NPPA outcome data 2020/24

This is a list of decisions on NPPA applications with their outcomes. We've included the indication where it would not compromise anyone's privacy.

Download the data as a spreadsheet (includes medicines, outcomes and some indications)

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Outcomes of applications by medicine 2020/24



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Medicine   Approved Declined Principles not met Withdrawn application Total
4-aminopyridine 5 2 7
Indication  
other indication(s) 5 2 7
               
adalimumab 24 6 10 40
Indication  
chronic recurrent multifocal osteomyelitis 7 7
other indication(s) 17 6 10 33
               
alirocumab 12 2 14
Indication  
hypercholesterolaemia 8 1 9
other indication(s) 4 1 5
               
alitretinoin 1 7 1 9
Indication  
other indication(s) 1 7 1 9
               
amifampridine [3,4-diaminopyridine] 7 7
Indication  
other indication(s) 7 7
               
amino acid formula 4 1 2 7
Indication  
other indication(s) 4 1 2 7
               
amino acid formula (without isoleucine, leucine and valine) 10 10
Indication  
other indication(s) 3 3
short-chain enoyl-CoA hydratase deficiency 7 7
               
amino acid formula low calcium 8 8
Indication  
hypercalcaemia 8 8
               
anakinra 23 5 3 31
Indication  
other indication(s) 23 5 3 31
               
apixaban 6 1 7
Indication  
other indication(s) 6 1 7
               
aprepitant 12 3 1 16
Indication  
intractable nausea or vomiting 8 2 1 11
other indication(s) 4 1 5
               
aripiprazole 6 1 7
Indication  
Schizoaffective Disorder 6 1 7
               
asparaginase 28 1 29
Indication  
acute lymphocytic leukaemia (ALL) 7 7
other indication(s) 6 1 7
pegasparaginase allergy 15 15
               
atezolizumab 1 1 16 1 19
Indication  
other indication(s) 1 1 16 1 19
               
azacitidine 27 1 2 30
Indication  
acute myeloid leukaemia (AML) 8 1 9
chronic myeloid leukemia (CML) 5 1 6
myelodysplasia 9 9
other indication(s) 5 1 6
               
azithromycin 6 3 3 12
Indication  
other indication(s) 6 3 3 12
               
bedaquiline 35 2 37
Indication  
multi-drug resistant (MDR) tuberculosis (TB) 18 2 20
mycobacterium abscessus 17 17
               
bendamustine hydrochloride 4 3 7
Indication  
other indication(s) 4 3 7
               
bevacizumab 29 13 1 43
Indication  
hereditary haemorrhagic telangiectasia (HHT) 7 3 10
other indication(s) 22 10 1 33
               
biotin 14 14
Indication  
other indication(s) 14 14
               
blinatumomab 28 1 2 31
Indication  
Acute Lymphoblastic Leukaemia (ALL) 11 11
B-Cell Acute Lymphoblastic Leukaemia (B-ALL) 15 1 2 18
other indication(s) 2 2
               
bortezomib 11 1 1 13
Indication  
other indication(s) 11 1 1 13
               
brentuximab vedotin 38 8 1 47
Indication  
Hodgkin's lymphoma 25 3 28
Large cell lymphoma 5 2 1 8
other indication(s) 1 3 4
T cell lymphoma 7 7
               
budesonide 2 4 1 7
Indication  
other indication(s) 2 4 1 7
               
cannabinoid 7 36 4 47
Indication  
epilepsy 2 13 2 17
other indication(s) 5 13 2 20
pain 9 9
               
ceftazidime and avibactam 9 1 10
Indication  
other indication(s) 9 1 10
               
ciclosporin eye preparations 241 7 1 249
Indication  
dry eyes 241 7 1 249
               
cinacalcet 3 16 6 25
Indication  
hyperparathyroidism 2 15 4 21
other indication(s) 1 1 2 4
               
continuous glucose monitor 24 17 3 44
Indication  
other indication(s) 17 5 2 24
type 1 diabetes 7 12 1 20
               
crizotinib 5 2 7
Indication  
other indication(s) 5 2 7
               
dabrafenib 12 4 1 17
Indication  
other indication(s) 12 4 1 17
               
danazol 8 3 11
Indication  
other indication(s) 8 3 11
               
daratumumab 2 5 7
Indication  
other indication(s) 2 5 7
               
deferasirox 4 4 4 12
Indication  
other indication(s) 4 4 4 12
               
denosumab 19 23 2 44
Indication  
giant cell tumour of the bone 14 14
hypercalcaemia 4 7 1 12
osteoporosis 9 9
other indication(s) 1 7 1 9
               
