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Table 2 Marketing authorisation and hta approvals of multi-indication oncology products in England, Scotland, France, Germany, Ontario, and Australia

From: Launch sequencing of pharmaceuticals with multiple therapeutic indications: evidence from seven countries

  

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%)

  1. 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)
  2. 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
  3. 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)
  4. cIn France, indications which receive an SMR rating of insufficient are categorized as having a negative HTA outcome (DNL)
  5. 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
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BMC Health Services Research

ISSN: 1472-6963

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