血癌先進免疫療法（CAR-T 與 BiTEs）與異體造血幹細胞移植（Allo-HSCT）等治療，延長了血液腫瘤病患存活期。但其長達 15 年的長期隨訪法規要求，導致集中式醫療體系面臨急性病床過載與護理人力流失的結構性困境。為回應此困境，本研究探討數位轉型下之血液腫瘤去中心化營運模式。本研究基於策略型態分析與比較型 SWOT 分析，得出醫學中心與專科護理診所之互補關係，並透過策略六大構面建構由專科護理師主導的軸輻協作網絡。本模式將亞急性期與長期隨訪轉移至社區，並規劃導入生物標記預防( BIOmarkers PREVENTion，BIOPREVENT) 針對骨髓移植後慢性移植物抗宿主疾病作為風險分層之輔助工具與將人工智慧 (AI)融入醫療與高科技領域系統化流程架構:學習-預測-監控-檢測-修正(Learn-Predict-Monitor-Detect-Correct，LPMDC)，以輔助護理管理之規模化，打破傳統勞力密集限制，實現護理管理的規模經濟。在可行性評估上，財務面考量健保給付、自費科技訂閱與藥廠 B2B 數據服務之混合營收機制。法規面則提出三階段動態授權的漸進式改革建議，以突破現行預立特定醫療流程之限制。總結而言，本研究期許透過去中心化的醫療照護模式，能提供一個兼顧醫學中心、基層診所與跨國藥廠三方需求的癌後照護模式，為台灣醫療體系提供兼顧臨床安全與永續營運之轉型方向。

Advanced immunotherapies like CAR-T and BiTEs, alongside Allo-HSCT, have significantly prolonged survival for patients with hematologic malignancies. However, the regulatory mandate for 15-year long-term follow-up has plunged centralized healthcare into structural dilemmas, notably acute bed shortages and severe nursing attrition. To resolve this, this study proposes a digitally transformed, decentralized operating model. Drawing on Strategic Profile Analysis and Comparative SWOT Analysis, this research establishes the complementary roles of medical centers and grassroots clinics, leveraging the Six Dimensions of Strategy framework to construct a Nurse Practitioner (NP)-led Hub-and-Spoke collaborative network. This model strategically shifts subacute care and long-term follow-up to the community. It incorporates "BIOPREVENT" (BIOmarkers PREVENTion) for risk stratification of chronic Graft-Versus-Host Disease and integrates AI into a systematic "LPMDC" (Learn-Predict-Monitor-Detect-Correct) operational framework. This digital integration scales nursing management, overcoming traditional labor-intensive limitations to achieve economies of scale. Feasibility assessments validate a hybrid revenue mechanism encompassing National Health Insurance reimbursements, out-of-pocket tech subscriptions, and pharmaceutical B2B data services. Regulatorily, a progressive, three-stage dynamic authorization reform is proposed to overcome current rigid protocol constraints. Ultimately, this decentralized framework aligns the tri-party needs of medical centers, community clinics, and multinational pharmaceutical companies, providing a transformative blueprint for Taiwan’s healthcare system to achieve clinical safety and operational sustainability.

