15.03.2025
04.09.2025
Fosdenopterin
Nulibry®
Sentynl Therapeutics
Nervous system diseases
Molybdenum cofactor deficiency type A
2
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2025
21.08.2025
Atogepant
Aquipta®
AbbVie Deutschland GmbH & Co. KG
Nervous system diseases
Migraine prophylaxis
1,386,900–1,726,200
100%
no additional benefit
01.07.2024
19.12.2024
Tofersen
Qalsody®
Biogen GmbH
Nervous system diseases
Amyotrophic lateral sclerosis (ALS)
90–170
100%
Hint for
non-quantifiable additional benefit
Orphan
01.04.2024
19.09.2024
Efgartigimod alfa (2, reassessment >€30m)
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+
6,300–19,000
100%
no additional benefit
Orphan (turnover limit)
15.03.2024
19.09.2024
Omaveloxolon
Skyclarys®
Biogen GmbH
Nervous system diseases
Friedreich's ataxia, ≥ 16 years
970
100%
Hint for
non-quantifiable additional benefit
Orphan
01.03.2024
15.08.2024
Zilucoplan
Zilbrysq®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
6,300–19,000
100%
no additional benefit
01.03.2024
15.08.2024
Rozanolixizumab
Rystiggo®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+, MuSK antibodies+
6,470–19,300
98%
Hint for
considerable additional benefit
Orphan
01.02.2024
01.08.2024
Ublituximab
Briumvi®
Neuraxpharm Arzneimittel GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis
70,300–274,900
63%
Indication of
minor additional benefit
01.12.2023
16.05.2024
Cannabidiol (8, reassessment >€30m)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
500–2,900
100%
no additional benefit
Orphan (turnover limit)
01.12.2023
16.05.2024
Cannabidiol (7, reassessment >€30m)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
1,700–22,700
100%
no additional benefit
Orphan (turnover limit)
15.09.2023
07.03.2024
Risdiplam (2)
Evrysdi®
Roche Pharma AG
Nervous system diseases
Spinal muscular atrophy, < 2 months
56–95
100%
no additional benefit
15.07.2023
18.01.2024
Dimethylfumarat (3)
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS) (new indication: children and adolescents aged 13 years and older))
350–1,200
100%
no additional benefit
15.06.2023
07.12.2023
Ravulizumab (5)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
460–1,170
100%
no additional benefit
01.05.2023
05.10.2023
Lasmiditan
Rayvow®
Lilly Deutschland GmbH
Nervous system diseases
Migraine acute therapy
2,750,000
100%
no additional benefit
01.04.2023
21.09.2023
Pitolisant (3)
Wakix®
Bioprojet Deutschland GmbH
Nervous system diseases
Narcolepsy, with or without cataplexy (children and adolescents, 6-17 years)
120–650
100%
Hint for
non-quantifiable additional benefit
Orphan
15.02.2023
03.08.2023
Fenfluramin (2)
Fintepla®
Zogenix GmbH
Nervous system diseases
Lennox-Gastaut syndrome, add-on therapy, ≥ 2 years
2,100–22,700
100%
Hint for
considerable additional benefit
Orphan
01.11.2022
20.04.2023
Ravulizumab (4)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
800–1,200
100%
no additional benefit
01.09.2022
16.02.2023
Efgartigimod alfa
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
0
14,000–16,800
100%
Hint for
considerable additional benefit
Orphan
01.09.2022
16.02.2023
Eptinezumab
Vyepti®
Lundbeck GmbH
Nervous system diseases
Migraine prophylaxis
1,614,300–1,645,200
100%
no additional benefit
01.08.2022
19.01.2023
Inebilizumab
Uplizna®
Horizon Therapeutics GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
460–980
100%
no additional benefit
01.03.2022
01.09.2022
Brivaracetam (3)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Focal seizures in epilepsy, additional therapy, 2 to < 4 years
300–1,800
100%
no additional benefit
01.12.2021
19.05.2022
Ponesimod (2)
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relaps multiple sclerosis (MS)
186,000–200,000
50%
Indication of
minor additional benefit
01.11.2021
21.04.2022
Pitolisant (2, Ozawade®)
Ozawade®
Bioprojet Deutschland GmbH
Nervous system diseases
Daytime sleepiness in obstructive sleep apnea, after previous therapy
200,000–400,000
100%
no additional benefit
01.10.2021
18.03.2022
Solriamfetol (2)
Sunosi®
Jazz Pharmaceuticals Ireland
Nervous system diseases
Daytime sleepiness in obstructive sleep apnoea, after previous therapy
