Erzsébet, 63, was diagnosed nearly four years ago with a rare and aggressive form of lung cancer. She had led an active life, always busy with work and housework. Looking back, she says fatigue was her only symptom, but she did not suspect anything this serious.

She went for a routine lung screening, where doctors noticed a patch on her lung the size of a palm. Further tests followed, and then came the severe diagnosis: a malignant tumor with metastases. The news shocked Erzsébet. “I felt as if I had been punched in the stomach,” she told Direkt36.

Doctors recommended immunotherapy combined with chemotherapy. Immunotherapy works by activating the body’s own immune system to fight cancer cells. The drug recommended for Erzsébet was Keytruda, the world’s best-selling cancer drug. However, it is expensive: a single treatment costs around 2 million forints (around €4900 at the current exchange rate).

In Hungary, this cost is covered by public health insurance, but only for certain types of cancer. In other cases, patients must submit a reimbursement request, and the National Health Insurance Fund (NEAK) decides whether to approve the treatment on a case-by-case basis. The process can be lengthy, and delays can even cost patients their lives.

Erzsébet also had to wait for the treatment: although her doctor recommended the drug, her condition did not automatically qualify her for it. She said she had to practically beg a NEAK official to take into account her advanced, life-threatening illness before she was granted reimbursement for the treatment.

Since Keytruda was approved in Hungary, the state has been spending increasing amounts on it—reaching 32 billion forints (€87,2 million) last year. No other drug has cost the health insurer this much.

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The developer of this cancer drug, the American pharmaceutical company Merck, has been doing everything it can to keep the price as high as possible for as long as the patent remains in force. This emerged from an international investigation carried out by a team of journalists. The project was led by the International Consortium of Investigative Journalists (ICIJ). Direkt36 was the only Hungarian participant.

The investigation is part of a global reporting project called Cancer Calculus, in which journalists from 37 countries conducted hundreds of interviews with oncologists, cancer patients, pharmaceutical insiders and others, and reviewed thousands of pages of documents.

The investigation revealed how this medication became the world’s best-selling drug within a few years, while remaining unaffordable for many patients in numerous countries. It also uncovered the strategies used by its U.S. manufacturer to keep prices high while attempting to delay the market entry of cheaper alternatives. Meanwhile, this medication does not help every cancer patient either. For some people, it does not lead to results, and it can also have serious side effects that may put certain patients at risk.

This article focuses on the challenges of accessing the medication in Hungary; further details of the international investigation can be found here.

In response to Direkt36, Hungary’s Ministry of Interior which is currently responsible for healthcare said that in recent years access has been expanded to dozens of oncology drugs. They added that Hungarian patients can already access cancer treatments through individual reimbursement schemes before full system-wide reimbursement, and therefore “there is no unmet medical need in the pharmaceutical treatment of oncological diseases.”

In its response, the National Health Insurance Fund emphasized that in life-threatening and urgent cases, as well as for minors, applications are assessed as a priority.

The Hungarian distributor of the drug, MSD Pharma Hungary, did not respond to our questions.

Metastatic patients may also be cured

Cancer has become an increasingly serious global problem, with roughly one in every six deaths worldwide linked to cancer. Hungary is in a particularly poor position in terms of cancer mortality compared to EU countries: in 2024, 31,000 people died of cancer in Hungary. According to data from the Hungarian Central Statistical Office, around 70,000 new cases of malignant tumors are diagnosed each year. In the case of malignant tumors, the body’s cells begin to grow uncontrollably and are able to form metastases, meaning they can spread to other parts of the body.

In recent years, a number of revolutionary oncology drugs and therapies have become available, which not only increase survival chances but also improve patients’ quality of life. One of the most significant developments has been immunotherapy drugs.

Oncologists and healthcare professionals interviewed by Direkt36 agree that immunotherapy drugs have represented a major breakthrough in cancer treatment. “Today it is even possible to recover from metastatic cancer, which was not possible before. The fact that these patients are given a chance is a fantastic advantage,” said Dr. István Peták, physician-researcher and founder of Oncompass Medicine.

One of the most widely used and well-known immunotherapy drugs is Keytruda. Its active substance is pembrolizumab, and it is used to treat several types of cancer, such as melanoma, lung cancer, and breast cancer. It has been available in Hungary since 2016. The drug is manufactured by the American pharmaceutical company Merck, and in Hungary it is distributed by MSD Pharma Hungary. Nearly half of the American company’s global annual revenue of 65 billion dollars (around € 55,9 billion) last year came from this medication.

