01.01.2026
18.06.2026
Nipocalimab (1)
Imaavy®
Johnson & Johnson
Nervous system diseases
Myasthenia gravis, AChR antibody-positive, MuSK antibody-positive, aged ≥ 12 years
6,570–19,990
100%
additional benefit not proven
01.11.2025
16.04.2026
Donanemab (1)
Kisunla®
Lilly Deutschland GmbH
Nervous system diseases
Early-onset Alzheimer’s disease
131,000–440,000
100%
additional benefit not proven
01.09.2025
19.02.2026
Lecanemab (1)
Leqembi®
Eisai GmbH
Nervous system diseases
Early-onset Alzheimer’s disease
131,000–440,000
100%
additional benefit not proven
01.08.2025
22.01.2026
Efgartigimod alfa (3)
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Chronic inflammatory demyelinating polyneuropathy, in patients who have received prior treatment
50–260
100%
additional benefit not proven
Orphan (turnover limit)
01.07.2025
18.12.2025
Omaveloxolon (2)
Skyclarys®
Biogen GmbH
Nervous system diseases
Friedreich’s ataxia, aged 16 years and over
990
100%
additional benefit not proven
Orphan (turnover limit)
01.06.2025
20.11.2025
Rimegepant (2)
Vydura®
Pfizer Pharma GmbH
Nervous system diseases
Migraine prophylaxis
1,386,900–1,726,200
100%
additional benefit not proven
01.06.2025
20.11.2025
Rimegepant (1)
Vydura®
Pfizer Pharma GmbH
Nervous system diseases
Acute treatment of migraine
2,825,000
100%
additional benefit not proven
15.03.2025
04.09.2025
Fosdenopterin (1)
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 (1)
Aquipta®
AbbVie Deutschland GmbH & Co. KG
Nervous system diseases
Migraine prophylaxis
1,386,900–1,726,200
100%
additional benefit not proven
01.07.2024
19.12.2024
Tofersen (1)
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)
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+
6,300–19,000
100%
additional benefit not proven
Orphan (turnover limit)
15.03.2024
19.09.2024
Omaveloxolon (1)
Skyclarys®
Biogen GmbH
Nervous system diseases
Friedreich's ataxia, ≥ 16 years
0
970
100%
Hint for
non-quantifiable additional benefit
Orphan
repealed
01.03.2024
15.08.2024
Zilucoplan (1)
Zilbrysq®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
6,300–19,000
100%
additional benefit not proven
01.03.2024
15.08.2024
Rozanolixizumab (1)
Rystiggo®
UCB Pharma GmbH
Nervous system diseases
Myasthenia gravis, AChR antibodies+, MuSK antibodies+
6,470–19,300
98%
Hint for
considerable additional benefit
Orphan
01.03.2024
15.08.2024
Daridorexant (2)
Quviviq®
Idorsia Pharmaceuticals Germany GmbH
Nervous system diseases
Sleep disorders
8,300–218,500
100%
additional benefit not proven
01.02.2024
01.08.2024
Ublituximab (1)
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 (6)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Dravet syndrome, ≥ 2 years, combination with clobazam
0
500–2,900
100%
additional benefit not proven
Orphan (turnover limit)
repealed
01.12.2023
16.05.2024
Cannabidiol (7)
Epidyolex®
Jazz Pharmaceuticals Germany GmbH
Nervous system diseases
Lennox-Gastaut syndrome, ≥ 2 years, combination with clobazam
1,700–22,700
100%
additional benefit not proven
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%
additional benefit not proven
15.07.2023
18.01.2024
Dimethylfumarat (2)
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%
additional benefit not proven
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%
additional benefit not proven
15.04.2023
05.10.2023
Lasmiditan (1)
Rayvow®
Lilly Deutschland GmbH