dexamethasone eye preparations 1 8 9
Indication  
other indication(s) 1 8 9
               
dipyridamole 11 11
Indication  
congenital nephrotic syndrome 11 11
               
dulaglutide 4 3 3 10
Indication  
other indication(s) 4 3 3 10
               
dupilumab 8 15 4 27
Indication  
atopic dermatitis 7 13 4 24
other indication(s) 1 2 3
               
eculizumab 5 2 9 4 20
Indication  
atypical haemolytic uraemic syndrome 3 2 2 7
other indication(s) 1 2 3
Paroxysmal Nocturnal Haemoglobinuria (PNH) 1 9 10
               
elexacaftor/tezacaftor/ivacaftor 3 3 1 7
Indication  
cystic fibrosis (CF) 3 3 1 7
               
eltrombopag 13 6 3 22
Indication  
other indication(s) 7 1 3 11
thrombocytopaenia 6 5 11
               
emicizumab 4 8 1 13
Indication  
haemophilia A 4 8 1 13
               
empagliflozin 5 11 1 17
Indication  
heart failure 8 8
other indication(s) 5 3 1 9
               
enoxaparin sodium 19 4 6 29
Indication  
other indication(s) 13 1 1 15
thrombosis 6 3 5 14
               
epoetin alfa 5 1 3 9
Indication  
other indication(s) 5 1 3 9
               
etanercept 12 4 6 22
Indication  
other indication(s) 12 4 6 22
               
everolimus 10 3 1 14
Indication  
metastatic chromophobe cell renal cell carcinoma 7 7
other indication(s) 3 3 1 7
               
fluoxetine hydrochloride 4 3 2 9
Indication  
other indication(s) 4 3 2 9
               
galcanezumab 2 7 9
Indication  
migraines 2 7 9
               
ganciclovir eye preparations 12 2 14
Indication  
Cytomegalovirus (CMV) uveitis 12 12
other indication(s) 2 2
               
gemtuzumab ozogamicin 5 3 8
Indication  
acute myeloid leukaemia (AML) 5 3 8
               
ibrutinib 4 21 25
Indication  
lymphoma 10 10
other indication(s) 4 11 15
               
indomethacin 19 2 1 22
Indication  
congenital nephrotic syndrome 10 10
hemicrania 9 1 1 11
other indication(s) 1 1
               
infliximab 35 19 6 60
Indication  
other indication(s) 24 17 6 47
sarcoidosis 10 2 12
               
inotuzumab ozogamicin 6 3 9
Indication  
B-Cell Acute Lymphoblastic Leukaemia (B-ALL) 5 2 7
other indication(s) 1 1 2
               
insulin pump 6 1 9 16
Indication  
other indication(s) 3 1 1 5
type 1 diabetes 3 8 11
               
insulin pump consumables 5 5 10
Indication  
other indication(s) 3 2 5
type 1 diabetes 2 3 5
               
isotretinoin 16 16
Indication  
High Risk Neuroblastoma 15 15
other indication(s) 1 1
               
ivabradine 6 14 1 21
Indication  
inappropriate sinus tachycardia 1 7 1 9
other indication(s) 5 7 12
               
ketamine 30 1 31
Indication  
other indication(s) 1 1
palliative pain care 30 30
               
ketotifen 5 3 8
Indication  
other indication(s) 5 3 8
               
lacosamide 6 2 8
Indication  
epilepsy 6 1 7
other indication(s) 1 1
               
lamotrigine 252 83 10 345
Indication  
epilepsy 192 64 3 259
mental health 53 17 6 76
other indication(s) 7 2 1 10
               
lenalidomide 27 5 4 36
Indication  
myelodysplastic syndrome with 5q deletion 14 1 1 16
other indication(s) 11 4 3 18
               
letermovir 6 1 7
Indication  
cytomegalovirus (CMV) 6 1 7
               
levetiracetam 56 1 5 62
Indication  
seizures 56 1 5 62
               
levocarnitine 5 3 8
Indication  
other indication(s) 5 3 8
               
levofloxacin 8 1 1 10
Indication  
other indication(s) 3 3
tuberculosis (TB) 5 1 1 7
               
linezolid 31 2 1 34
Indication  
other indication(s) 11 1 1 13
tuberculosis (TB) 20 1 21
               
