15.02.2026
06.08.2026
Teplizumab (1)
Teizeild®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Type 1 diabetes mellitus, aged ≥ 8 years
57,000
100%
Hint for
non-quantifiable additional benefit
01.12.2025
21.05.2026
Olezarsen (1)
Tryngolza®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Chylomicronemia syndrome
60–130
100%
Indication of
minor additional benefit
Orphan
15.11.2025
07.05.2026
Diflunisal (1)
Attrogy®
Purpose Pharma International AB
Metabolic diseases
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
360
100%
additional benefit not proven
15.07.2025
22.01.2026
Sepiapterin (1)
Sephience®
PTC Therapeutics International Limited
Metabolic diseases
Hyperphenylalaninaemia in phenylketonuria
4,700–6,800
100%
Hint for
non-quantifiable additional benefit
Orphan
15.07.2025
22.01.2026
Vutrisiran (2)
Amvuttra®
Alnylam Germany GmbH
Metabolic diseases
Wild-type or hereditary transthyretin amyloidosis with cardiomyopathy
1,760–2,120
100%
additional benefit not proven
Orphan
01.05.2025
16.10.2025
Ivacaftor / Tezacaftor / Elexacaftor (17)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination therapy with ivacaftor, ≥ 2 years, non-Class I mutation (a gating mutation and no F508del mutation)
100
100%
additional benefit not proven
Orphan (turnover limit)
01.05.2025
16.10.2025
Ivacaftor / Tezacaftor / Elexacaftor (16)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination therapy with ivacaftor, ≥ 2 years, non-Class I mutation (no F508del mutation and no gating mutation)
375
64%
Hint for
major additional benefit
Orphan (turnover limit)
01.05.2025
16.10.2025
Tiratricol (1)
Emcitate®
Rare Thyroid Therapeutics International AB
Metabolic diseases
Peripheral thyrotoxicosis associated with monocarboxylate transporter 8 deficiency (Allan-Herndon-Dudley syndrome), present from birth
40–110
100%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2025
16.10.2025
Eplontersen (1)
Wainzua®
AstraZeneca GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
360
100%
additional benefit not proven
01.04.2025
18.09.2025
Acoramidis (1)
Beyonttra®
Bayer Vital GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis in adult patients with cardiomyopathy
1,760–2,120
100%
additional benefit not proven
01.03.2025
21.08.2025
Setmelanotid (3)
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, POMC, PCSK1, LEPR deficiency or Bardet-Biedl syndrome, ≥ 2 to < 6 years of age
24–67
100%
Hint for
non-quantifiable additional benefit
Orphan
01.01.2025
18.06.2025
Eliglustat (2)
Cerdelga®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Gaucher disease type 1, ≥ 6 to < 18 years, ≥ 15 kg bw
10–30
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2024
20.02.2025
Insulin icodec (1)
Awiqli®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
855,000–1,184,000
100%
additional benefit not proven
01.09.2024
20.02.2025
Insulin icodec (2)
Awiqli®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1
161,750
100%
additional benefit not proven
01.02.2024
01.08.2024
Patiromer (2)
Veltassa®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Hyperkalaemia, ≥ 12 to < 18 years
370–790
100%
additional benefit not proven
15.01.2024
04.07.2024
Pegzilarginase (1)
Loargys®
Immedica Pharma Germany GmbH
Metabolic diseases
Hyperargininemia (ARG1-D), ≥ 2 years
50
100%
Hint for
non-quantifiable additional benefit
Orphan
15.01.2024
04.07.2024
Evinacumab (1)
Evkeeza®
Ultragenyx Germany GmbH
Metabolic diseases
Homozygous familial hypercholesterolemia, ≥ 12 years of age
73–80
100%
additional benefit not proven
15.01.2024
04.07.2024
Evinacumab (2)
Evkeeza®
Ultragenyx Germany GmbH
Metabolic diseases
Homozygous familial hypercholesterolemia, ≥ 5 to < 12 years of age
5–6
100%
additional benefit not proven
01.01.2024
20.06.2024
Palopegteriparatid (1)
Yorvipath®
Ascendis Pharma Endocrinology GmbH
Metabolic diseases
Chronic hypoparathyroidism, parathyroid hormone (PTH) substitution therapy
18,300–20,800
100%
additional benefit not proven
Orphan
01.01.2024
20.06.2024
Empagliflozin (6)
Jardiance®
Boehringer Ingelheim Pharma GmbH
Metabolic diseases
Diabetes Mellitus Type 2, ≥ 10 years
300–385
100%
