The first seetion of this Program elaborated the rationale and PrineiPles of establishing the framework and reviewing existing eeonomie evidenee on marketed medieines
.Although a systematie review of Published eeonomie evidenee 15 useful to inform eost一effeetiveness ofm田火eted medieines，such method 15 limited due to quality andti妞nsferability of Pnm娜 eCOnomiC evidenee. When a systematie review 15 unable to evaluate the件conomic profiles of marketed medicines， eC0nO】 】】IC eCOnon】IC studies should be earried out.The ne丫V ne丫V evaluations，whieh are Performed on basis of systematie weaknesses and stren review，eould reeognize the the the Possible Pitfalls， 廿助sferability. This gths of Published studies，avoid and 50 imProve the quality and PaPer introduees the methods of eondueting new eeonomie evaluations on marketed medieines，in Partieulat， study designs，valuation of outeomes and eosts，and sensitivity analyses. The eomPonents of eeonomie framework，sueh as PersPeetive and time horizon，have been introdueed in the first seetion of this Program，and will not be Presented in this PaPer.Rather than detailing the teehniques and methods，this PaPer Presents the key PrineiPles and rationale.The details and examPles on condueting eeonomic evaluations by using varieties of techniques will be Presented in later Papers. Study design Generally，there are four designs of eeonomie evaluations:①Trial一based evaluations:a)pragmatie trials，b)“Piggy一baek”studies(eeonomie evaluation a一ongside randomized eontrolled trials)， ② observational studies:a)ProsPeetive observational studies，b)retrospeetive dstabase studies，③Modeling studies(studies whieh eombine data obtained from dirrerent sourees in deeision analytie models)， ④ Hybrid studies(modeling 15 neeessary adjunet to Primary measurement). Seleeting an aPProaeh to the study design must generally strike balanee between what 15 needed and various limitations，it must also eonsider the eosts and benefits of research designs with different Preeision and strength.It 15，therefore，suggested that the aPProaeh to be used should have a solid base in reality and should combine the exaetness of Controlled eliniCal trials with elements obtaified from observational studies，esPeeially with regard to the util技洛tion ofresourCeS. Tria卜based eVd!UationS The studies whieh，more than others，ean Provide reliable elements for econo而e evaluation of marketed medieines are Pragmatie trials(real一world ProsPective， randomized elinieal一economic trials some ComPromlSC external validity<2，3>. between the goals of whieh offer internal and The main advanta studies ar。: ① 5 ofPragmatie 『L‘’‘，·1 ne maln aavantagCS 01 PfagmatlC subjeets are rePresentative of Patients typieally seen ine一inieal practiee，②the settings and Physieians involved are rePresentative of real一life praetiee，③physieians and patients are not blind to the therap%④a一enrol一ed patients are fol一owed under routine eonditions(e.g.eomPlianee with study theraPy 15 not enforeed，Physieians determine frequeney of all follow一uP serviees，Patients Paid for all medieal eare as they eustomarily would，all study medication was dispensed through retail pharmaeies)， and⑤a wide range of endPoints 15 measured(effectiveness， toleranee，quality of life，resouree use，etc).DesPite interest in the design of Pragmatie trials to address eeonomie Problems，sueh research may be infeasible due to substantial eosts and time. p iggybaeked studies may have a low degree of external validity(i.e.transferability to the real- world setting and use of the treatment)and this 1 imits its usefulness for eeonomie evaluation of marketed medieines.Potential Problems with Piggy- baek eva一uations are<4>:①trial setting，dietated by exPerimental eonsiderations，may be atyPieal of real world(earefully一seleeted study eenters and Patients)， ②adherenee to striet researeh protocol may affeet study outeomes:noneo娜lianee with study，③ther叩y may be aetively diseouraged，and Patients who do not eomply may be dropped out，④eomparator， dictated b
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