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Ongoing (preliminary decision published)

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

 

Completed (final decision published)

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

Subject:

  • Active Substance: Nivolumab (combi with Ipilimumab, melanoma, re-assessment)
  • Name: Opdivo®
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 15.06.2018
  • Final decision by G-BA: 20.12.2018

Final decision:

  • Indication for less benefit (treatment-naive BRAFwt patients)

Subject:

  • Active Substance: Velmanase alfa
  • Name: Lamzede©
  • Therapeutic area: Alpha-mannosidosis
  • Pharmaceutical company: Chiesi GmbH

Time table:

  • Start: 01.07.2018
  • Final decision by G-BA: 20.12.2018

Final decision:

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

Subject:

  • Active Substance: Bictegravir/ emtricitabine/ tenofovir alafenamide
  • Name: Biktarvy©
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.07.2018
  • Final decision by G-BA: 10.12.2018

Final decision:

  • Therapy-naive patients: no additional benefit proved.
  • Pre-treated patients: no additional benefit proved.

Subject:

  • Active Substance: Ipilimumab
  • Name: Yervoy©
  • Therapeutic area: Melanoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.07.2018
  • Final decision by G-BA: 10.12.2018

Final decision:

  • Treatment-naive BRAFwt patients: indication for less benefit
  • Treatment-naive BRAFmut patients: no additional benefit proved
  • Pre-treated patients: no additional benefit proved

Subject:

  • Active Substance: Pertuzumab
  • Name: Perjeta©
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.07.2018
  • Final decision by G-BA: 10.12.2018
  • This decision remains valid until: 02.01.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Olaparib (new indication: high-grade cancer of the ovary, fallopian tube or peritoneum)
  • Name: Lynparza®
  • Therapeutic area: Ovarian neoplasms
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.06.2018
  • Final decision by G-BA: 06.12.2018

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Dolutegravir/ rilpivirin
  • Name: Juluca®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 15.06.2018
  • Final decision by G-BA: 06.12.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Cabozantinib (new indication: 1st line treatment)
  • Name: Cabometyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.06.2018
  • Final decision by G-BA: 06.12.2018
  • This decision remains valid until: 06.06.2019

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2018
  • Final decision by G-BA: 22.11.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Darvadstrocel
  • Name: Alofisel®
  • Therapeutic area: Rectal fistulas in adults with Morbus Crohn’s disease
  • Pharmaceutical company: Takeda Pharma Vertrieb GmbH & Co. KG

Time table:

  • Start: 01.06.2018
  • Final decision by G-BA: 22.11.2018

Final decision:

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

Subject:

  • Active Substance: Extract of Cannabis sativa
  • Name: Sativex®
  • Therapeutic area: Spasticity related to multiple sclerosis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.05.2018
  • Final decision by G-BA: 01.11.2018

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Rheumatoid Arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2018
  • Final decision by G-BA: 01.11.2018

Final decision:

  • b2) insufficiently pre-treated patients who are bDMARD-naïve: no additional benefit proved

Subject:

  • Active Substance: Rurioctocog alfa pegol
  • Name: Adynovi®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: Shire Deutschland GmbH

Time table:

  • Start: 15.05.2018
  • Final decision by G-BA: 01.11.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ertugliflozin/ sitagliptin
  • Name: Steglujan®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.05.2018
  • Final decision by G-BA: 01.11.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Hydrocortisone
  • Name: Alkindi®
  • Therapeutic area: Adrenal insufficiency of patients › 18 years
  • Pharmaceutical company: Diurnal Ltd.

Time table:

  • Start: 15.05.2018
  • Final decision by G-BA: 01.11.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Burosumab
  • Name: Crysvita©
  • Therapeutic area: Hypophosphataemia
  • Pharmaceutical company: Kyowa Kirin GmbH

Time table:

  • Start: 15.04.2018
  • Final decision by G-BA: 04.10.2018
  • The decision remains valid until: 01.10.2019

Final decision:

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

Subject:

  • Active Substance: Cariprazine
  • Name: Reagila©
  • Therapeutic area: Schizophrenia
  • Pharmaceutical company: Recordati Pharma GmbH

Time table:

  • Start: 15.04.2018
  • Final decision by G-BA: 04.10.2018

Final decision:

  • Acute treatment of schizophrenia: No additional benefit proved
  • Schizophrenia with predominantly negative symptoms in long term treatment: Hint for a minor additional benefit
  • Schizophrenia without predominantly negative symptoms in long term treatment: No additional benefit proved

Subject:

  • Active Substance: Bezlotoxumab
  • Name: Zinplava©
  • Therapeutic area: Clostridium difficile infection
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Glycopyrroniumbromid
  • Name: Sialanar©
  • Therapeutic area: Sialorrhea
  • Pharmaceutical company: Proveca Limited

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

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

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • Patients for whom exclusive on-demand treatment with bypassing products equals a patient-individual therapy: hint for a non-quantifiable additional benefit
  • Patients for whom another therapy equals a patient-individual therapy: no additional benefit proved.

