Hungary Announces Major Reforms to Named Patient Reimbursement Program
**Hungary Announces Major Reforms to Named Patient Reimbursement Program**
*Budapest, Hungary – April 2024* — The Hungarian government has unveiled a sweeping reform of its Named Patient Reimbursement (NPR) program, signaling a significant shift in how patients gain access to innovative and life-saving medications not yet approved for general use in Hungary. The changes, announced by the Ministry of Interior and the National Health Insurance Fund Administration (NEAK), aim to streamline access, increase transparency, and improve efficiency in the approval and funding of off-label or unregistered treatments for patients with urgent medical needs.
### What is the Named Patient Reimbursement Program?
The NPR program is a regulatory mechanism that allows physicians to request access to medications that are not yet reimbursed or authorized in Hungary for specific patients. This is typically used in cases where no alternative treatment options are available, and the patient’s condition is severe or life-threatening. Under the current system, physicians submit a detailed application to NEAK, which evaluates the clinical justification and cost-effectiveness of the requested treatment before granting or denying reimbursement.
### Key Reforms Announced
The reforms, set to take effect in July 2024, include several major changes:
#### 1. **Digitalization and Centralized Application Portal**
NEAK will launch a new digital platform to manage NPR applications. The portal will allow physicians to submit, track, and manage requests online, replacing the current paper-based system. This is expected to significantly reduce processing times and administrative burdens.
#### 2. **Faster Decision Timelines**
Under the new rules, NEAK will be required to issue a decision within 15 working days of receiving a complete application—down from the current average of 30–45 days. In urgent cases, such as those involving terminal illnesses or rapidly progressing conditions, decisions must be made within 5 working days.
#### 3. **Expanded Eligibility Criteria**
The revised program will broaden the scope of eligible conditions and patient groups. Notably, rare disease patients and pediatric cases will receive prioritized consideration. Additionally, the reforms will allow for earlier access to medications that have received conditional approval from the European Medicines Agency (EMA) but are not yet reimbursed in Hungary.
#### 4. **Transparent Pricing and Budget Allocation**
To address concerns over cost variability and lack of transparency, NEAK will publish anonymized data on approved NPR cases, including drug names, indications, and reimbursement costs. A fixed annual budget will also be allocated specifically for NPR cases, with quarterly reviews to ensure sustainability.
#### 5. **Clinical Advisory Board**
A new multidisciplinary Clinical Advisory Board will be established to support NEAK in evaluating complex or high-cost cases. The board will include experts in oncology, rare diseases, pharmacoeconomics, and patient advocacy, ensuring a more holistic and evidence-based approach to decision-making.
### Government and Stakeholder Reactions
Dr. István Takács, Deputy Minister for Health Policy, emphasized the importance of the reforms: “These changes are about putting patients first. We are committed to ensuring that Hungarian citizens have timely and equitable access to the most advanced therapies, especially when no other options exist.”
Patient advocacy groups have largely welcomed the reforms. Anna Szabó, president of the Hungarian Rare Disease Association, called the changes “a long-overdue step toward fairness and transparency,” though she cautioned that “implementation will be key.”
Pharmaceutical companies have also expressed cautious optimism. The Association of Innovative Pharmaceutical Manufacturers (AIPM) noted that the reforms could improve predictability and foster earlier dialogue between regulators and industry.
### Challenges and Next Steps
While the reforms are ambitious, experts note that successful implementation will require significant investment in digital infrastructure, staff training, and inter-agency coordination. There are also concerns about how the fixed budget will be managed if demand for NPR cases increases.
NEAK has announced that it will conduct a public consultation period in May 2024, inviting feedback from healthcare professionals, patient organizations, and industry representatives. Final implementation guidelines are expected to be published in June.
### Conclusion
Hungary’s overhaul of its Named Patient Reimbursement program marks a pivotal moment in the country’s healthcare policy. By modernizing the application process, expediting access, and enhancing transparency, the government aims to better serve patients with urgent medical needs while maintaining fiscal responsibility. As the reforms roll out, all eyes will be on their real-world impact—and whether they can serve as a model for other countries in Central and Eastern Europe.