The price of the drug is very high: in Hungary, one treatment costs more than 1.8 million forints ((around €4900 at the current exchange rate). However, modern oncology drugs are generally among the most expensive therapies. Healthcare professionals working in the field of oncology interviewed by Direkt36 explain the relatively high price of new oncology drugs by the fact that their development is costly, many projects fail, and these costs are also built into the price by pharmaceutical companies.

According to the prescribing information, adult patients receive 200 mg every three weeks or a double dose every six weeks, regardless of body weight, meaning that a 100-kilogram patient receives the same dose as a 50-kilogram patient. The drug is administered via infusion. Therapy can last only a few months, but in some cases it can continue for years, meaning dozens of infusions. Keytruda is centrally procured by the National Health Insurance Fund (NEAK), and hospitals do not participate in price negotiations, so according to a healthcare professional working in the field of oncology interviewed by Direkt36, hospital staff often “have no idea how much Keytruda actually costs.”

In response to a freedom of information request by Direkt36, NEAK revealed that since 2019, more than 125 billion forints (€343,45 million) have been spent in total on procuring the immunotherapy drug. This amount increases year by year; two years ago it already exceeded 32 billion forints (€89,1 million). Since 2021, this drug has been the most expensive item purchased by the health insurer every year.

NEAK did not provide information on how many patients receive Keytruda treatment for specific cancer types, citing business confidentiality. However, based on publicly available framework contract data related to the procurement of the medication, it is estimated that the quantity purchased in 2024 was sufficient for 17,500 infusions. This does not allow an estimate of how many patients were treated, since the duration of therapy varies greatly.

Waiting can cost a patient’s life

When it comes to cancer, time is of the essence. Early diagnosis and starting therapy as soon as possible significantly increase the chances of survival and recovery. In Hungary, however, many revolutionary cancer drugs are not covered by social insurance, meaning the state does not automatically pay for treatment. In such cases, the doctor must request reimbursement of the patient’s therapy costs. These requests are evaluated individually by the health insurer.

Thus, while patients are struggling with a sudden and severe diagnosis, they must also cope with weeks of waiting. A Budapest-based oncologist told Direkt36 that patients often call NEAK’s customer service to try to speed up the process.

This is what happened to 63-year-old Erzsébet, who was diagnosed four years ago with a rare, aggressive form of lung cancer. Her doctor had to submit a reimbursement request to start treatment. One week after submission, following her doctor’s advice, Erzsébet called NEAK’s customer service. The man who answered the phone, according to Erzsébet, told her to be patient like everyone else. Eventually, however, he transferred her to a colleague handling her case. By then, Erzsébet was in a very different emotional state. “I started begging, saying I was terminally ill and needed the treatment. I asked what he would do if it were his relative. I also said I was stage 3C, very close to stage 4,” she recalled. The man then said he would take care of it. About a week later, she received the approval decision.

She has been receiving Keytruda ever since, for more than three years. She said this is an enormous achievement compared to the less than six months survival time initially predicted by doctors. When she was diagnosed, she herself did not give much chance of survival. “But I am here, I am well, I do not feel sick,” she said, adding that she knows her condition could still worsen at any time.

NEAK, in its response to Direkt36, emphasized that their telephone customer service can be reached on Tuesdays and Thursdays between 9 a.m. and 3 p.m., and that they also try to take into account the requests of patients, doctors, and pharmacists.

Several doctors have confirmed to Direkt36 that long waiting times can have serious consequences for cancer patients. In their experience, some patients die while still waiting for approval. According to Dr. Tamás Kullmann, chief oncologist, it also happens that by the time patients receive treatment, their condition has deteriorated so much that the drug can no longer have a beneficial effect.

According to the National Health Insurance Fund, sudden, life-threatening deterioration in a patient’s condition may occur during the course of the disease, which can affect outcomes independently of access to medication.

According to a Budapest-based oncologist, another problem is that NEAK is an administrative authority where decisions are not based purely on medical considerations but also on financing. This means that when the drug budget is empty and there is less money available, rejections or requests for additional documentation occur more often, which can extend the evaluation process by several weeks. The doctor gave an example of two very similar patients in terms of age, condition, and diagnosis who received completely different decisions a year apart: one application was approved and treatment started, while the other was rejected. The reason stated was that the treatment was not cost-effective and that other therapeutic options were available.

