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Assessment of Overall Survival, Quality of Life, And Supplementary Online Content Salas-Vega S, Iliopoulos O, Mossialos E. Assesment of overall survival, quality of life, and safety benefits associated with new cancer medicines [published online December 29, 2016]. JAMA Oncol. doi:10.1001/jamaoncol.2016.4166 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 eTable 2. Regulatory evidence in support of classification of drug clinical benefits eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits eTable 3. Interagency agreement–Krippendorff’s alpha coefficients eMethods This supplementary material has been provided by the authors to give readers additional information about their work. Online-Only Supplement © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Contents eExhibits ......................................................................................................................................................... 3 eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003- 2013 (Summary of eTable 2) ................................................................................................................... 3 eTable 2. Regulatory evidence in support of classification of drug clinical benefits ....................... 6 eFigure 1. Number of cancer drugs that were evaluated by all three HTA agencies, sorted by magnitude of clinical benefits ................................................................................................................ 72 eTable 3. Interagency agreement – Krippendorff’s alpha coefficients ............................................ 73 eMethods ...................................................................................................................................................... 74 Drug inclusion/exclusion criteria............................................................................................................ 74 Drug appraisals ....................................................................................................................................... 74 Overall survival .................................................................................................................................... 76 Quality of life ........................................................................................................................................ 77 Safety .................................................................................................................................................... 78 Overall therapeutic benefits ............................................................................................................... 78 Limitations ................................................................................................................................................ 79 © 2016 American Medical Association. All rights reserved. Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines eExhibits eTable 1. Therapeutic profile of all cancer medicines approved by the FDA between 2003-2013 (Summary of eTable 2) a FDA- or EMA-approved Appraisal OS effect (in Active ingredient Comparator(s) QoL effect Safety effect indication dates months) Ascites catumaxomab Ascites (EMA) Dec 09 paracentesis NE NE NE Bladder Exact Carcinoma of the urothelial tract vinflunine Dec 09–Jan 13 BSC magnitude NE Reduction (EMA) uncertain Breast ado-trastuzumab Mixed Breast cancer Mar 14–Nov 14 lapatinib + capecitabine ≥ 3 (5.8) Improvement emtansine evidence eribulin Breast cancer Jul 11–Nov 13 TPC < 3 (2.5–2.7) NE Reduction ixabepilone Breast cancer n/a n/a n/a n/a n/a lapatinib Breast cancer Nov 07–May 10 capecitabine monotherapy < 3 (0.3–2.4) NE Reduction pertuzumab Breast cancer Jul 13–Mar 14 trastuzumab + docetaxel ≥ 3 (15.7) Improvement Reduction Gastro-intestinal bevacizumab Colorectal carcinoma Jun 05–Jul 08 IFL/5-FU/LV ≥ 3 (3.0–4.7) NE Reduction Exact cetuximab Colorectal carcinoma Mar 05–Mar 09 BSC magnitude NE Reduction uncertain panitumumab Colorectal carcinoma Apr 08–Nov 13 BSC/cetuximab (safety) ≥ 3 (2.7–3.2) NE NE regorafenib Colorectal cancer May 14–Jul 14 placebo < 3 (1.4) NE Reduction tegafur/gimeracil/oteracil Gastric cancer (EMA) Oct 12–Mar 13 5-FU/cisplatin NE NE NE ziv-aflibercept Colorectal cancer Jul 13–Mar 14 placebo < 3 (1.4) Improvement Reduction Gastro-intestinal/Renal Gastrointestinal stromal tumor / Renal Sep 06–Sep 09 / ≥ 3 (7.8) / ≥ 3 sunitinib BSC/interferon-alfa Improvement Reduction cell carcinoma May 07–Mar 09 (10.0) Hematological asparaginase E. Acute lymphoblastic leukemia n/a n/a n/a n/a n/a chrysanthemi azacitidine Myelodysplastic syndromes Jul 09–Mar 