Sur Croatia

The new EU Pharma legislation draft intends to incentivize companies to reach more patients within the EU.

Leverage Croatia’s strategic location as a gateway to the Southeast European market.

Consider using Croatia as a hub for regional expansion.

F E A T U R E S

Market Access for Croatia

 We provide local expert guidance for companies to enter the Croatian market.

Local Presence

We act as your representative Croatian office to establish a local presence and facilitate market entry.

Stakeholders

We have established relationships with key stakeholders, healthcare providers, pharmacies, and regulatory authorities.

CROATIA

Pharmaceutical Market Access Overview


Croatia operates a centralized pharmaceutical pricing and reimbursement (P&R) system, primarily managed by the Croatian Health Insurance Fund (HZZO) and the Croatian Agency for Medicines and Medical Products (HALMED). Navigating this landscape is crucial for market entry and ensuring patient access to innovative therapies.


Centralized Reimbursement

  • HZZO is the sole public payer, managing the Basic and Supplementary Lists of reimbursed medicines, as well as the special List of Particularly Expensive Medicines (PSL).

Two-step Pricing Process

  • HALMED's Role: Determines the Maximum Wholesale Price (MWP) based on external reference pricing (averaging lowest prices from Italy, Slovenia, Czech Republic, and potentially Spain/France). This is re-calculated annually.

  • HZZO's Role: Determines the final reimbursement price and decides on listing, considering the MWP, therapeutic value, public health importance, and pharmacoeconomic analyses.

Aggressive Generic and Biosimilar Pricing

  • The first generic must be priced at least 40% lower than the originator's price on the HZZO list.

  • First biosimilars must be at least 30% lower than the originator. Subsequent generic/biosimilar entries trigger further price reductions.

Defined P&R Timelines

  • HALMED's MWP decision is typically within 30 days, followed by HZZO's P&R decision within 90 days for a complete application.

Managed Entry Agreements

  • Used to facilitate access for new, often high-cost medicines, especially those on the PSL.

  • MEAs (including financial caps, payback obligations, and price-volume agreements) are mandatory for PSL drugs and can also be concluded optionally for other listed products to define prices different from the list price.

Orphan Drugs & ATMPs

  • Follow the general P&R process but can propose inclusion on the PSL, where ethical aspects and significant long-term benefits are assessed.

Hospital Procurement Impact

  • Prices in hospital procurement are directly linked to HZZO list prices, and the entry of a first generic can trigger contract termination clauses for originator products in hospital supply.