additional benefit not proven
15.12.2023
06.06.2024
Alirocumab (3)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolaemia, ≥ 8 years to 17 years
958–1,178
100%
additional benefit not proven
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (11)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, from 2 to ≤ 5 years of age (heterozygous for F508del and MF mutation)
160
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (12)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, combination treatment with ivacaftor, 2 to ≤ 5 years (homozygous for F508del mutation)
250
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (13)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
13
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (14)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and RF mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
20
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2023
16.05.2024
Ivacaftor / Tezacaftor / Elexacaftor (15)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and other or unknown mutation, ≥ 2 to ≤ 5 years, combination with ivacaftor
33
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2023
16.05.2024
Patisiran (2)
Onpattro®
Alnylam Germany GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis with polyneuropathy (stage 1 or 2)
360
100%
Indication of
less benefit
Orphan (turnover limit)
15.11.2023
02.05.2024
Tirzepatid (1)
Mounjaro®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
1,461,000–2,021,000
23%
Hint for
minor additional benefit
01.11.2023
02.05.2024
Somapacitan (1)
Sogroya®
Novo Nordisk Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 years
9,150–11,600
100%
Hint for
non-quantifiable additional benefit
Orphan
01.10.2023
21.03.2024
Pegunigalsidase alfa (1)
Elfabrio®
Chiesi GmbH
Metabolic diseases
Morbus Fabry
60–1,260
100%
additional benefit not proven
15.09.2023
07.03.2024
Lonapegsomatropin (1)
Skytrofa®
Ascendis Pharma Endocrinology GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years.
5,710–6,550
100%
Hint for
non-quantifiable additional benefit
Orphan
15.08.2023
15.02.2024
Migalastat (3)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, ≥ 12 years
20–460
100%
additional benefit not proven
Orphan (turnover limit)
01.08.2023
01.02.2024
Cipaglucosidase alfa (1)
Pombiliti®
Amicus Therapeutics GmbH
Metabolic diseases
Pompe's disease, combination with miglustat
170–1,760
100%
Hint for
minor additional benefit
15.07.2023
18.01.2024
Lumacaftor / Ivacaftor (5)
Orkambi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis, homozygous F508del mutation in CFTR gene, 1 to < 2 years)
50
100%
Hint for
non-quantifiable additional benefit
15.05.2023
02.11.2023
Setmelanotid (2)
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, Bardet-Biedl syndrome, ≥ 6 years
300–1,100
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2023
21.09.2023
Dulaglutid (3)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, ≥ 10 years
640–710
100%
additional benefit not proven
15.10.2022
06.04.2023
Vutrisiran (1)
Amvuttra®
Alnylam Germany GmbH
Metabolic diseases
Hereditary transthyretin amyloidosis (hTTA) with polyneuropathy (stage 1 or 2)
360
100%
Indication of
minor additional benefit
Orphan
01.10.2022
16.03.2023
Olipudase alfa (1)
Xenpozyme®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Acid sphingomyelinase deficiency (ASMD) type A/B or type B
70–80
100%
Hint for
non-quantifiable additional benefit
Orphan
01.09.2022
16.02.2023
Burosumab (6)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
FGF23-related hypophosphatemia in tumour-induced osteomalacia
60–140
100%
additional benefit not proven
Orphan (turnover limit)
15.08.2022
02.02.2023
Eladocagene exuparvovec (1)
Upstaza®
PTC Therapeutics International Limited
Metabolic diseases
Aromatic L-amino acid decarboxylase (AADC) deficiency, ≥ 18 months
4–30
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2022
15.12.2022
Cerliponase alfa (2)
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis (NCL) type 2
40–50
100%
Hint for
major additional benefit
Orphan
01.06.2022
01.12.2022
Setmelanotid (1)
Imcivree®
Rhythm Pharmaceuticals Inc.
