Considering equity in priority setting using transmission models: Recommendations and data needs.

OBJECTIVES: Disease transmission models are used in impact assessment and economic evaluations of infectious disease prevention and treatment strategies, prominently so in the COVID-19 response. These models rarely consider dimensions of equity relating to the differential health burden between individuals and groups. We describe concepts and approaches which are useful when considering equity in the priority setting process, and outline the technical choices concerning model structure, outputs, and data requirements needed to use transmission models in analyses of health equity. METHODS: We reviewed the literature on equity concepts and approaches to their application in economic evaluation and undertook a technical consultation on how equity can be incorporated in priority setting for infectious disease control. The technical consultation brought together health economists with an interest in equity-informative economic evaluation, ethicists specialising in public health, mathematical modellers from various disease backgrounds, and representatives of global health funding and technical assistance organisations, to formulate key areas of consensus and recommendations. RESULTS: We provide a series of recommendations for applying the Reference Case for Economic Evaluation in Global Health to infectious disease interventions, comprising guidance on 1) the specification of equity concepts; 2) choice of evaluation framework; 3) model structure; and 4) data needs. We present available conceptual and analytical choices, for example how correlation between different equity- and disease-relevant strata should be considered dependent on available data, and outline how assumptions and data limitations can be reported transparently by noting key factors for consideration. CONCLUSIONS: Current developments in economic evaluations in global health provide a wide range of methodologies to incorporate equity into economic evaluations. Those employing infectious disease models need to use these frameworks more in priority setting to accurately represent health inequities. We provide guidance on the technical approaches to support this goal and ultimately, to achieve more equitable health policies.

Lessons Learned From Developing an Eradication Investment Case for Lymphatic Filariasis.

In the last few years, the concepts of disease elimination and eradication have again gained consideration from the global health community, with Guinea worm disease (dracunculiasis) on track to become the first parasitic disease to be eradicated. Given the many complex and interlinking issues involved in committing to a disease eradication initiative, such commitments must be based on a solid assessment of a broad range of factors. In this chapter, we discuss the value and implications of undertaking a systematic and fact-based analysis of the overall situation prior to embarking on an elimination or eradication programme. As an example, we draw upon insights gained from a series of lymphatic filariasis (LF) studies from our research group that adopted an eradication investment case (EIC) framework. The justification for EICs, and related epidemiological, geospatial and other mathematical/operational research modelling, stems from the necessity for proper planning prior to committing to disease eradication. Across all considerations for LF eradication, including: time, treatments, level of investments necessary, health impact, cost-effectiveness, and broader economic benefits, scaling-up mass drug administration coverage to all endemic communities immediately provided the most favourable results. The coherent and consistent pursuit of eradication goals, operationally tailored to a given socioecological system and based on integrated measures of available tools will lead relatively rapidly to elimination in many parts of endemic areas and provide the cornerstone towards eradication.

Towards a comprehensive simulation model of malaria epidemiology and control.

Planning of the control of Plasmodium falciparum malaria leads to a need for models of malaria epidemiology that provide realistic quantitative prediction of likely epidemiological outcomes of a wide range of control strategies. Predictions of the effects of control often ignore medium- and long-term dynamics. The complexities of the Plasmodium life-cycle, and of within-host dynamics, limit the applicability of conventional deterministic malaria models. We use individual-based stochastic simulations of malaria epidemiology to predict the impacts of interventions on infection, morbidity, mortality, health services use and costs. Individual infections are simulated by stochastic series of parasite densities, and naturally acquired immunity acts by reducing densities. Morbidity and mortality risks, and infectiousness to vectors, depend on parasite densities. The simulated infections are nested within simulations of individuals in human populations, and linked to models of interventions and health systems. We use numerous field datasets to optimise parameter estimates. By using a volunteer computing system we obtain the enormous computational power required for model fitting, sensitivity analysis, and exploration of many different intervention strategies. The project thus provides a general platform for comparing, fitting, and evaluating different model structures, and for quantitative prediction of effects of different interventions and integrated control programmes.