Subject:

  • Active Substance: Patiromer
  • Name: Veltassa©
  • Therapeutic area: Hyperkalemia
  • Pharmaceutical company: Fresenius Medical Care Nephrologica Deutschland GmbH

Time table:

  • Start: 01.04.2018
  • Final decision by G-BA: 20.09.2018

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Evolocumab (re-assessment accord. to § 14)
  • Name: Repatha®
  • Therapeutic area: Hypercholesterolemia
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 06.09.2018

Final decision:

  • Evolocumab in combination with a statin or a statin and other lipid lowering therapies:
    • Patients without known atherosclerotic cardiovascular disease: no additional benefit proved
    • Patients with known atherosclerotic cardiovascular disease: no additional benefit proved
  • Patients whose medicinal and dietetic therapy options to lower lipids have been exhausted: no additional benefit proved

Subject:

  • Active Substance: Insulin glargine/ lixisenatide
  • Name: Suliqua®
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • Patients for whom the treatment with at least two blood glucose lowering medicines (only oral drugs including metformin) is inadequate: no additional benefit proved
  • Patients who are inadequately treated by insulin (in combination with another blood glucose lowering medicine, here metformin): no additional benefit proved

Subject:

  • Active Substance: Fluticasone furoate/ umeclidinium bromide/ vilanterol
  • Name: Trelegy Ellipta©
  • Therapeutic area: Chronic obstructive pulmonary disease (COPD)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Glycerol phenylbutyrate
  • Name: Ravicti©
  • Therapeutic area: Urea cycle disorders (UCD)
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

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

Subject:

  • Active Substance: Ixekizumab
  • Name: Taltz©
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.03.2018
  • Final decision by G-BA: 16.08.2018

Final decision:

  • Patients for whom another classical disease-modifying anti-rheumatic drug (DMARD) therapy except MTX is indicated: no additional benefit proved
  • bDMARD-naïve patients for whom a therapy with bDMARDs is indicated for the first time: hint for a minor additional benefit
  • Patients who have responded inadequately or who are intolerant to one prior therapy with bDMARDs: no additional benefit proved

Subject:

  • Active Substance: Ocrelizumab
  • Name: Ocrevus©
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Patients with RMS and active disease who either have not been pretreated with a disease-modifying therapy or have been pretreated but do not have highly active disease: Proof for a minor additional benefit
  • Patients with RMS and highly active disease despite treatment with a disease-modifying therapy: No additional benefit proved
  • Patients with primary progredient MS (PPMS): Hint for a minor additional benefit

Subject:

  • Active Substance: Lumacaftor/ ivacaftor
  • Name: Orkambi©
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Europe) Limited

Time table:

  • Start: 01.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Letermovir
  • Name: Prevymis©
  • Therapeutic area: Cytomegalovirus infections
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

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

Subject:

  • Active Substance: Benralizumab
  • Name: Fasenra©
  • Therapeutic area: Asthma
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • a) Pre-treated patients who have not exhausted further therapy options: No additional benefit proved
  • b) Pre-treated patients who have exhausted all therapy options: Hint for a minor additional benefit

Subject:

  • Active Substance: Sonidegib
  • Name: Odomzo©
  • Therapeutic area: Basal cell carcinoma
  • Pharmaceutical company: Sun Pharmaceuticals Germany GmbH

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Fluticasone furoate/ vilanterol
  • Name: Relvar® Ellipta®
  • Therapeutic area: Asthma, bronchial
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • Proof for therapeutic improvements not provided (no comparative therapy as Relvar Ellipta® is part of the reference price group “combination of glucocorticoids and long-acting beta2-agonists”)

Subject:

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

Time table:

  • Start: 15.02.2018
  • Final decision by G-BA: 02.08.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Brentuximab vedotin
  • Name: Adcetris©
  • Therapeutic area: Non-Hodgkin lymphoma, CD30+ cutaneous T-cell lymphoma (CTCL)
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018

Final decision:

  • Minor additional benefit (proven because of orphan drug designation)

Subject:

  • Active Substance: Elvitegravir/ cobicistate/ emtricitabine/ tenofovir alafenamide
  • Name: Genvoya©
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018

Final decision:

  • Treatment-naïve patients (age ≥ 6 years < 12 years): No additional benefit proved
  • Pre-treated patients (age ≥ 6 years < 12 years): No additional benefit proved

Subject:

  • Active Substance: Allogeneic, genetically modified T cells
  • Name: Zalmoxis©
  • Therapeutic area: Haematopoietic stem cell transplantation (HSCT), graft-versus-host disease (GvHD)
  • Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

  • Start: 15.01.2018
  • Final decision by G-BA: 05.07.2018
  • The decision remains valid until: 01.04.2021

Final decision:

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

Subject:

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

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Alecitinib
  • Name: Alecensa©
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Roche Pharma GmbH

Time table:

  • Start: 01.01.2018
  • Final decision by G-BA: 21.06.2018

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Abiraterone acetate
  • Name: Zytiga©
  • Therapeutic area: Prostatic neoplasms
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.12.2017
  • Final decision by G-BA: 07.06.2018

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Niraparib
  • Name: Zejula©
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