Metabolic diseases
Obesity and control of hunger, POMC-, PCSK1- or LEPR-deficient obesity, ≥ 6 years
140–280
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2022
15.09.2022
Somatrogon (1)
Ngenla®
Pfizer Pharma GmbH
Metabolic diseases
Growth disturbance due to growth hormone deficiency, ≥ 3 to < 18 years of age
5,710–6,550
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (10)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
56
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (9)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor
21
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (8)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis, F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor)
28
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (7)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
470
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor / Tezacaftor / Elexacaftor (6)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor, from 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
233
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (27)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and other or unknown mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
56
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (26)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and RF mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor
21
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (25)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, heterozygous and gating mutation, ≥ 6 to ≤ 11 years, combination with ivacaftor / tezacaftor / elexacaftor).
28
100%
additional benefit not proven
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (24)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (homozygous for F508del mutation)
470
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.02.2022
04.08.2022
Ivacaftor (23)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor, 6 to ≤ 11 years (heterozygous for F508del and MF mutation)
230
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.02.2022
21.07.2022
Calcifediol (1)
Rayaldee®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Secondary hyperparathyroidism in chronic renal failure
146,700–184,300
100%
additional benefit not proven
01.02.2022
21.07.2022
Burosumab (5)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 18 years of age
410–810
100%
additional benefit not proven
Orphan (turnover limit)
01.02.2022
21.07.2022
Burosumab (4)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia, ≥ 1 to < 18 years of age
200–550
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.01.2022
16.06.2022
Evolocumab (3)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia, ≥ 10 to < 18 years of age
768–950
100%
additional benefit not proven
15.12.2021
16.06.2022
Dapagliflozin (7)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus Type 2, ≥ 10 years
650–710
100%
additional benefit not proven
01.12.2021
19.05.2022
Ertugliflozin (1)
Steglatro®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus (DM) type 2
1,451,000–2,021,000
100%
additional benefit not proven
01.09.2021
05.05.2022
Icosapent-Ethyl (1)
Vazkepa®
Amarin Pharmaceuticals Ireland Limited
Metabolic diseases
Dyslipidemia, pre-treated patients
844,000–878,000
100%
additional benefit not proven
01.10.2021
18.03.2022
Lumacaftor / Ivacaftor (4)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, ≥ 2 to ≤ 5 years
290
100%
Hint for
non-quantifiable additional benefit
01.09.2021
17.02.2022
Migalastat (2)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease, 12 to < 16 years
0
1–19
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (5)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation).
310
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (4)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
173
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor / Tezacaftor / Elexacaftor (3)
Kaftrio®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients > 12 years (heterozygous for F508del and gating mutation (incl. R117H)).
133
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (22)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and others or unknown mutation)
310
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (21)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and RF mutation)
173
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2021
19.11.2021
Ivacaftor (20)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and gating mutation (incl. R117H))
133
100%
additional benefit not proven
Orphan (turnover limit)
01.05.2021
04.11.2021
Atidarsagen autotemcel OTL-200 (1)
Libmeldy®
Orchard Therapeutics GmbH
Metabolic diseases
Metachromatic leukodystrophy with biallelic mutation in the ARSA gene
2–4
67%
Hint for
major additional benefit
Orphan
01.04.2021
16.09.2021
Natrium-Zirkonium-Cyclosilikat (1)
Lokelma®
AstraZeneca GmbH
Metabolic diseases
Hyperkalemia
77,700–308,500
100%
additional benefit not proven
01.02.2021
15.07.2021
Inclisiran (1)
Leqvio®
