Laboratory testing as a part of laboratory in vitro diagnostic (IVD) has become required tool in clinical practice for diagnosing, monitoring and prognosis of diseases, as well as for prediction of treatment response. The number of IVD tests available in laboratory practice has increased over the past decades and is likely to further increase in the future. Consequently, there is growing concern about the overutilization of laboratory tests and rising costs for laboratory testing. It is estimated that IVD accounts for between 1.4 and 2.3% of total healthcare expenditure and less than 5% of total hospital cost (Lewin Group report). These costs are rather low when compared to pharmaceuticals and medical aids which account for 15 and 5%, respectively. On the other hand, IVD tests play an important role in clinical practice, as they influence from 60% to 70% of clinical decision-making. Unfortunately, constant increases in healthcare spending are not directly related to healthcare benefit. Since healthcare resources are limited, health payers are interested whether the benefits of IVD tests are actually worth their cost. Many articles have introduced frameworks to assess the economic value of IVD tests. The most appropriate tool for quantitative assessment of their economic value is cost-effectiveness (CEA) and cost-utility (CUA) analysis. The both analysis determine cost in terms of effectiveness or utilities (combine quantity and quality of life) of new laboratory test against its alternative. On the other hand, some investigators recommended calculation of laboratory test value as product of two ratios: Laboratory test value = (Technical accuracy/Turnaround time) × (Utility/Costs). Recently, some researches used multicriteria decision analysis which allows comparison of diagnostic strategies in terms of benefits, opportunities, costs and risks. All analyses are constructed to identify laboratory test that produce the greatest healthcare benefit with the resources available. Without solid evidence that certain laboratory tests are cost-effective, laboratory services cannot be improved. Consequently, simple policy measures such as cost cutting may be imposed upon many laboratories while patients will have limited access to laboratory service.
Laboratorijska ispitivanja, kao deo in vitro dijagnostike (IVD), neophodan su alat u kliničkoj praksi za dijagnostiku, praćenje i prognozu bolesti, kao i za predviđanje odgovora na terapiju. Tokom proteklih nekoliko decenija broj dostupnih IVD testova rastao je postepeno i verovatno će se takav trend nastaviti i u budućnosti. Postoji zabrinutost zbog povećanog i neracionalnog korišćenja laboratorijskih testova i shodno tome, porasta troškova za laboratorijsko testiranje. Međutim, na osnovu izveštaja Levin Groupe procenjuje se da IVD testovi čine manje od 2% troškova ukupne zdravstvene zaštite (ZZ) i manje od 5% bolničkih troškova. Ovi troškovi su prilično mali u poređenju sa izdacima za lekove (15%) i medicinskapomagala (5%). S druge strane, laboratorijska ispitivanja igraju važnu ulogu u kliničkoj praksi, jer omogućavaju donošenje 60% do 70% kliničkih odluka. Na žalost, konstantan porast izdataka u ZZ nije u relaciji sa porastom zdravstvene koristi. Pošto su resursi za ZZ ograničeni, finansijere u zdravstvu (fondove zdravstvenih osiguranja) interesuje da li troškovi laboratorijskih testova (posebno novih testova) opravdavaju dobijenu korist. Preporučeni su okviri za procenu ekonomske vrijednosti laboratorijskih testova. Najpo god - niji instrumenti za kvantitativno procenu njihove ekonomske vrednosti su analiza troškovne isplativosti (CEA) i analiza korisnosti troškova (CUA). Obe analize procenjuju troškove u odnosu na efektivnost (CEA) ili u odnosu na korist (kombinuje kvantitet i kvalitet života – CUA) laboratorijskog testa poređenjem sa alternativom. S druge strane, neki istraživači preporučuju izračunavanje vrednosti laboratorijskog testa iz proizvoda dva količnika: vrednost laboratorijskog testa =(tačnost / TAT) × (klinička korist / troškovi). Poslednjih nekoliko godina preporučuje se i analiza višekriterijumskog donošenja odluka koja omogućava poređenje dijagnostičkih strategija u smislu korisnosti, mogućnosti, troškova i rizika. Ove analize mogu da identifikuju laboratorijski test koji ima najveću zdravstvenu korist za raspoloživa sredstva. Bez dokaza da su laboratorijski testovi isplativi u smislu efekata i troškova, korišćenje laboratorijskih usluga ne može se unaprediti. Posledično, mogu biti primenjene mere kao {to su smanjeno finansiranje laboratorija, a pacijenti će imati ograničen pristup laboratorijskim uslugama.
Keywords: cost-effectiveness; cost-utility; laboratory tests; multicriteria decision analysis.