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Subject:

• Active Substance: Emicizumab
• Name: Hemlibra^®
• Therapeutic area: Hemophilia A
• Pharmaceutical company: Roche Pharma AG

Time table:

• Start: 15.03.2019
• Publication of assessment: 17.06.2019
• End of public hearing: 08.07.2019
• Final decision by G-BA: expected for the beginning of September 2019

Comparative therapy:

• Recombinant or human plasma-derived blood coagulation factor VIII products (prophylaxis treatment)

Subject:

• Active Substance: Brentuximab vedotin
• Name: Adcetris^®
• Therapeutic area: Hodgkin’s lymphoma
• Pharmaceutical company: Takeda GmbH & Co. KG

Time table:

• Start: 15.03.2019
• Publication of assessment: 17.06.2019
• End of public hearing: 08.07.2019
• Final decision by G-BA: expected for the beginning of September 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Pembrolizumab
• Name: Keytruda^®
• Therapeutic area: NSCLC
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 01.04.2019
• Publication of assessment: 01.07.2019B
• End of public hearing: 22.07.2019
• Final decision by G-BA: Middle of September 2019

Comparative therapy:

• Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS)): pembrolizumab (monotherapy)
• Patients with PD-L1 expression < 50 % (TPS): cisplatin or carboplatin each in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel) or carboplatin in combination with nab-paclitaxel

Subject:

• Active Substance: Pembrolizumab
• Name: Keytruda^®
• Therapeutic area: NSCLC
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 01.04.2019
• Publication of assessment: 01.07.2019
• End of public hearing: 22.07.2019
• Final decision by G-BA: Middle of September 2019

Comparative therapy:

• Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS)): pembrolizumab (monotherapy)
• Patients with PD-L1 expression < 50 % (TPS):
• cisplatin in combination with a third generation cytostatic (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed) under consideration of the authorization status or
• carboplatin in combination with a third generation cytostatic (only for patients with increased risk for cisplatin-induced adverse events during combination therapy) or
• Carboplatin in combination with nab-paclitaxel

Subject:

• Active Substance: Pembrolizumab
• Name: Keytruda^®
• Therapeutic area: Melanoma
• Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

• Start: 01.04.2019
• Publication of assessment: 01.07.2019
• End of public hearing: 22.07.2019
• Final decision by G-BA: Middle of September 2019

Comparative therapy:

• Watchful waiting

Subject:

• Active Substance: Galcanezumab
• Name: Emgality^®
• Therapeutic area: Prophylaxis of migraine
• Pharmaceutical company: Lilly Deutschland GmbH

Time table:

• Start: 01.04.2019
• Publication of assessment: 01.07.2019
• End of public hearing: 22.07.2019
• Final decision by G-BA: Middle of September 2019

Comparative therapy:

• Treatment-naïve patients and patients that have responded insufficiently, have not tolerated, or are not suitable for at least one prophylactic medication: metoprolol or propranolol or flunarizine or topiramate or amitryptilin
• Patients ineligible, intolerant or irresponsive to any of the above drug classes: valproic acid or clostridium botulinum toxin type A (in accordance to the authorization status for chronic migraine)
• Patients ineligible, intolerant or irresponsive to any of the above drug classes: best supportive care

Subject:

• Active Substance: Nintedanib
• Name: Ofev^®
• Therapeutic area: Idiopathic pulmonary fibrosis (IPF)
• Pharmaceutical company: Boehringer Ingelheim Pharma GmbH

Time table:

• Start: 15.04.2019
• Publication of assessment: 15.07.2019
• End of public hearing: 05.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• Pirfenidone (only for patients with mild to moderate IPF) or
• Best supportive care

Subject:

• Active Substance: Glecaprevir / pibrentasvir (new indication: chronic hepatitis C, adolescent patients at the age of 12 to < 18 years)
• Name: Maviret^®
• Therapeutic area: Chronic hepatitis C
• Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

• Start: 15.04.2019
• Publication of assessment: 15.07.2019
• End of public hearing: 05.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• Patients with genotype 1, 4, 5 or 6: Ledipasvir / sofosbuvir
• Patients with genotype 2 or 3: Sofosbuvir plus ribavirin

Subject:

• Active Substance: Radium-223 dichloride (re-assessment accord. to §13)
• Name: Xofigo^®
• Therapeutic area: Prostate cancer
• Pharmaceutical company: Bayer Vital GmbH

Time table:

• Start: 15.04.2019
• Publication of assessment: 15.07.2019
• End of public hearing: 05.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• Best supportive care (especially adequate pain therapy, treatment with biphosphonates, denosumab and/or radionucleotides)

Subject:

• Active Substance: Voretigene neparvovec
• Name: Luxturna^®
• Therapeutic area: Retinal dystrophy
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.04.2019
• Publication of assessment: 15.07.2019
• End of public hearing: 05.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Dapagliflozin
• Name: Forxiga^®
• Therapeutic area: Diabetes mellitus type 1
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 01.05.2019
• Publication of assessment: 01.08.2019
• End of public hearing: 22.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• Human insulin or insulin analogues (insulin detemir, insulin glargin, insulin aspart, insulin glulisin, insulin lispro

Subject:

• Active Substance: Lisdexamfetamine dimesilat
• Name: Elvanse Adult^®
• Therapeutic area: Adults with Attention Deficit Hyperactivity Disorder (ADHD)
• Pharmaceutical company: Shire Deutschland GmbH, now part of Takeda Group

Time table:

• Start: 01.05.2019
• Publication of assessment: 01.08.2019
• End of public hearing: 22.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• a) Adults with ADHD since childhood with at least moderate severity and pre-treatment with one medicinal therapy: patient individual therapy considering atomoxetine and methylphenidate, in the context of an overall therapeutic strategy; a potential continuation or re-start of an already used medicinal product has to be tested and shown
  b)Adults with ADHD since childhood with at least moderate severity who have not received a medicinal therapy yet: atomoxetine or methylphenidate, in the context of an overall therapeutic strategy

Subject:

• Active Substance: Dacomitinib
• Name: Vizimpro^®
• Therapeutic area: Non-small cell lung cancer
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.05.2019
• Publication of assessment: 01.08.2019
• End of public hearing: 22.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• a) Adult patients with locally advanced or metastatic NSCLC with the activating EGFR mutations K858R or del19: afatinib or gefitinib or erlotinib
  b)Adult patients with locally advanced or metastatic NSCLC with other activating EGFR mutations than K858R or del19: a patient-individual therapy under consideration of the activating EGFR mutation choosing from:
  - afatinib, gefitinib, erlotinib
  - cisplatin in combination with a third-generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed)
  - carboplatin in combination with a third-generation cytostatic drug (vinorelbine or gemcitabine or docetaxel or paclitaxel or pemetrexed)
  - carboplatin in combination with nab-paclitaxel
  AND
  - monotherapy with gemcitabine or vinorelbine (only for patients with ECOG performance status 2 and as alternative to platin-based combination therapy)

Subject:

• Active Substance: Prasterone
• Name: Intrarosa^®
• Therapeutic area: Post menopause
• Pharmaceutical company: Endoceutics, Inc.

Time table:

• Start: 01.05.2019
• Publication of assessment: 01.08.2019
• End of public hearing: 22.08.2019
• Final decision by G-BA: expected for the middle of October 2019

Comparative therapy:

• Estrogens as vaginal applications

Subject:

• Active Substance: Fremanezumab
• Name: Ajovy^®
• Therapeutic area: Migraine prophylaxis
• Pharmaceutical company: Teva GmbH

Time table:

• Start: 15.05.2019
• Publication of assessment: 15.08.2019
• End of public hearing: 05.09.2019
• Final decision by G-BA: expected for the beginning of November 2019

Comparative therapy:

• Treatment-naïve adult patients with inadequate response or who are intolerant or contraindicated to at least one prophylactic therapy: metoprolol or propranolol or flunarizine or topiramate or amitriptyline ( 4 substance classes)
• Adult patients who show no response or are intolerant or contraindicated to those 4 substance classes: valproate (valproic acid) or clostridium botulinum toxin type A
• Adult patients who show now response or are intolerant or contraindicated to any of the above mentioned substance classes: best supportive care (BSC)

Subject:

• Active Substance: Lumacaftor/ ivacaftor (new indication: patients at the age of 2 to 5 years)
• Name: Orkambi^®
• Therapeutic area: Cystic fibrosis
• Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

• Start: 15.02.2019
• Final decision by G-BA: 15.08.2019
• Decision remains valid until: 01.10.2021

Final decision:

• Hint for a non-quantifiable additional benefit

Subject:

• Active Substance: Blinatumomab (new indication: ALL, MRD-positive patients)
• Name: Blincyto^®
• Therapeutic area: Acute lymphoblastic leukaemia (ALL)
• Pharmaceutical company: Amgen GmbH

Time table:

• Start: 15.02.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Blinatumomab (new indication: ALL, pediatric patients)
• Name: Blincyto^®
• Therapeutic area: Acute lymphoblastic leukaemia (ALL)
• Pharmaceutical company: Amgen GmbH

Time table:

• Start: 15.02.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Ipilimumab (new indication: renal cell carcinoma, in combination with nivolumab, 1st line)
• Name: Yervoy^®
• Therapeutic area: Renal cell carcinoma
• Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

• Start: 15.02.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
• Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

Subject:

• Active Substance: Nivolumab (new indication: renal cell carcinoma, in combination with ipilimumab, 1st line)
• Name: Opdivo^®
• Therapeutic area: Renal cell carcinoma
• Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