liraglutide 1 15 16
Indication  
other indication(s) 1 4 5
weight loss 11 11
               
macitentan 11 3 1 15
Indication  
other indication(s) 4 4
Pulmonary arterial hypertension (PAH) 7 3 1 11
               
melatonin 1 11 1 13
Indication  
insomnia 1 6 1 8
other indication(s) 5 5
               
meningococcal (a, c, y and w-135) conjugate vaccine 8 8
Indication  
meningococcal disease 8 8
               
mepolizumab 7 7 3 17
Indication  
hypereosinophilia 4 3 3 10
other indication(s) 3 4 7
               
methylphenidate hydrochloride 1 6 2 9
Indication  
other indication(s) 1 6 2 9
               
midostaurin 2 1 3 1 7
Indication  
other indication(s) 2 1 3 1 7
               
mitotane 22 22
Indication  
adrenocortical carcinoma 22 22
               
moxifloxacin 16 3 2 21
Indication  
other indication(s) 16 3 2 21
               
multivitamin and mineral supplement 1 5 1 7
Indication  
other indication(s) 1 5 1 7
               
naltrexone hydrochloride 1 8 1 10
Indication  
other indication(s) 1 8 1 10
               
nelarabine 8 2 10
Indication  
acute lymphocytic leukaemia (ALL) 8 2 10
               
nintedanib 1 6 2 9
Indication  
other indication(s) 1 6 2 9
               
nirmatrelvir with ritonavir 1 3 6 10
Indication  
COVID-19 1 3 6 10
               
nivolumab 6 6 1 13
Indication  
other indication(s) 6 6 1 13
               
obinutuzumab 4 3 2 9
Indication  
other indication(s) 4 3 2 9
               
octreotide lar 7 5 3 15
Indication  
other indication(s) 7 5 3 15
               
olanzapine 1 1 18 20
Indication  
other indication(s) 1 1 7 9
Schizophrenia 11 11
               
olaparib 16 8 24
Indication  
breast cancer 7 6 13
other indication(s) 9 2 11
               
omalizumab 10 3 3 16
Indication  
other indication(s) 10 3 3 16
               
oral feed liquid 1 10 11
Indication  
other indication(s) 1 10 11
               
oral feed paediatric renal 7 7
Indication  
renal disease 7 7
               
palivizumab 1 4 3 8
Indication  
other indication(s) 1 1
prevention of respiratory syncytial virus (RSV) 1 4 2 7
               
pazopanib 15 8 1 24
Indication  
other indication(s) 15 8 1 24
               
pegylated interferon alfa-2a 10 3 2 15
Indication  
Erdheim-Chester disease 7 1 8
other indication(s) 3 3 1 7
               
pegylated liposomal doxorubicin hydrochloride 5 20 25
Indication  
other indication(s) 5 4 9
Ovarian Cancer 16 16
               
pembrolizumab 26 37 2 65
Indication  
carcinoma 1 14 15
Hodgkin's lymphoma 14 1 1 16
other indication(s) 11 22 1 34
               
perampanel 8 5 5 18
Indication  
epilepsy 8 5 5 18
               
ponatinib 10 1 3 14
Indication  
chronic myeloid leukemia (CML) 6 1 3 10
other indication(s) 4 4
               
posaconazole 36 3 2 41
Indication  
aspergillus infection 14 14
mucormycosis 8 8
other indication(s) 13 3 2 18
               
potassium citrate 6 5 11
Indication  
other indication(s) 6 5 11
pristinamycin 39 1 40
Mycoplasma genitalium infection 37 1 38
other indication(s) 2 2
               
prucalopride 18 16 3 37
Indication  
constipation 4 11 1 16
gastroparesis 8 5 2 15
other indication(s) 6 6
               
retinol (vitamin a) 425 2 6 433
Indication  
cystic fibrosis (CF) 45 45
liver disease or short gut syndrome 310 1 1 312
other indication(s) 70 1 5 76
               
ribavirin 6 1 2 9
Indication  
other indication(s) 6 1 2 9
               
rifaximin 2 7 9
Indication  
other indication(s) 2 7 9
               
rituximab 144 45 24 213
Indication  
encephalitis 9 3 12
glomerulonephritis 11 1 12
interstitial lung disease 8 5 3 16
leukaemia 4 1 5
lymphoma 12 1 2 15
mucous pemphigoid 12 2 1 15
myositis 8 5 13
nephrotic syndrome 14 13 27
other indication(s) 66 17 14 97
               
