Nervous system diseases

This category includes diseases such as epilepsy, Parkinson’s and multiple sclerosis, as well as migraines. To date, the G-BA has assessed XX different medicinal products in this therapeutic area within the scope of XX procedures, which in turn were divided into xx subpopulations. A major additional benefit has been identified for xx% of these subpopulations, with a considerable additional benefit seen for XX%. The G-BA has confirmed a minor additional benefit for XX% of the subpopulations and a non-quantifiable additional benefit for another XX% in relation to the comparative treatment. No additional benefit in relation to the comparative therapy was proved for XX% of the subpopulations weighted according to the share of resolutions, corresponding to xx% of the maximum xx million patients treatable with these medicinal products.

All G-BA resolutions concerning nervous system diseases

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
Donanemab (1) Kisunla® Lilly Deutschland GmbH Nervous system diseases Early-onset Alzheimer’s disease 131,000–440,000 100% additional benefit not proven
Lecanemab (1) Leqembi® Eisai GmbH Nervous system diseases Early-onset Alzheimer’s disease 131,000–440,000 100% additional benefit not proven
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)
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)
Rimegepant (2) Vydura® Pfizer Pharma GmbH Nervous system diseases Migraine prophylaxis 1,386,900–1,726,200 100% additional benefit not proven
Rimegepant (1) Vydura® Pfizer Pharma GmbH Nervous system diseases Acute treatment of migraine 2,825,000 100% additional benefit not proven
Fosdenopterin (1) Nulibry® Sentynl Therapeutics Nervous system diseases Molybdenum cofactor deficiency type A 2 100% Hint for non-quantifiable additional benefit Orphan
Atogepant (1) Aquipta® AbbVie Deutschland GmbH & Co. KG Nervous system diseases Migraine prophylaxis 1,386,900–1,726,200 100% additional benefit not proven
Tofersen (1) Qalsody® Biogen GmbH Nervous system diseases Amyotrophic lateral sclerosis (ALS) 90–170 100% Hint for non-quantifiable additional benefit Orphan
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)
Omaveloxolon (1) Skyclarys® Biogen GmbH Nervous system diseases Friedreich's ataxia, ≥ 16 years 0
970
100% Hint for non-quantifiable additional benefit Orphan repealed
Zilucoplan (1) Zilbrysq® UCB Pharma GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 6,300–19,000 100% additional benefit not proven
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
Daridorexant (2) Quviviq® Idorsia Pharmaceuticals Germany GmbH Nervous system diseases Sleep disorders 8,300–218,500 100% additional benefit not proven
Ublituximab (1) Briumvi® Neuraxpharm Arzneimittel GmbH Nervous system diseases Relapsing-remitting multiple sclerosis 70,300–274,900 63% Indication of minor additional benefit
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
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)
Risdiplam (2) Evrysdi® Roche Pharma AG Nervous system diseases Spinal muscular atrophy, < 2 months 56–95 100% additional benefit not proven
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
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
Lasmiditan (1) Rayvow® Lilly Deutschland GmbH Nervous system diseases Migraine acute therapy 2,750,000 100% additional benefit not proven
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
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
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
Ravulizumab (4) Ultomiris® Alexion Pharma Germany GmbH Nervous system diseases Myasthenia gravis, AChR antibody+ 800–1,200 100% additional benefit not proven
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
Eptinezumab (1) Vyepti® Lundbeck GmbH Nervous system diseases Migraine prophylaxis 1,614,300–1,645,200 100% additional benefit not proven
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
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
Ponesimod (2) Ponvory® Janssen-Cilag GmbH Nervous system diseases Relaps multiple sclerosis (MS) 186,000–200,000 50% Indication of minor additional benefit
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
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
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
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
Ponesimod (1) Ponvory® Janssen-Cilag GmbH Nervous system diseases Relapsing multiple sclerosis (MS) 21,000–23,000 100% additional benefit not proven
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
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)
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
