"Modernization and equipment of the department of production of radiopharmaceuticals of the All-Ukrainian center of radiosurgery of the Feofania Clinical Hospital of the State Administration of Affairs for the implementation of new diagnostic methods in oncology


Sector
Healthcare
Stream
Development of a network of institutions providing medical care to patients with cancer
Preliminary Investment Feasibility Study
Project Status
Investment Feasibility Study
Entry into Portfolio
State Single Project Pipeline
Implementation
Completion

General information

Description of the project

The Investment Project envisages  increasing the level of diagnostics  of oncological diseases using new radiopharmaceuticals for PET/CT diagnostics. The project provides for a full range of measures to improve the existing system of production and use of radiopharmaceuticals in order to  implement modern standards of medical care, which will ensure that patients' needs for effective, high-quality and highly specialized medical care are met, in particular for those conditions that are currently not treated in Ukraine and require additional funding from the state budget. The project implementation provides for the modernization and equipping of the radiopharmaceutical production department of the All-Ukrainian Center for Radiosurgery of the Feofaniya Clinical Hospital of the State Administration of Affairs for the introduction of new diagnostic methods in oncology, which will make it possible to provide a full range based on modern standards of medical care, as well as the ability to increase the number of medical services provided  and overcome the scarce need for such services. The project provides for: introduction of drugs for the diagnosis of prostate cancer and brain tumors; increase from 200 series of F18-Fluorodeoxyglucose to 500 series of F18 (FDG and 18F-PSMA; increase the number of medical services by 50%, which will allow providing about 2,500 patients with high-quality medical diagnostics and treatment; provide highly specialized medical care in accordance with the requirements of world standards, namely the “Guidelines of the European Association of Nuclear Medicine” - FDG PET/CT: EANM procedure guidelines for tumor imaging: version 2.0; availability of diagnostic examinations to citizens in Ukraine, not abroad. 

The purpose of the project

Main goal:

Meeting demand

Secondary goal:

Increasing compliance with modern standards, Improving the equality of wealth distribution, Improving the condition of infrastructure, Improving the quality of services, Поява нових виробничих потужностей, Increasing compliance with modern standards