Novartis Pharma GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–410,900
100%
additional benefit not proven
01.01.2021
01.07.2021
Afamelanotid (2)
Scenesse®
Clinuvel (Europe) Limited
Metabolic diseases
Erythropoietic protoporphyria
540–1,090
100%
Hint for
non-quantifiable additional benefit
Orphan
01.01.2021
01.07.2021
Lumasiran (1)
Oxlumo®
Alnylam Germany GmbH
Metabolic diseases
Hyperoxaluria
50–880
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
03.06.2021
Sebelipase alfa (2)
Kanuma®
Alexion Pharma Germany GmbH
Metabolic diseases
Lysosomal acid lipase deficiency
35–70
100%
Hint for
non-quantifiable additional benefit
Orphan
01.12.2020
20.05.2021
Tezacaftor / Ivacaftor (5)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (heterozygous for F508del and RF mutation)
50
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Tezacaftor / Ivacaftor (4)
Symkevi®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor in patients 6 to < 12 years (homozygous for F508del)
470
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Tafamidis (4)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
1,760–1,810
100%
Indication of
considerable additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Tafamidis (3)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
230
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (19)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (heterozygous for F508del and MF mutation)
50
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (18)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with tezacaftor/ivacaftor in patients 6 to < 12 years (homozygous for F508del mutation)
470
100%
additional benefit not proven
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (17)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, R117H mutation
1
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.12.2020
20.05.2021
Ivacaftor (16)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), patients from 4 to < 6 months, gating mutations
1
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.11.2020
15.04.2021
Burosumab (3)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 18 years
0
410–810
100%
Hint for
minor additional benefit
Orphan
repealed
01.11.2020
15.04.2021
Bempedoinsäure / Ezetimib (1)
Nustendi®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–286,750
100%
additional benefit not proven
01.11.2020
15.04.2021
Bempedoinsäure (1)
Nilemdo®
Daiichi Sankyo Deutschland GmbH
Metabolic diseases
Primary hypercholesterolaemia or mixed dyslipidaemia
284,750–286,750
100%
additional benefit not proven
01.11.2020
15.04.2021
Semaglutid (Rybelsus, Ozempic, 1)
Rybelsus, Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
0
2,107,999–2,108,001
100%
additional benefit not proven
repealed
01.09.2020
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor (2)
Kaftrio®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del mutation)
2,400
100%
Indication of
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor / Tezacaftor / Elexacaftor (1)
Kaftrio®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥12 years (heterozygous for F508del and MF mutation)
1,000
100%
Hint for
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor (14)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (heterozygous for F508del and MF mutation)
1,000
100%
Hint for
major additional benefit
Orphan (turnover limit)
01.09.2020
18.02.2021
Ivacaftor (15)
Kalydeco®
Vertex Pharmaceuticals (Ireland) Limited
Metabolic diseases
Cystic fibrosis (CF), combination therapy with ivacaftor/tezacaftor/elexacaftor in patients ≥ 12 years (homozygous for F508del mutation)
2,400
100%
Indication of
major additional benefit
Orphan (turnover limit)
15.07.2020
07.01.2021
Osilodrostat (1)
Isturisa®
Recordati Rare Diseases Germany GmbH
Metabolic diseases
Endogenous Cushing syndrome
1,130–1,550
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2020
17.12.2020
Ivacaftor (13)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 6 months to < 18 years
26
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.07.2020
17.12.2020
Tezacaftor / Ivacaftor (2)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (homozygous for F508del)
2,400
100%
additional benefit not proven
Orphan (turnover limit)
01.07.2020
17.12.2020
Tezacaftor / Ivacaftor (3)
Symkevi®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), combination treatment with ivacaftor in patients ≥ 12 years (heterozygous for F508del)
200–300
100%
additional benefit not proven
Orphan (turnover limit)
15.04.2020
15.10.2020
Insulin glargin / Lixisenatid (2)
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin and with SGLT-2 inhibitors
532,000
100%
additional benefit not proven
15.04.2020
15.10.2020
Givosiran (1)
Givlaari®
Alnylam Germany GmbH
Metabolic diseases
Acute hepatic porphyria, ≥ 12 years
1,000–1,700
100%
Indication of
considerable additional benefit
Orphan
01.03.2020
20.08.2020
Tafamidis (2)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid cardiomyopathy
0
1,630–1,730
100%
Hint for
considerable additional benefit