[Health care provider payment systems]. / La remunerazione delle prestazioni sanitarie: principi e modelli.

Health care provider payment systems regulate the relationship between patients, providers, and third payers in order to maximise benefits and minimise costs of the whole health care system. Health care providers could be paid by a price or a fee for service, by capitation systems, or by reimbursement of production costs. It would be interesting to develop innovative payment systems aimed to the payment of the entire health care pattern of patients. This would be particularly desirable for certain health conditions where it is impossible to divide the health care delivery pattern into single health services e.g. psychiatric care, long term and rehabilitation care.

Pharmacoeconomic analysis of prescriptions in Italian pediatric general practice.

Most drugs used by children are prescribed by general pediatric practitioners (GPPs) in ambulatory settings. Prescription profiles are affected by GPPs' attitudes while the cost is related to the reimbursement modality. This study evaluated the Italian National Health Service (INHS) and family expenditures associated with prescribing practices to children younger than 12 years. Forty-two GPPs from southern Italy participated in the study. All visits recorded by GPPs during a 13-week period (February-April 1998), including telephone contacts and office and home visits were analyzed. The cost analysis of prescriptions is based on a sample of randomly selected consultations. INHS and family expenditures were evaluated according to reimbursement modalities for drug prescriptions. Total expenditure induced by all prescriptions during the study period was about 148 million Italian lire (7650 euros); 54% of this was borne by the INHS and the rest remaining by families. When corrections according to prescription modalities - following appropriate reimbursement form - were applied, only 49% of total expenditure were covered by INHS and 51% by families. Analysis of expenditures showed that drugs for symptomatic therapies (e.g., cough and cold preparations, analgesics, antipyretics) and vitamins accounted for most of the families' expenditure, while antibacterial and antiasthmatic drugs did so for the INHS. Of the ten most prescribed drugs the cost of three fell entirely on the family: paracetamol (the most commonly prescribed drug),morniflumate, and ambroxol. Therapeutic indications causing greatest expenditures for families were all the common,trivial childhood symptoms such as cough, fever, rhinitis, flu, and pharyngitis. Despite the universal coverage for pharmaceutical care more than one-half of drug therapy expenditures for children was covered directly by the parents. Prescription attitudes by GPPs remain the crucial factor for an equal cost distribution between families and the INHS.

Resource utilization and hospital cost of HIV/AIDS care in Italy in the era of highly active antiretroviral therapy.

This study set out: (1) to describe resource utilization patterns among four groups of HIV-infected patients at different stages of the disease, and (2) to estimate the direct hospital costs of HIV/AIDS care among these patients in Italy. It is a multi-centre, prospective observational study conducted between August 1997 and July 1998. The 483 patients, enrolled in five infectious diseases departments located in different areas of Italy, were stratified into four groups according to their CD4+ lymphocyte cell count and status of AIDS Defining Illness (ADI) at enrolment. Average direct hospital costs (L = Italian Lire, 1997 exchange rate US$ 1 = 1,704 Italian Lire) were L.23,725,584 (US$ 13,923.5), L.15,208,287 (US$ 8,925.1), L.11,942,761 (US$ 7,008.7) and L.7,660,942 (US$ 4,495.9) for the four groups of patients. More than 80% of patients in the first group and about 65% of patients in the second group received highly active antiretroviral therapy (HAART). The proportion of patients receiving HAART in the third and fourth group increased from 37.1% to 56.5% and from 15.3% to 31.5%. The number of hospital days observed in this study was much lower than previously published numbers in Italy. These results may indicate a shift of costs from hospitalisation to outpatient care and ARV.

The outpatient cost of diabetes care in Italian diabetes centers.