11 conventional care ≥ 3 (9.4–9.6) Improvement Reduction bendamustine Lymphocytic leukemia Oct 10–Feb 11 chlorambucil NE Reduction Reduction Mixed bortezomib Multiple myeloma Oct 04–Oct 07 high-dose dexamethasone ≥ 3 (6.1–11.5) Improvement evidence ≥ 3 (exact gain bosutinib Chronic myelogenous leukemia Nov 13–Feb 14 BSC NE Improvement uncertain) brentuximab vedotin Hodgkin lymphoma / Systemic Mar 13–Mar 14 multi-agent salvage Exact NE Mixed 3 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines lymphoma chemotherapy magnitude evidence uncertain carfilzomib Multiple myeloma n/a n/a n/a n/a n/a clofarabine Acute lymphoblastic leukemia Dec 06 non-comparative NE NE NE Chronic myeloid leukemia // Acute Mixed dasatinib Mar 07–Jan 12 non-comparative NE NE lymphoblastic leukemia evidence decitabine Myelodysplastic syndromes n/a n/a n/a n/a n/a ibrutinib Mantle cell lymphoma n/a n/a n/a n/a n/a Exact Transfusion-dependent anemia due to lenalidomide Mar 13–Nov 14 placebo magnitude Improvement Reduction myelodysplastic syndromes uncertain Acute lymphoblastic leukemia / nelarabine Dec 07 non-comparative NE NE NE Lymphoblastic lymphoma nilotinib Chronic myelogenous leukemia Feb 08–Jan 12 non-comparative NE NE Improvement Exact Mixed obinutuzumab Chronic lymphocytic leukemia Jul 14–Mar 15 chlorambucil magnitude Mixed evidence evidence uncertain ofatumumab Chronic lymphocytic leukemia Oct 10–Nov 14 chlorambucil NE NE NE omacetaxine Chronic myeloid leukemia n/a n/a n/a n/a n/a mepesuccinate standard care / high-dose ≥ 3 (exact gain pomalidomide Multiple myeloma Jan 14–Mar 15 Improvement Reduction dexamethasone (safety) uncertain) Chronic myeloid leukemia / Acute ponatinib Nov 14–Jan 15 dasatinib/nilotinib NE NE Reduction lymphoblastic leukemia pralatrexate Peripheral lymphoma n/a n/a n/a n/a n/a romidepsin Cutaneous lymphoma n/a n/a n/a n/a n/a Exact ruxolitinib Myelofibrosis Jan 13–Jul 13 BSC magnitude Improvement Reduction uncertain tositumomab Non-Hodgkin’s lymphoma n/a n/a n/a n/a n/a Mixed vorinostat Cutaneous lymphoma Mar 11 BSC NE NE evidence Lung afatinib Non-small cell lung cancer Jul 13–Apr 14 erlotinib/gefitinib NE Improvement Reduction crizotinib Non-small cell lung cancer Sep 13–Nov 14 pemetrexed ≥ 3 (3.1–3.5) Improvement NE Mixed erlotinib Non-small cell lung cancer Mar 06–Nov 08 placebo/BSC < 3 (2.0) Improvement evidence gefitinib Non-small cell lung cancer Nov 09–Jul 13 paclitaxel + carboplatin NE Improvement Improvement pemetrexed Pleural mesothelioma Mar 05–Jan 08 cisplatin ≥ 3 (2.8–3.3) Improvement Reduction Prostate abiraterone acetate Prostate cancer Feb 12–Jul 12 BSC (prednisolone) ≥ 3 (3.9–4.6) Improvement Improvement cabazitaxel Prostate cancer Nov 11–Oct 12 mitoxantrone ≥ 3 (2.4–4.2) NE Reduction leuproprelin + LHRH degarelix Prostate cancer Sep 09–Apr 14 NE NE Reduction agonists 4 Downloaded From: https://jamanetwork.com/ on 09/25/2021 Clinical value of cancer medicines Mixed enzalutamide Prostate cancer Nov 13–Jul 14 placebo ≥ 3 (4.5–4.8) Improvement evidence radium-223 dichloride Prostate cancer Apr 14 placebo < 3 (2.8) NE NE sipuleucel-T Prostate cancer Feb 15 BSC ≥ 3 (4.0) Improvement Improvement Renal ≥ 3 (exact gain Mixed axitinib Renal cell carcinoma Jan 13–Feb 15 BSC NE uncertain) evidence everolimus Renal cell carcinoma Nov 09–Apr 11 BSC ≥ 3 (5.2) Improvement Reduction ≥ 3 (exact gain Mixed pazopanib Advanced renal cell carcinoma Feb 11–Jun 13 BSC/interferon-alfa NE uncertain) evidence ≥ 3 (exact gain sorafenib Renal cell carcinoma Sep 06–Aug 09 BSC Improvement Reduction uncertain) temsirolimus Renal cell carcinoma Feb 08–Aug 09 interferon-alfa ≥ 3 (3.6) Improvement Improvement Skin Exact dacarbazine/vemurafenib dabrafenib Melanoma Oct 14 magnitude Reduction Improvement (safety) uncertain ipilimumab Melanoma Nov 12–Nov 14 dacarbazine ≥ 3 (5.7) NE Reduction Exact trametinib Melanoma Nov-14 dabrafenib magnitude Improvement NE uncertain vemurafenib Melanoma Oct 12–Mar 13 dacarbazine ≥ 3 (3.3–3.9) Improvement Reduction vismodegib Basal cell carcinoma Dec 13 non-comparative NE NE NE Soft tissue ≥ 3 (exact gain trabectedin Soft tissue sarcoma (EMA) Apr 08–Feb 10 BSC NE Improvement uncertain) Thyroid cabozantinib Medullary thyroid cancer Dec14 placebo NE NE Reduction vandetanib Medullary thyroid cancer Jun 12 placebo NE NE NE Source: Authors’ analysis of data from sources identified in the “Methods” section. Notes: Drug and therapeutic features associated with all new cancer medicines approved by the FDA between 2003-2013, and appraised by NICE, HAS, or PBAC through May 2015. Change in overall survival (OS), quality of life (QoL) and safety is given as composite magnitude of
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