New innovative drugs on reimbursement list by late 2016? - No new therapies in Serbia for years, possible solution in special contracts

Of the new innovative pharmaceutical drugs which have appeared in the EU countries since January 1, 2010, only one is covered by health insurance in Serbia.

The study on possible ways to increase the efficiency of the healthcare system in Serbia, which was initiated by AmCham Serbia in cooperation with the Ministry of Health last year, shows that Serbia has nearly 9 times fewer new innovative pharmaceutical drugs compared to Italy, Slovenia, Croatia and Bulgaria (reference countries for drug prices). Since 2007, twelve new innovative drugs have been put on the list in Serbia, compared to 133 in Italy, 148 in Slovenia, 62 in Croatia and 83 in Bulgaria.

The Association of the Manufacturers of Innovative Drugs INOVIA says that the reimbursement list hasn't been updated with new drugs for 4 to 5 years, which is why there's a lack of modern innovative therapies in nearly all areas. The member-companies of INOVIA currently have more than 180 unresolved requests for putting drugs on the reimbursement list, whether it's new drugs or new indications. Some of these requests are more than 6 years old.

According to the National Health Insurance Fund (NHIF) data, the last time an innovative drug was put on the reimbursement list was early 2014, an A-list drug for treatment of HIV. The C-list, which contains drugs dispensed through special procedures, hasn't been updated since late 2012.

Special contracts making up for insufficient funds

The annual budget of the NHIF for all drugs amounts to around EUR 360 million, which is only around EUR 50 per resident of Serbia, which places us at the bottom of the list of European countries. Nevertheless, Bojan Trkulja, the president of INOVIA, says for our portal that the low percentage of the state budget which is spent on drugs does make it more difficult to implement modern therapies, but can't be the only reason why innovative therapies haven't been available to patients in Serbia for years. The data from the countries of the region, which have no problem with availability of innovative drugs, and which don't invest much more than Serbia in the field, show that health insurance holders could get a larger number of modern innovative therapies even with the current amount of investments.

– The financial plan for 2016 contains an item of around RSD 900 million meant for updating the list with new drugs, but none of it has been spent yet, even though it's already September – Trkulja says.

The NHIF has been saying for a long time now that they are aware of the need to include innovative drugs on the reimbursement list, but they also point out that such therapies require significantly larger budget expenditures. As the price of an innovative drug ranges from tens of thousands to hundreds of thousands of dinars, they expect to reach an agreement with pharmaceutical companies on the model of special contracts, which is envisioned by the rulebook on putting pharmaceutical drugs on the reimbursement list from April 2014.

The purpose of these contracts is to have drug manufacturers or marketing permit holders shoulder a part of the expense of the procurement of a drug financed by the NHIF. In the past two and a half years, several initiatives have been started in order to popularize special contracts. A work group was formed and both sides were happy to announce that the first contracts would be signed in June. The two models offered by the NHIF, however, proved to be unacceptable to manufacturers, which then proposed minimal changes which needed to be made.

The main problem, Trkulja says, is the lack of predictability as the crucial element of such contracts, because “the models offered protect the interests of one party very well, but in turn fail to define in any way what drug manufacturers' obligations are”.

– According to the models offered, the manufacturers' obligations could be several times larger than the agreed amount – Trkulja emphasizes and adds that, even though there are certain indications that the requested changes might take place, it's a great pity that so much time has been lost.

– If the state is truly willing to do this, the question of models for special contracts could be solved very quickly, and with the decisions made by the expert commissions of the NHIF, expected in the weeks ahead, we might get the first innovative drugs after many years before the end of 2016.

Prioritization criteria needed

Our interviewee reminds that special contracts can't be the only way of introducing innovative drugs to the reimbursement list, as it is not the case in European countries either, so the NHIF has the opportunity to provide health insurance holders with these drugs soon, certainly before the year ends.

The chairperson of the Healthcare Committee of AmCham Serbia, Sandra Marinkovic, agrees with this. What's missing, she emphasizes, is a concrete prioritization criterion.

– Maybe Serbia can't afford all innovative drugs, but there need to be clear criteria for deciding which therapies or drugs are the country's priority and the first ones to be available to patients.

Marinkovic adds that reimbursement procedures for new innovative drugs in the market need to be simplified, since this kind of therapy can significantly reduce other healthcare expenses.

– Introducing these drugs doesn't necessarily mean increasing expenses. On the contrary, in addition to improving patients' general condition and extending their lives, the use of innovative therapies reduces expenses in other segments of healthcare. It shortens hospital stays, reduces the number of sick leaves, prevents further complications requiring expensive surgical procedures and so on – Marinkovic says.

By increasing efficiency and improving the safety profile, which in turn leads to better treatment outcomes, innovative drugs cause significant advancements in modern medicine. Research shows that standard therapies for oncology patients extend life by 6 to 9 months, whereas innovative therapies can extend life to up to three years.

LONCAR: innovative drug commission formed

Minister of Health Zlatibor Loncar stated last week that the government's commission for innovative drugs had been formed with the aim to put innovative drugs on the reimbursement list of the NHIF.

– The commission has been formed which will be systematically introducing innovative drugs to the reimbursement list by 2020 – Loncar said and added that the aim was to make people in Serbia realize that prevention is the foundation of successful treatment.

Ivana Bezarevic

Udruženje proizvođača inovativnih lekova INOVIA

Republički fond za zdravstveno osiguranje Beograd

Ministarstvo zdravlja Republike Srbije

Američka privredna komora u Srbiji AmCham Serbia

The Association of the Manufacturers of Innovative Drugs

INOVIA

National Health Insurance Fund

NHIF

innovative pharmaceutical drugs

NHIF reimbursement list

study on possible ways to increase efficiency of healthcare system in Serbia

AmCham

Ministry of Health

Sandra Marinkovic

innovative drugs covered by insurance

Zlatibor Loncar