中文文獻
1.中華民國血液病學會、中華民國血液及骨髓移植學會、中華民國癌症醫學會、台灣免疫暨腫瘤學會（2024）。臺灣CAR-T細胞治療手冊。https://www.tsitc.org.tw/uploads/guide_taiwan_file/1713154894_d7ca15aa8e84e4b0aa7a.pdf
2.司徒達賢（2001）。策略管理新論：觀念架構與分析方法。智勝文化。
3.立法院（2024）。《再生醫療法》。中華民國113年6月19日華總一義字第11300052981號令制定公布。
4.立法院（2024）。《再生醫療製劑條例》。中華民國113年6月19日華總一義字第11300052991號令制定公布。
5.社團法人台灣在宅醫療學會（2023）。遠距科技智慧照護應用於急重暨安寧病患之在宅住院創新模式計畫期末成果報告（計畫編號：MOHW112-MD-C-114-000001）。衛生福利部醫事司。
6.厚生労働省（2015）。特定行為に係る看護師の研修制度について。https://www.mhlw.go.jp/stf/seisakunitsuite/bunya/0000050325.html
7.專科護理師於醫師監督下執行醫療業務辦法（衛部照字第 1131560194C 號）。https://law.moj.gov.tw/LawClass/LawAll.aspx?pcode=L0020166
8.梁智瑋、葉宗讓、林俊祐、陳惇杰（2024）。血液幹細胞移植病人的巨細胞病毒感染：風險因子、診斷監測與處置。感染控制雜誌，34（3），162–171。https://doi.org/10.6526/ICJ.202406_34(3).0004衛生福利部（2024）。
9.衛生福利部（2025）。長期照顧十年計畫 3.0（115–124年）（核定本）。https://www.mohw.gov.tw/
10.衛生福利部（2018）。《特定醫療技術檢查檢驗醫療儀器施行或使用管理辦法》。中華民國107年9月6日衛部醫字第1071665417號令修正發布。可見於法務部全國法規資料庫。
11.衛生福利部中央健康保險署（2023）。《全民健康保險藥物給付項目及支付標準》特材部分修正規定（CAR-T 細胞治療藥品暫時性支付）。中華民國112年11月1日生效。
英文文獻
1. Abramson, J. S., Palomba, M. L., Gordon, L. I., Lunning, M. A., Wang, M., Arnason, J., Mehta, A., Purev, E., Maloney, D. G., Andreadis, C., Sehgal, A., Solomon, S. R., Ghosh, N., Dogan, A., Ward, P. R., Francica, M., Chen, L., … Kamdar, M. (2020). Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): A multicentre seamless design study. The Lancet, 396(10254), 839–852. https://doi.org/10.1016/S0140-6736(20)31366-0
2. Ahn, M.-J., Cho, B. C., Felip, E., Korantzis, I., Ohashi, K., Majem, M., Juan-Vidal, O., Handzhiev, S., Izumi, H., Lee, J.-S., Dziadziuszko, R., Wolf, J., Blackhall, F., Reck, M., Bustamante Alvarez, J., Hummel, H.-D., Dingemans, A.-M. C., Sands, J., Akamatsu, H., … Paz-Ares, L. (2023). Tarlatamab for patients with previously treated small-cell lung cancer. New England Journal of Medicine, 389(22), 2063–2075. https://doi.org/10.1056/NEJMoa2307980
3. Aitken, M., & Nass, D. (2024). Digital health trends 2024: Implications for research and patient care. IQVIA Institute for Human Data Science. https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/digital-health-trends-2024
4. American Association of Nurse Practitioners. (2024). State practice environment. https://www.aanp.org/advocacy/state/state-practice-environment
5. American Association of Nurse Practitioners. (2025). State practice environment. https://www.aanp.org/advocacy/state/state-practice-environment
6. Amicucci, M., & Ciaralli, I. (2021). Nurse practitioner management of a blinatumomab infusion program: Impact on patient safety and quality of care. Journal of Infusion Nursing, 44(1), 34–40. https://doi.org/10.1097/NAN.0000000000000409
7. Arnaudo, L. (2022). On CAR-Ts, decentralized in-house models, and the hospital exception. Journal of Law and the Biosciences, 9(2), Article lsac027. https://doi.org/10.1093/jlb/lsac027
8. Australian Government, Department of Health, Disability and Ageing. (2024). Collaborative arrangements. https://www.health.gov.au/our-work/collaborative-arrangements
9. Baer, L. K., Brister, L., & Mazanec, S. R. (2021). Development and implementation of an advanced practitioner–led survivorship clinic for patients status post allogeneic transplant. Journal of the Advanced Practitioner in Oncology, 12(8), 775–783. https://doi.org/10.6004/jadpro.2021.12.8.2
10. Bhatia, S. (2011). Long-term health impacts of hematopoietic stem cell transplantation inform recommendations for follow-up. Expert Review of Hematology, 4(4), 437–454. https://doi.org/10.1586/ehm.11.39
