Hungary has approved a simplified procedure for using Keytruda, a widely used cancer immunotherapy, before surgery for malignant melanoma. However, the decision does not automatically mean that all eligible patients will receive state-funded treatment.
Hungary has introduced a simplified procedure for using Keytruda in the pre-operative treatment of malignant melanoma, the National Centre for Public Health and Pharmacy (NNGYK) announced on 15 October.
The decision covers two formulations of the cancer drug, whose active ingredient is pembrolizumab: a 25 mg/ml concentrate for infusion and a 395 mg solution for injection, both manufactured by Merck Sharp & Dohme BV.
The new procedure applies to neoadjuvant treatment, meaning therapy administered before a tumour is surgically removed.
However, the decision does not automatically make the treatment available with public health insurance funding to every patient who may benefit from it.
How does Keytruda work?
According to Telex, Keytruda is one of the best-known cancer immunotherapy medicines. Rather than attacking cancer cells directly in the same way as conventional chemotherapy, it helps the body’s immune system recognise and fight cancer.
Its uses include several types of cancer, among them lung cancer, breast cancer and melanoma. The latest Hungarian decision concerns its use before surgery for malignant melanoma, an aggressive form of skin cancer.
The simplified procedure represents a regulatory step towards making this particular treatment application possible in Hungary. Access to publicly funded treatment, however, remains a separate issue.
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Why access to Keytruda remains a concern in Hungary
A May investigation by Direkt36 highlighted the difficulties some Hungarian cancer patients face when trying to obtain publicly funded Keytruda treatment.
According to the investigation, Hungary’s National Health Insurance Fund Management (NEAK) automatically finances the medicine only for certain cancer types and treatment indications. In other cases, patients must apply for individual funding approval.
The report featured the case of a 63-year-old woman diagnosed with severe lung cancer whose doctors recommended Keytruda. She needed special approval to receive public funding for the treatment.
“I started begging, saying that I was terminally ill and needed the treatment,” she recalled, according to the investigation. Her application was eventually approved.
Oncologists interviewed by Direkt36 said that decisions on individual funding applications could take weeks, potentially affecting treatment prospects for seriously ill patients. The NEAK said urgent, life-threatening cases were handled as a priority.
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Treatment can cost millions of forints
The financial implications are substantial. Data obtained by Direkt36 indicated that a single Keytruda treatment could cost more than HUF 1.8 million (EUR 4,950).
According to the investigation, the NEAK had spent more than HUF 125 billion on the medicine since 2019. Around 1,000 individual funding applications for Keytruda are submitted each year, with close to 90% approved.
Nevertheless, incorporating additional uses of the drug into the standard public reimbursement system has historically been a lengthy process. The data obtained by Direkt36 showed that decisions on reimbursement applications took an average of 441 days.
What does the new decision mean for patients?
The simplified procedure concerns the use of Keytruda before surgery for malignant melanoma. It should not be confused with an automatic expansion of public funding for every patient who needs the medicine. For patients, access depends not only on the authorised use of a drug but also on the applicable reimbursement rules and individual eligibility.