OBJECTIVE: To provide resource utilization patterns and cost estimates of outpatient care for types I and II diabetes mellitus in Italy, based on retrospectively collected data. DESIGN: Multicenter, retrospective observational study analyzing individual costs in a sample of patients with diabetes mellitus. STUDY POPULATION: A total of 2260 patients were stratified into eight groups by type of diabetes, glycemic control, and age. SETTING: Thirty-five centers for diabetes care in Italy. RESULTS: The per-patient cost of treatment was [symbol: see text] 136.8 in two months for type I diabetes (N = 592) and [symbol: see text] 123.3 for type II diabetes (N = 1668). Pharmaceutical therapy consisting of antidiabetic drugs only accounted for only 32% to 36% of treatments cost in type I patients and between 13% and 24% in type II. Diagnostic tests accounted for 27% to 42% of treatment costs in patients with both type I and type II diabetes, day-hospital days accounted for 15% to 22% in type I, 25% to 27% in type II, and consultations accounted for 16% to 20% in type I patients and between 17% and 21% in type II diabetes. CONCLUSION: Despite limitations caused by the short period considered, and considering that in Italy the cost of diabetes has received limited attention, we believe this study presents some interesting information on the burden of diabetes in this country.

A comparative analysis of domiciliary oxygen therapy in five European countries.

This comparative study analyses the domestic market of domiciliary oxygen therapy in five European countries (Denmark, France, Germany, Italy, and the UK) according to a common checklist of subjects. Domestic legislation, prescription procedures, delivery, and the market situation concerning oxygen therapy were considered. The analysis involved (i) reviewing the literature on oxygen therapy in national and international journals, and (ii) interviewing a selected expert panel of market operators in each country (composed of at least one civil servant, one physician, one distributor, and one oxygen manufacturer). The analysis did not find any specific relationship between the health care system framework and the oxygen therapy market, except for a greater inclination towards home care in national health services. In all these countries oxygen therapy is reimbursed, but the type of supply and its diffusion differ widely. The spread of domiciliary care has undermined the traditional role of pharmacies in the oxygen distribution chain in all countries except Italy. The study did not help identify any specific country that can be considered a benchmark for oxygen therapy, each one dealing with oxygen therapy in a different way. An economic evaluation of the different supply modalities could help improve decision making by public authorities.

The costs of childhood epilepsy in Italy: comparative findings from three health care settings.

PURPOSE: To determine the direct costs of epilepsy in a child neurology referral population, stratified by disease, duration, and severity, comparing three different health care settings [i.e., teaching or clinical research (CR) hospitals, general hospitals, and outpatient services]. METHODS: Patients were accepted if they had confirmed epilepsy and were resident in the center catchment area. Eligible subjects were grouped in the following categories: (a) newly diagnosed patients; (b) patients with epilepsy in remission; (c) patients with active non-drug-resistant epilepsy; and (d) those with drug-resistant epilepsy. Over a 12-month period, data regarding the consuming of all resources (i.e., consultations, tests, hospital admissions, drugs), were collected for each patient. Using the Italian National Health Service tariffs, the unit cost of each resource was calculated and indicated in Euros, the European currency. RESULTS: A total of 189 patients was enrolled by two teaching-CR hospitals, two general hospitals, and two outpatient services. The patients were evenly distributed across the four categories of epilepsy. The mean annual cost per person with epilepsy was 1,767 Euros. Drug-resistant epilepsy was the most expensive category (3,268 Euros) followed by newly diagnosed epilepsy (1,907 Euros), active non-drug-resistant epilepsy (1,112 Euros), and epilepsy in remission (844 Euros). Costs were generally highest in teaching-CR hospitals and lowest in outpatient services. Hospital services were the major cost in all epilepsy groups, followed by drugs. CONCLUSIONS: The cost of epilepsy in children and adolescents in Italy tends to vary significantly depending on the severity and duration of the disease Hospitals services and drugs are the major sources of costs. The setting of health care plays a significant role in the variation of the costs, even for patients in the same category of epilepsy.

Cost analysis of dialysis modalities in Italy.