Orphan
repealed
01.02.2020
16.07.2020
Dulaglutid (2)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
2,108,000
31%
Hint for
minor additional benefit
15.12.2019
04.06.2020
Ivacaftor (12)
Kalydeco®
Vertex Pharmaceuticals
Metabolic diseases
Cystic fibrosis (CF), ≥ 6 to < 12 months
2
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
15.10.2019
02.04.2020
Asfotase alfa (2)
Strensiq®
Alexion Pharma Germany GmbH
Metabolic diseases
Hypophosphatasia (HPP)
1,074
0.8%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.10.2019
02.04.2020
Burosumab (2)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
0
200–500
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.09.2019
20.02.2020
Ivacaftor (11)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), 12 ro < 24 months
5
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (10)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), patients ≥ 18 years with R117H mutation
35–44
100%
Hint for
minor additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (9)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), patients from 2 to 5 years
15
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (8)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), various gating mutations, ≥ 6 years
10–11
100%
Hint for
non-quantifiable additional benefit
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (7)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), heterozygous for F508del, ≥ 12 years, combination with tezacaftor
200–300
100%
additional benefit not proven
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (6)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), homozygous for F508del, ≥ 12 years, combination with tezacaftor
2,400
100%
additional benefit not proven
Orphan (turnover limit)
01.09.2019
20.02.2020
Ivacaftor (5)
Kalydeco®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
210
86%
Hint for
considerable additional benefit
Orphan (turnover limit)
15.08.2019
20.02.2020
Volanesorsen (1)
Waylivra®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Chylomicronaemia syndrome
60–120
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2019
19.12.2019
Pegvaliase (1)
Palynziq®
BioMarin International Limited
Metabolic diseases
Phenylketonuria
435
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2019
19.12.2019
Dapagliflozin / Metformin (3)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
1,139,000
50%
Hint for
minor additional benefit
01.07.2019
19.12.2019
Dapagliflozin (4)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
2,108,000
41%
Hint for
minor additional benefit
01.06.2019
22.11.2019
Empagliflozin / Linagliptin (1)
Glyxambi®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
326,100–341,100
100%
additional benefit not proven
01.05.2019
17.10.2019
Dapagliflozin (3)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 1
0
19,200
100%
Hint for
minor additional benefit
repealed
15.02.2019
15.08.2019
Lumacaftor / Ivacaftor (3)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in the CFTR gene, 2 to 5 years
0
280
100%
Hint for
non-quantifiable additional benefit
repealed
15.01.2019
04.07.2019
Glycerolphenylbutyrat (2)
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), 0 to < 2 months
10–18
100%
non-quantifiable additional benefit
Orphan
01.12.2018
16.05.2019
Tezacaftor / Ivacaftor (1)
Symkevi®
Vertex Pharmaceuticals (Germany) GmbH
Metabolic diseases
Cystic fibrosis (CF), F508del mutation, ≥ 12 years
0
2,600–2,700
91%
considerable additional benefit
Orphan
repealed
01.12.2018
16.05.2019
Insulin degludec (4)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
776,100–991,100
100%
additional benefit not proven
01.11.2018
02.05.2019
Alirocumab (2)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
271,750
100%
additional benefit not proven
01.11.2018
02.05.2019
Semaglutid (1)
Ozempic®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,969,100–2,184,100
37%
Hint for
minor additional benefit
repealed
01.10.2018
22.03.2019
Patisiran (1)
Onpattro®
Alnylam Germany GmbH
Metabolic diseases
Amyloidosis
0
350
100%
considerable additional benefit
Orphan
repealed
01.10.2018
22.03.2019
Inotersen (1)
Tegsedi®
Akcea Therapeutics Germany GmbH
Metabolic diseases
Amyloidosis
350
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Metreleptin (1)
Myalepta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Lipodystrophy
90–180
100%
non-quantifiable additional benefit
Orphan
01.10.2018
22.03.2019
Sitagliptin (3)
Januvia, Xelevia®
MSD SHARP & DOHME GMBH
Metabolic diseases
Diabetes mellitus type 2, combination with metformin
781,600
100%
Hint for
minor additional benefit
01.10.2018
22.03.2019
Vestronidase alfa (1)
Mepsevii®
Ultragenyx Germany GmbH
Metabolic diseases
Mucopolysaccharidosis (MPS VII; Sly syndrome)
2–7
100%
non-quantifiable additional benefit
Orphan
01.07.2018
20.12.2018
Velmanase alfa (1)
Lamzede®
Chiesi GmbH
Metabolic diseases
Alpha mannosidosis
70–140
100%
non-quantifiable additional benefit
Orphan
15.05.2018
01.11.2018
Hydrocortison (1)
Alkindi®
Diurnal Ltd.
