r.o.:
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PharmDr. Pavel Vizner
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PharmDr. Faith Vizner
The meeting took place at the request of the company representatives Izomedact, s.r.o., who asked for a meeting regarding the increase of the official the determined prices of 99mTc/99Mo generators.
The meeting was opened by State Secretary Doc. Dr. Andrea Kalavská, PhD., MHA
Isomedact, s.r.o.:
Izomedact, s.r.o. is a supplier of radiopharmaceuticals Mallinckrodt Medical BV Mallinckrodt Medical BV, holder of registration of Ultra-TechneKow FM radiopharmaceutical (99mTC generator) urges price increases due to significant increases in entry costs for the production of technetium generators. Mallinckrodt Medical B.V. plans to increase prices of 99mTc/99Mo generators by about 35% which is contrary to Slovak legislation allowing maximum 5% increase in the price of the product in the calendar year. Mallinckrodt Medical B.V. makes efforts to maintain the prices of radiopharmaceuticals at the same level. For Their prices have not increased in recent years. The cost of producing Mo-99 is significantly they will increase and therefore the price of these radiopharmaceuticals will need to be increased for the final customer (nuclear medicine centres).
The main reason for the increase is the global shift in production from Highly enriched uranium (HEU) for enriched uranium (LEU). Additional costs linked to production and also lower yield forces production companies to increase price 99mTc/99Mo generators.
Izomedact, s.r.o. pointed out the necessity price increases for technetium generators due to continuous provision supply of UTK generators for nuclear medicine workplaces.
MZ SR:
He asked Izomedact s.r.o. to inform the holder Mallinckrodt Medical B.V. on current legislation options for dealing with an application for an increase in an officially determined price.
The Ministry informed whether it is possible to reduce the assumed an increase in prices declared to 35%. He was wondering since he planned the holder of the registration authorisation to increase the prices of UTK generators.
The registration holder must proceed with the price change in accordance with existing legislation. The proposal for an official price of the medicinal product cannot exceed the European the reference price of the medicinal product. According to § 2 letter. f) Act 363/2011 Z.z. o scope and conditions for reimbursement of medicinal products, medical devices and dietetic foods for on the basis of public health insurance and amending certain laws as amended, the European reference price for the medicinal product shall be understood as average of the three lowest prices among the official drug prices in the other Member States; if the medicinal product has an officially fixed price in only one of the other Member States the official price of the medicinal product in that State; if the medicinal product is officially priced at two of the other Member States, average prices in those Member States.
The sitting was closed by State Secretary Doc. Dr. Andrea Kalavsky, PhD., MHA.
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She wrote: |
Judita Janek |