DAC Meeting Outcome
DAC Meeting Outcome - Apr 2023
Drug Advisory Committee April 2023 Meeting Outcome
|
|
Generic name |
Brand name |
Therapeutic Class |
Meeting outcome |
Primary reason for rejection1 |
|
1 |
Alpelisib / Fulvestrant |
Piqray |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence to demonstrate significant clinical outcome benefits |
|
2 |
Atezolizumab |
Tecentriq |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence to demonstrate significant clinical outcome benefits |
|
3 |
Brolucizumab |
Beovu |
Eye |
Rejected |
Alternative(s) available in HADF with comparable benefits |
|
4 |
Burosumab |
Crysvita |
Endocrine system |
Approved |
|
|
5 |
Busulfan |
Busulfex |
Malignant disease and immunosuppression |
Approved |
|
|
6 |
Capmatinib |
Tabrecta |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence of long-term clinical outcome benefits |
|
7 |
Daratumumab / Bortezomib |
Darzalex |
Malignant disease and immunosuppression |
Approved |
|
|
8 |
Dupilumab |
Dupixent |
Ear, nose, and oropharynx |
Pending |
Pending further information |
|
9 |
Empagliflozin |
Jardiance |
Endocrine system |
Rejected |
Insufficient evidence to demonstrate significant clinical outcome benefits |
|
10 |
Esketamine |
Spravato |
Central nervous system |
Approved |
|
|
11 |
Faricimab |
Vabysmo |
Eye |
Pending |
Pending further information |
|
12 |
Finerenone |
Kerendia |
Cardiovascular system |
Pending |
Pending further information |
|
13 |
Isatuximab / Pomalidomide |
Sarclisa |
Malignant disease and immunosuppression |
Approved |
|
|
14 |
L-arginine hydrochloride L-lysine hydrochloride |
LysaKare |
Nutrition and blood |
Rejected |
The justification of the treatment’s cost in relation to its benefits is insufficient |
|
15 |
Latanoprostene Bunod |
Vyzulta |
Eye |
Approved |
|
|
16 |
Lutetium oxodotreotide |
Lutathera |
Radiopharmaceuticals |
Rejected |
The justification of the treatment’s cost in relation to its benefits is insufficient |
|
17 |
Mepolizumab |
Nucala |
Malignant disease and immunosuppression |
Approved |
|
|
18 |
Nivolumab |
Opdivo |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence of long-term clinical outcome benefits |
|
19 |
Nonacog alfa |
BeneFIX |
Cardiovascular system |
Approved |
|
|
20 |
Olaparib / Bevacizumab |
Lynparza |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence of long-term clinical outcome benefits |
|
21 |
Onasemnogene abeparvovec |
Zolgensma |
Musculoskeletal and joint disease |
Pending |
Pending further information |
|
22 |
Osimertinib |
Tagrisso |
Malignant disease and immunosuppression |
Rejected |
Insufficient evidence of long-term clinical outcome benefits |
|
23 |
Oxycodone / Naloxone |
Targin |
Central nervous system |
Pending |
Pending further information |
|
24 |
Polatuzumab vedotin / Rituximab |
Polivy |
Malignant disease and immunosuppression |
Approved |
|
|
25 |
Ravulizumab |
Ultomiris |
Nutrition and blood |
Approved |
|
|
26 |
Ripretinib |
Qinlock |
Malignant disease and immunosuppression |
Pending |
Pending further information |
|
27 |
Ruxolitinib |
Jakavi |
Malignant disease and immunosuppression |
Pending |
Pending further information |
|
28 |
Siltuximab |
Sylvant |
Malignant disease and immunosuppression |
Approved |
|
|
29 |
Tolvaptan |
Jinarc |
Endocrine system |
Approved |
|
|
30 |
Trastuzumab Deruxtecan |
Enhertu |
Malignant disease and immunosuppression |
Pending |
Pending further information |
|
31 |
Trifluridine/tipiracil |
Lonsurf |
Malignant disease and immunosuppression |
Approved |
|
|
32 |
Tucatinib / Trastuzumab |
Tukysa |
Malignant disease and immunosuppression |
Pending |
Pending further information |
|
33 |
Upadacitinib |
Rinvoq |
Skin |
Approved |
|