Table 2.
Marketing authorisation and hta approvals of multi-indication oncology products in England, Scotland, France, Germany, Ontario, and Australia
| Regulatory Approvals | HTA Approvals | |||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Molecule | First indication approval datea | Total number of distinct indications identifiedb |
FDA approvals n (%) |
EMA approvals n (%) |
HC approvals n (%) |
TGA approvals n (%) |
NICE approvals n (%) |
SMC approvals n (%) |
HAS approvalsc n (%) |
GBA approvalsd n (%) |
CADTH approvals n (%) |
PBAC approvals n (%) |
| Ibrutinib | 13/11/2013 | 6 | 6 (100%) | 4 (67%) | 6 (100%) | 4 (67%) | 3 (50%) | 3 (50%) | 4 (67%) | 3 (50%) | 3 (50%) | 3 (50%) |
| Nintedanib | 25/09/2014 | 2 | 1 (50%) | 2 (100%) | 1 (50%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 2 (100%) | 1 (50%) | 1 (50%) |
| Aflibercept | 20/09/2011 | 7 | 5 (71%) | 6 (86%) | 6 (86%) | 6 (86%) | 5 (71%) | 6 (86%) | 6 (86%) | 1 (14%) | 4 (57%) | 5 (71%) |
| Everolimus | 30/03/2009 | 7 | 7 (100%) | 7 (100%) | 7 (100%) | 6 (86%) | 4 (57%) | 3 (43%) | 7 (100%) | 1 (14%) | 3 (43%) | 5 (71%) |
| Cabozantinib | 29/11/2012 | 4 | 4 (100%) | 4 (100%) | 3 (75%) | 3 (75%) | 3 (75%) | 1 (25%) | 3 (75%) | 3 (75%) | 2 (50%) | 1 (25%) |
| Pazopanib | 19/10/2009 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) | 0 (0%) | 1 (50%) | 2 (100%) |
| Tisagenlecleucel | 30/08/2017 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 0 (0%) | 0 (0%) |
| Regorafenib | 27/09/2012 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 2 (67%) | 2 (67%) | 3 (100%) | 2 (67%) | 2 (67%) | 0 (0%) |
| Ramucirumab | 21/04/2014 | 3 | 3 (100%) | 3 (100%) | 1 (33%) | 1 (33%) | 0 (0%) | 0 (0%) | 2 (67%) | 1 (33%) | 1 (33%) | 1 (33%) |
| Avelumab | 23/03/2017 | 2 | 2 (100%) | 1 (50%) | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) |
| Atezolizumab | 18/05/2016 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 1 (33%) | 2 (67%) | 2 (67%) | 1 (33%) | 2 (67%) |
| Eribulin | 15/11/2010 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 2 (100%) | 1 (50%) | 1 (50%) | 2 (100%) |
| Ruxolitinib | 16/11/2011 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) |
| Nivolumab | 22/12/2014 | 13 | 13 (100%) | 10 (77%) | 10 (77%) | 11 (85%) | 9 (69%) | 9 (69%) | 9 (69%) | 7 (54%) | 8 (62%) | 7 (54%) |
| Pembrolizumab | 04/09/2014 | 16 | 16 (100%) | 11 (69%) | 10 (63%) | 12 (75%) | 8 (50%) | 8 (50%) | 8 (50%) | 7 (44%) | 8 (50%) | 7 (44%) |
| Brentuximab vedotin | 19/08/2011 | 6 | 6 (100%) | 5 (83%) | 6 (100%) | 4 (67%) | 3 (50%) | 3 (50%) | 4 (67%) | 3 (50%) | 6 (100%) | 4 (67%) |
| Ipilimumab | 25/03/2011 | 5 | 5 (100%) | 3 (60%) | 3 (60%) | 3 (60%) | 3 (60%) | 3 (60%) | 3 (60%) | 2 (40%) | 3 (60%) | 3 (60%) |
| Romidepsin | 01/05/2009 | 2 | 2 (100%) | 0 (0%) | 1 (50%) | 1 (50%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (50%) | 0 (0%) |
| Vemurafenib | 17/08/2011 | 2 | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 0 (0%) | 0 (0%) |
| Lenvatanib | 13/02/2015 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 1 (33%) | 2 (67%) | 2 (67%) | 2 (67%) |
| Abiraterone Acetate | 28/04/2011 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 2 (67%) | 3 (100%) | 3 (100%) | 3 (100%) | 1 (33%) | 1 (33%) |
| Afatinib | 12/07/2013 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) | 1 (50%) |
| Blinatumomab | 03/12/2014 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 2 (67%) | 3 (100%) | 2 (67%) | 3 (100%) | 2 (67%) | 2 (67%) |
| Enzalutamide | 31/08/2012 | 3 | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 2 (67%) | 2 (67%) | 3 (100%) | 2 (67%) | 3 (100%) | 1 (33%) |
| Rucaparib | 19/12/2016 | 2 | 2 (100%) | 2 (100%) | 0 (0%) | 0 (0%) | 1 (50%) | 1 (50%) | 1 (50%) | 0 (0%) | 0 (0%) | 0 (0%) |
| Osimertinib | 13/11/2015 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 2 (100%) | 1 (50%) | 2 (100%) | 1 (50%) |
| Crizotinib | 26/08/2011 | 3 | 3 (100%) | 3 (100%) | 2 (67%) | 3 (100%) | 3 (100%) | 3 (100%) | 3 (100%) | 2 (67%) | 2 (67%) | 2 (67%) |
| Bosutinib | 04/09/2012 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) | 2 (100%) | 1 (50%) | 1 (50%) | 1 (50%) |
| Alectinib | 11/12/2015 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 1 (50%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) |
| Ceritinib | 29/04/2014 | 2 | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 2 (100%) | 1 (50%) | 2 (100%) | 0 (0%) | 1 (50%) | 1 (50%) |
| Ofatumumab | 26/10/2009 | 4 | 4 (100%) | 0 (0%) | 0 (0%) | 2 (50%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 0 (0%) | 1 (25%) |
Abbreviations: CADTH Canadian Agency for Drugs and Technologies in Health, EMA European Medicines Agency, FDA Food and Drug Administration (USA), GBA Federal Joint Committee (Germany), HAS Haute Autorité de Santé (France), HC Health Canada, HTA health technology assessment, NICE National Institute of Health and Care Excellence (England and Wales), PBAC Pharmaceutical Benefits Advisory Committee (Australia), SMC Scottish Medicines Consortium (Scotland), TGA Therapeutic Goods Administration (Australia)
aThe date in which a molecule first received a marketing authorisation in one of the FDA, EMA, TGA or Health Canada. A detailed list of included indications is provided in Additional file 1: Appendix C
bThe total number of distinct indications identified with approval in one or more of the FDA, EMA, TGA or Health Canada for a specific multi-indication molecule during the study period (01/01/2009 – 01/01/2019)
cIn France, indications which receive an SMR rating of insufficient are categorized as having a negative HTA outcome (DNL)
dIn Germany, indications which receive a rating of lesser benefit or no proof of added benefit are categorized as having a negative HTA outcome (DNL). In practice, these indications may still be reimbursed at a price determined based on reference pricing, and the HTA approval sequence does not necessarily reflect the order in which indications are launched within the country