200,000–400,000
100%
no additional benefit
01.08.2021
20.01.2022
Teriflunomid (2)
Aubagio®
Sanofi-Aventis Deutschland GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS), 10 to 17 years
350–1,200
100%
no additional benefit
15.07.2021
06.01.2022
Satralizumab
Enspryng®
Roche Pharma AG
Nervous system diseases
Neuromyelitis optica spectrum disorders (NMOSD), anti-aquaporin-4 IgG seropositive, ≥ 12 years
460–5,050
100%
Hint for
minor additional benefit
Orphan
15.06.2021
02.12.2021
Ponesimod
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relapsing multiple sclerosis (MS)
21,000–23,000
100%
no additional benefit
01.06.2021
19.11.2021
Cenobamat
Ontozry®
Angelini Pharma Deutschland GmbH
Nervous system diseases
Epilepsy, focal seizures, after at least 2 previous therapies
52,910–167,470
100%
no additional benefit
15.05.2021
04.11.2021
Onasemnogen-Abeparvovec
Zolgensma®
Novartis Gene Therapies EU Limited
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
46–67
100%
no additional benefit
Orphan (turnover limit)
01.05.2021
21.10.2021
Erenumab (2, reassessment)
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
1,540,100–1,568,800
100%
Hint for
considerable additional benefit
01.05.2021
21.10.2021
Risdiplam
Evrysdi®
Roche Pharma AG
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
992–2,142
42%
Hint for
non-quantifiable additional benefit
Orphan
01.02.2021
15.07.2021
Fenfluramin
Fintepla®
Zogenix GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years
450–2,450
100%
Hint for
considerable additional benefit
Orphan
15.12.2020
03.06.2021
Perampanel (5)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years
2,950–6,700
100%
no additional benefit
15.12.2020
03.06.2021
Perampanel (4)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years
195–663
100%
no additional benefit
01.12.2020
20.05.2021
Nusinersen (2, reassessment >€50m)
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
1,013–1,203
19%
Indication of
major additional benefit
Orphan (turnover limit)
15.02.2021
06.05.2021
Eszopiclon
Lunivia®
Hennig Arzneimittel GmbH & Co. KG
Nervous system diseases
Sleep disorders
0
100%
no additional benefit
15.10.2020
15.04.2021
Cannabidiol (3, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
0
1,100–3,100
100%
Hint for
considerable additional benefit
Orphan
15.10.2020
15.04.2021
Cannabidiol (4, reassessment)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
0
2,600–22,700
100%
Hint for
considerable additional benefit
Orphan
15.07.2020
07.01.2021
Ozanimod
Zeposia®
Celgene GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
149,500–166,000
90%
Indication of
minor additional benefit
15.05.2020
05.11.2020
Solriamfetol
Sunosi®
Jazz Pharmaceuticals
Nervous system diseases
Narcolepsy
16,200–19,500
100%
no additional benefit
15.02.2020
20.08.2020
Siponimod
Mayzent®
Novartis Pharma GmbH
Nervous system diseases
Secondary progressive multiple sclerosis (MS)
13,200–28,900
100%
no additional benefit
15.10.2019
02.04.2020
Cannabidiol (2)
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
0
1,100–3,100
100%
Hint for
non-quantifiable additional benefit
Orphan
15.10.2019
02.04.2020
Cannabidiol
Epidyolex®
GW Pharmaceuticals plc
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
0
2,600–22,700
100%
Hint for
non-quantifiable additional benefit
Orphan
01.07.2019
19.12.2019
Vigabatrin
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, West syndrome, < 7 years
0
1,000–2,400
100%
no additional benefit
01.07.2019
19.12.2019
Vigabatrin (2)
Kigabeq®
Desitin GmbH
Nervous system diseases
Epilepsy, focal seizures, < 7 years
0
7,300–14,500
100%
no additional benefit
15.05.2019
07.11.2019
Fremanezumab
Ajovy®
Teva GmbH
Nervous system diseases
Migraine prophylaxis
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
01.04.2019
19.09.2019
Galcanezumab
Emgality®
Lilly Deutschland GmbH
Nervous system diseases
Migraine prophylaxis
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
01.02.2019
01.08.2019
Mexiletin
Namuscla®
Lupin Europe GmbH
Nervous system diseases
Myotonia
530–650
100%
non-quantifiable additional benefit
Orphan