Nervous system diseases
Migraine acute therapy
2,750,000
100%
additional benefit not proven
01.04.2023
21.09.2023
Pitolisant (2)
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
15.11.2022
12.05.2023
Daridorexant (1)
Quviviq®
Idorsia Pharmaceuticals Germany GmbH
Nervous system diseases
Sleep disorders (mental illnesses)
0
1,900–79,000
100%
additional benefit not proven
repealed
01.11.2022
20.04.2023
Ravulizumab (4)
Ultomiris®
Alexion Pharma Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
800–1,200
100%
additional benefit not proven
01.09.2022
16.02.2023
Efgartigimod alfa (1)
Vyvgart®
Argenx Germany GmbH
Nervous system diseases
Myasthenia gravis, AChR antibody+
0
14,000–16,800
100%
Hint for
considerable additional benefit
Orphan
repealed
01.09.2022
16.02.2023
Eptinezumab (1)
Vyepti®
Lundbeck GmbH
Nervous system diseases
Migraine prophylaxis
1,614,300–1,645,200
100%
additional benefit not proven
01.08.2022
19.01.2023
Inebilizumab (1)
Uplizna®
Horizon Therapeutics GmbH
Nervous system diseases
Neuromyelitis optica spectrum disorders, anti-aquaporin-4 IgG seropositive
460–980
100%
additional benefit not proven
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%
additional benefit not proven
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 (Ozawade, 1)
Ozawade®
Bioprojet Deutschland GmbH
Nervous system diseases
Daytime sleepiness in obstructive sleep apnea, after previous therapy
200,000–400,000
100%
additional benefit not proven
01.10.2021
18.03.2022
Solriamfetol (2)
Sunosi®
Jazz Pharmaceuticals Ireland Ltd.
Nervous system diseases
Daytime sleepiness in obstructive sleep apnoea, after previous therapy
200,000–400,000
100%
additional benefit not proven
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%
additional benefit not proven
15.07.2021
06.01.2022
Satralizumab (1)
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 (1)
Ponvory®
Janssen-Cilag GmbH
Nervous system diseases
Relapsing multiple sclerosis (MS)
21,000–23,000
100%
additional benefit not proven
01.06.2021
19.11.2021
Cenobamat (1)
Ontozry®
Angelini Pharma Deutschland GmbH
Nervous system diseases
Epilepsy, focal seizures, after at least 2 previous therapies
52,910–167,470
100%
additional benefit not proven
15.05.2021
04.11.2021
Onasemnogen-Abeparvovec (2)
Zolgensma®
Novartis Gene Therapies EU Limited
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
46–67
100%
additional benefit not proven
Orphan (turnover limit)
01.05.2021
21.10.2021
Risdiplam (1)
Evrysdi®
Roche Pharma AG
Nervous system diseases
5q-associated spinal muscular atrophy (SMA)
992–2,142
42%
Hint for
non-quantifiable additional benefit
Orphan
01.05.2021
21.10.2021
Erenumab (2)
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
1,540,100–1,568,800
100%
Hint for
considerable additional benefit
01.02.2021
15.07.2021
Fenfluramin (1)
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 (4)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years
2,950–6,700
100%
additional benefit not proven
15.12.2020
03.06.2021
Perampanel (5)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, primary generalised seizures, ≥ 12 years, ≥ 7 years to < 12 years
195–663
100%
additional benefit not proven
01.12.2020
20.05.2021
Nusinersen (2)
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 (1)
Lunivia®
Hennig Arzneimittel GmbH & Co. KG
Nervous system diseases
Sleep disorders
n.d.