Although in theory patients can choose to pay for treatment themselves after a rejection, healthcare professionals say this is not very common in Hungary, as very few people can afford therapies costing several thousand euros.

Long-term, prolonged treatment

The slow and lengthy assessment of individual reimbursement requests can also influence therapeutic decisions. A Budapest-based oncologist told Direkt36 that they have a patient whose tumors have disappeared as a result of treatment, yet they still do not dare to stop therapy, because they fear that if the disease were to return, they would not be able to obtain renewed funding from NEAK.

A similar case happened to a woman in her early 60s living in the countryside. She was diagnosed in 2023 with a malignant colorectal cancer. She first underwent surgery, during which “a hernia the size of a human head and a tumor the size of a child’s head were removed,” she told Direkt36. After the operation, her doctors recommended immunotherapy.

Since this cancer type is not automatically covered by the health insurer, she had to submit an individual reimbursement request. Eventually, she received her first treatment about a month and a half after submitting the application. She has been receiving the drug ever since, for more than two and a half years.

According to her, the results of the immunotherapy have been very good, and her regular CT scans have also shown improvement. “However, my doctor told me I should prepare for the fact that I have to take this for the rest of my life,” she said. The doctor explained this by saying that for a previous patient, the drug had successfully eliminated the tumor, but when the treatment was stopped, the cancer returned years later.

Several oncologists interviewed by Direkt36 confirmed that for some patients, treatment can last for years or even until the end of life.

Increasing spending on individual reimbursements

The slow assessment of individual reimbursement requests is also explained by the fact that the number of applications submitted to the health insurer has been increasing year by year. Expensive drugs are still most commonly accessed through individual funding requests.

In response to Direkt36’s freedom of information request, NEAK provided data on the number of such applications. According to this, the number of Keytruda-related requests increased sharply after 2020: currently around one thousand applications are submitted each year, and nearly 90 percent of them are approved. Applications related to Keytruda account for about 3–4 percent of all individual funding requests annually.

NEAK did not disclose, citing business confidentiality, how much money has been spent on treatments provided through individual reimbursement decisions. (This likely refers to the commercial interests of the manufacturer or the distributor MSD Hungary.)

Not only has the number of immunotherapy-related applications increased; in general, doctors are requesting state funding for patient therapies in more and more cases. According to health insurer data, 9,245 applications were submitted in 2015, while by 2024 this number had tripled to more than 32,000. At the same time, NEAK’s spending on individually assessed treatments has also increased: in 2015 it was still 18 billion forints (€50,4 million), while two years ago it had risen to 47 billion forints (€123 million). One reason for this is that new drugs often take a very long time to enter the list of publicly funded treatments.

The Ministry of Interior stated in response to Direkt36 that if centrally procured high-cost drugs are also included alongside individual requests, it can be said that “we spend 34% of pharmaceutical funding on 1% of patients.”

The government is aware of the issue: in December 2022, at a conference, plans were announced to streamline the prescribing of discretionary medicines. The measure was justified by the fact that the number of such applications is increasing year by year. Judit Bidló, Deputy Director General of NEAK, said at the conference that they have about 40 minutes to evaluate each application, and in many cases, this is not enough to consider all aspects. She also revealed that patients typically receive access to therapy in the second half of the 60-day administrative deadline, on average after 41 days. In severe cases, delays reduce the chances of full recovery and even survival.

According to data from the Ministry of Interior and NEAK, last year the average processing time for individual reimbursement requests was 36 days, and 18.5 days for cancer-related applications.

Regulation struggles to keep up with new drugs

The slow reimbursement process and the growing number of individual funding requests are also explained by the fact that it can take a long time—sometimes years—for new medicines to be included in social insurance coverage. Moreover, compared to other EU countries, fewer important drugs are available under public funding in Hungary, including cancer treatments.

Medicines in EU member states are authorised by the European Medicines Agency (EMA). After that, the manufacturer decides whether to market the drug in a given country and whether to apply for reimbursement by the national health insurer.

However, it can take years for a new medicine to become publicly funded. One study found that in Hungary, it typically takes around three years for new oncology drugs to enter reimbursement schemes.

According to NEAK data, nearly 40 reimbursement applications for Keytruda have been submitted by the Hungarian distributor so far. In about one-third of cases, the health insurer decided to approve them, meaning the treatment would be publicly financed. On average, decisions on reimbursement applications for the drug took 441 days. Many applications are still pending.