Erenumab (2) Aimovig® Novartis Pharma GmbH Nervous system diseases Migraine prophylaxis 1,540,100–1,568,800 100% Hint for considerable additional benefit
Fenfluramin (1) Fintepla® Zogenix GmbH Nervous system diseases Dravet syndrome, ≥ 2 years 450–2,450 100% Hint for considerable additional benefit Orphan
Perampanel (4) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years, ≥ 4 years 2,950–6,700 100% additional benefit not proven
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
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)
Eszopiclon (1) Lunivia® Hennig Arzneimittel GmbH & Co. KG Nervous system diseases Sleep disorders n.d. 100% additional benefit not proven
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
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
Ozanimod (1) Zeposia® Celgene GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 149,500–166,000 90% Indication of minor additional benefit
Solriamfetol (1) Sunosi® Jazz Pharmaceuticals Nervous system diseases Narcolepsy 16,200–19,500 100% additional benefit not proven
Siponimod (1) Mayzent® Novartis Pharma GmbH Nervous system diseases Secondary progressive multiple sclerosis (MS) 13,200–28,900 100% additional benefit not proven
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
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
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
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
Fremanezumab (1) Ajovy® Teva GmbH Nervous system diseases Migraine prophylaxis 1,443,400–1,471,000 1.0% Hint for considerable additional benefit
Galcanezumab (1) Emgality® Lilly Deutschland GmbH Nervous system diseases Migraine prophylaxis 1,443,400–1,471,000 1.0% Hint for considerable additional benefit
Mexiletin (1) Namuscla® Lupin Europe GmbH Nervous system diseases Myotonia 530–650 100% non-quantifiable additional benefit Orphan
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
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
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
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
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
Ocrelizumab (1) Ocrevus® Roche Pharma AG Nervous system diseases Multiple sclerosis (MS) 165,300–182,200 81% Proof of minor additional benefit
Cladribin (1) Mavenclad® Merck Serono GmbH Nervous system diseases Highly active relapsing multiple sclerosis (MS) 40,300–41,000 100% additional benefit not proven
Perampanel (3) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, primary generalised seizures, ≥ 12 years 15,600–50,700 100% additional benefit not proven
Nusinersen (1) Spinraza® Biogen GmbH Nervous system diseases Spinal muscular atrophy (SMA) 0
840–1,060
10% major additional benefit Orphan repealed
Opicapon (1) Ongentys® Bial-Portela & Ca, S.A. Nervous system diseases Morbus Parkinson 45,200–61,100 100% additional benefit not proven
Tasimelteon (1) Hetlioz® Vanda Pharmaceuticals Inc. Nervous system diseases Sleep disorders (sleep-wake rhythm), blind adults 7,000 100% non-quantifiable additional benefit Orphan
Pitolisant (1) Wakix® Bioprojet Pharma SARL Nervous system diseases Narcolepsy 15,000–30,000 100% non-quantifiable additional benefit Orphan
Brivaracetam (1) Briviact® UCB Pharma GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 16 years 86,000–200,000 100% additional benefit not proven
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
Safinamid (1) Xadago® Zambon S.p.A. Nervous system diseases Morbus Parkinson 45,200–61,100 100% additional benefit not proven
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
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
Perampanel (2) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 70,600–106,800 100% additional benefit not proven
Dimethylfumarat (1) Tecfidera® Biogen Idec GmbH Nervous system diseases Relapsing-remitting multiple sclerosis (MS) 85,000–105,000 100% additional benefit not proven
Retigabin (3) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 26,800–53,600 100% additional benefit not proven
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
Perampanel (1) Fycompa® Eisai GmbH Nervous system diseases Epilepsy, focal seizures, ≥ 12 years 0
70,600–106,800
100% additional benefit not proven repealed
Fampridin (1) Fampyra® Biogen Idec GmbH Nervous system diseases Multiple sclerosis (MS) 43,100–49,900 100% additional benefit not proven
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
Retigabin (1) Trobalt® GlaxoSmithKline GmbH & Co. KG Nervous system diseases Epilepsy, focal seizures 0
85,000–175,000
100% additional benefit not proven repealed
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