Ewa Orlewska1, Piotr Mierzejewski1, 2
Polish guidelines for conducting financial analysis (project)
1Department of Experimental and Clinical Pharmacology, Medical University of Warsaw
Head of Department: professor Andrzej Członkowski, MD, PhD
2Ministry of Health, Poland

1. Objectives, use and status of financial analysis, responsibility for conducting and target audience
1.1. Objective
The aim of the financial analysis is to measure the impact of the reimbursement decision of a given drug on:
a) the health care budget for drugs,
b) the health care budget (as total).
The financial analysis is not a part of a pharmacoeconomic analysis, however, data sourced from pharmacoeconomic analyses can be useful in the financial evaluations. Both analyses, the pharmacoeconomic and financial, do not exclude each other but are complementary methods which support the decision whether a drug at a given price should be reimbursed. They are not a substitute for the decision.
1.2. Use and status of the Financial Analysis
The financial analysis has to be performed for all pharmaceutical products for which an application for reimbursement has been submitted. This principle shall not apply to pharmaceutical products with the same active ingredient as in a pharmaceutical products for which reimbursement has already been granted, including generic pharmaceuticals, parallel-imported products and/or products with new packaging.
1.3. Responsibility for Carrying out the Financial Analysis
The carrying out (financing and conduct) of financial analysis rests within the responsibility of the reimbursement applicant.
Financial analyses, including appendices, must be written in Polish.
1.4. Target audience
In Poland the Minister of Health decides as to whether a pharmaceutical product will be reimbursed and he or she is the recipient of financial analyses.
2. Methodology
2.1. General Remarks
2.1.1. Transparency
The financial analysis should be transparent and allow the understanding of all input assumptions, the estimations and relations between the selected variables and the resulting outcomes. Since some of necessary data may not be available the analysis may require modeling. It is therefore recommended to present the structure, rationale behind chosen model both in wording and in graphical way. It would be recommended as well to make every predictive model as interactive as possible to allow examination of credibility and input variables adopted to reflect local treatment practices, if the intent of the analysis is to inform both national and local purchasing decisions makers.
2.1.2. Data Sources
The source of all data on resources, costs and epidemiology, as well as additional assumptions made in the absence of "real” data, should be clearly stated.
2.1.3. Perspective
The financial analysis should be performed with reference to:
a) the health care budget for drugs,
b) the health care budget (as total).
All expenses and savings considered in the analysis must be identified and estimated in accordance with these perspectives.
2.1.4. Time Horizon
The financial analysis should project for the period of time whereas the proposed drug is predicted to have achieved its peak or stabilized market share. Annual financial implications to the health care budget (as total and for drugs only) should be evaluated to this time horizon for minimum first 2 years from the date of listing for reimbursement.
2.1.5. Target Population
The basis for conducting the financial analysis are the registered indications for the use of a given drug in Poland.
The target population is defined based on these indications. If the drug is to be reimbursed only in the case of some indications, the target population is defined based on the indications which are significant for the reimbursement. If, based on the difference in effectiveness, costs and/or preferences, a sub-population can be selected (smaller size than the population predetermined by the registered indications), such sub-population should be isolated and a financial analysis should be conducted for the sub-population as well as for the general population.
2.1.6. Presentation of results
of financial analysis
The results of the financial analysis should be presented in both monetary and natural units (the type of used resources). For decision makers information about the impact of the new program on the healthcare budget (i.e., finances) both quantitative and qualitative, the type of resources which must be used (for example, out-patient consultations, hospitalizations, etc.) is of major importance.
In some cases, the quantitative impact of the new intervention on the budget may even be of a secondary importance to the impact on the current use of resources such as GP consultations, nursing care, etc.
2.1.7.The probability of re-deploying resources
In the financial analysis it is important to state whether or not the calculated savings will be actually achievable in practice. Therefore, if possible, the models used in the financial analysis should predict the probability of re-deploying any labor or capital savings to other areas of medical care and predict the way the savings will be achieved over time.
2.1.8. Sensitivity analysis
The sensitivity analysis is conducted in order to examine how the outcomes of analysis will be influenced by change of the parameters in key assumptions. A reliable range of variations should be defined on the basis of available scientific literature, experts opinions or based on the trust level towards the average. Alternative assumptions and parameters can change across a scale that is regarded as probable, for example, some costs can change from -25% to +25% in the relation to the basic value. Since it is not always possible to obtain all data necessary to carry out the financial analysis therefore, interactive predictive models should be exploited. They guarantee transparency and the possibility of conducting a sensitivity analysis by the decision making bodies.
2.2. Detailed Remarks
2.2.1. Data on a pharmaceutical agent and its use
The financial analysis must include data on the preparation´s name, ATC classification, date of approval for use in Poland, information of efficacy, safety based on the accepted SmPC. It must specify in the indications description whether the indication in its integrity or in part of the indications is most relevant for reimbursement and which parts of the indication the analysis covers. It must describe daily doses and expected treatment period, as well as anticipated frequency of repeated treatment where applicable. It should be stated which other drugs or forms of medical treatment can be expected to be used concomitantly. If the treatment is expected to result in a reduction in the use of other drugs or additional therapies, this should be specified and reasons given. It should be stated which other reimbursed products shall be used less frequently due to the fact of listing of the drug in question and what would be the reasons for it within the target population:
therapeutic reasons,
side effects of the currently used therapy.
2.2.2. Estimation of the use of the product proposed for reimbursement
The estimated use of the drug to be reimbursed in each of the first two years starting from the date of placing the drug on the reimbursed drugs list should be included in the financial analysis. The probable number of patients eligible for the proposed drug, the daily dosage, the estimated time of treatment and, if necessary, the frequency of repeated treatment should be evaluated.
The probable number of patients using proposed drug and its therapeutic substitutes should be based on epidemiological data. If treatment is expected to last up to one year or two, this should be most accurately reflected in the annual incidence of the disease. In the case of drug to treat more chronic condition, estimates of the prevalence of the disease are more indicative. If the increase of survival is expected, it may be necessary to consider the increase over time of the prevalence of a given illness.
The expected number of patients for each of the suggested indications for the reimbursement should be estimated separately and then sum the outcomes. This summed up data are the basis for the estimate of the potential prescription volumes of the proposed drug during each of the first two years from the date of placing the drug on the list of reimbursed drugs.
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