15.01.2019
04.07.2019
Melatonin
Slenyto®
InfectoPharm Arzneimittel und Consilium GmbH
Nervous system diseases
Sleep disorders
0
8,000–86,000
100%
Hint for
minor additional benefit
01.01.2019
20.06.2019
Fingolimod (5)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), ≥ 10 to < 18 years
190–840
57%
Hint for
non-quantifiable additional benefit
01.11.2018
02.05.2019
Erenumab
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
14,000–15,000
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
01.08.2018
17.01.2019
Brivaracetam (2)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, add-on therapy, 4 to < 16 years
5,000–10,000
100%
no additional benefit
01.05.2018
01.11.2018
Extrakt aus Cannabis Sativa (2, reassessment)
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
13,400–38,500
100%
Indication of
minor additional benefit
01.02.2018
02.08.2018
Ocrelizumab
Ocrevus®
Roche Pharma AG
Nervous system diseases
Multiple sclerosis (MS)
165,300–182,200
81%
Proof of
minor additional benefit
01.12.2017
17.05.2018
Cladribin
Mavenclad®
Merck Serono GmbH
Nervous system diseases
Highly active relapsing multiple sclerosis (MS)
40,300–41,000
100%
no additional benefit
01.12.2017
17.05.2018
Perampanel (3)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years
15,600–50,700
100%
no additional benefit
01.07.2017
21.12.2017
Nusinersen
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
0
840–1,060
10%
major additional benefit
Orphan
01.10.2016
16.03.2017
Opicapon
Ongentys®
Bial-Portela & Ca, S.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
no additional benefit
01.08.2016
19.01.2017
Tasimelteon
Hetlioz®
Vanda Pharmceutical Inc
Nervous system diseases
Sleep disorders (sleep-wake rhythm), blind adults
7,000
100%
non-quantifiable additional benefit
Orphan
01.08.2016
19.01.2017
Pitolisant
Wakix®
Bioprojet Pharma SARL
Nervous system diseases
Narcolepsy
15,000–30,000
100%
non-quantifiable additional benefit
Orphan
15.02.2016
04.08.2016
Brivaracetam
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 16 years
86,000–200,000
100%
no additional benefit
01.12.2015
19.05.2016
Fingolimod (4)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Highly active relapsing-remitting multiple sclerosis (MS), after inadequate pre-treatment
14,000–16,000
100%
no additional benefit
15.05.2015
05.11.2015
Safinamid
Xadago®
Zambon S.p.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
no additional benefit
01.04.2015
01.10.2015
Fingolimod (3, reassessment)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
4,600–12,300
17,100–24,800
21%
Indication of
considerable additional benefit
01.07.2014
18.12.2014
Fingolimod (2)
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Multiple sclerosis (MS), pre-treated
0
8,240–8,390
100%
no additional benefit
15.05.2014
06.11.2014
Perampanel (2, reassessment)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
70,600–106,800
100%
no additional benefit
01.05.2014
16.10.2014
Dimethylfumarat
Tecfidera®
Biogen GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
no additional benefit
15.01.2014
03.07.2014
Retigabin (3, reassessment)
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
26,800–53,600
100%
no additional benefit
01.10.2013
20.03.2014
Teriflunomid
Aubagio®
sanofi-aventis groupe / Genzyme GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
no additional benefit
15.09.2012
07.03.2013
Perampanel
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
0
70,600–106,800
100%
no additional benefit
29.07.2011
02.08.2012
Fampridin
Fampyra®
Biogen GmbH
Nervous system diseases
Multiple sclerosis (MS)
43,100–49,900
100%
no additional benefit
01.07.2011
21.06.2012
Extrakt aus Cannabis Sativa
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
0
13,400–38,500
100%
Hint for
minor additional benefit
15.05.2011
03.05.2012
Retigabin
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
0
85,000–175,000
100%
no additional benefit
15.04.2011
29.03.2012
Fingolimod
Gilenya®
Novartis Pharma GmbH
Nervous system diseases
Rapidly progressing relapsing-remitting multiple sclerosis (MS)
0
9,500–7,500
18%
Hint for
minor additional benefit