This study analyses management and costs of dialysis in the Italian National Health Service (NHS). Information on efficacy and health-related quality of life (HRQOL) based on the existing literature also is presented. The clinical differences between the dialysis modalities seem to be related to their appropriateness to specific patient groups. Efficacy rates are similar and the only differences are in complications and HRQOL. Traditional haemodialysis (THD) can be done by Italian patients in dialysis centres or in hospital. Highflux haemodialysis (HFHD) is generally only done in hospital. Peritoneal dialysis (PD) is usually done at home. The cost analysis was performed on a sample of Italian dialysis centres and hospitals, according to the full cost method. As expected, HFHD was more expensive than THD and PD, but no marked differences emerged among the different HFHD modalities. THD modalities in dialysis centres were less costly than in hospitals. Automated PD (APD) was much more expensive (almost twice) than continuous ambulatory PD (CAPD), the cheapest method in absolute terms. This study confirms that dialysis is costly and that it is very difficult to assess the cost-effectiveness of the different approaches. Although this study has limits, it should provide sufficient analytical information to local healthcare managers for more rational allocation of financial resources to dialysis services.

Direct costs of schizophrenia in Italian community psychiatric services.

OBJECTIVE: To estimate resource utilisation and direct costs of treatment for patients with schizophrenia in Italian Community Mental Health Centers (CMHCs). DESIGN: Multicentre, retrospective observational study. CMHCs recruited all patients who attended a follow-up consultation during the period September to December 1998. At enrollment, psychiatrists completed a questionnaire on consumption of resources in the 2 months before recruitment. SETTING: 14 CMHCs. PERSPECTIVE: Italian National Health Service (INHS). PATIENTS: 702 patients with a diagnosis of schizophrenia or other psychotic disorders, defined according to the Diagnostic and Statistical Manual of Mental Disorders-fourth edition. These patients had been followed by the CMHCs for at least 2 years and attended a follow-up consultation either during the period September to December 1998 or on randomly selected days during this period. Patients were classified into seven groups according to their diagnosis. RESULTS: The mean direct cost of patients with schizophrenia in the 2-month observation period was 2,234,475 Italian lire [L] (1154.01 Euro; EUR); direct costs ranged from L.1,545,818 to L.2,775,658 (EUR798.35 to EUR1433.51) by prognostic group. There was wide variability for prognostic groups in the impact of most cost components on total cost. Admissions accounted for between 11.4 and 56.3% of the total cost, daycare centre days for between 11.3 and 35.5%, home visits for 7.8 to 16.4%, and day-hospital days for 5.4 to 32.8%. Antipsychotics and anxiolytics were the most prescribed drugs and also the most costly. CONCLUSION: Despite the limitations of the study related to the short period considered, we believe this study offers some interesting information on the burden of schizophrenia, a disease for which its cost has received limited attention so far in Italy.

The cost of urinary incontinence in Italian women. A cross-sectional study. Gruppo di Studio Incontinenza.

OBJECTIVE: To offer cost estimates of urinary incontinence (UI) in the general population based on prospectively collected data. DESIGN: We analyzed individual costs in a sample of women with UI who were identified in the framework of a cross-sectional study on the prevalence of UI in women aged > 40 years. SETTING: Six areas in Italy. INTERVENTION: Home interview. PATIENTS AND PARTICIPANTS: Women were identified among the patients registered with a network of general practitioners operating in each area using computer-generated random number lists. RESULTS: A total of 2767 women were identified. Of these, 408 (14.7%) reported UI during the year before the interview and 229 underwent a detailed interview on UI-related costs. On the basis of this information, we estimated the direct costs associated with UI from the perspective of the Italian National Health Service (INHS). The lifetime cost per patient of diagnosis was 80,131 Italian lire (L) (exchange rate: $US1 = L1618). Consultations accounted for only 20% of the diagnostic cost, diagnostic tests for 36% and hospital admissions for diagnostic procedures accounted for 44%. The diagnosis cost estimate seems low, partly because several women did not request either consultations or diagnostic tests (the overall rate per patient was 0.76 for consultations and 0.39 for diagnostic tests). The only appreciable treatment cost, according to the INHS perspective, was for diapers. The annual cost per patient for diapers was L255,519. The prevalence of UI in women aged > 40 years in Italy is estimated in the study at 9.3%. Thus, combining this information with the cost estimates, the annual treatment cost of UI in Italian women aged > 40 years is L351,800 billion, considering diapers and drugs only. CONCLUSION: This study has estimated the individual cost of UI in the general population. These figures may be useful when designing economic evaluations of UI.

