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Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) monotherapy: sulfonyl urea (glibenclamide or glimepiride)
• b) in combination with another antidiabetic (except for insulin, here: metformin):
• metformin + sulfonyl urea (glibenclamide or glimepiride) or
• metformin + empagliflozin or
• metformin + liraglutide (liraglutide in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)
• Human insulin, if metformin is according to the SmPC not appropriate due to intolerance or contraindication
• c) in combination with two other antidiabetics (except for insulin):
• insulin + metformin or
• insulin + empagliflozin or
• insulin + liraglutide
  (liraglutide and empagliflozin only in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)
• d) in combination with insulin (with or w/o another antidiabetic): optimization of insulin regimen
  (+ metformin or empagliflozin or liraglutide, if appropriate) (liraglutide and empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) Treatment-naïve patients and patients who failed treatment with at least one medication: metropolol or propranolol or flunarizine or topiramate or amitriptyline
• b) Patients who are not eligible for the above mentioned therapies (substance classes): valproate or clostridium botulinum toxin type A
• c) Patients who are not eligible for any of the above mentioned therapies (substance classes): best supportive care

Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) as initial endocrine therapy
• a1) for postmenopausal women: anastrozole or letrozole or fulvestrant or tamoxifen (if appropriate, if aromatase inhibitors are not indicated)
• a2) for pre- and perimenopausal women: tamoxifen in combination with elimination of ovarian function
• b) with endocrine therapy pre-treated
• b1) for postmenopausal women with progress after endocrine therapy:
• tamoxifen or
• anastrozole or
• fulvestrant (only for patients with relapse or progress after anti estrogen therapy) or
• letrozole (only for patients with relapse or progress after anti estrogen therapy) or
• exemestane (only for patients with progress after anti estrogen therapy) or
• everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis, after progress with a non-steroidal aromatase inhibitor)
• b2) for pre- and perimenopausal women with progress after endocrine therapy: endocrine therapy at the physician’s discretion (approved are: tamoxifen, letrozole, exemestane, megestrol acetate and medroxyprogesterone acetate)

Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) as initial endocrine therapy
• a1) for postmenopausal women: anastrozole or letrozole or fulvestrant or tamoxifen (if appropriate, if aromatase inhibitors are not indicated)
• a2) for pre- and perimenopausal women: tamoxifen in combination with elimination of ovarian function
• b) with endocrine therapy pre-treated
• b1) for postmenopausal women with progress after endocrine therapy:
• tamoxifen or
• anastrozole or
• fulvestrant (only for patients with relapse or progress after anti estrogen therapy) or
• letrozole (only for patients with relapse or progress after anti estrogen therapy) or
• exemestane (only for patients with progress after anti estrogen therapy) or
• everolimus in combination with exemestane (only for patients without symptomatic visceral metastasis, after progress with a non-steroidal aromatase inhibitor)
• b2) for pre- and perimenopausal women with progress after endocrine therapy: endocrine therapy at the physician’s discretion (approved are: tamoxifen, letrozole, exemestane, megestrol acetate and medroxyprogesterone acetate)

Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) patients who are eligible for statins: maximum tolerated medicinal and dietary lipid-lowering therapy
• b) patients who are intolerant or contraindicated for statins: other lipid-lowering medicinal products (fibrates, anion exchangers, inhibitors of cholesterol absorption) as monotherapy and dietary therapy

Subject:

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

Time table:

• Start: 01.11.2018
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 01.02.2019
• End of public hearing: 22.02.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 15.02.2019
• End of public hearing: 08.03.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• a) Patients for whom a systemic therapy for the first time is indicated: adalimumab or ciclosporin or ixekizumab or methotrexate or phototherapy (NB*-UV-B, photo-brine therapy) or secukinumab
• b) Patients who were insufficiently treated with a systemic therapy: adalimumab or infliximab or ixekizumab or secukinumab or ustekinumab

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
• Publication of assessment: 15.02.2019
• End of public hearing: 08.03.2019
• Final decision by G-BA: expected for the beginning of May 2019

