Value in Health Regional Issues

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Presentation transcript:

Value in Health Regional Issues How Data Packages Lacking Phase III Pivotal Trial Data Can Support Regulatory Approval and Reimbursement for Oncologics in Australia  Richard Macaulay, PhD, Mohammad Kashif Siddiqui, MPharm, Samuel Stoddart, PhD  Value in Health Regional Issues  Volume 6, Pages 143-149 (May 2015) DOI: 10.1016/j.vhri.2015.03.021 Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

Fig. 1 Timeline of oncology appraisals by the PBAC on the basis of a pivotal trial data package lacking comparative phase III data. ALL, acute lymphoblastic leukemia; ASM, aggressive systemic mastocytosis; CML, chronic myeloid leukemia; CRC, colorectal cancer; DMSP, dermatofibrosarcoma protuberans; GBM, glioblastoma; HES-CEL, hypereosinophilic syndrome-chronic eosinophilic leukemia; LYG, life-year gained; PBAC, Pharmaceutical Benefits Advisory Committee; MDS/MPD, myelodysplastic/myeloproliferative diseases; sALCL, systemic anaplastic large cell lymphoma. Value in Health Regional Issues 2015 6, 143-149DOI: (10.1016/j.vhri.2015.03.021) Copyright © 2015 International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Terms and Conditions

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