A comparative analysis of generics markets in five European countries.

A generic medicine is a faithful copy of a mature drug--no longer under patent marketed with the chemical name of the active ingredient. This article analyses generics markets in five European countries: France, Germany Italy, The Netherlands and the U.K. The study investigate all the main issues--patent, approval to market, pricing and reimbursement, prescription and distribution--which affect the life cycle of a pharmaceutical product. The situation in the five countries varied widely. Because of European harmonization, patent legislation and approval procedures no longer affect much the development of generics. Only national legislation on patent protection approved before the EU directive came into force still plays a role. Approval differences seem to be due mainly to common practice, rather than to the regulations themselves. None of the countries have an efficient public information system on patent expiry. Generics have had more success in countries with more flexible pricing policies. Reimbursement has not yet been used widely to discriminate between generics and proprietary drugs. Financial incentives are based more on physicians' prescribing behaviour than on pharmacists. The freedom of pharmacy ownership and the consequent possibility of dispensing pharmaceuticals through different channels affects dramatically the structure of generics markets. A free market of wholesalers and retailers can enhance a comparative market, through horizontal and vertical integration all along the distribution chain. Such an environment has stimulate the success of unbranded generics by delegating strong purchasing power to distributors.

How do Italian pharmacoeconomists evaluate indirect costs?

OBJECTIVES: To investigate how indirect costs are evaluated in pharmacoeconomic studies in Italy and the attitude of Italian pharmacoeconomists toward indirect costs. METHODS: A literature review was conducted, specifically focused on pharmacoeconomic studies including indirect costs carried out in Italy, and a suevey among Italian pharmacoeconomics experts. RESULTS: Nineteen studies were available for review. Although the methods used to calculate the value of production loss due to morbidity were all based on the Human Capital Approach (HCA), there was a wide variability among studies in practical methods. The parameters used to value production losses varied widely too. Of the 25 survey responders, 20 considered it important to include indirect costs in pharmacoeconomic studies; 56% of those interviewed stated that health authorities should require indirect cost evaluations. Most of these experts would include indirect cost estimates in drug-pricing calculation. CONCLUSIONS: In Italy studies evaluating indirect costs are still only few, although there is evidence of an increase. Italian pharmacoeconomists are far from reaching any consensus on methods for evaluating these costs. Methods need to be standardized particularly with respect to the parameters used to quantify productive time lost in monetary terms.

Costs of diabetes. A methodological analysis of the literature.

OBJECTIVE: To review studies on the costs of diabetes and its complications through a scheme designed specifically for assessing the quality of cost-of-illness (COI) studies. DESIGN AND SETTING: The methodology of COI studies in diabetes was analysed in order to assess the significance of quantitative results. The scheme adopted 7 items identified as the main points for discussing the methodological choices governing the results. We also used a checklist based on questions related to the 7 items. MAIN OUTCOME MEASURES AND RESULTS: The answers showed that many studies appear not to give technical details, so it is hard to understand the method. Methodological choices varied widely between the studies. This is probably due to the lack of consensus on the methodology of COI studies. Based on the findings of this review, we suggest also some specific points that could help produce more reliable results on the costs of diabetes. CONCLUSIONS: Clearly, a general consensus on COI studies is still remote, making the value of any comparison of results questionable.