[en] This dissertation addresses the analysis of the difficulties presented by genetic technologies and genomic tests and to achieve their incorporation into health care portfolios. Given that the price and economic evaluation as decision criteria are very relevant, the analysis of the incorporation of the multigenic test Oncotype Dx © into the portfolio of the Basque Health Service (Osakidetza) was established. The determination of market conditioning factors was dealt with a phenomenological perspective from the view of 19 participants belonging to 5 stakeholders related to the development, clinical incorporation and use of these technologies. The professional scope of the group of participants was related to the Basque Country. At the same time the economic evaluation of the multigenic test was determined in the Osakidetza health context. The characterization of the population was established from the treatment registry analysis of 401 patients with early stage breast cancer that fulfilled the criteria to be analyzed with the multigenic test. The results established that the use of new technologies based on genetic knowledge is scarce and focused on certain health areas such as oncology, despite the fact that they maintain a progressive sanitary implantation. However, the analysis results achieved five main conclusions. The training of professionals related to the use and application of technologies conditions their development. Increasing the clinicians' basic training in genetics does not imply a transformation of professional roles. Collaboration between different knowledge areas requires conceptually similar elements of communication. The educational change constitutes a primordial element for the beginning of collaborative processes. Changes in training must occur in both clinicians and biotechnologists with a common communicative goal. The market access legislation for genetic / genomic technologies and tests is a limiting aspect. The regulation of research areas and the sanitary validation of new technologies must be modified according to the characteristics of genetic techniques. In particular, legislative changes are relevant in the validation of drug-related genetic tests. The need for legislative changes was confirmed respect to genomic tests with analytical functions too. The Direct-to-consumer services of these technologies require a high level of regulatory control over the data safekeeping. As well as the need for clinical supervision for users communication of such sensitive health information. The criteria for the decision on the services portfolio incorporation of new technologies are centered in the control of the cost, therefore the price constitutes a very relevant aspect. However, the consideration of the price must be conditioned by the health benefits provided by the technological substitution. The evaluation criteria used by decision makers are very relevant for the industry and the genetically based technologies development. The provision of economic assessments by the industry allows to know and improve competitive positions. In addition, the status as prescriber of the industry is reinforced through the use of economic assessments in the presentation of new technologies. A specific test consideration such as Oncotype Dx © confirmed that the inclusion of the test in the service portfolio leads to an increase in treatment costs per patient. The negative budget xvi impact was established when using a health approach. The new technology leads to a significant reduction in the number of patients who are prescribed chemo during the treatment of breast cancer. Including the cost of lost productivity will reverse the impact on the budget, taking a social perspective. Finally, the economic analysis of the new technology also demonstrated that the incorporation of the multigenic test is cost-effective, result in an incremental cost-effectiveness ratio (ICER) below of € 30,000 / QALY as acceptability threshold. The consideration of productivity loss costs results in the test dominant position compared to the histochemical criteria. In addition, the patient differentiation criteria change, discussed in the literature, was also cost effective, with an ICER reduction regarding histochemical criteria. The modification of the classification criteria of Oncotype Dx © test is dominant from the Basque Health System health approach.

