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Subject:

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

Time table:

• Start: 01.09.2018
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• Diclofenac hyaluronic acid gel (3 %) or 5-fluorouracil (5-FU) for topical application or (surgical) cryotherapy for treatment of single lesions

Subject:

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

Time table:

• Start: 01.09.2018
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• Patients in chronic disease phase that are eligible to ponatinib: ponatinib
• Patients in chronic disease phase that are ineligible to ponatinib: interferon alfa
• Patients in accelerated disease phase and in blast crisis: ponatinib

Subject:

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

Time table:

• Start: 01.09.2018
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• Watchful waiting

Subject:

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

Time table:

• Start: 01.09.2018
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• Patients who have not responded sufficiently, do not respond any more or have a contraindication or intolerance to a conventional treatments: TNF-alfa antagonist (adalimumab or infliximab or golimumab)
• 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: TNF-alfa antagonist (adalimumab or infliximab or golimumab) or integrin inhibitor (vedolizumab), each in consideration of the authorization status and previous therapies

Subject:

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

Time table:

• Start: 01.09.2018
• Publication of assessment: 03.12.2018
• End of public hearing: 24.12.2018
• Final decision by G-BA: expected for the end of February 2019

Comparative therapy:

• Patients that have not responded sufficiently or tolerated a previous antirheumatic (DMARD-) therapy: TNF-alfa inhibitor (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab) if applicable in combination with methotrexate
• Patients that have not responded sufficiently or tolerated a previous therapy with bDMARD: switch to another bDMARD (adalimumab or certolizumab pegol or etanercept or golimumab or infliximab or secukinumab or ustekinumab) if applicable in combination with methotrexate

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
• Publication of assessment: 17.12.2018
• End of public hearing: 07.01.2019
• Final decision by G-BA: expected for the beginning of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 17.12.2018
• End of public hearing: 07.01.2019
• Final decision by G-BA: expected for the beginning of March 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Combination therapy at the physician’s discretion

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Therapy-naïve adult patients: (peg-)interferon alfa or tenofovir disoproxil or entecavir
• Pre-treated adult patients: patient-individual antiviral therapy
• Therapy-naïve adolescent (12 years and older) patients: tenofovir disoproxil or entecavir
• Pre-treated adolescent (12 years and older) patients: tenofovir disoproxil

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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Metformin + sulfonylurea (glibenclamide or glimepiride) or
• Metformin + empagliflozin or
• Metformin + liraglutide (only for patients with cardiovascular disease)

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Continuation of optimized therapy of severe asthma according to grade 5 of NVL Asthma 2018 guideline and in addition to escalation therapy with omalizumab, if indicated

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Patients with Child-Pugh A or without cirrhosis of the liver: sorafenib
• Patients with Child-Pugh B: best supportive care

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• b1) postmenopausal women with progress after endocrine therapy: An additional endocrine therapy in consideration of pre-treatment with tamoxifen OR anastrozole OR fulvestrant (only for patients with recurrence or progress after anti-estrogen therapy) OR letrozole (only for patients with recurrence or progress after anti-estrogen therapy) OR exemestane (only for patients with progress after anti-estrogen therapy)
• b2) pre- and perimenopausal women with progress after endocrine therapy:Endocrine therapy at the physician’s discretion (tamoxifen, letrozole, exemestane, megestrol acetate and medroxyprogesterone are approved for this indication)

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Treatment-naïve patients: dabrafenib/trametinib or vemurafenib/cobimetinib
• Pre-treated patients: patient-individual therapy

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Treatment-naïve patients: dabrafenib/trametinib or vemurafenib/cobimetinib
• Pre-treated patients: patient-individual therapy

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• No comparative therapy 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
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Watchful waiting

Subject:

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

Time table:

• Start: 01.10.2018
• Publication of assessment: 02.01.2019
• End of public hearing: 23.01.2019
• Final decision by G-BA: expected for the end of March 2019

Comparative therapy:

• Watchful waiting

Subject:

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

Time table:

• Start: 15.10.2018
• Publication of assessment: 15.01.2019
• End of public hearing: 05.02.2019
• Final decision by G-BA: expected for the beginning of April 2019

Comparative therapy:

• a) for patients with light pathology (e.g. minor worsening of visual acuity, slightly impaired vision, no progression of symptoms): watchful waiting
• b) for patients with severe pathology (e.g. progressive worsening of visual acuity, progressive retinal disorder, progressive impaired vision): pars plana vitrectomy

Subject:

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

Time table:

• Start: 15.10.2018
• Publication of assessment: 15.01.2019
• End of public hearing: 05.02.2019
• Final decision by G-BA: expected for the beginning of April 2019

Comparative therapy:

• Best Supportive Care

Subject:

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

Time table:

• Start: 15.10.2018
• Publication of assessment: 15.01.2019
• End of public hearing: 05.02.2019
• Final decision by G-BA: expected for the beginning of April 2019

Comparative therapy:

• a) for patients with light pathology (e.g. minor worsening of visual acuity, slightly impaired vision, no progression of symptoms): watchful waiting
• b) for patients with severe pathology (e.g. progressive worsening of visual acuity, progressive retinal disorder, progressive impaired vision): pars plana vitrectomy

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: 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