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Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 15.05.2019
  • Publication of assessment: 15.08.2019
  • End of public hearing: 05.09.2019
  • Final decision by G-BA: expected for the beginning of November 2019

Comparative therapy:

  • Treatment-naïve adult patients with inadequate response or who are intolerant or contraindicated to at least one prophylactic therapy: metoprolol or propranolol or flunarizine or topiramate or amitriptyline ( 4 substance classes)
  • Adult patients who show no response or are intolerant or contraindicated to those 4 substance classes: valproate (valproic acid) or clostridium botulinum toxin type A
  • Adult patients who show now response or are intolerant or contraindicated to any of the above mentioned substance classes: best supportive care (BSC)

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
  • Publication of assessment: 02.09.2019
  • End of public hearing: 23.09.2019
  • Final decision by G-BA: expected for the middle of November 2019

Comparative therapy:

  • Human insulin + metformin or
  • Human insulin + empagliflozin (in combination with an additional medication against cardiovascular risk factors, especially antihypertensives, anticoagulants and/or lipid-lowering agents, for patients with a manifested cardiovascular disease) or
  • Human insulin + liraglutide (in combination with an additional medication against cardiovascular risk factors, especially antihypertensives, anticoagulants and/or lipid-lowering agents, for patients with a manifested cardiovascular disease)

Subject:

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

Time table:

  • Start: 01.06.2019
  • Publication of assessment: 02.09.2019
  • End of public hearing: 23.09.2019
  • Final decision by G-BA: expected for the middle of November 2019

Comparative therapy:

  • a) Adult patients with moderate to severe plaque psoriasis that are not eligible for a conventional therapy as part of the first systemic treatment: adalimumab or guselkumab or ixekizumab or secukinumab
  • b) Adult patients with moderate to severe plaque psoriasis that have responded insufficiently to or are intolerant to a systemic treatment: adalimumab or guselkumab or infliximab or ixekizumab or secukinumab or ustekinumab

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
  • Publication of assessment: 02.09.2019
  • End of public hearing: 23.09.2019
  • Final decision by G-BA: expected for the middle of November 2019

Comparative therapy:

  • a) Adult patients eligible for another antineoplastic systemic therapy: patient-individual therapy under consideration of the ALK inhibitors alectinib and ceritinib and combination- and monotherapies
  • b) Adult patients not eligible for another antineoplastic systemic therapy: best supportive care (BSC)

Subject:

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

Time table:

  • Start: 15.06.2019
  • Publication of assessment: 16.09.2019
  • End of public hearing: 07.10.2019
  • Final decision by G-BA: expected for the beginning of December 2019

Comparative therapy:

  • Bortezomib in combination with pegylated liposomal doxorubicin or
  • bortezomib in combination with dexamethasone or
  • lenalidomide in combination with dexamethasone or
  • elotuzumab in combination with lenalidomide and dexamethasone or
  • carfilzomib in combination with lenalidomide and dexamethasone or
  • carfilzomib in combination with dexamethasone or
  • daratumumab in combination with lenalidomide and dexamethasone or
  • daratumumab in combination with bortezomib and dexamethasone or

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

 

Completed (final decision published)

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)

› 17.10.2019: Radium-223 dichloride (re-assessment accord. to §13)

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

› 17.10.2019: Glecaprevir / pibrentasvir (new indication: chronic hepatitis C, adolescent patients at the age of 12 to < 18 years)

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

 

Ansprechpartner

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