Country in Focus: Croatia
Croatia is a CSEE country at the crossroads of the Central and Southeast Europe, next to the Adriatic Sea. It gained independence in 1991 and has been a member of the EU since 2013. Croatia's economy has been strongly evolving and is dominated by service, industrial sectors, and agriculture.
Croatia is ranked as one of the most popular tourist destinations in the world, generally recognized by the beautiful Adriatic Sea coastline. Tourism accounts for up to 20% of Croatian GDP.
The currency is Croatian kuna, however, Croatia is working seriously and intensively to create the prerequisites for its admission to the euro area.
Medis in the Croatian Pharma Market
Medis, a leading commercialization partner in the CSEE with HQs in Slovenia, opened a Croatian affiliate in 1995. The Croatian affiliate is our second biggest subsidiary, with 55 employees and expected € 33 million sales in 2019 (30% of Total). Croatia presents our fastest growing market in the region.
Today, Medis is among the top 20 pharmaceutical companies in the Croatian pharma market. Core focus areas are CNS/orphan, Pulmonology and Rheumatology, Ophthalmology, ICU, Pediatrics, and OTC.
The value of the pharma market in Croatia is € 972 million and is slowly growing, mainly due to the implementation of innovative therapies. Price pressure and constraints are ongoing, however, Medis has managed to navigate successfully through this specific challenging environment.
Most of the commercialization activities in Croatia – regulatory, distribution, quality, marketing, medical and safety, are closely coordinated and supported from the Medis HQ in Ljubljana to ensure a smooth launch and availability of medicines on the Croatian market. Additionally, local marketing, medical and regulatory teams back up the growth of the Croatian business. Strong and highly motivated local sales field team consist of 30 people and is responsible for the implementation of the strategic activity plan on the field.
Health Insurance System
The main payer in Croatia is the Croatian Health Insurance Fund (CHIF). Private insurance companies offer some additional services, such as partial reimbursement of the hospital costs. The pharmaceutical industry is involved in the risk-sharing policy through a special agreement with an existing version of the payback contracts for the expensive drugs.
Agency for Medicinal Products and Medical Devices of Croatia (HALMED) determines the maximum allowed prices of Rx medicines in Croatia since 2019. Prices are calculated based on prices set in three main reference countries ‒ Italy, Slovenia and Czech Republic (Spain, France being backup countries) and are recalculated annually, in March/April every year. Reimbursed price is defined and funded by the CHIF.
For a longer period, the health care system in Croatia has been showing negative trends in cash flow and year after year has generated substantial losses. As a consequence, the CHIF has been paying to pharmacies and hospitals with delay, which led to a substantial delay in hospital payments towards wholesalers. The most recent data suggest that some hospitals were delaying in payment for more than two years and that financial debts of all hospitals in Croatia towards wholesalers have exceeded $ 400 million. Medis as one of the biggest players on the market has been successfully navigating this critical issue, however, great pressure remains.
The Reimbursement Procedures and Timelines
The reimbursement procedure in Croatia usually takes around 15 months and is governed by the HIF. Price constraints and cost cuts apply. Co-payment up to € 15 per prescription is a common practice. The entrance barrier through health insurance remains accessible, which means that more expensive medicines are also eligible for reimbursement.
Medis’ Recent Market Access Achievements
Medis has a proven track record of finding innovative market access solutions also in Croatia. Some of the latest reimbursement success stories include:
- Reimbursement for an orphan medicine, the first treatment approved for the underlying cause of muscular dystrophy. We are very proud that we managed to draw the attention of the HIF to this debilitating disease and promptly arranged availability to patients in need.
The initial reimbursement decision covering the pediatric population was later extended also to the adult population. The excellent stakeholder management, backed up with close cross-functional collaboration and local knowledge, have led to accelerated approval of this breakthrough medicine.
- Reimbursement of an innovative medicine indicated for multiple sclerosis backing up multiple choices in the treatment of this devastating disease. The process was concluded in less than 6 months, which is extraordinary fast for the Croatian environment.
- Accelerated funding approval of novel treatment option for pulmonary arterial hypertension through special Hospital Budget.
- Reimbursement of the first and currently the only approved therapeutic option for treatment of severe keratitis in patients with dry eye disease. After longer negotiations and strong support from the HCP community, we succeeded with targeted price and outcome.
- Enabling access to innovative treatment for severe dystonia patients, later extended also to spasticity.
- Reimbursement of innovative combination therapy for glaucoma suffering patients despite the very competitive market place.