Comparative therapy:

• Patient-individual optimization of existing therapy of LABA + LAMA with LABA + LAMA and ICS, if appropriate

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
• Publication of assessment: 01.03.2019
• End of public hearing: 22.03.2019
• Final decision by G-BA: expected for the middle of May 2019

Comparative therapy:

• 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):
• optimization of insulin regimen
  (+ metformin or empagliflozin or liraglutide, if appropriate) (liraglutide and empagliflozin in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease)

Subject:

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

Time table:

• Start: 01.12.2018
• Publication of assessment: assessment stopped (€50 million sales exceeded)

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 01.12.2018
• Publication of assessment: 01.03.2019
• End of public hearing: 22.03.2019
• Final decision by G-BA: expected for the middle of May 2019

Comparative therapy:

• a) patients with 17p deletion or TP53 mutation who are unsuitable for or have failed a B-cell receptor pathway inhibitor: ibrutinib or idelalisib + rituximab or best supportive care (BSC only if other two options have failed)
• b) patients without 17p deletion or TP53 mutation who have failed chemoimmunotherapy and a B-cell receptor pathway inhibitor: ibrutinib or idelalisib + rituximab or best supportive care (BSC)

Subject:

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

Time table:

• Start: 01.12.2018
• Publication of assessment: 01.03.2019
• End of public hearing: 22.03.2019
• Final decision by G-BA: expected for the middle of May 2019

Comparative therapy:

• a) patients without 17p deletion and/or TP53 mutation who are suitable for chemoimmunotherapy: patient-individual chemoimmunotherapy at the physician’s discretion under consideration of the general health condition as well as success and tolerability of previous treatments
• b) patients with 17p deletion and/or TP53 mutation or for whom a chemoimmunotherapy is not suitable: ibrutinib or idelalisib + rituximab or best supportive care (BSC only if other two options have failed)

Subject:

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

Time table:

• Start: : 01.12.2018
• Publication of assessment: 01.03.2019
• End of public hearing: 22.03.2019
• Final decision by G-BA: expected for the middle of May 2019

Comparative therapy:

• Watchful waiting under maintenance of existing conventional androgen deprivation

Subject:

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

Time table:

• Start: 01.12.2018
• Publication of assessment: 01.03.2019
• End of public hearing: 22.03.2019
• Final decision by G-BA: expected for the middle of May 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 15.12.2018
• Publication of assessment: 15.03.2019
• End of public hearing: 05.04.2019
• Final decision by G-BA: expected for the beginning of June 2019

Comparative therapy:

• With sorafenib pre-treated patients: Best supportive care

Subject:

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

Time table:

• Start: 01.01.2019
• Publication of assessment: 01.04.2019
• End of public hearing: 23.04.2019
• Final decision by G-BA: expected for the middle of June 2019

Comparative therapy:

• Chemotherapy at the physician’s discretion

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
• End of public hearing: 23.04.2019
• Final decision by G-BA: expected for the middle of June 2019

Comparative therapy:

• Chemotherapy at the physician’s discretion

Subject:

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

Time table:

• Start: 01.01.2019
• Publication of assessment: 01.04.2019
• End of public hearing: 23.04.2019
• Final decision by G-BA: expected for the middle of June 2019

Comparative therapy:

• 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: therapy at the physician’s discretion
• 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: interferon (IFN) beta-1a or IFN beta-1b or glatiramer acetate under consideration of the marketing authorization
• 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: interferon (IFN) beta-1a or IFN beta-1b or glatiramer acetate under consideration of the marketing authorization
• 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: therapy at the physician’s discretion

Subject:

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

Time table:

• Start: 01.01.2019
• Publication of assessment: 01.04.2019
• End of public hearing: 23.04.2019
• Final decision by G-BA: expected for the middle of June 2019

Comparative therapy:

• Recombinant or human plasma-derived blood coagulation factor VIII products

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: 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