[eu] Doktoretza tesi honetan test eta teknologia genetikoak aurkezten duten osasun karteran sartzeko zailtasunak aztertzen dira. Balioa eta ebaluaketa ekonomikoak ebazpide bezala hartzeko erabakiak duen garrantzia ikusita, Oncotype Dx© test multigenikoaren analisia sustatu zen osasun zerbitzuetako zerrendetan gehitea. Merkatuaren gaineko faktoreak ikertu ziren fenomenologiaren ikuspuntutik 5 stakeholderreko 19 partaideen iritzia kontuan edukita. Stakeholderrak teknologiaren garapenarekin, osasun zerbitzutan sartzeko erabakiekin eta erabilerarekin erlazionatuta zeuden. Partaide taldearen profesional eremua Euskadirekin erlazionatuta zegoen. Aldi berean, test multigenikoaren ebaluaketa ekonomikoa Osakidetzako osasun kontestuan zehaztu egin zen. Populazioaren ezaugarriak ezarri ziren test multigenikoarekin aztertuak izateko baldintzak bete zituzten goiz estadio bular minbiziko 401 gaixoen erregistroak analizatuta. Emaitzak argitaratu zuten ezagutza genetikoan oinarrituta dauden teknologien erabilera txikia dela, eta minbizia bezalako osasun arlo zehatzetan kokatuta dago, etengabeko ezarkuntza adierazten badute ere. Dena dela, heldutako analisien emaitzak bost ondorio nagusiei bide eman zieten. Teknologien erabilera eta aplikazioarekin erlazionatutako profesionalen heziketa eragina dauka beraien garapenarekin. Medikuen heziketaren areagotzea genetikan ez du esan nahi beren rol profesionalak aldatu behar dituztela. Ezagutzaren arlo desberdinen kolaborazioak komunikazioan kontzeptuzko elementu antzekoak behar ditu. Formakuntzaren aldaketa beharrezko elementu da kolaborazio prozesuak hasteko. Heziketa aldaketa hau medikuen eta bioteknologoen komunikazio bateratu bat lortzeko balio behar du. Teknologia eta test genetiko/genomikoen merkatu sarrera arautzen duten legeak oztopatu egiten dute. Ikerketa arloen eta osasun Teknologi berrien erregulatzen duten legeak aldatu behar dute teknika genetikoen ezaugarriei aintzat edukita. Batez ere, test genetikoak medikamentuekin bat eginda dauden balidazio prozesuen lege aldaketak nabarmengarriak dira. Test genetikoak funtzio analitikoei buruz ezartzen da lege aldaketa bat merkatu sarrera kontrolpean jartzeko. Teknologi hauen Direct-to-consumer zerbitzuak ikuskapen normatibo handi bat behar dute datuen zaintzarako. Baita ere medikuen ikuspenaren beharra erabiltzaileei horrelako informazio sentikor baten komunikazioa egiteko. Teknologia berrien osasun karteretan barneratzeko erabakiak hartzeko ebazpideak balioaren kontrolean zentratuta daude, horregatik prezioak alde garrantzitsu bat osatzen du. Hala ere, prezioaren hausnarketa aldaketa teknologikoaren bidez lortzen den osasun onurari baldintzatuta dago. Kontuan hartutako jarraibideak erabakiak hartzen duten kudeatzaileengatik oso garrantzitsuak dira industriarentzat eta base genetikoa duten teknologien garapenerako. Ebaluaketa ekonomikoen prestakuntza industriaren aldetik posizio konpetitiboak ezagutu eta hobetzea bideratzen ditu. Gainera, teknologia berrien aurkezpenetan ebaluaketa ekonomikoen erabilera indartzen du industriaren preskriptore bezalako gaitasuna. Oncotype Dx bezalako test espezifiko baten hausnarketak egiaztatu zuen testaren sarrera osasun zerbitzuen karteran kostuen handiagotze bat eragiten duela paziente bakoitzaren xiv tratamenduan. Ondorio negatiboak aurrekontuetan adierazi ziren osasun ikuspuntua erabilita. Teknologi berriak bular minbiziaren tratamenduan kimioterapia agintzen zaien paziente kopuru handi baten beheraldi bideratzen du. Ikuspuntu sozial bat hartuta eta produktibitate galeren kostea kontuan hartuta aurrekontuen gan duen efektua adierazten da. Azkenik, teknologia berriaren analisi ekonomikoak baieztatu zuen test multigenikoaren gaineratzea koste-efektiboa dela ere bai, ratio koste-efektibitate handitzea (ICER) 30.000 €/QALY hastapenaren baino gutxiagoa izanik. Produktibitate galeraren balioa kontuan hartuta testa nagusitzen da ebazpide histokimikoekin konparaketa egiterakoan. Gainera, literaturan eztabaidatzen diren pazienteak desberdintzeko ebazpideen aldaketa kontuan hartuta testa koste-efektiboa da, ICER-aren murrizketa bat lortzeko ebazpide histokimikoekin aurrean. Oncotype Dx©-en sailkaketa ebazpideen aldaketa nagusia da Euskadiko Osasun Sistemaren ikuspuntutik.