Metabolic diseases
Adrenal insufficiency, < 18 years
780–1,180
100%
additional benefit not proven
15.05.2018
01.11.2018
Ertugliflozin / Sitagliptin (1)
Steglujan®
MSD Sharp & Dohme GmbH
Metabolic diseases
Diabetes mellitus type 2
326,100–341,100
100%
additional benefit not proven
15.04.2018
04.10.2018
Burosumab (1)
Crysvita®
Kyowa Kirin GmbH
Metabolic diseases
X-linked hypophosphatemia (XLH), ≥ 1 to < 18 years
0
200–500
100%
non-quantifiable additional benefit
Orphan
repealed
01.04.2018
20.09.2018
Patiromer (1)
Veltassa®
Fresenius Medical Care Nephrologica Deutschland GmbH
Metabolic diseases
Hyperkalemia
61,700
100%
additional benefit not proven
15.03.2018
06.09.2018
Evolocumab (2)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
271,500
100%
additional benefit not proven
01.03.2018
16.08.2018
Glycerolphenylbutyrat (1)
Ravicti®
Swedish Orphan Biovitrum GmbH
Metabolic diseases
Urea cycle disorders (UCD), ≥ 2 months
100–250
100%
non-quantifiable additional benefit
Orphan
01.03.2018
16.08.2018
Insulin glargin / Lixisenatid (1)
Suliqua®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
461,400–472,500
100%
additional benefit not proven
01.02.2018
02.08.2018
Lumacaftor / Ivacaftor (2)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), homozygous F508del mutation in CFTR gene, ≥ 6 years
500
100%
Hint for
non-quantifiable additional benefit
01.01.2018
21.06.2018
Dapagliflozin / Metformin (2)
Xigduo®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
468,700
100%
additional benefit not proven
repealed
01.01.2018
21.06.2018
Dapagliflozin (2)
Forxiga®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
468,700
100%
additional benefit not proven
repealed
15.09.2017
16.03.2018
Elosulfase alfa (2)
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
20–100
100%
minor additional benefit
Orphan
01.08.2017
01.02.2018
Saxagliptin / Metformin (4)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy other than insulin and sulphonylurea
77,400
100%
additional benefit not proven
01.07.2017
21.12.2017
Cerliponase alfa (1)
Brineura®
BioMarin Deutschland GmbH
Metabolic diseases
Neuronal ceroid lipofuscinosis type 2
0
20–40
100%
non-quantifiable additional benefit
Orphan
repealed
01.06.2017
17.11.2017
Etelcalcetid (1)
Parsabiv®
Amgen GmbH
Metabolic diseases
Secondary hyperparathyroidism (HPT)
21,896–26,360
100%
additional benefit not proven
01.07.2016
15.12.2016
Sitagliptin / Metformin (2)
Janumet, Velmetia®
MSD SHARP & DOHME GMBH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with sulphonylurea or insulin
792,050–810,850
100%
additional benefit not proven
01.07.2016
15.12.2016
Sitagliptin (2)
Januvia, Xelevia®
MSD SHARP & DOHME GMBH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with metformin, sulphonylurea or PPARɣ
1,070,800–1,270,800
1,705,400–1,905,400
35%
Hint for
minor additional benefit
repealed subpopulations
01.07.2016
15.12.2016
Saxagliptin / Metformin (3)
Komboglyze®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, monotherapy or combination with insulin
729,650–748,450
100%
additional benefit not proven
01.07.2016
15.12.2016
Saxagliptin (3)
Onglyza®
AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
1,182,900–1,382,900
100%
additional benefit not proven
01.06.2016
01.12.2016
Migalastat (1)
Galafold®
Amicus Therapeutics GmbH
Metabolic diseases
Fabry disease
0
20–490
100%
non-quantifiable additional benefit
Orphan
repealed
01.03.2016
01.09.2016
Empagliflozin / Metformin (1)
Synjardy®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
615,299–615,301
100%
additional benefit not proven
01.03.2016
01.09.2016
Empagliflozin (2)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
1,253,400–1,453,400
42%
Hint for
considerable additional benefit
15.02.2016
04.08.2016
Afamelanotid (1)
Scenesse®
Clinuvel (UK) Limited
Metabolic diseases
Erythropoietic protoporphyria
0
540–1,090
100%
non-quantifiable additional benefit
Orphan
repealed
15.12.2015
02.06.2016
Ivacaftor (3)
Kalydeco®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), R117H mutation, 2 to 5 years, > 18 years
0
59
75%
minor additional benefit
Orphan
repealed
15.12.2015
02.06.2016
Lumacaftor / Ivacaftor (1)
Orkambi®
Vertex Pharmaceuticals (Europe) Limited
Metabolic diseases
Cystic fibrosis (CF), > 12 years, homozygous F508del mutation
2,600
100%
Indication of
considerable additional benefit
15.11.2015
04.05.2016
Alirocumab (1)
Praluent®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Hypercholesterolemia or mixed dyslipidaemia
1,500
273,250
100%
additional benefit not proven
repealed subpopulations
01.10.2015
17.03.2016
Sebelipase alfa (1)
Kanuma®
Synageva BioPharma Limited
Metabolic diseases
Lysosomal acid lipase deficiency
0
31–843
100%
non-quantifiable additional benefit
Orphan
repealed
01.10.2015
17.03.2016
Asfotase alfa (1)
Strensiq®
Alexion Europe SAS
Metabolic diseases
Hypophosphatasia (HPP)
0
1,000
100%
non-quantifiable additional benefit
Orphan
repealed
15.09.2015
09.03.2016
Evolocumab (1)
Repatha®
Amgen GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
1,810–1,819
273,310–273,319
100%
additional benefit not proven
repealed subpopulations
15.08.2015
04.02.2016
Insulin degludec / Liraglutid (2)
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with oral antidiabetics
78,500–170,000
100%
additional benefit not proven
15.08.2015
04.02.2016
Gaxilose (1)
LacTest®
VENTER PHARMA S.L.
