Savings could be made with more generic drugs on the Croatian market

August 16, 2022 – Replacements of some drugs are expected to hit the Croatian market as cost savings become extremely necessary in the weakened Croatian healthcare system.

As Poslovni Dnevnik/Josipa Ban writes, counting the pennies in the wider Croatian healthcare system, especially in the consumption of medicines, is now more necessary than ever. We have been witnessing for decades accumulated debts for medicines which, after numerous attempts at rehabilitation by the Ministry of Finance, are still far from being reduced. In fact, they only increased enough to reach just over six billion kuna at the end of April this year.

HUP – the Pharmaceutical Manufacturers Association has been warning about some of these debts for some time, noting that they can certainly be reduced. The annual savings of the Croatian healthcare system could increase from the current 300 million to one billion kuna if consumption were to increase and if the procedure for including generic drugs in the HZZO drug list for the Croatian market was finally accelerated.

Some substitute drugs enter the Croatian market when the original drug’s patent rights expire. As bringing them to the Croatian market means more competition, the price of the drug also drops at the same time. The situation here, at least according to 2019 data, is that 61% of the volume of prescription drug consumption in the Republic of Croatia is generic drugs, and they only account for 5% of total healthcare. sector budget.

“Although this percentage has increased over the years, it is still a bit below the EU average of 67%. This shows us that there is still great potential for the use of medicines generic in this country,” they pointed out. of HUP – the Association of Drug Manufacturers, whose members invested a total of 5.4 billion kuna between 2010 and 2020. With regard to biosimilar drugs, the situation is much worse, and in 2019 they occupied a modest 13% of the Croatian market.

A complicated process…

One of the reasons for the low uptake of generic and biosimilar drugs, which leads to higher spending on these drugs, is the process manufacturers must follow to get on the HZZO drug formulary.

Jerko Jaksic, chairman of the board of directors of PharmaS and president of the HUP association of drug manufacturers, explained that the process of bringing a generic drug to the Croatian market takes about one to two years.

“The first step is the registration of the medicine with HALMED or, for biosimilar medicines, with the European Medicines Agency (EMA). After approval by HALMED or EMA, it takes up to six months at HZZO to get drugs on their list. Although it’s a bit better than it was a decade ago, this part of HZZO could and should be accelerated, what I mean by that is is that after the approval of HALMED and EMA, these drugs should automatically be included in the drug lists, without any additional administrative steps because there is no need for them. Unfortunately, here too, we have an example of resistance to changes and adaptation of the system, as well as the classic slowness of administration,” stressed Jaksic, adding that the automatic inclusion would speed up the processes and the arrival of medicines on the Croatian market, while like drug therapies less expensive services for patients in three to six months.

“It would also bring savings of several tens of millions of kuna at the annual level for the entire Croatian market,” said the Chairman of the Board of Directors of PharmaS. HUP noted that the role of generic and biosimilar medicines is extremely important both for the healthcare system and for the patients themselves.

“In fact, these drugs are making many key therapies available to more patients, and at the same or lower cost than before they were introduced. For example, two to three boxes of prescription drugs dispensed in Croatia come from the generic industry, and the Share of generic drugs in the cost of all drugs is only 27%.If we look at the pharmaceutical system, the share of generic drugs is 65%, and this represents less than 40% of the drug budget,” they explained.

Great potential

In addition to all the above, there is no fear for the patient because prescription drugs and generic drugs are the most organized part of the healthcare system. Jerko Jaksic noted that their importance has long been recognized by general practitioners. However, hospital doctors have yet to follow suit.

“Hospital doctors have a lower level of knowledge of generic and especially biosimilar therapies, they also lack a developed awareness of the financial savings they can allow. There is great untapped potential here, especially in the sense of use cheaper generic and biosimilar therapies in order to reduce costs for hospitals,” Jaksic said.

There are therefore several mechanisms that we need to change in order to speed up the introduction of generic and biosimilar medicines on the Croatian market, and thus contribute to significant savings.

“There is a need to consistently implement existing regulations for drug pricing, to include generic drugs on the HZZO drug list more quickly, and to enable faster penetration of generic and biosimilar drugs into the system. hospital in the broad sense,” said the HUP association. of drug makers believes.

With these measures, together with measures of treatment outcomes, they say, savings in the healthcare system can reach up to 1 billion kuna per year. So the ruling party has a solution. But is the will there?

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