Every type of cancer can have many different forms, each of which may be treated in different ways. In medical terminology, the conditions or patient groups for which a given drug can be used are referred to as indications. Drug manufacturers must obtain separate approval for each indications, and the health insurance provider decides on a case-by-case basis which ones it will cover.

A study by the OECD, which examined drugs used for lung and breast cancer across 25 countries, found that Hungary does not finance the majority of approved indications. Only 38.5% of indications are publicly funded, compared to an EU average of 59%. This is partly explained by the fact that pharmaceutical companies often do not submit reimbursement applications at all.

Another investigation by the international journalistic consortium Investigate Europe reached a similar conclusion. Two years ago, they examined access to essential medicines, including oncology drugs, in 28 countries. Their findings showed that Hungary has the highest number of missing reimbursed medicines: out of 32 drugs studied, 25 are not covered by public insurance.

A senior official at the Ministry of Interior, Judit Bidló said last year on a conference that spending on rare disease drugs is increasing the most in relative terms: “We are spending an enormous amount on immuno-oncology.” She added that individual funding costs are also rising. “One reason is clearly that reimbursement is not progressing at the pace we would like,” she said.

Keytruda is currently approved for more than 30 indications in the European Union according to the product information, covering around a dozen cancer types, including certain forms of lung cancer, breast cancer, and melanoma. In Hungary, however, the drug is only automatically reimbursed for around 10 indications across five cancer types. In other cases, access is only possible through individual reimbursement requests.

According to a new decree published in the Hungarian Official Gazette, from May 1 additional cancer types are included in the reimbursement system, including certain cases of cervical cancer and renal cell carcinoma.

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The Ministry of Interior stated to Direkt36 that oncology drug indications are continuously expanding. According to them, reimbursement decisions for new medicines are preceded by a lengthy evaluation process, and individual funding decisions help ensure that patients’ interests are not harmed during this period.

The Hungarian distributor of the drug, MSD Pharma Hungary, did not respond to questions regarding the criteria used to decide which indications they submit for reimbursement, or whether they have experienced changes in approval times.

Fewer side effects, but potentially very serious ones

Although immunotherapy can significantly prolong patients’ lives and is often more effective than previously available treatments, it does not work for everyone and can sometimes cause severe side effects.

According to doctors interviewed by Direkt36, the treatment is effective in roughly one-third of patients. However, as Dr. Tamás Kullmann, chief oncologist, put it: “The main problem is that we do not know for sure who it will work for.”

In some cases, autoimmune reactions may occur, meaning the immune system mistakenly attacks and destroys healthy cells as well. Healthcare professionals interviewed by Direkt36 say that doctors often do not recognise in time that the symptoms are caused by an autoimmune reaction. “I have seen more serious, even fatal side effects than cases where the patient did not receive approval,” said Dr. Kullmann.

In December 2023, Nikoletta accompanied her 68-year-old father to an ear, nose and throat clinic at a hospital in the countryside after he had been frequently hoarse and had repeatedly lost his voice. Tests confirmed a malignant tumor. On medical advice, the elderly man decided to undergo a total laryngectomy, although he was very afraid of the procedure. Post-operative check-ups initially showed improvement, but less than six months later the cancer returned as a squamous cell carcinoma. This is a common type of cancer, most often originating from squamous cells in the skin, lungs, or oral cavity.

He received his first Keytruda treatment nearly three months after the recurrence was confirmed, at the end of March last year. According to Nikoletta, he weakened immediately after the first infusion. When his lab results began to worsen, they returned to the doctor, but she felt their concerns were not taken seriously. Shortly afterwards, a large lump appeared on his chest and his hand became swollen. Two days later, in the evening, rashes appeared all over his body. They went to another hospital, where it was discovered that the rash had also appeared on his internal organs. According to Nikoletta, it was there that doctors first stated that the symptoms were caused as a side effect of the immunotherapy.

“Everything happened very suddenly,” she added. The day after her father was admitted to hospital, her mother visited the elderly man. After returning home, Nikoletta was about to go to the hospital as well, but never got the chance. “Just as I was about to leave, I got the call that my father had died,” she said.

She told Direkt36 she does not understand why doctors did not consider earlier that immunotherapy could be responsible for his father’s symptoms. “Even though his lab results were bad, nothing was done. They just kept telling us to do blood tests” – she added.

Zsuzsanna Wirth contributed to this article.

Illustration: Chelsea Conrad/ICIJ