100%
additional benefit not proven
15.10.2020
15.04.2021
Cannabidiol (4)
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
repealed
15.10.2020
15.04.2021
Cannabidiol (3)
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
repealed
15.07.2020
07.01.2021
Ozanimod (1)
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 (1)
Sunosi®
Jazz Pharmaceuticals
Nervous system diseases
Narcolepsy
16,200–19,500
100%
additional benefit not proven
15.02.2020
20.08.2020
Siponimod (1)
Mayzent®
Novartis Pharma GmbH
Nervous system diseases
Secondary progressive multiple sclerosis (MS)
13,200–28,900
100%
additional benefit not proven
15.10.2019
02.04.2020
Cannabidiol (2)
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
repealed
15.10.2019
02.04.2020
Cannabidiol (1)
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
repealed
01.07.2019
19.12.2019
Vigabatrin (2)
Kigabeq®
Desitin Arzneimittel GmbH
Nervous system diseases
Epilepsy, West syndrome, < 7 years
0
1,000–2,400
100%
additional benefit not proven
repealed
01.07.2019
19.12.2019
Vigabatrin (1)
Kigabeq®
Desitin Arzneimittel GmbH
Nervous system diseases
Epilepsy, focal seizures, < 7 years
0
7,300–14,500
100%
additional benefit not proven
repealed
15.05.2019
07.11.2019
Fremanezumab (1)
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 (1)
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 (1)
Namuscla®
Lupin Europe GmbH
Nervous system diseases
Myotonia
530–650
100%
non-quantifiable additional benefit
Orphan
15.01.2019
04.07.2019
Melatonin (1)
Slenyto®
InfectoPharm Arzneimittel und Consilium GmbH
Nervous system diseases
Sleep disorders
0
8,000–86,000
100%
Hint for
minor additional benefit
repealed
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 (1)
Aimovig®
Novartis Pharma GmbH
Nervous system diseases
Migraine prophylaxis
15,400–26,000
1,443,400–1,471,000
1.0%
Hint for
considerable additional benefit
repealed subpopulations
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%
additional benefit not proven
01.05.2018
01.11.2018
Extrakt aus Cannabis Sativa (2)
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 (1)
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 (1)
Mavenclad®
Merck Serono GmbH
Nervous system diseases
Highly active relapsing multiple sclerosis (MS)
40,300–41,000
100%
additional benefit not proven
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%
additional benefit not proven
01.07.2017
21.12.2017
Nusinersen (1)
Spinraza®
Biogen GmbH
Nervous system diseases
Spinal muscular atrophy (SMA)
0
840–1,060
10%
major additional benefit
Orphan
repealed
01.10.2016
16.03.2017
Opicapon (1)
Ongentys®
Bial-Portela & Ca, S.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
additional benefit not proven
01.08.2016
19.01.2017
Tasimelteon (1)
Hetlioz®
Vanda Pharmaceuticals 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 (1)
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 (1)
Briviact®
UCB Pharma GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 16 years
86,000–200,000
100%
additional benefit not proven
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%
additional benefit not proven
15.05.2015
05.11.2015
Safinamid (1)
Xadago®
Zambon S.p.A.
Nervous system diseases
Morbus Parkinson
45,200–61,100
100%
additional benefit not proven
01.04.2015
01.10.2015
Fingolimod (3)
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
repealed subpopulations
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%
additional benefit not proven
repealed
15.05.2014
06.11.2014
Perampanel (2)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
70,600–106,800
100%
additional benefit not proven
01.05.2014
16.10.2014
Dimethylfumarat (1)
Tecfidera®
Biogen Idec GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
additional benefit not proven
15.01.2014
03.07.2014
Retigabin (3)
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
26,800–53,600
100%
additional benefit not proven
01.10.2013
20.03.2014
Teriflunomid (1)
Aubagio®
Sanofi-aventis groupe/Genzyme GmbH
Nervous system diseases
Relapsing-remitting multiple sclerosis (MS)
85,000–105,000
100%
additional benefit not proven
15.09.2012
07.03.2013
Perampanel (1)
Fycompa®
Eisai GmbH
Nervous system diseases
Epilepsy, focal seizures, ≥ 12 years
0
70,600–106,800
100%
additional benefit not proven
repealed
29.07.2011
02.08.2012
Fampridin (1)
Fampyra®
Biogen Idec GmbH
Nervous system diseases
Multiple sclerosis (MS)
43,100–49,900
100%
additional benefit not proven
01.07.2011
21.06.2012
Extrakt aus Cannabis Sativa (1)
Sativex®
Almirall Hermal GmbH
Nervous system diseases
Multiple sclerosis (MS), spasticity
0
13,400–38,500
100%
Hint for
minor additional benefit
repealed
15.05.2011
03.05.2012
Retigabin (1)
Trobalt®
GlaxoSmithKline GmbH & Co. KG
Nervous system diseases
Epilepsy, focal seizures
0
85,000–175,000
100%
additional benefit not proven
repealed
15.04.2011
29.03.2012
Fingolimod (1)
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
repealed