11. Boussi Rahmouni, H., Hassine, N. B. E. H., Chouchen, M., Ceylan, H. İ., Muntean, R. I., Bragazzi, N. L., & Dergaa, I. (2025). Healthcare 5.0-driven clinical intelligence: The learn-predict-monitor-detect-correct framework. Healthcare, 13(20), Article 2553. https://doi.org/10.3390/healthcare13202553
12. Budde, L. E., Sehn, L. H., Matasar, M., Schuster, S. J., Assouline, S., Giri, P., Kuruvilla, J., Canales, M., Dietrich, S., Fay, K., Ku, M., Nastoupil, L., Cheah, C. Y., Wei, M. C., Yin, S., Li, C.-C., Huang, H., Kwan, A., Penuel, E., & Bartlett, N. L. (2022). Safety and efficacy of mosunetuzumab, a bispecific antibody, in patients with relapsed or refractory follicular lymphoma: A single-arm, multicentre, phase 2 study. The Lancet Oncology, 23(8), 1055–1065. https://doi.org/10.1016/S1470-2045(22)00335-7
13. Cancer Institute NSW. (2023). Immune effector cell-associated neurotoxicity syndrome (ICANS) assessment tool (Version 2). eviQ. https://www.eviq.org.au/clinical-resources/immune-effector-cell-therapy/3719-iCANs-assessment-tool
14. Celis, P., Farinelli, G., Hidalgo-Simon, A., Meij, P., Tihaya, M., Schüssler-Lenz, M., & Timón, M. (2024). EMA commentary on the guideline on quality, nonclinical and clinical aspects of medicinal products containing genetically modified cells. British Journal of Clinical Pharmacology, 90(5), 1203–1212. https://doi.org/10.1111/bcp.16047
15. Chari, A., Minnema, M. C., Berdeja, J. G., Oriol, A., van de Donk, N. W. C. J., Rodríguez-Otero, P., Askari, E., Mateos, M.-V., Costa, L. J., Caers, J., Verona, R., Girgis, S., Yang, S., Goldsmith, R. B., Yao, X., Pillarisetti, K., Hilder, B. W., Russell, J., Goldberg, J. D., & Krishnan, A. (2022). Talquetamab, a T-cell–redirecting GPRC5D bispecific antibody for multiple myeloma. New England Journal of Medicine, 387(24), 2232–2244. https://doi.org/10.1056/NEJMoa2204591
16. Committee for Medicinal Products for Human Use. (2009). Guideline on follow-up of patients administered with gene therapy medicinal products (EMEA/CHMP/GTWP/60436/2007). European Medicines Agency.
17. Dickinson, M. J., Carlo-Stella, C., Morschhauser, F., Bachy, E., Corradini, P., Iacoboni, G., Khan, C., Wróbel, T., Offner, F., Trněný, M., Wu, S.-J., Cartron, G., Hertzberg, M., Sureda, A., Perez-Callejo, D., Lundberg, L., Relf, J., Dixon, M., Clark, E., … Hutchings, M. (2022). Glofitamab for relapsed or refractory diffuse large B-cell lymphoma. New England Journal of Medicine, 387(24), 2220–2231. https://doi.org/10.1056/NEJMoa2206913
18. Enthoven, A. C. (1993). The history and principles of managed competition. Health Affairs, 12(Suppl. 1), 24–48. https://doi.org/10.1377/hlthaff.12.suppl_1.24
19. Gauthier, J., & Yakoub-Agha, I. (2023). Bispecific antibodies and CAR T-cells in B-cell malignancies: A strategic review. Current Research in Translational Medicine, 71(2), Article 103388. https://doi.org/10.1016/j.retram.2023.103388
20. Gouvernement du Québec. (2024). Services offered by specialized nurse practitioners. https://www.quebec.ca/en/health/health-system-and-services/service-organization/specialized-nurse-practitioners/services-offered-specialized-nurse-practitioners
21. Health Legislation Amendment (Removal of Requirement for Collaborative Arrangement) Act 2024 (Cth). Federal Register of Legislation. https://www.legislation.gov.au
22. Huehls, A. M., Coupet, T. A., & Sentman, C. L. (2015). Bispecific T-cell engagers for cancer immunotherapy. Immunology and Cell Biology, 93(3), 290–296. https://doi.org/10.1038/icb.2014.104
23. The Human Medicines Regulations 2012, SI 2012/1916. https://www.legislation.gov.uk/uksi/2012/1916
