The changes were introduced through a decree published on April 17 and took effect, in the main, from May 1. They amend reimbursement and specialist-care financing rules, extending state support to therapies used across immunology, dermatology, gastroenterology, hematology and oncology.
The package includes new or expanded access to medicines containing active substances such as upadacitinib, risankizumab, guselkumab, filgotinib, mirikizumab, bimekizumab, dupilumab, anifrolumab, pirtobrutinib, blinatumomab, zanubrutinib, osimertinib and tislelizumab. The covered conditions range from inflammatory bowel disease and severe skin disorders to systemic lupus, blood cancers and lung cancer.
The decision does not mean that every medicine became immediately available to every eligible patient on publication. For newly included hospital medicines financed through itemized reimbursement, implementation may depend on procurement, contracts and the designation of authorized institutions. The decree states that the provisions must be applied once a successful procurement contract enters into force, and no later than the first day of the fourth month following the rules’ effective date.
The expansion is significant for patients whose treatment options were restricted by reimbursement criteria or the absence of routine public funding. It should not, however, be interpreted as the introduction of 83 entirely new medicines or as evidence that the listed diseases were previously untreatable. The figure combines new active substances with fresh or modified indications for products already used in other settings.
AIPM says it cannot yet quantify the annual budget impact because access does not become automatic after a reimbursement decision, meaning both the therapeutic and financial effects will emerge over time. It expects 2027 to be the first full year in which the impact can be assessed and believes the treatment pathways of tens of thousands of people could change.
The association cautions, however, that many of the 83 entries are indication extensions and that some patients were already receiving the medicines through case-by-case reimbursement, with the new arrangements mainly simplifying administration.
Hungary uses health technology assessment, price negotiations and reimbursement criteria to determine which medicines receive public funding. AIPM says risk-sharing agreements are becoming increasingly important for high-cost medicines, although the contracts are confidential. It argues that the National Health Insurance Fund (NEAK) can use such agreements effectively only if it has adequate staff and financial resources to design and monitor them, and says the industry supports strengthening the payer institution.
“Every new active substance admitted into reimbursement represents hope and the possibility of recovery for Hungarian patients, which is why supporting innovation is a shared social interest,” says Dr. Katalin Szalóki, director of AIPM Hungary. “At the same time, technological progress and international practice both show that a step like this should not be a one-off event after several years, but part of a predictable, legally defined and regular process.”
The association argues that regular decisions would improve planning for patients, providers, the state and pharmaceutical companies. Predictability could also reduce pending applications, although a faster process would still need to preserve evidence standards and budget controls.
Hungary’s reimbursement debate sits within a wider European problem. Data published by the European pharmaceutical industry in June indicated that newly approved medicines now take an average of 597 days to become available to patients across Europe, compared with 504 days in 2019.
Those figures come from EFPIA, the European pharmaceutical industry federation. They underline that European Medicines Agency authorization does not automatically produce funded access, because national pricing, reimbursement and implementation remain separate stages.
EFPIA president Stefan Oelrich warns that pharmaceutical companies could increasingly direct manufacturing and clinical research toward markets offering viable commercial conditions.
“Investments will follow or not, depending on what the conditions are in a given market,” he says. Governments, however, must assess whether new medicines deliver sufficient additional benefit to justify their cost.
For Hungary, the April decision addresses part of the backlog but does not establish how frequently future reimbursement packages will be approved. AIPM said additional therapies remain under review and called for a process measured in months rather than years.
The decree was signed by then-Minister of Interior Sándor Pintér under the previous Fidesz-led government, in which healthcare policy fell within his superportfolio. Following the May change of government, Hungary again has a separate Ministry of Health, led by orthopedic surgeon Dr. Zsolt Hegedűs.
The new ministry inherits both the implementation of the April package and the question of how reimbursement decisions should be organized. AIPM has proposed expanding NEAK’s authority and reducing the number of cases requiring separate legislative amendments.
“The important thing is that the process should not stop in the coming months,” Szalóki says. “We hope that, with the commitment of the new health ministry and stronger professional cooperation, new therapies will become available to Hungarian patients in months rather than years.”
Answering questions from the BBJ, AIPM says consultations with the new ministry have begun and it has seen greater openness at state secretary level to regular dialogue, although it is too early for concrete commitments or a timetable for the next reimbursement round. The association says tangible progress is still needed toward a predictable and transparent process, particularly after the backlog of recent years.
The April package is therefore a substantial reimbursement decision, but its effect will be measured through delivery. The next tests are how many patients receive treatment and whether the government establishes a repeatable schedule for therapies still awaiting funding.
This article was first published in the Budapest Business Journal print issue of September 4, 2026.
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