Cost–benefit analysis

Defining the type of facility based upon the considerations discussed above will determine the scope of the project and the required resources. At some stage, discussion with and guidance from an experienced advisor may prove to be quite valuable in not only defining the scope and goals of the facility, but also in identifying and defining the equipment and resource requirements for successful planning and implementation of the project.

In the final assessment, it is the cost–benefit analysis which will provide the basis for the decision whether or not the establishment of a cyclotron facility is justified.

It is generally true that a cyclotron facility and a radiopharmaceutical production programme are expensive both to establish and operate. Return on investment and profits are unlikely except in those cases where there is a substantial customer base paying for the products. For example, a type I facility defined above will be intrinsically financially viable. Moreover, research related to drug development, outsourced by pharmaceutical companies based on ¹¹C labelled tracers, can make type II and III facilities financially viable as well.

2.4.1. Facility benefits

On balance, however, there are several tangible and non-tangible benefits to society from such a facility, which may be viewed as offsetting the fact that the facility is very costly and may operate at a deficit. The benefits are sometimes hard to define, but include:

— Improved health care;

— Advancement of scientific expertise;

— Enhancement of technological competence in the country;

— Increasing self-sufficiency;

— Heightened national pride.

2.4.2. Facility costs

Regardless of the driving force and the financial resources, evaluation of financial viability is absolutely vital for success of the project. It is very important to know if the facility will always operate at a deficit so that a source of operational funds can be identified.

The cost of the facility will entail at least the following:

— Buildings and utilities;

— Equipment;

— Operational costs

Each of these aspects is described below in some detail.

2.4.2.1. Buildings and utilities

Site design and the cost of construction will be dictated by the scope of the programme and the type of cyclotron needed to achieve the goals and objectives as defined by a task force. It is clear that structural and financial requirements for a comprehensive radionuclide and radiopharmaceutical manufacturing facility comprising a 30 MeV cyclotron are quite different from that needed for a small PET radiopharmaceutical production centre. Cyclotron vendors can provide basic information on the space needed and a provisional layout for installing the cyclotron and its utilities. Advice from an operational facility of similar nature would be another way to assess the requirements.

From the different programmes which will be supported, one can estimate the space needed for the production and QC laboratories, auxiliary rooms, offices, hot cells, heating, ventilation and air conditioning (HVAC), etc. An experienced architect and HVAC engineer should be involved in this process.

With an estimate of the overall space needed and the floor loading, one should assess the possibilities for establishing the centre within an existing building or, alternatively, a green field installation should be evaluated. Renovation of an existing building may be not always the cheaper solution. Factors such as radiation protection issues, weight of the cyclotron, crane access for installing the cyclotron, etc., might make the establishment of the centre in an existing building impractical.

In addition to the space requirements for the cyclotron and the associated infrastructure, the planners should make provision for a GMP compliant radiopharmaceutical manufacturing facility incorporating a pharmaceutical quality clean room environment for control of air quality during production of radiopharmaceuticals.

2.4.2.2. Equipment

In addition to the physical structure, laboratories must be equipped with a range of production and analytical instrumentation. Equipment requirements will depend largely upon the scope and type of facility being developed. For a

production facility, the major equipment will be the cyclotron and the hot cells.

For a facility that includes an imaging centre (a PET/CT facility), the scanner will be a major expense. The cost of other specialized equipment can be substantial, forming a significant fraction of the overall cost of the production facility. Some critical pieces of equipment may need backups in case of equipment failure. The following is a typical list (not all inclusive) of equipment which will be necessary for viable operation of the facility. The type of equipment and the quantity will depend largely upon the scope of the facility:

— Cyclotron (9–30 MeV);

— Hot cells (with or without manipulators);

— Radiation protection (shielding, monitoring);

— Synthesis modules;

— Chromatography (HPLC, GC, TLC scanner);

— Pyrogen and perhaps sterility testing (incubators, laminar flow cabinets);

— Gamma spectrometer;

— Gamma counter;

— Dose calibrator;

— QC laboratory equipment (pH meters, weighing balances, osmometers).

2.4.2.3. Operational costs

In addition to facility and major equipment installation costs, sustained operation of facility is also relatively costly, and will play an important role in deciding if the facility can be financially viable. The critical items include:

— Supplies (chemicals, kits, spare parts, etc.);

— Utilities (power, water);

— Staff salaries;

— Maintenance;

— Depreciation (replacement).

Operation of a cyclotron centre requires a continuous supply of various raw materials and spare parts and it might consume significant amounts of electric power. Thus, one should make a reasonable estimate of the running costs summing up all expenses related to the operation of the centre including the salaries of the personnel, depreciation of the facility, and other liabilities (if applicable). The decommissioning costs should also be considered.

Staffing requirements will vary according to the scope of the facility.

Concurrently, the cost of hiring qualified individuals will depend upon the number of staff as well as level of expertise required. This includes: cyclotron

engineers, medical physicists, radiochemists, radiopharmacists, QC chemists and administrative staff. The technical staff is likely to require additional specialized training and continuing education. Therefore, cost of such training should also be calculated in the cost–benefit analysis.

2.4.3. Source of funds (sustained support)

Operating funds can have several sources including:

— Grants or government funding and continued support;

— Sale of products;

— User fees.

In order to build and run the cyclotron centre, all possible sources of funding should be identified. The required funds for building the centre should be secured at the planning stage. It is of utmost importance to avoid launching the project before the required funds are assured, regardless of the source (government investment, private investment, loan, grant, or a mixture of all of the above). The self-sustainability of the project should be also evaluated: the sources for covering the operational costs (sales of products, grants, lease of beam time, etc.) should be identified and evaluated.