Description of the purpose of the project and ways to achieve it

Today, nuclear medicine methods are widely used in the diagnosis and treatment of cancer. In Ukraine, the use of radionuclide diagnostics is represented in oncology by the following methods: osteoscintigraphy, lymphoscintigraphy, mammoscintigraphy, scintigraphy: brain, kidneys, thyroid and parathyroid glands, liver and biliary tract, adrenal glands and intraoperative detection of sentinel lymph nodes, positron emission tomography methods. Positron emission tomography methods in Ukraine are used only in three clinics throughout the country (two state and one private). Positron emission tomography / computed tomography is a highly informative method of radiation (radionuclide) diagnostics with unique capabilities for determining metabolism at the cellular and molecular levels during life. This is a nuclear medicine method, which is today considered the “gold standard” for the diagnosis of malignant neoplasms in the world, PET/CT allows for a single study to determine the stage of the disease, obtaining an image of the primary tumor, regional and distant metastases. The PET method is one of the most high-tech and informative methods of medical imaging, which are part of the group of molecular medicine methods. Positron emission tomography has significant advantages over ultrasound diagnostics, CT, magnetic resonance imaging (MRI) and single-photon emission computed tomography (SPECT). The sensitivity of the method is twice as high as the sensitivity of SPECT. It is possible to measure functional changes in biochemical processes in the patient's body, which makes it possible to achieve high accuracy in the differential diagnosis of a benign neoplasm from a malignant neoplasm, and to assess the effectiveness of treatment in a timely manner. It is also possible to early detect metastases measuring 4–5 mm in size. The patient's entire body is scanned for the presence of a primary tumor and almost all metastases are identified in one session. Since 2010, the All-Ukrainian Center for Radiosurgery with the use of PET technologies has been operating within the hospital structure, where the production of the radiopharmaceutical 18F-Fluorideoxyglucose for PET/CT diagnostics has been successfully established. The production and quality control laboratory comply with the international GMP standard and have a license from the State Medical Service. Today, in the Feofania Clinical Hospital, in the radiopharmaceutical production department of the All-Ukrainian Center for Radiosurgery, the production of the only radiopharmaceutical "F18-Fluorideoxyglucose" has been established, which has the widest application in oncology. Each year, the center produces about 200 batches of the drug, in accordance with the existing license. In 2023, the hospital introduced the production of the radiopharmaceutical for prostate cancer diagnostics F-18-PSMA-1007. The practical implementation of the above provisions in the Feofaniya Clinical Hospital of the State Medical University allowed not only to build and organize the work of a domestic PET center, but also to examine about 4,500 patients in three years. The average load on the PET center is 1,520 combined examinations per year. The vast majority of examined patients are oncology patients (> 90%) with the following distribution by nosology: lymphoma (32.4%), breast cancer (12.2%), colorectal cancer (8.6%), lung cancer (6.6%), tumors of the female reproductive system (5.0%), melanoma (3.0%), thyroid cancer (2.6%), pancreatic cancer (2.0%), nasopharyngeal cancer (1.0%) and other localizations (26.0%). Today, the Feofaniya Clinical Hospital is the only clinic in Ukraine that, subject to the modernization of existing, modern equipment, can produce new radiopharmaceuticals, namely: (18F)NaF, (18F)FLT, (18F)FMISO, (18F)FCHOLIN 18F-PSMA and use them to conduct diagnostic examinations of brain and prostate tumors. Every year, more than two thousand oncological patients receive about twenty thousand procedures of highly specialized modern medical care at the All-Ukrainian Center for Radiosurgery. At the time of its establishment, the Center was equipped with the latest equipment for the production of radiopharmaceuticals, conducting PET/CT studies and conducting radiation therapy. Today, the Center remains the only certified manufacturer of sterile radiopharmaceuticals in Ukraine. The relevance of the project is that as a result of its implementation, more patients will be able to receive timely diagnosis and treatment of oncological diseases in conditions that meet European standards. In the event of non-implementation of the project: taking into account the analysis of the actual state of the existing equipment of the radiopharmaceutical production department without urgent modernization of hot chambers, gas supply system and radiopharmaceutical filling module, a complete stop of production is predicted. This, in turn, will lead to the impossibility of citizens' access to high-precision diagnostic methods, which in turn will increase the population's demand for diagnosis and treatment of oncological diseases, and the clinic will not be able to fully provide treatment standards as an institution of specialized (tertiary) medical care,

Problems and solutions resulting from project implementation

The implementation of the Project will allow: - introduction of drugs for the diagnosis of prostate cancer and brain tumors; - increase from 200 doses of F18-Fluorodeoxyglucose to 500 doses of F18(FDG), (18F)NaF, (18F)FLT, (18F)FMISO, (18F)FCHOLINE, (18F)PSMA; - increase the number of medical services by 50%, which will allow providing about 2000 patients with high-quality medical diagnostics and treatment; - provide highly specialized medical care in accordance with the requirements of world standards, namely the “Guidelines of the European Association of Nuclear Medicine” - FDG PET/CT: EANM procedure guidelines for tumor imaging: version 2.0; - accessibility to diagnostic examinations for citizens in Ukraine, not abroad; - improve the financial condition of the hospital by providing paid medical services, including under contracts with the National Health Service of Ukraine (NHSU). Thus, as a result of the implementation of the investment project, the project will be effective due to the increase in the provision of medical services to ensure the activities of the hospital, which require the creation of modern modernized working conditions, and will also increase the accessibility of citizens to modern methods of diagnosis and treatment of malignant tumors.