• Start:15.02.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Patients with intermediate risk profile (IMDS score 1-2): Indication for a considerable additional benefit
• Patients with unfavourable risk profile (IMDS score ≥ 3): Indication for a considerable additional benefit

Subject:

• Active Substance: Lenvatinib (repeal of orphan drug designation)
• Name: Lenvima^®
• Therapeutic area: Thyroid carcinoma
• Pharmaceutical company: Eisai GmbH

Time table:

• Start: 15.02.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Additional benefit not proved

Subject:

• Active Substance: Regadenoson
• Name: Rapiscan^®
• Therapeutic area: Measurement of fractional flow reserve (FFR) of stenosis
• Pharmaceutical company: GE Healthcare Buchler GmbH & Co. KG

Time table:

• Start: 01.03.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Additional benefit not proved (no dossier submitted)

Subject:

• Active Substance: Rucaparib
• Name: Rubraca^®
• Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

• Start: 01.03.2019
• Final decision by G-BA: 15.08.2019
• The decision remains valid until: 01.04.2023

Final decision:

• Additional benefit not proved

Subject:

• Active Substance: Rucaparib
• Name: Rubraca^®
• Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: Clovis Oncology Germandy GmbH

Time table:

• Start: 01.03.2019
• Final decision by G-BA: 15.08.2019

Final decision:

• Additional benefit not proved

Subject:

• Active Substance: Apalutamide
• Name: Erleada^®
• Therapeutic area: Prostatic Neoplasms
• Pharmaceutical company: Janssen-Cilag GmbH

Time table:

• Start: 01.02.2019
• Final decision by G-BA: 01.08.2019
• The decision remains valid until: 15.05.2020

Final decision:

• Hint for minor additional benefit

Subject:

• Active Substance: Lanadelumab
• Name: Takhzyro^®
• Therapeutic area: Hereditary Angioedemas
• Pharmaceutical company: Shire Deutschland GmbH, part of the Takeda Group

Time table:

• Start: 01.02.2019
• Final decision by G-BA: 01.08.2019

Final decision:

• Considerable additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Mexiletine
• Name: Namuscla^®
• Therapeutic area: Myotonic Disorders
• Pharmaceutical company: Lupin Europe GmbH

Time table:

• Start: 01.02.2019
• Final decision by G-BA: 01.08.2019

Final decision:

• Non-quantifiable benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Glycerol phenylbutyrate
• Name: Ravicti^®
• Therapeutic area: Urea cycle disorders
• Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019

Final decision:

• Non-quantifiable additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Brigatinib
• Name: Alunbrig^®
• Therapeutic area: Non-small cell lung cancer (NSCLC)
• Pharmaceutical company: Takeda GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Bedaquilin
• Name: Sirturo^®
• Therapeutic area: Tuberculosis
• Pharmaceutical company: Janssen-Cilag GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019
• This decision remains valid until: 30.06.2021

Final decision:

• Considerable additional benefit (proved because of orphan drug designation)

Subject:

• Active Substance: Melatonin
• Name: Slenyto^®
• Therapeutic area: Insomnia
• Pharmaceutical company: InfectoPharm Arzneimittel und Consilium GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019

Final decision:

• Hint for a minor additional benefit

Subject:

• Active Substance: Ribociclib
• Name: Kisqali^®
• Therapeutic area: Breast cancer
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019
• This decision remains valid until: 01.03.2022

Final decision:

• A) For women who are not pre-treated with an endocrine therapy:
• A1) post-menopausal women: no additional benefit proved
• A2) pre- and peri-menopausal women: no additional benefit proved
• B) For women who are pre-treated with an endocrine therapy:
• B1) post-menopausal women with progress after endocrine therapy: no additional benefit proved
• B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

Subject:

• Active Substance: Ribociclib
• Name: Kisqali^®
• Therapeutic area: Breast cancer
• Pharmaceutical company: Novartis Pharma GmbH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019
• This decision remains valid until: 01.03.2022

Final decision:

• A) For women who are not pre-treated with an endocrine therapy:
• A2) pre- and peri-menopausal women: no additional benefit proved
• B) For women who are pre-treated with an endocrine therapy:
• B2) pre- and peri-menopausal women with progress after endocrine therapy: no additional benefit proved

Subject:

• Active Substance: Doravirine/ lamivudine/ tenofovir disproxil
• Name: Delstrigo^®
• Therapeutic area: HIV infection
• Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019

Final decision:

• Therapy-naïve patients: no additional benefit proved
• Pre-treated patients: no additional benefit proved

Subject:

• Active Substance: Doravirine
• Name: Pifeltro^®
• Therapeutic area: HIV infection
• Pharmaceutical company: MSD SHARH & DOHME GMBH

Time table:

• Start: 15.01.2019
• Final decision by G-BA: 04.07.2019

Final decision:

• Therapy-naïve patients: no additional benefit proved
• Pre-treated patients: no additional benefit proved