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Subject:

• Active Substance: Vigabatrine
• Name: Kigabeq^®
• Therapeutic area: West syndrome
• Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

• Start: 01.07.2019
• Publication of assessment: 01.10.2019
• End of public hearing: 22.10.2019
• Final decision by G-BA: expected for the middle of December 2019

Comparative therapy:

• Tetracosactide or glucocorticoids (prednisone, prednisolone)

Subject:

• Active Substance: Vigabatrine
• Name: Kigabeq^®
• Therapeutic area: Epilepsy
• Pharmaceutical company: Desitin Arzneimittel GmbH

Time table:

• Start: 01.07.2019
• Publication of assessment: 01.10.2019
• End of public hearing: 22.10.2019
• Final decision by G-BA: expected for the middle of December 2019

Comparative therapy:

• Patient-individual optimization of antiepileptic therapy under consideration of pretreatment

Subject:

• Active Substance: Pegvaliase
• Name: Palynziq^®
• Therapeutic area: Phenylketonuria
• Pharmaceutical company: BioMarin International Limited

Time table:

• Start: 01.07.2019
• Publication of assessment: 01.10.2019
• End of public hearing: 22.10.2019
• Final decision by G-BA: expected for the middle of December 2019

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Dapagliflozin/metformin
• Name: Xigduo^®
• Therapeutic area: Diabetes mellitus, type 2
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 01.07.2019
• Publication of assessment: 01.10.2019
• End of public hearing: 22.10.2019
• Final decision by G-BA: expected for the middle of December 2019

Comparative therapy:

a) Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin):
• Metformin + sulfonylurea (glibenclamide or glimepiride) or
• Metformin + empagliflozin or
• Metformin + liraglutide (1)
b) Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin):
• Human insulin + metformin or
• Human insulin + empagliflozin (1) or
• Human insulin + liraglutide (1)
c) Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin):
• Optimization of human insulin regimen (+ metformin or empagliflozin (1) or liraglutide (1), if appropriate)
  (1) Empagliflozin and liraglutide only in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease

Subject:

• Active Substance: Dapagliflozin
• Name: Forxiga^®
• Therapeutic area: Diabetes mellitus, type 2
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 01.07.2019
• Publication of assessment: 01.10.2019
• End of public hearing: 22.10.2019
• Final decision by G-BA: expected for the middle of December 2019

Comparative therapy:

a) Patients whose blood sugar is not sufficiently controlled by diet and exercise and who are not indicated for metformin due to intolerance: sulfonylurea (glibenclamide or glimepiride) b) Patients whose blood sugar is not sufficiently controlled by one other antidiabetic treatment (except insulin, here: metformin):
• Metformin + sulfonylurea (glibenclamide or glimepiride) or
• Metformin + empagliflozin or
• Metformin + liraglutide (1)
c) Patients whose blood sugar is not sufficiently controlled by at least two antidiabetic treatments (amongst metformin, except insulin):
• Human insulin + metformin or
• Human insulin + empagliflozin (1) or
• Human insulin + liraglutide (1)
d) Patients whose blood sugar is not sufficiently controlled by insulin (with another antidiabetic treatment, here: metformin):
• Optimization of human insulin regimen (+ metformin or empagliflozin (1) or liraglutide (1), if appropriate)
  (1) Empagliflozin and liraglutide only in combination with standard of care for treatment of cardiovascular risk factors and only for patients with manifest cardiovascular disease

Subject:

• Active Substance: Olaparib
• Name: Lynparza^®
• Therapeutic area: ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 15.07.2019
• Publication of assessment: 15.10.2019
• End of public hearing: 05.11.2019
• Final decision by G-BA: expected for the middle of January 2020

Comparative therapy:

• Watchful waiting

Subject:

• Active Substance: Olaparib
• Name: Lynparza^®
• Therapeutic area: ovarian, fallopian tube, or primary peritoneal cancer
• Pharmaceutical company: AstraZeneca GmbH

Time table:

• Start: 15.07.2019
• Publication of assessment: 15.10.2019
• End of public hearing: 05.11.2019
• Final decision by G-BA: expected for the middle of January 2020