Socio-economic context

Indicator

Value

Number of people who will use the service

535 human

Strategic Case

Strategic feasibility of the project

Sector

Healthcare

Subsector

Specialized medical care

Stream

Development of a network of institutions providing medical care to patients with cancer

Strategic document

National Strategy for Cancer Control until 2030

Task

1 Ensuring the effective functioning of a capable network of healthcare facilities that provide medical care to patients with cancer

Project objectives

Indicator
Base value
Target value
Number of modernized medical and technological equipment for the production of radioisotopes
2 units
7 units
Area of premises renovated for equipment installation
122 m2
122 m2

Demand for the service and its dynamics

Indicator
Year
Demand
Annual demand for services/infrastructure
1
140 thous. people
Economic justification

Alternative technical solutions

Technical Solution 1

Modernization and equipment of the radiopharmaceutical production department of the All-Ukrainian Center for Radiosurgery of the Feofaniya Clinical Hospital of the State Administration for the implementation of new diagnostic methods in oncology

Technical Solution 2

Joint cluster production for several regional medical facilities.

Total costs1'019'437'600 UAH6'700'000'000 UAH
  • For preparation
  • 0 UAH10'000'000 UAH
  • For implementation
  • 239'718'800 UAH6'000'000'000 UAH
  • For operation
  • 270'000'000 UAH690'000'000 UAH
    Average annual costs29'000'000 UAH55'000'000 UAH
    Project duration, incl.156 months228 months
  • Deadline for developing a FFS
  • 12 months12 months
  • Service life
  • 120 months180 months
  • Implementation period
  • 24 months36 months
    Target indicatorsDefined Defined
    Components of a technical solution
    To components
    2
    To components
    0

    Financial justification

    Total project budget

    Total preliminary budget101'943'760'004 UAH670'000'000'001 UAH
    Capital costs101'943'760'004 UAH670'000'000'001 UAH
    Operational costs0 UAH0 UAH

    Preliminary cost breakdown

    Operating costs for implementation0 UAH0 UAH
    For preparation2 UAH10'000'000 UAH
    For implementation479'437'600 UAH6'000'000'000 UAH
    For operation540'000'000 UAH690'000'000 UAH
    For closing2 UAH1 UAH

    Average project cost per service recipient

    Service UnitКількість отримувачів послуг
    Service Unit Cost68'500 UAH

    Profitability of the project

    Is the project expected to generate income?

    ResponseYesNo

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    spi.projectFinancingMechanisms.rowTitleYesNo

    Funding Sources

    Approved Funds216'658'800 UAH0 UAH
    Expected Funds216'658'800 UAH0 UAH
    Management Rationale

    Risk assessment

    Financial riskDefined
    Economic riskDefined
    Political riskDefined

    Organizational events

    Formation and justification of the project idea1 week
    Feasibility study6 weeks
    Project evaluation6 weeks
    Results of the feasibility analysis
    Economic Analysis
    Social benefits and costs
    Coverage of a significant portion of the population with cancer diagnostic services.
    Environmental benefits and costs
    The project will be implemented in accordance with the requirements of environmental legislation and does not foresee negative environmental impacts.
    Indirect benefits and costs
    Savings for society in the cost of medical services. The calculation takes into account the loss in value of uncreated GDP due to premature mortality. According to the Ministry of Finance of Ukraine, the nominal GDP of Ukraine for 2024 per capita is 94,590 UAH. Patients who have not been treated for cancer according to vital indicators in most cases die within a year. The payment of disability benefits for cancer is currently 2,093 UAH. per year 25,116 UAH. Payment of benefits for temporary disability. According to statistical data, the salary level for December 2024 in Kyiv is 21,449 UAH. The stay of patients in bed with serious diseases, including cancer, leads to the patient's stay in healthcare institutions for up to four months, and provides for the payment of funds from the state budget for temporary disability benefits. The total cost of payments per patient is 85,796 UAH.