Skopje, 22 January 2025 (MIA) — All six biologic drugs for cancer the Oncology and Radiotherapy Clinic has a shortage of at the moment will be available again by the end of January, Health Insurance Fund director Sasho Klekovski said Wednesday in a statement for MIA after patients said Tuesday the clinic had run out of biologics due to the recent rise in cancer cases nationwide and the complicated procurement procedures.

"Of the six drugs that are unavailable, four will be solved administratively very quickly through annexes, one will most likely be solved through a donation from the manufacturer, and we will find a solution for the other one as well," Klekovski told MIA.

Earlier on Wednesday, ahead of his meeting with representatives of several hospitals, Klekovski told the press that two of the biologics would be available as soon as this week and the procurement procedures for the others had been initiated.

Asked whether there was a specific plan on how to overcome the shortage of biologic therapeutics for cancer in the future, Klekovski said the problem was not financial. He reiterated that the most recent budget for medications had been EUR five million higher than the previous one.

"This year we will approve even more considerable finances," Klekovski said, adding: "Because the problem, again, is not financial, but organizational."

The long-term problem, he said, was that health authorities did not know how many cancer patients required biologics.

"How many patients are there and how much therapy do we need?" he asked, pointing out the need of keeping a national registry of people living with cancer.

"We have to establish a patient registry, as is already the case for rare diseases, as is already the case for diabetes," Klekovski said.

He said the registry would help the Oncology Clinic determine the necessary quantities and plan accordingly. He also said the clinic should develop transparent criteria for administrating the medications.

His Wednesday meeting with hospital representatives would focus on registries of patients requiring "particularly expensive medications," he said. 

"These are the Oncology, the Hematology, the Children's Clinic – they have registries – and at Transfusiology, we plan to establish a registry of hemophilia patients," Klekovski said.

"These are several clinics administering particularly expensive therapy, where the treatment of one patient can cost tens of thousands of euros per year so I think this has to done clearly, transparently and responsibly," he said.

He said the registries should be established in the first half of the year. "I will insist on it," he said, "because we are planning to significantly increase the 2025 budget."

In response to a question if the biologics would be put on the national Positive List of Prescribed Drugs, he asked, "If we don't know the number of patients, how can we put something that could cost five million denars a year on the Positive List?"

"I will insist on keeping a registry. We cannot continue financing something that is unclear and non-transparent," Klekovski told reporters.

On Tuesday, Hema-Onko cancer patients association member Ana Marjanovikj told MIA the Oncology Clinic was unable to respond to the increasing number of patients with metastatic cancers as it had run out of biologics on Friday.

In addition to new cancer cases, she said another reason for the shortage was that biological therapy treatments helped people with cancer live longer. "Which is why they need to take this therapy longer," she added.

Since Friday, cancer patients have been unable to fill their prescriptions for the lung cancer drug atezolizumab (tecentriq), the metastatic colorectal cancer medication bevacizumab (avastin), the breast cancer growth blockers palbociclib and ribociclib, the advanced breast cancer treatment fulvestrant as well as the advanced bowel cancer, head cancer and neck cancer drug cetuximab.

Hema-Onko members are afraid that soon there will also be a shortage of the breast cancer treatment trastuzumab emtansine (kadcyla), the immunotherapy drugs nivolumab and cobimetinib as well as the metastatic melanoma cancer growth blocker vemurafenib. mr/