Comparative therapy:

• Capecitabine or vinorelbine or eribulin or, if appropriate, an anthracycline- or taxane-based therapy

Subject:

• Active Substance: Turoctocog alfa pegol
• Name: Esperoct^®
• Therapeutic area: hemophilia A
• Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

• Start: 01.08.2019
• Publication of assessment: 01.11.2019
• End of public hearing: 22.11.2019
• Final decision by G-BA: expected for the beginning of February 2020

Comparative therapy:

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

Subject:

• Active Substance: Dolutegravir / lamivudine
• Name: Dovato^®
• Therapeutic area: HIV infection
• Pharmaceutical company: ViiV Healthcare GmbH

Time table:

• Start: 01.08.2019
• Publication of assessment: 01.11.2019
• End of public hearing: 22.11.2019
• Final decision by G-BA: expected for the beginning of February 2020

Comparative therapy:

• Therapy-naïve adults: rilpivirine in combination with tenofovir disoproxil / -alafenamide plus emtricitabine or in combination with abacavir plus lamivudine OR dolutegravir in combination with tenofovir disoproxil / -alafenamide plus emtricitabine or in combination with abacavir plus lamivudine
• Pre-treated patients adults: a patient-individual anti-retroviral therapy under consideration of pre-treatment and the reason for change of therapy, especial with respect to failure of therapy due to virological failure and possible formation of resistance because of adverse events
• Therapy-naïve adolescents at the age of ≥ 12 years: rilpivirine in combination with tenofovir alafenamide plus emtricitabine or in combination with abacavir plus lamivudine OR dolutegravir in combination with tenofovir alafenamide plus emtricitabine or in combination with abacavir plus lamivudine
• Pre-treated adolescents at the age of ≥ 12 years: a patient-individual anti-retroviral therapy under consideration of pre-treatment and the reason for change of therapy, especial with respect to failure of therapy due to virological failure and possible formation of resistance because of adverse events

Subject:

• Active Substance: Ravulizumab
• Name: Ultomiris^®
• Therapeutic area: Paroxysmal nocturnal haemoglobinuria (PNH)
• Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

• Start: 01.08.2019
• Publication of assessment: 01.11.2019
• End of public hearing: 22.11.2019
• Final decision by G-BA: expected for the beginning of February 2020

Comparative therapy:

• Eculizumab

Subject:

• Active Substance: Cemiplimab
• Name: Libtayo^®
• Therapeutic area: Cutaneous squamous cell carcinoma
• Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

• Start: 01.08.2019
• Publication of assessment: 01.11.2019
• End of public hearing: 22.11.2019
• Final decision by G-BA: expected for the beginning of February 2020

Comparative therapy:

• Patients who have not been treated with medicinal products yet: a systemic anti-neoplastic therapy at the discretion of the physician
• Patients whose carcinoma has progressed after treatment with medicinal products: Best supportive care

Subject:

• Active Substance: Volanesorsen
• Name: Waylivra^®
• Therapeutic area: Familial chylomicronaemia syndrome (FCS)
• Pharmaceutical company: Akcea Therapeutics Germany GmbH

Time table:

• Start: 15.08.2019
• Publication of assessment:15.11.2019
• End of public hearing: 06.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• No comparative therapy because of orphan drug designation

Subject:

• Active Substance: Ibrutinib
• Name: Imbruvica^®
• Therapeutic area: Waldenström’s macroglobulinaemia
• Pharmaceutical company: Janssen-Cilag GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Patient-individual therapy in consideration of the state of health of the patient and, if appropriate, previous therapies

Subject:

• Active Substance: Ibrutinib
• Name: Imbruvica^®
• Therapeutic area: Chronic lymphocytic leukaemia (CLL)
• Pharmaceutical company: Janssen-Cilag GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Patients for whom a therapy with fludarabine in combination with cyclophosphamide and rituximab is indicated: fludarabine in combination with cyclophosphamide and rituximab (FCR)
• Patients for whom a therapy with FCR is not indicated: bendamustine in combination with rituximab or ofatumumab OR chlorambucil in combination with rituximab or obinutuzumab or ofatumumab
• Patients with 17p depletion and/or TP53 mutation or who are not indicated for a chemo-immunotherapy due to other reasons: ibrutinib