24. Institute of Medicine. (2010). The future of nursing: Leading change, advancing health. National Academies Press. https://doi.org/10.17226/12956
25. Jagasia, M. H., Greinix, H. T., Arora, M., Williams, K. M., Wolff, D., Cowen, E. W., Palmer, J., Weisdorf, D., Treister, N. S., Cheng, G. S., Kerr, H., Stratton, P., Duarte, R. F., McDonald, G. B., Inamoto, Y., Vigodin, A., Pidala, J., Lee, S. J., Pavletic, S. Z., … Flowers, M. E. D. (2015). National Institutes of Health Consensus Development Project on Criteria for Clinical Trials in Chronic Graft-versus-Host Disease: I. The 2014 Diagnosis and Staging Working Group Report. Biology of Blood and Marrow Transplantation, 21(3), 389–401. https://doi.org/10.1016/j.bbmt.2014.12.001
26. Kantarjian, H., Stein, A., Gökbuget, N., Fielding, A. K., Schuh, A. C., Topp, M. S., O'Brien, S., Zugmaier, G., DaSilva, C. D., Nägele, V., Forman, S. J., Rambaldi, A., & Stelljes, M. (2017). Blinatumomab versus chemotherapy for advanced acute lymphoblastic leukemia. New England Journal of Medicine, 376(9), 836–847. https://doi.org/10.1056/NEJMoa1609783
27. Kuo, Y.-F., Agrawal, P., Chou, L.-N., Jupiter, D., & Raji, M. A. (2020). Assessing association between team structure and health outcome and cost by social network analysis. Journal of the American Geriatrics Society, 68(12), 2839–2847. https://doi.org/10.1111/jgs.16962
28. Lee, D. W., Santomasso, B. D., Locke, F. L., Ghobadi, A., Turtle, C. J., Brudno, J. N., Maus, M. V., Park, J. H., Mead, E., Pavletic, S., Go, W. Y., Eldjerou, L., Gardner, R. A., Frey, N., Curran, K. J., Peggs, K., Pasquini, M., DiPersio, J. F., van den Brink, M. R. M., Komanduri, K. V., … Neelapu, S. S. (2019). ASTCT consensus grading for cytokine release syndrome and neurologic toxicity associated with immune effector cells. Biology of Blood and Marrow Transplantation, 25(4), 625–638. https://doi.org/10.1016/j.bbmt.2018.12.758
29. Lee, S. J., Onstad, L., Chow, E. J., Shaw, B. E., Jim, H. S. L., Syrjala, K. L., Baker, K. S., Buckley, S., Flowers, M. E., & Martin, P. J. (2018). Patient-reported outcomes and health status associated with chronic graft-versus-host disease. Haematologica, 103(9), 1535–1541. https://doi.org/10.3324/haematol.2018.192930
30. Lesokhin, A. M., Tomasson, M. H., Arnulf, B., Bahlis, N. J., Miles Prince, H., Niesvizky, R., … Mohty, M. (2023). Elranatamab in relapsed or refractory multiple myeloma: Phase 2 MagnetisMM-3 trial results. Nature Medicine, 29(9), 2259–2267. https://doi.org/10.1038/s41591-023-02528-9
31. Li, C. C., Tsai, X. C. H., Huang, W. H., & Wang, T. F. (2024). Recent advancements in hematopoietic stem cell transplantation in Taiwan. Tzu Chi Medical Journal, 36(2), 127–135. https://doi.org/10.4103/tcmj.tcmj_276_23
32. Martens, M. J., Dutta, D., Yu, Y., Rein, L. E., Ritz, J., Logan, B. R., & Paczesny, S. (2026). The BIOPREVENT machine-learning algorithm predicts chronic graft-versus-host disease and mortality risk using posttransplant biomarkers. The Journal of Clinical Investigation, 136(4), Article e195228. https://doi.org/10.1172/JCI195228
33. Medcalf, N. (2016). Centralized or decentralized manufacturing? Key business model considerations for cell therapies. Cell and Gene Therapy Insights, 2(1), 95–109. https://doi.org/10.18609/cgti.2016.012
34. Medicines and Healthcare products Regulatory Agency. (2017). Patient group directions: Who can use them. GOV.UK. https://www.gov.uk/government/publications/patient-group-directions-pgds
35. Medsafe. (2025, March 6). Immune effector cell-associated neurotoxicity syndrome (ICANS). Prescriber Update, 46(1), 15–16.
