Prescription Charges in Croatia
Pharmaceutical pricing and reimbursement policies
Since 1990, the Croatian health care system has changed considerably. Reforms were undertaken to totally re-organize the health care system by introducing privatization of primary health care and institutional changes to increase efficiency and ensure accessibility and funding for health care (1-5). In 1999, the Croatian Institute for Health Insurance (CIHI), as key third-party payer, was set up (6), as well as another institution, the Agency for Medicinal Products and Medical Devices, which started to work in 2003 (7). At that time, Croatia, which had been granted candidate status for the European Union (EU) in June 2004 (8), had already been working for years on harmonizing its pharmaceutical legislation with the “acquis communautaire” (ie, accumulated legislation, legal acts, and court decisions, which constitute the body of European Union law) (7). This concerned, in particular, the regulatory framework regarding marketing authorization that is harmonized in the EU (9). Further major components of a pharmaceutical system, besides market authorization, are pharmacovigilance, pricing, reimbursement, and distribution; for all of which specific regulation is in place in most countries with a well-developed health system.
In 2009 and 2010, Croatia substantially reformed its regulation on pharmaceutical pricing and reimbursement. A maximization of “value for money” was one of the major objectives strived for in the reform.
Pricing at distribution level
Pricing at distribution level refers to the remuneration of distributors (wholesalers and retailers) for their services of handling, distributing, and dispensing medicines.
In Croatia, a statutory maximum wholesale mark-up of 8.5% of the ex-factory price is applied. The most common one is the remuneration by a regressive mark-up scheme, but a few countries have decided for the policy option of offering (dispensing) fees or charges for the services which a pharmacy performs. Such a fee-for-service remuneration can be found in Croatia, the Netherlands, Slovenia, and the United Kingdom. In Croatia, the pharmacy service fee is calculated on granting specific points for different services (eg, dispensing, accounting activities, preparation of antibiotics of oral use).
Pharmacists in Croatia are allowed to substitute a prescribed medicine with a product of the same or cheaper price if the prescribed one is not on the market. However, the reference price system, which is in place in Croatia, might motivate patients to ask for the least expensive alternative, as the CIHI always pays the reference price.
In Croatia, the competent authority for reimbursement is the CIHI, which acts as major third party payer for medicines. Having been granted a marketing authorization, a pharmaceutical company may apply for reimbursement for its product at CIHI. In the reimbursement decision, the Reimbursement Committee acts as an advisory body that, following an evaluation of the application, recommends based on specified criteria if a medicine is eligible for reimbursement and on which of the two Croatian reimbursement lists it should be placed. The final decision is taken by the board of the CIHI.
Such an approach is called product-specific reimbursement, meaning that the third party payer (either a social health insurance institution or a national health service) decides about the reimbursement eligibility of a specific medicine.
Reimbursement lists and reimbursement criteria
If in Croatia a medicine is considered eligible for reimbursement, it will be put on one of the two positive lists:
• List A, which is the basic list providing 100% reimbursement of the reference price for listed products (eg, Clexane, Amlopin, Simvastatin) or
• List B, where patients are charged co-payments (eg, Fosamax, Voltaren).
Being included in the positive list does not automatically mean that the cost of the medicine will be fully covered by the third party payer. Croatia grants 100% reimbursement for selected medicines (eg, usually essential and life-saving medicines), while other reimbursable medicines are reimbursed at lower rates.
In Croatia, a key criterion for inclusion into reimbursement is clinical effectiveness, which is defined as allows: importance of the medicine from a public health perspective, its therapeutic importance and its relative therapeutic value, ethical aspects and its quality, the reliability of data, and assessment from reference sources. There is no formal HTA assessment in Croatia’s reimbursement system. All reimbursement applications for original medicines must contain a budget impact analysis in line with the ISPOR guidelines .