Subject:

• Active Substance: Andexanet alfa
• Name: Ondexxya^®
• Therapeutic area: Stopping of bleeding due to anticoagulants
• Pharmaceutical company: Portola Deutschland GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Optimized standard therapy for life-threatening or uncontrolled bleeding

Subject:

• Active Substance: Dupilumab
• Name: Dupixent^®
• Therapeutic area: Atopic dermatitis
• Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Patient-individual optimized therapy regimen consisting of topic and systemic therapy depending on disease characteristics and under consideration of pre-treatment, considering the following therapies:
  - Topic glucocorticoids classes 2 to 4,
  - Tacrolimus (topical),
  - ciclosporin

Subject:

• Active Substance: Dupilumab
• Name: Dupixent^®
• Therapeutic area: Asthma
• Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Pre-treated adolescents (12–17 years): patient-individual therapy escalation under consideration of the previous therapy and one of the following therapies:
• High-dosed ICS and LABA and LAMA OR
• high-dosed ICS and LABA and, if appropriate, LAMA and omalizumab, provided that the criteria needed for using omalizumab are fulfilled
• Pre-treated adults: patient-individual therapy escalation in consideration of the previous therapy and pathogenesis of the asthma and one of the following therapies:
• High-dosed ICS and LABA and LAMA OR
• high-dosed ICS and LABA and, if appropriate, LAMA and omalizumab, provided that the criteria needed for using omalizumab are fulfilled OR
• high-dosed ICS and LABA and, if appropriate, LAMA and mepolizumab or reslizumab or benralizumab, provided that the criteria needed for using these antibodies are fulfilled

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzymes against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzyme against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzyme against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzyme against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzyme against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Lumacaftor/ivacaftor

Subject:

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

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care (especially antibiotics against pulmonary infections, mucolytics, pancreas enzyme against pancreas insufficiency, physiotherapy and exhaustion of all possible dietary provisions)

Subject:

• Active Substance: Ramucirumab
• Name: Cyramza^®
• Therapeutic area: Hepatocellular carcinoma (HCC)
• Pharmaceutical company: Lilly Deutschland GmbH

Time table:

• Start: 01.09.2019
• Publication of assessment: 02.12.2019
• End of public hearing: 23.12.2019
• Final decision by G-BA: expected for the middle of February 2020

Comparative therapy:

• Best supportive care OR cabozantinib

Subject:

• Active Substance: Pomalidomide
• Name: Imnovid^®
• Therapeutic area: Multiple myeloma
• Pharmaceutical company: Celgene GmbH

Time table:

• Start: 15.06.2019
• Final decision by G-BA: 05.12.2019

Final decision:

• No additional benefit proved

Subject:

• Active Substance: Empagliflozin/linagliptin
• Name: Glyxambi^®
• Therapeutic area: Diabetes mellitus, type 2
• Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

• Start: 01.06.2019
• Final decision by G-BA: 22.11.2019

Final decision: No additional benefit proved

Subject:

• Active Substance: Risankizumab
• Name: Skyrizi^TM
• Therapeutic area: Plaque psoriasis
• Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

• Start: 01.06.2019
• Final decision by G-BA: 22.11.2019

Final decision:

• Patients that are not eligible for a conventional therapy as part of the first systemic treatment: No additional benefit proved
• Patients that have responded insufficiently to or are intolerant to a systemic treatment: Proof for a considerable additional benefit

Subject:

• Active Substance: Lorlatinib
• Name: Lorviqua^®
• Therapeutic area: Non-small cell lung cancer (NSCLC)
• Pharmaceutical company: Pfizer Pharma GmbH

Time table:

• Start: 01.06.2019
• Final decision by G-BA: 22.11.2019

Final decision:

• a) Patients eligible for another antineoplastic systemic therapy: No additional benefit proved
• b) Patients not eligible for another antineoplastic systemic therapy: No additional benefit proved

Subject:

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

Time table:

• Start: 15.05.2019
• Final decision by G-BA: 07.11.2019

Final decision:

• Treatment-naïve adult patients with inadequate response or who are intolerant or contraindicated to at least one prophylactic therapy: No additional benefit proved
• Adult patients who show no response or are intolerant or contraindicated to the medicinal products/substance classes metoprolol, propranolol, flunarizine, topiramate, amitriptyline: No additional benefit proved
• Adult patients who show now response or are intolerant or contraindicated to any of the above-mentioned substance classes: Hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.05.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• The assessment has been stopped because the launched package is not reimbursable by SHI

Subject:

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

Time table:

• Start: 01.05.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• a) Adult patients with the activating EGFR mutations K858R or del19: No additional benefit proven
  b) Adult patients with lother activating EGFR mutations than K858R or del19: No additional benefit proven

Subject:

• Active Substance: Lisdexamfetamine dimesilate
• 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
• Final decision by G-BA: 17.10.2019

Final decision:

• a) Adults with ADHD since childhood with at least moderate severity and pre-treatment with one medicinal therapy: No additional benefit proven
  b) Adults with ADHD since childhood with at least moderate severity who have not received a medicinal therapy yet: No additional benefit proven

Subject:

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

Time table:

• Start: 01.05.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• Hint for a minor additional benefit

Subject:

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

Time table:

• Start: 15.04.2019
• Final decision by G-BA: 17.10.2019
• The decision is limited until: 31.12.2021

Final decision:

• Hint for a considerable additional benefit (orphan drug designation)

Subject:

• Active Substance: Radium-223 dichloride
• Name: Xofigo^®
• Therapeutic area: Prostate cancer
• Pharmaceutical company: Bayer Vital GmbH

Time table:

• Start: 15.04.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• Patients with progression of disease after treatment with at least two prior systemic therapy lines: No additional benefit proven
• Patients for whom no other systemic mCRPC treatment is appropriate: No additional benefit proven

Subject:

• Active Substance: Glecaprevir/pibrentasvir
• Name: Maviret^®
• Therapeutic area: Chronic hepatitis C
• Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

• Start: 15.04.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• Patients with genotype 1, 4, 5, or 6: No additional benefit proven
• Patients with genotype 2 or 3: No additional benefit proven

Subject:

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

Time table:

• Start: 15.04.2019
• Final decision by G-BA: 17.10.2019

Final decision:

• Hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.04.2019
• Final decision by G-BA: 19.09.2019

Final decision:

• Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): no additional benefit proved
• Patients with PD-L1 expression < 50 % (TPS): hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 01.04.2019
• Final decision by G-BA: 19.09.2019

Final decision:

• Patients with PD-L1 expression ≥ 50 % (tumor proportion score (TPS): hint for a non-quantifiable additional benefit
• Patients with PD-L1 expression < 50 % (TPS): hint for a non-quantifiable additional benefit

Subject:

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

Time table:

• Start: 01.04.2019
• Final decision by G-BA: 19.09.2019
• The decision remains valid until: 01.04.2024

Final decision:

• Indication for a non-quantifiable additional benefit

Subject:

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

Time table:

• Start: 01.04.2019
• Final decision by G-BA: 19.09.2019

Final decision:

• Treatment-naïve patients and patients that have responded insufficiently, have not tolerated, or are not suitable for at least one prophylactic medication: no additional benefit proved
• Patients ineligible, intolerant or irresponsive to any of the above drug classes: no additional benefit proved
• Patients ineligible, intolerant or irresponsive to any of the above drug classes: hint for a considerable additional benefit

Subject:

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

Time table:

• Start: 15.03.2019
• Final decision by G-BA: 05.09.2019

Final decision:

• No additional benefit proved

Subject:

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

Time table:

• Start: 15.03.2019
• Final decision by G-BA: 05.09.2019

Final decision:

• Non-quantifiable additional benefit (proved 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
• 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