Result card

  • ORG7: What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?

What is the likely budget impact of the implementation of FIT for the payers (e.g. government)?

Authors: Principal investigators: Valentina Prevolnik Rupel, Nika Berlic Investigators: Dominika Novak Mlakar, Taja Čokl, Plamen Dimitrov, Marta López de Argumedo

Internal reviewers: Americo Cicchetti, Daniela D'Angela, Marco Marchetti

Acknowledgments: /

Analysis of selected studies extracted from the basic literature search. Two articles were identified to be relevant to this question. Survey gave additional information on this question.


Budget impact analysis (BIA) of the implementation of FIT as a new technology was not found by the literature review. On the other hand literature search did provide information on importance of BIA and guidance for developing BIA. It was noticed that countries on their national level have already perform some BIA of a new technology but since those reports were note prepared precisely for FIT technology they weren’t included into this document.

Budget impact analysis in combination with cost study and economic evaluation play a crucial part in the comprehensive assessment of a health technology and may inform reimbursement decisions. Reimbursement may be withheld from a cost-effective health technology if it has a high budgetary impact. Conversely, a cost-ineffective technology may receive reimbursement if its budgetary impact is limited. This is because the opportunity cost of adopting such a technology is low (little other activity would need to be displaced) and the adoption may meet other important objectives of a decision-maker such as equity {31}. The methodology of budget impact analysis is still developing. While cost-effectiveness analyses (CEAs) are well accepted, the same progress has not been made for BIA. In 2005 Task Force was established by International Society for Pharmacoeconomics and Outcomes Research (ISPOR) to develop and present guidance on methodologies for those undertaking such analyses or for those reviewing the results of such analyses. The BIA is important, along with the CEA, as part of a comprehensive economic evaluation of a new health technology.  A BIA starts with providing all relevant epidemiological, clinical and economic information of the disease. More precisely, it should be performed using data that reflect, for a specific health condition, the size and characteristics of the population, the current and new treatment mix, the efficacy and safety of the new and current treatments, and the resource use and costs for the treatments and symptoms as would apply to the population of interest. The Task Force recommended that budget impact analyses be generated as a series of scenario analyses in the same manner that sensitivity analyses would be provided for CEAs. In particular, the input values for the calculation and the specific cost outcomes presented (a scenario) should be specific to a particular decision-maker’s population and information needs. Sensitivity analysis should also be in the form of alternative scenarios chosen from the perspective of the decision-maker. The primary data sources for estimating the budget impact should be published clinical trial estimates and comparator studies for efficacy and safety of current and new technologies as well as, where possible, the decision-maker’s own population for the other parameter estimates. Suggested default data sources also are recommended. These include the use of published data, well-recognized local or national statistical information and in special circumstances, expert opinion. Finally, the Task Force recommended that the analyst use the simplest design that will generate credible and transparent estimates. If a health condition model is needed for the BIA, it should reflect health outcomes and their related costs in the total affected population for each year after the new intervention is introduced into clinical practice. The model should be consistent with that used for the CEA with regard to clinical and economic assumptions {32}.

The survey, implemented among 11 European countries (i. e. Austria, Russia, Luxembourg, Lithuania, Italy, Scotland, Spain, Romania, France, Croatia and Slovenia), indicated that only 6 countries (Russia, Lithuania, Italy, Scotland, Spain and Slovenia) out of 11 uses FIT technology. In addition to that Luxembourg indicated that FIT is relatively new technology and isn't widely accepted in their country. All countries stated that FIT screening is free of charge for target population and founded by the country. Not all country indicated the payers. In Spain for example the payer are Regional Health Services; Russia has stated that reimbursement is provided under the program for Mandatory health Checks. CRC checks in high risk population and patients with CRC symptoms are covered under the Health Service State Guaratees Program. In Scotland FIT is supplied by NHS (National Health Service). Slovenia also stated that FIT is covered by compulsory Health insurance. In addition, only two countries indicated the costs that were related to the screening (i.e. Lithuania and Slovenia).

Unfortunately information obtained from the survey was not sufficient for the budget impact analysis. Data from the survey could present only one part of BIA. In addition, BIA is very country specific and therefore one general model of BIA of FIT couldn’t be applicable to all countries.  Nevertheless there are some general guidance that each country should stick to, when preparing their own BIA.

We believe that further research and countries’ in-depth studies would be necessary to indicate the budget impact of the implementation of FIT for the payers.

Data of budget impact of the implementation of FIT for the different payers was, by the literature review, not found.

Rupel P et al. Result Card ORG7 In: Rupel P et al. Organisational aspects In: Jefferson T, Cerbo M, Vicari N [eds.]. Fecal Immunochemical Test (FIT ) versus guaiac-based fecal occult blood test (FOBT) for colorectal cancer screening [Core HTA], Agenas - Agenzia nazionale per i servizi sanitari regionali; 2014. [cited 3 December 2022]. Available from: