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Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • No comparative therapy because of orphan drug status

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • Ceritinib

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • No comparative therapy because of orphan drug status

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • A) For women who are not pre-treated with an endocrine therapy:
  • A1) post-menopausal women: anastrozole OR letrozole OR fulvestrant or (if appropriate) tamoxifen only if aromatase inhibitors are not indicated
  • A2) pre- and peri-menopausal women: tamoxifen in combination with depletion of ovarian function
  • B) For women who are pre-treated with an endocrine therapy:
  • B1) post-menopausal women with progress after endocrine therapy: another endocrine therapy with respect to pre-treatment with: tamoxifen OR anastrozole OR fulvestrant (only for patients with recurrence or progress after anti-estrogen treatment) OR letrozole (only for patients with recurrence or progress after anti-estrogen treatment) OR exemestane (only for patients with progress after anti-estrogen treatment) OR everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis after progress with a non-steroidal aromatase inhibitor)
  • B2) pre- and peri-menopausal women with progress after endocrine therapy: endocrine therapy at the physician’s discretion and under consideration of the respective marketing authorization

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
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • Therapy-naïve patients: rilpivirine OR dolutegravir, each in combination with 2 nucleoside-/ nucleotide analogs (tenofovir disoproxil/ alafenamide plus emtricitabine or abacavir plus lamivudine)
  • Pre-treated patients: individual anti-retroviral therapy under consideration of pre-treatment(s) and the reason for change of therapy, especially treatment failure due to loss of virologic response and accompanied formation of resistance or due to adverse events

Subject:

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

Time table:

  • Start: 15.01.2019
  • Publication of assessment: 15.04.2019
  • End of public hearing: 06.05.2019
  • Final decision by G-BA: expected for the beginning of July 2019

Comparative therapy:

  • Therapy-naïve patients: rilpivirine OR dolutegravir, each in combination with 2 nucleoside-/ nucleotide analogs (tenofovir disoproxil/ alafenamide plus emtricitabine or abacavir plus lamivudine)
  • Pre-treated patients: individual anti-retroviral therapy under consideration of pre-treatment(s) and the reason for change of therapy, especially treatment failure due to loss of virologic response and accompanied formation of resistance or due to adverse events

Subject:

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

Time table:

  • Start: 01.02.2019
  • ublication of assessment: 02.05.2019
  • End of public hearing: 23.05.2019
  • Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

  • Watchful waiting with continuation of existing conventional androgen deprivation

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
  • Publication of assessment: 02.05.2019
  • End of public hearing: 23.05.2019
  • Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

  • No comparative therapy 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
  • Publication of assessment: 02.05.2019
  • End of public hearing: 23.05.2019
  • Final decision by G-BA: expected for the beginning of August 2019

Comparative therapy:

  • No comparative therapy because of orphan drug designation

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Best supportive care

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • No comparative therapy because of orphan drug indication

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • No comparative therapy because of orphan drug indication

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Patients with intermediate risk profile (IMDS score 1-2): bevacizumab in combination with interferon alfa-2a OR monotherapy with pazopanip OR sunitinib
  • Patients with unfavourable risk profile (IMDS score ≥ 3): temsirolimus OR sunitinib

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Patients with intermediate risk profile (IMDS score 1-2): bevacizumab in combination with interferon alfa-2a OR monotherapy with pazopanib OR sunitinib
  • Patients with unfavourable risk profile (IMDS score ≥ 3): temsirolimus OR sunitinib

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
  • Publication of assessment: 15.05.2019
  • End of public hearing: 05.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Sorafenib

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
  • Publication of assessment: 03.06.2019
  • End of public hearing: 24.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Therapy at the physician’s discretion

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
  • Publication of assessment: 03.06.2019
  • End of public hearing: 24.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Watchful waiting

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
  • Publication of assessment: 03.06.2019
  • End of public hearing: 24.06.2019
  • Final decision by G-BA: expected for the middle of August 2019

Comparative therapy:

  • Monotherapy with topotecan or monotherapy with pegylated liposomal doxorubicin

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

 

Completed (final decision published)

Subject:

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

Time table:

  • Start: 01.01.2019
  • Final decision by G-BA: 20.06.2019
  • The decision remains valid until: 01.07.2020

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Urothelial cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.01.2019
  • Publication of assessment: 01.04.2019
  • Final decision by G-BA: 20.06.2019
  • The decision remains valid until: 01.10.2021

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Fingolimod
  • Name: Gilenya®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.01.2019
  • Final decision by G-BA: 20.06.2019

Final decision:

  • a1) children and adolescents (≥ 10 and < 18 years) with highly active, relapsing-remitting multiple sclerosis (RRMS) despite a full and adequate course of treatment with at least one disease-modifying therapy (DMT) who are eligible for a therapy escalation: No additional benefit proved
  • a2) children and adolescents (≥ 10 and < 18 years) with highly active RRMS despite a full and adequate course of treatment with at least one DMT for whom a change within the basic therapeutics is indicated: Hint for a non-quantifiable additional benefit
  • b1) children and adolescents (≥ 10 and < 18 years) with rapidly evolving severe RRMS defined by 2 or more disabling relapses within one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI, who have not had a DMT: Hint for a non-quantifiable additional benefit
  • b2) children and adolescents (≥ 10 and < 18 years) with rapidly evolving severe RRMS defined by 2 or more disabling relapses within one year, and with 1 or more Gadolinium enhancing lesions on brain MRI or a significant increase in T2 lesion load as compared to a previous recent MRI despite DMT: No additional benefit proved

Subject:

  • Active Substance: Damoctocog alfa pegol
  • Name: Jivi®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 01.01.2019
  • Final decision by G-BA: 20.06.2019

Final decision by G-BA:

  • No additional benefit proved.

Subject:

  • Active Substance: Cabozantinib
  • Name: Cabometyx®
  • Therapeutic area: Hepatocellular carcinoma (HCC)
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.12.2018
  • Final decision by G-BA: 06.06.2019

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: : Insulin degludec
  • Name: Tresiba®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.12.2018
  • Final decision by G-BA: 16.05.2019

Final decision:

  • a) patients who are not sufficiently controlled by treatment with at least two antidiabetics (except insulin):
    • insulin + metformin or
    • insulin + empagliflozin (empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
    • insulin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease) or
    • insulin, if metformin and empagliflozin and liraglutide are according to the SmPC not appropriate due to intolerance or contraindication
  • b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic):
    • a) patients who are not sufficiently controlled by treatment with ≥ 2 antidiabetics (except insulin): additional benefit not proved
    • b) patients who are not sufficiently controlled by treatment with insulin (with or w/o another antidiabetic): additional benefit not proved

Subject:

  • Active Substance: Ivacaftor
  • Name: Kalydeco®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.12.2018
  • Final decision by G-BA: [assessment stopped]

Final decision:

  • assessment stopped

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Chronic lymphatic leukemia (CLL)
  • Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

  • Start: 01.12.2018
  • Final decision by G-BA: 16.05.2019

Final decision:

  • a) patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor: additional benefit not proved
  • b) patients without 17p deletion or TP53 mutation who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor: additional benefit not proved

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Chronic lymphatic leukemia (CLL)
  • Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

  • Start: 01.12.2018
  • Final decision by G-BA: 16.05.2019

Final decision:

  • a) patients without 17p deletion and/or TP53 mutation who are suitable for chemoimmunotherapy
    • a1) for whom the combination therapy of bendamustine and rituximab is the patient-individual therapy: indication for a minor additional benefit
    • a2) for whom other therapies than bendamustine plus rituximab is the patient-individual therapy: additional benefit not proved
  • b) patients with 17p deletion and/or TP53 mutation or for whom a chemoimmunotherapy is not suitable: additional benefit not proved

Subject:

  • Active Substance: Enzalutamide
  • Name: Xtandi®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: : 01.12.2018
  • Final decision by G-BA: 16.05.2019
  • This decision remains valid until: 15.05.2020

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Tezacaftor / ivacaftor
  • Name: Symkevi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.12.2018
  • Final decision by G-BA: 16.05.2019

Final decision:

  • a) Patients with homozygous F508del mutation: considerable additional benefit (proved because of orphan drug designation)
  • b) Patients with heterozygous F508del mutation: minor additional benefit (proved because of orphan drug designation)

Subject:

  • Active Substance: Semaglutide
  • Name: Ozempic®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019

Final decision:

  • a) monotherapy: No additional benefit proved.
  • b) in combination with another antidiabetic (except for insulin, here: metformin):
    • b1) patients with high CV risk: Hint for a minor additional benefit.
    • b2) patients without high CV risk: No additional benefit proved.
  • c) in combination with two other antidiabetics (except for insulin):
    • c1) patients with high CV risk: Hint for a minor additional benefit.
    • c2) patients without high CV risk: No additional benefit proved.
  • d) in combination with insulin (with or w/o another antidiabetic):
    • d1) patients with high CV risk: Hint for a minor additional benefit.
    • d2) patients without high CV risk: No additional benefit proved.

Subject:

  • Active Substance: Erenumab
  • Name: Aimovig®
  • Therapeutic area: Migraine
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019

Final decision:

  • a) Treatment-naïve patients and patients who failed treatment with at least one medication: No additional benefit proved.
  • b) Patients who are not eligible for the following therapies/substance classes (metoprolol or propranolol or flunarizine or topiramate or amitriptyline): No additional benefit proved.
  • c) Patients who are not eligible for any of the following therapies/substance classes (metoprolol or propranolol or flunarizine or topiramate or amitriptyline or valproic acid or clostridium botulinum toxin type A): Hint for considerable additional benefit.

Subject:

  • Active Substance: Abemaciclib
  • Name: Verzenios®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019
  • This decision remains valid until: 31.12.2022

Final decision:

  • a) as initial endocrine therapy
    • a1) for postmenopausal women: No additional benefit proved.
    • a2) for pre- and perimenopausal women: No additional benefit proved.
  • b) with endocrine therapy pre-treated
    • b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
    • b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

Subject:

  • Active Substance: Abemaciclib
  • Name: Verzenios®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019
  • This decision remains valid until: 31.12.2020

Final decision:

  • a) as initial endocrine therapy
    • a1) for postmenopausal women: No additional benefit proved.
    • a2) for pre- and perimenopausal women: No additional benefit proved.
  • b) with endocrine therapy pre-treated
    • b1) for postmenopausal women with progress after endocrine therapy: No additional benefit proved.
    • b2) for pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

Subject:

  • Active Substance: Alirocumab
  • Name: Praluent®
  • Therapeutic area: Hypercholesterolemia
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019

Final decision:

  • a) patients who are eligible for statins
    • a1) without known CV disease: No additional benefit proved.
    • a2) with known CV disease: No additional benefit proved.
  • b) patients who are intolerant or contraindicated for statins: No additional benefit proved.
    • b1) without known CV disease: No additional benefit proved.
    • b2) with known CV disease: No additional benefit proved.

Subject:

  • Active Substance: Axicabtagene ciloleucel
  • Name: YESCARTA®
  • Therapeutic area: Lymphoma
  • Pharmaceutical company: Kite, a Gilead Company

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019
  • This decision remains valid until: 15.05.2022

Final decision:

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

Subject:

  • Active Substance: Axicabtagene ciloleucel
  • Name: YESCARTA®
  • Therapeutic area: Lymphoma
  • Pharmaceutical company: Kite, a Gilead Company

Time table:

  • Start: 01.11.2018
  • Final decision by G-BA: 02.05.2019
  • This decision remains valid until: 15.05.2022

Final decision:

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

Subject:

  • Active Substance: Tildrakizumab
  • Name: Ilumetri®
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 15.11.2018
  • Final decision by G-BA: 02.05.2019

Final decision:

  • a) Patients for whom a systemic therapy for the first time is indicated: No additional benefit proved.
  • b) Patients who were insufficiently treated with a systemic therapy: No additional benefit proved.

Subject:

  • Active Substance: Fluticasone furoate/ umeclidinium/ vilanterol fluticasone (new indication: COPD, not adequately treated with LAMA and LABA combination)
  • Name: Trelegy Ellipta®/ Elebrato Ellipta®
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.11.2018
  • Final decision by G-BA: 02.05.2019

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Head and neck squamous cell carcinoma (HNSCC)
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 15.10.2018
  • Final decision by G-BA: 04.04.2019
  • This decision remains valid until: 01.10.2019

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Durvalumab
  • Name: Imfinzi®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.10.2018
  • Final decision by G-BA: 04.04.2019

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Ocriplasmin
  • Name: Jetrea®
  • Therapeutic area: Vitreomacular traction (VMT)
  • Pharmaceutical company: Oxurion NV

Time table:

  • Start: 15.10.2018
  • Final decision by G-BA: 04.04.2019

Final decision:

  • a) for patients with light symptoms (e.g. minor worsening of visual acuity, slightly impaired vision, no progression of symptoms): hint for a minor additional benefit
  • b) for patients with severe symptoms (e.g. progressive worsening of visual acuity, progressive retinal disorder, progressive impaired vision): no additional benefit proved

Subject:

  • Active Substance: Daratumumab
  • Name: Darzalex®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019
  • This decision remains valid until: 01.03.2022

Final decision:

  • Hint for a considerable additional benefit (orphan drug, €50 million sales already exceeded)

Subject:

  • Active Substance: Vestronidase alfa
  • Name: Mepsevii®
  • Therapeutic area: Mucopolysaccharidosis
  • Pharmaceutical company: Ultragenyx Germany GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: Caplacizumab
  • Name: Cablivi®
  • Therapeutic area: Acquired thrombotic thrombocytopenic purpura (aTTP)
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: : Tenofovir alafenamide
  • Name: Vemlidy®
  • Therapeutic area: Chronic hepatitis B
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • Therapy-naïve adult patients: No additional benefit proved.
  • Pre-treated adult patients: No additional benefit proved.
  • Therapy-naïve adolescent (12 years and older) patients: No additional benefit proved.
  • Pre-treated adolescent (12 years and older) patients: No additional benefit proved.

Subject:

  • Active Substance: Sitagliptin
  • Name: Januvia®, Xelevia®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Mepolizumab
  • Name: Nucala®
  • Therapeutic area: Asthma
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Daunorubicin/ cytarabine
  • Name: Vyxeos®
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Jazz Pharmaceuticals

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: Lenvatinib
  • Name: Lenvima®
  • Therapeutic area: Hepatocellular carcinoma (HCC)
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • Patients with Child-Pugh A or without cirrhosis of the liver: No additional benefit proved.
  • Patients with Child-Pugh B: No additional benefit proved.

Subject:

  • Active Substance: Palbociclib
  • Name: Ibrance®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • b1) postmenopausal women with progress after endocrine therapy: No additional benefit proved.
  • b2) pre- and perimenopausal women with progress after endocrine therapy: No additional benefit proved.

Subject:

  • Active Substance: Encorafenib
  • Name: Braftovi®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • Treatment-naïve patients: No additional benefit proved.
  • Pre-treated patients: No additional benefit proved.

Subject:

  • Active Substance: Binimetinib
  • Name: Mektovi®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Pierre Fabre Pharma GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

  • Treatment-naïve patients: No additional benefit proved.
  • Pre-treated patients: No additional benefit proved.