rufinamide 34 1 35
Indication  
epilepsy 20 1 21
Lennox-Gastaut syndrome 9 9
other indication(s) 5 5
               
ruxolitinib 22 12 1 35
Indication  
Graft vs Host Disease 4 5 9
other indication(s) 11 4 1 16
VEXAS syndrome 7 3 10
               
sargramostim 22 22
Indication  
High Risk Neuroblastom 19 19
other indication(s) 3 3
               
secukinumab 17 11 3 31
Indication  
ankylosing spondylitis 1 1
hidradenitis suppurativa (HS) 7 1 8
other indication(s) 6 8 14
psoriasis 4 2 2 8
               
selexipag 6 9 15
Indication  
pulmonary hypertension 6 9 15
sirolimus 28 2 2 32
facial angiofibromas 5 5
other indication(s) 23 2 2 27
               
sirolimus 13 1 14
Indication  
facial angiofibromas 10 10
other indication(s) 3 1 4
               
sitafloxacin 10 10
Indication  
Mycoplasma genitalium infection 10 10
               
sodium chloride 3 13 1 17
Indication  
hyponatraemia 7 7
other indication(s) 3 6 1 10
               
sofosbuvir with velpatasvir 5 1 1 7
Indication  
hepatitis C 5 1 1 7
               
sorafenib 9 3 12
Indication  
fibromatosis 7 1 8
other indication(s) 2 2 4
               
stanozolol 35 1 36
Indication  
hereditary angioedema 35 35
other indication(s) 1 1
               
sunitinib 6 3 2 11
Indication  
other indication(s) 6 3 2 11
               
tacrolimus 13 7 10 30
Indication  
other indication(s) 13 7 10 30
               
tadalafil 11 8 1 20
Indication  
other indication(s) 2 2
pulmonary hypertension 11 6 1 18
               
taurolidine and citrate 4 5 9
Indication  
other indication(s) 4 5 9
               
temozolomide 29 4 33
Indication  
neuroblastoma 8 8
other indication(s) 21 4 25
               
teriparatide 5 6 11
Indication  
other indication(s) 5 6 11
               
thalidomide 16 2 18
Indication  
other indication(s) 16 2 18
               
tinidazole 18 18
Indication  
trichomonas infection 18 18
               
tobramycin 1 6 3 10
Indication  
other indication(s) 1 6 3 10
               
tocilizumab 79 22 10 111
Indication  
COVID-19 46 46
giant cell arteritis 6 15 1 22
other indication(s) 27 7 9 43
               
tofacitinib 9 10 1 20
Indication  
other indication(s) 9 5 14
rheumatoid arthritis 5 1 6
               
topotecan 26 1 27
Indication  
neuroblastoma 22 22
other indication(s) 4 1 5
               
trametinib 47 9 1 57
Indication  
astrocytoma 12 1 13
glioma 8 8
neurofibroma 10 2 12
other indication(s) 17 6 1 24
               
trastuzumab 5 9 1 15
Indication  
breast cancer 5 1 1 7
other indication(s) 8 8
               
upadacitinib 25 23 2 50
Indication  
atopic dermatitis 20 6 1 27
other indication(s) 5 17 1 23
               
ursodeoxycholic acid 5 2 2 9
Indication  
other indication(s) 5 2 2 9
               
ustekinumab 7 15 2 24
Indication  
Crohn's disease 3 9 2 14
other indication(s) 4 6 10
               
valganciclovir 23 23
Indication  
cytomegalovirus (CMV) 18 18
other indication(s) 5 5
               
varicella zoster vaccine 8 8 16
Indication  
other indication(s) 3 3
shingles prevention 5 8 13
               
vedolizumab 4 8 1 13
Indication  
Crohn's disease 3 5 1 9
other indication(s) 1 3 4
               
vemurafenib 6 1 1 8
Indication  
other indication(s) 6 1 1 8
               
venetoclax 14 1 30 3 48
Indication  
acute myeloid leukaemia (AML) 7 11 1 19
chronic lymphocytic leukaemia (CLL) 2 4 1 7
mantle cell lymphoma 1 7 8
other indication(s) 5 8 1 14
               
venlafaxine 1 5 2 8
Indication  
depression 1 5 2 8
               
vinorelbine 8 1 9
Indication  
other indication(s) 2 2
rhabdomyosarcoma 6 1 7
               
voriconazole 21 2 23
Indication  
aspergillus infection 8 8
fungal infection 8 2 10
other indication(s) 5 5
               
zonisamide 44 5 49
Indication  
epilepsy 44 5 49