36. Mishra, V., Gedde-Dahl, T., Remberger, M., Solvang, G., Selvaag, K. L., Fosseng, A., Abrahamsen, I. W., Myhre, A. E., Hagen, T. P., & Tjønnfjord, G. E. (2025). Hospital at home following allogeneic hematopoietic stem cell transplantation: An economic analysis. Healthcare, 13(14), Article 1648. https://doi.org/10.3390/healthcare13141648
37. Moore, S. L., Peterson, G. J., Montoya, S. R., Conte, B. K., Brahler, R. K., Hutchison, C., Hoople, K. L., & Smith, C. A. (2025). Using technology for patient-centered care at home after CAR T-cell therapy or stem cell transplant: A prospective feasibility study. Frontiers in Immunology, 16, Article 1403249. https://doi.org/10.3389/fimmu.2025.1403249
38. Moreau, P., Garfall, A. L., van de Donk, N. W. C. J., Nahi, H., San-Miguel, J. F., Oriol, A., Nooka, A. K., Martin, T., Rosinol, L., Chari, A., Karlin, L., Benboubker, L., Mateos, M.-V., Bahlis, N., Popat, R., Besemer, B., Martínez-López, J., Sidana, S., Delforge, M., … Usmani, S. Z. (2022). Teclistamab in relapsed or refractory multiple myeloma. New England Journal of Medicine, 387(6), 495–505. https://doi.org/10.1056/NEJMoa2203478
39. National Health Insurance Administration, Ministry of Health and Welfare. (2024). New drugs added and restrictions loosened in the NHI reimbursement scheme [Press release]. https://www.nhi.gov.tw/en/cp1326-cf066-8-2.html
40. National Institute for Health and Care Excellence. (2017). Patient group directions (Medicines practice guideline MPG2). https://www.nice.org.uk/guidance/mpg2
41. Neelapu, S. S., Locke, F. L., Bartlett, N. L., Lekakis, L. J., Miklos, D. B., Jacobson, C. A., Braunschweig, I., Oluwole, O. O., Siddiqi, T., Lin, Y., Timmerman, J. M., Stiff, P. J., Friedberg, J. W., Flinn, I. W., Goy, A., Hill, B. T., Smith, M. R., Deol, A., Farooq, U., … Go, W. Y. (2017). Axicabtagene ciloleucel CAR T-cell therapy in refractory large B-cell lymphoma. New England Journal of Medicine, 377(26), 2531–2544. https://doi.org/10.1056/NEJMoa1707447
42. Nursing and Midwifery Board of Australia. (2021). Nurse practitioner standards for practice. https://www.nursingmidwiferyboard.gov.au/codes-guidelines-statements/professional-standards/nurse-practitioner-standards-of-practice.aspx
43. Ordre des infirmières et infirmiers du Québec. (2021). Specialized nurse practitioners and their practice. OIIQ.
44. PDQ Pediatric Treatment Editorial Board. (2024). Pediatric chimeric antigen receptor (CAR) T-cell therapy (PDQ®): Health professional version. National Cancer Institute. https://www.cancer.gov/types/lymphoma/hp/pediatric-CAR-T-cell-therapy-pdq
