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Ongoing (preliminary decision published)

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)

 

Completed (final decision published)

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

 

Ansprechpartner

 
 
 
 
Dr. Thomas Ecker
Tel. +49 (40) 41 33 081-10
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