Metabolic diseases
Diagnosis of hypolactasia
180,000–230,000
100%
additional benefit not proven
15.06.2015
27.11.2015
Lomitapid (2)
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
60–69
100%
additional benefit not proven
01.05.2015
15.10.2015
Insulin degludec / Liraglutid (1)
Xultophy®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
752,000–903,000
100%
additional benefit not proven
01.04.2015
01.10.2015
Eliglustat (1)
Cerdelga®
Genzyme GmbH
Metabolic diseases
Sphingolipidoses (Gaucher disease type 1)
150–500
100%
non-quantifiable additional benefit
Orphan
01.03.2015
20.08.2015
Insulin degludec (3)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2, ≥ 1 to < 18 years
20,200
100%
additional benefit not proven
01.02.2015
16.07.2015
Dulaglutid (1)
Trulicity®
Lilly Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,705,500–1,905,500
31%
Hint for
minor additional benefit
repealed
01.01.2015
18.06.2015
Pasireotid (2)
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Acromegaly
265–1,133
100%
minor additional benefit
Orphan
01.12.2014
21.05.2015
Vildagliptin (2)
Galvus, Jalra, Xiliarx®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
35,900
100%
additional benefit not proven
01.11.2014
21.05.2015
Alipogentiparvovec (1)
Glybera®
Chiesi GmbH
Metabolic diseases
Familial lipoprotein lipase deficiency
17–35
100%
non-quantifiable additional benefit
Orphan
01.10.2014
19.03.2015
Albiglutid (1)
Eperzan®
GlaxoSmithKline GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
1,705,400–1,905,400
35%
Indication of
minor additional benefit
01.09.2014
19.02.2015
Ivacaftor (2)
Kalydeco®
Vertex Pharmaceuticals Limited
Metabolic diseases
Cystic fibrosis (CF), various mutations, ≥ 6 years
0
10–11
100%
minor additional benefit
Orphan
repealed
15.08.2014
05.02.2015
Empagliflozin (1)
Jardiance®
Boehringer Ingelheim Pharma GmbH & Co. KG
Metabolic diseases
Diabetes mellitus type 2
0
1,253,400–1,453,400
100%
additional benefit not proven
repealed
15.08.2014
05.02.2015
Canagliflozin / Metformin (1)
Vokanamet®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
615,300
100%
additional benefit not proven
15.06.2014
04.12.2014
Insulin degludec (2)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with GLP-1 agonists
0
170,100
100%
additional benefit not proven
repealed
01.06.2014
20.11.2014
Elosulfase alfa (1)
Vimizim®
BioMarin Deutschland GmbH
Metabolic diseases
Mucopolysaccharidosis (type IVA)
0
15–95
100%
minor additional benefit
Orphan
repealed
15.05.2014
06.11.2014
Cholsäure (1)
Orphacol®
Laboratoires CTRS
Metabolic diseases
Bile acid synthesis disorder
10–25
100%
non-quantifiable additional benefit
Orphan
01.05.2014
16.10.2014
Insulin degludec (1)
Tresiba®
Novo Nordisk Pharma GmbH
Metabolic diseases
Diabetes mellitus type 1 and type 2
161,750
1,095,950
100%
additional benefit not proven
repealed subpopulations
15.03.2014
04.09.2014
Canagliflozin (1)
Invokana®
Janssen-Cilag GmbH
Metabolic diseases
Diabetes mellitus type 2
1,253,400–1,453,400
100%
additional benefit not proven
15.02.2014
07.08.2014
Dapagliflozin / Metformin (1)
Xigduo®
Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
615,300
100%