45. Rogers, E. M. (2003). Diffusion of innovations (5th ed.). Free Press.
46. Romon, I., Gonzalez-Barrera, S., Coello de Portugal, C., Ocio, E., & Sampedro, I. (2024). Brave new world: Expanding home care in stem cell transplantation and advanced therapies with new technologies. Frontiers in Immunology, 15, Article 1366962. https://doi.org/10.3389/fimmu.2024.1366962
47. Sainatham, C., Yadav, D., Dilli Babu, A., Tallapalli, J. R., Kanagala, S. G., Filippov, E., Murillo Chavez, F., Ahmed, N., & Lutfi, F. (2024). The current socioeconomic and regulatory landscape of immune effector cell therapies. Frontiers in Medicine, 11, Article 1462307. https://doi.org/10.3389/fmed.2024.1462307
48. Schuster, S. J., Bishop, M. R., Tam, C. S., Waller, E. K., Borchmann, P., McGuirk, J. P., Jäger, U., Jaglowski, S., Andreadis, C., Westin, J. R., Fleury, I., Bachanova, V., Foley, S. R., Ho, P. J., Mielke, S., Magenau, J. M., Holte, H., Pantano, S., Pacaud, L. B., … Maziarz, R. T. (2019). Tisagenlecleucel in adult relapsed or refractory diffuse large B-cell lymphoma. New England Journal of Medicine, 380(1), 45–56. https://doi.org/10.1056/NEJMoa1804980
49. Shah, R., Murphy, D., Logue, M., et al. (2024). Multidisciplinary management of morbidities associated with chronic graft-versus-host disease. Clinical Hematology International, 6(4), 93–107. https://doi.org/10.46989/001c.124926
50. Saleh, S., Dabbous, O., Sullivan, S.D. et al. A practical approach for adoption of a hub and spoke model for cell and gene therapies in low- and middle-income countries: framework and case studies. Gene Ther 31, 1–11 (2024). https://doi.org/10.1038/s41434-023-00425-x
51. Smith, M., & Rodriguez, R. (2022, April). What drug therapy is recommended for management of immune-related adverse events in patients treated with chimeric antigen receptor T-cell therapy? Drug Information Group, University of Illinois Chicago. https://dig.pharmacy.uic.edu/
52. Taiwan Blood and Marrow Transplantation Registry. (2024). Annual report on hematopoietic stem cell transplantation in Taiwan: 1983–2022. Taiwan Blood and Marrow Transplantation Society. https://www.tbmt.org.tw/publicUI/B/B10101.aspx?arg=8DE9F9A69BBF95A07
53. Thieblemont, C., Phillips, T., Ghesquieres, H., Cheah, C. Y., Clausen, M. R., Cunningham, D., Do, Y. R., Feldman, T., Gasiorowski, R., Jurczak, W., Kim, T. M., Lewis, D. J., van der Poel, M., Poon, M. L., Cota Stirner, M., Kilavuz, N., Chiu, C., Chen, M., Sacchi, M., … Lugtenburg, P. J. (2023). Epcoritamab, a novel, subcutaneous CD3×CD20 bispecific T-cell–engaging antibody, in relapsed or refractory large B-cell lymphoma: Dose expansion in a phase I/II trial. Journal of Clinical Oncology, 41(12), 2238–2247. https://doi.org/10.1200/JCO.22.01725
54. Turner, A. J., Laskin, B. L., & Dandoy, C. E. (2021). Long-term complications after hematopoietic stem cell transplantation. Pediatric Clinics of North America, 68(1), 187–202. https://doi.org/10.1016/j.pcl.2020.09.012
55. University Hospital Southampton NHS Foundation Trust. (2022). Chemotherapy protocol: Chimeric antigen receptor T-cell (CAR-T) therapy Axicel—Cyclophosphamide (500)—Fludarabine (30). https://www.uhs.nhs.uk/Media/UHS-website-2019/Patientinformation/Cancercare/CAR-T-cell-therapy-Axicel-chemotherapy-protocol.pdf
56. U.S. Food and Drug Administration. (2020). Long-term follow-up after administration of human gene therapy products: Guidance for industry. U.S. Department of Health and Human Services.
57. U.S. Food and Drug Administration. (2025a). FDA eliminates Risk Evaluation and Mitigation Strategies (REMS) for autologous chimeric antigen receptor (CAR) T cell immunotherapies. https://www.fda.gov/vaccines-blood-biologics/safety-availability-biologics/fda-eliminates-risk-evaluation-and-mitigation-strategies-rems-autologous-chimeric-antigen-receptor
58. U.S. Food and Drug Administration. (2025b). FDA grants traditional approval to tarlatamab-dlle for extensive-stage small cell lung cancer. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-traditional-approval-tarlatamab-dlle-8xtensive-stage-small-cell-lung-cancer
59. Voytilla, K. L., & Ayres, C. N. (2023). Overcoming challenges to provide BiTE and CAR T cell therapy at a community cancer center. HOPA News, 19(4), 3–6.
60. Wolff, D., Peric, Z., & Lawitschka, A. (2024). Chronic graft-versus-host disease. In A. Sureda et al. (Eds.), The EBMT handbook: Hematopoietic cell transplantation and cellular therapies (8th ed., pp. 395–410). Springer. https://doi.org/10.1007/978-3-031-44080-9_44