Reference price system
Croatia has a reference price system. A reference price system is a pharmaceutical reimbursement element in which identical or similar products are clustered in so-called reference groups. For each cluster, a maximum amount (reference price) to be covered by the third party payer is decided. The patient must pay the difference between this reference price and the actual pharmacy retail price of the medicine, in addition to any other co-payments.
In Croatia, the clustering is done based on a broad definition of a reference group, taking into consideration identical and similar products at ATC 5, 4, and 3 level. Most EU countries apply a rather strict understanding of a cluster, which is built on products with the same active ingredient (ATC 5) and even the same pharmaceutical form.
Croatia decided to take as the reference product the lowest priced product that accounts for at least 5% of the sales in the cluster, which is in line with the procedure chosen by the majority of the EU countries. Fifteen EU Member States reimburse at the level of the lowest price as well, while the remaining countries define the maximum reimbursement amount around and above the average of the prices of medicines in the group.
The reference price system is regularly updated in Croatia.
Patients have to pay out of pocket for pharmaceutical expenditure that is not covered by the state. This concerns private expenses for self-medication, but also any kinds of co-payments.
In Croatia, co-payments for medicines on the positive list B are applied. Additionally, a prescription fee of HRK 15 (around € 2) per prescription is charged for reimbursable medicines. Finally, due to the reference price system, co-payments may also occur if the patient opts for a product on List B with a price above the reference price.
Percentage co-payments are also the most common co-payment in the EU countries (21 EU Member States), as most countries apply different reimbursement rates for the products on the positive list. Prescription fees are in place in 10 EU countries. No co-payments at all (apart from those applicable under the reference price system) are charged in some regions in Italy, in the public sector in Malta, and in the Netherlands.
In Croatia, specific medicines (in particular some orphan medicines) are excluded from co-payments, since the government runs a special budget for these medicines.
In the field of distribution, the Croatian regulatory framework is partly similar to the EU countries, with regulated maximum allowed remuneration for both wholesalers and pharmacies. To remunerate pharmacies, Croatia opted for a performance-based system (fee-for-service remuneration), which is rather rare in EU countries, only seen in Croatia’s neighboring country Slovenia and – to some extent – in the Netherlands and UK. Whereas a pharmacy’s remuneration, organized as a margin scheme, is based on the prices of the medicines dispensed, a fee for service remuneration takes the broader range of pharmacy services into account.
In the current reimbursement legislation in Croatia, a budget impact analysis is asked for. A key element in the Croatian reimbursement system is a reference price system, which has been introduced in more and more countries. In fact, Croatia applies a broad definition of a reference group whereas most EU countries opted for sticking to a rather strict scope of a cluster.
In Croatia, incentives for generic promotion are not considered necessary since the Social Insurance pays the reference prices, and as a consequence most manufacturers lower their prices to avoid co-payments.
Authors: Sabine Vogler, Claudia Habl, Martina Bogut, and Luka Vončina
Notes and References
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3. Hebrang A. Reorganization of the Croatian health care system. Croat Med J. 1994;35:130–6.
4. Mastilica M, Bozikov J. Out-of-pocket payments for health care in Croatia: implications for equity. Croat Med J. 1999;40:152–9.
5. Mastilica M. Kusec S. Croatian healthcare system in transition, from the perspective of users. BMJ. 2005;331:223–6.
6. Turek S. Reform of health insurance in Croatia. Croat Med J. 1999;40:143–51.
7. Tomic S, Filipovic Sucic A, Plazonic A, Truban Zulj R, Macolic Sarinic V, Cudina B, et al. Regulating medicines in Croatia: five-year experience of Agency for Medicinal Products and Medical Devices. Croat Med J. 2010;51:104–12.
8. European Union candidate countries. Available from: europa.eu/abc/european_countries/candidate_countries/index_en.htm. Accessed: March 22, 2011.
9. Pignatti F, Boone H, Moulon I. Overview of the European regulatory approval system. J Ambul Care Manage. 2004;27:89–97