additional benefit not proven
repealed
15.12.2013
05.06.2014
Lomitapid (1)
Lojuxta®
Aegerion Pharmaceuticals GmbH
Metabolic diseases
Hypercholesterolemia
0
61–71
100%
additional benefit not proven
repealed
01.04.2013
01.10.2013
Vildagliptin (1)
Galvus, Jalra, Xiliarx®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
1,669,500–1,869,500
1,705,400–1,905,400
100%
additional benefit not proven
repealed subpopulations
01.04.2013
01.10.2013
Vildagliptin / Metformin (1)
Eucreas, Icandra, Zomarist®
Novartis Pharma GmbH
Metabolic diseases
Diabetes mellitus type 2
792,050–811,850
100%
additional benefit not proven
01.04.2013
01.10.2013
Sitagliptin / Metformin (1)
Janumet, Velmetia®
MSD SHARP & DOHME GmbH
Metabolic diseases
Diabetes mellitus type 2
0
792,050–810,850
78%
Hint for
minor additional benefit
repealed
01.04.2013
01.10.2013
Sitagliptin (1)
Januvia, Xelevia®
MSD SHARP & DOHME GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,705,400–1,905,400
64%
Hint for
minor additional benefit
repealed
01.04.2013
01.10.2013
Saxagliptin / Metformin (2)
Komboglyze®
Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination with sulphonylurea
62,400
100%
additional benefit not proven
01.04.2013
01.10.2013
Saxagliptin (1)
Onglyza®
Bristol-Myers Squibb GmbH & Co. KGaA / AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2, combination therapy
0
1,182,900–1,382,900
50%
Hint for
minor additional benefit
repealed
15.03.2013
05.09.2013
Lixisenatid (1)
Lyxumia®
Sanofi-Aventis Deutschland GmbH
Metabolic diseases
Diabetes mellitus type 2
903,000
100%
additional benefit not proven
15.12.2012
06.06.2013
Dapagliflozin (1)
Forxiga®
Bristol-Myers Squibb GmbH & Co. KGaA/ AstraZeneca GmbH
Metabolic diseases
Diabetes mellitus type 2
0
896,100
100%
additional benefit not proven
repealed
01.12.2012
16.05.2013
Linagliptin (3)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
450,000–650,000
100%
additional benefit not proven
15.11.2012
02.05.2013
Saxagliptin / Metformin (1)
Komboglyze®
Astra Zeneca GmbH & Bristol-Myers Squibb GmbH CO. KG
Metabolic diseases
Diabetes mellitus type 2
0
729,650–748,450
85%
Hint for
minor additional benefit
repealed
01.09.2012
21.02.2013
Linagliptin (2)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
1,219,500
100%
additional benefit not proven
15.08.2012
07.02.2013
Ivacaftor (1)
Kalydeco®
Vertex Pharmaceuticals GmbH
Metabolic diseases
Cystic fibrosis (CF), G551D mutation, ≥ 6 years
0
170
84%
considerable additional benefit
Orphan
repealed
15.06.2012
06.12.2012
Pasireotid (1)
Signifor®
Novartis Pharma GmbH
Metabolic diseases
Pituitary dysfunction
160–360
100%
minor additional benefit
Orphan
15.12.2011
07.06.2012
Tafamidis (1)
Vyndaqel®
Pfizer Pharma GmbH
Metabolic diseases
Amyloid Neuropathy
0
40–104
100%
minor additional benefit
Orphan
repealed
01.10.2011
29.03.2012
Linagliptin (1)
Trajenta®
Boehringer Ingelheim International GmbH
Metabolic diseases
Diabetes mellitus type 2
0
1,219,500
100%
additional benefit not proven
repealed
01.06.2011
18.08.2011
Pitavastatin (1)
Livazo®
Merckle Recordati GmbH
Metabolic diseases
Primary hypercholesterolaemia, mixed dyslipidaemia
n.d.
100%
additional benefit not proven