Subject:

  • Active Substance: Metreleptin
  • Name: Myalepta®
  • Therapeutic area: Lipodystrophy
  • Pharmaceutical company: Aegerion Pharmaceuticals GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: Inotersen
  • Name: Tegsedi®
  • Therapeutic area: Amyloidosis
  • Pharmaceutical company: Akcea Therapeutics Germany GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: Patisiran
  • Name: Onpattro®
  • Therapeutic area: Amyloidosis
  • Pharmaceutical company: Alnylam Germany GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019

Final decision:

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

Subject:

  • Active Substance: Dabrafenib
  • Name: Tafinlar®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019
  • This decision remains valid until: 01.04.2024

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Trametinib
  • Name: Mekinist®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.10.2018
  • Final decision by G-BA: 22.03.2019
  • This decision remains valid until: 01.04.2024

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Tisagenlecleucel
  • Name: Kymriah®
  • Therapeutic area: B-cell acute lymphoblastic leukemia (ALL)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.09.2018
  • Final decision by G-BA: 07.03.2019
  • This decision remains valid until: 15.03.2020

Final decision:

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

Subject:

  • Active Substance: Tisagenlecleucel
  • Name: Kymriah®
  • Therapeutic area: Diffuse large B-cell lymphoma (DLBCL)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.09.2018
  • Final decision by G-BA: 07.03.2019
  • This decision remains valid until: 15.03.2020

Final decision:

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

Subject:

  • Active Substance: Ingenol mebutate
  • Name: Picato®
  • Therapeutic area: Actinic keratosis (AK)
  • Pharmaceutical company: Leo Pharma GmbH

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019
  • This decision remains valid until: 28.02.2022

Final decision:

  • Adult patients with actinic keratosis on the face and scalp: hint for a non-quantifiable additional benefit
  • Adult patients with actinic keratosis on the trunk and extremities: no additional benefit proved

Subject:

  • Active Substance: Bosutinib
  • Name: Bosulif®
  • Therapeutic area: Chronic myeloid leukemia (CML)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019

Final decision:

  • Patients in chronic disease phase: no additional benefit proved
  • Patients in accelerated disease phase and in blast crisis: no additional benefit proved

Subject:

  • Active Substance: Gemtuzumab ozogamicin
  • Name: Mylotarg®
  • Therapeutic area: Acute myeloid leukemia (AML)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019

Final decision:

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

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019
  • This decision remains valid until: 01.04.2021

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Colitis ulcerosa
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019

Final decision:

  • Patients who have not responded sufficiently, do not respond any more or have a contraindication or intolerance to a conventional treatment: no additional benefit proved
  • Patients who have responded insufficiently to a biological such as TNF-alfa antagonist or integrin inhibitor or do not respond any more or have an intolerance against such treatments: no additional benefit proved

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Psoriasis arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.09.2018
  • Final decision by G-BA: 21.02.2019

Final decision:

  • Patients who have not responded sufficiently or tolerated a previous antirheumatic (DMARD-) therapy: hint for a minor additional benefit
  • Patients who have not responded sufficiently or tolerated a previous therapy with bDMARD: no additional benefit proved

Subject:

  • Active Substance: Osimertinib
  • Name: Tagrisso©
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.07.2018
  • Final decision by G-BA: 17.01.2019

Final decision:

  • Patients with activating EGFR mutations L858 or del 19: hint for a considerable additional benefit
  • Patients with activating EGFR mutations other than L858 or del 19 (except for de novo T790M): no additional benefit prove

Subject:

  • Active Substance: Brivaracetam
  • Name: Briviact®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: UCB Pharma GmbH

Time table:

  • Start: 01.08.2018
  • Final decision by G-BA: 17.01.2019

Final decision:

  • No additional benefit proved

 

Ansprechpartner

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