  • Start: 15.12.2017
  • Final decision by G-BA: 07.06.2018
  • The decision remains valid until: 01.10.2020

The decision:

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

Subject:

  • Active Substance: Cladribine
  • Name: Mavenclad©
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Merck Serono GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Patients who have not had a disease-modifying therapy yet: additional benefit not proved
  • Patients with highly active disease despite a disease-modifying therapy: additional benefit not proved

Subject:

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

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Guselkumab
  • Name: Tremfya©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Patients for whom systemic therapy is appropriate: indication for a considerable additional benefit
  • Patients whose response to other systemic therapies, including ciclosporin, methotrexate or oral PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: proof for a considerable additional benefit

Subject:

  • Active Substance: Perampanel
  • Name: Fycompa©
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: Eisai GmbH

Time table:

  • Start: 01.12.2017
  • Final decision by G-BA: 17.05.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Elvitegravir/ cobicistat/ emtricitabine/ tenofovir disoproxil
  • Name: Stribild©
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.11.2017
  • Final decision by G-BA: 02.05.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Cenegermin
  • Name: Oxervate©
  • Therapeutic area: Keratitis
  • Pharmaceutical company: Dompé farmaceutici S.p.A.

Time table:

  • Start: 15.11.2017
  • Final decision by G-BA: 02.05.2018

Final decision:

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

Subject:

  • Active Substance: Nonacog beta pegol
  • Name: Refixia©
  • Therapeutic area: Haemophilia B
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.11.2017
  • Final decision by G-BA: 19.04.2018

Final decision:

  • Additional benefit not proved

Subject:

  • Active Substance: Tivozanib
  • Name: Fotivda©
  • Therapeutic area: Renal cell carcinoma (RCC)
  • Pharmaceutical company: EUSA Pharma GmbH

Time table:

  • Start: 01.11.2017
  • Final decision by G-BA: 19.04.2018

Final decision:

  • First line therapy:
    1. with favorable or intermediate prognosis (MSKCC score 0-2): additional benefit not proved
    2. with non-favorable prognosis (MSKCC score ≥ 3): additional benefit not proved
  • With progression following cytokine therapy but only if treatment-naïve regarding VEGFR or TOR pathway inhibitors: additional benefit not proved

Subject:

  • Active Substance: Telotristat ethyl
  • Name: Xermelo©
  • Therapeutic area: Carcinoid syndrome diarrhoea
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

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

Subject:

  • Active Substance: Midostaurin
  • Name: Rydapt©
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

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

Subject:

  • Active Substance: Midostaurin
  • Name: Rydapt©
  • Therapeutic area: Advanced systemic mastocytosis (advSM)
  • Pharmaceutical company: : Novartis Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

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

Subject:

  • Active Substance: Cabozantinib
  • Name: Cabometyx©
  • Therapeutic area: Renal cell carcinoma (RCC)
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Indication for a minor additional benefit

Subject:

  • Active Substance: Sofosbuvir
  • Name: Sovaldi©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

  • Treatment-naïve patients: hint for a non-quantifiable additional benefit
  • Pre-treated patients: hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro©
  • Therapeutic area: Follicular lymphoma (FL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.10.2017
  • Final decision by G-BA: 05.04.2018

Final decision:

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

Subject:

  • Active Substance: Elosulfase alfa (re-assessment)
  • Name: Vimizim©
  • Therapeutic area: Mucopolysaccharidosis type IVA (Morquio A syndrome, MPS IVA)
  • Pharmaceutical company: BioMarin Deutschland GmbH

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Minor additional benefit proven (because of orphan drug status)

Subject:

  • Active Substance: Pembrolizumab (new indication: urothelial carcinoma)
  • Name: Keytruda©
  • Therapeutic area: Urothelial carcinoma
  • Pharmaceutical company: MSD SHARP & DOHME GMBH

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Patients for whom cisplatin-based chemotherapy based is inappropriate: no additional benefit proved
  • Patients who are pretreated with cisplatin-based chemotherapy: indication for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.09.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Darunavir/ cobicistat/ emtricitabine/ tenofovir alafenamide
  • Name: Symtuza©
  • Therapeutic area: HIV infections
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Dimethyl fumarate
  • Name: Skilarence©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Avelumab
  • Name: Bavencio©
  • Therapeutic area: Merkel cell carcinoma (MCC)
  • Pharmaceutical company: Merck Serono GmbH/ Pfizer Pharma GmbH

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

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

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq©
  • Therapeutic area: Urothelial carcinoma (UC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Patients for whom a cisplatin-based chemotherapy is inappropriate (first-line): no additional benefit proved
  • Patients with prior platin-based therapy: hint for a minor additional benefit

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq©
  • Therapeutic area: Non-small cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.10.2017
  • Final decision by G-BA: 16.03.2018

Final decision:

  • Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is indicated: indication for a considerable additional benefit
  • Pre-treated patients for whom a therapy with docetaxel, pemetrexed, nivolumab or pembrolizumab is not indicated: no additional benefit proved

Subject:

  • Active Substance: Brodalumab
  • Name: Kyntheum©
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Leo Pharma GmbH

Time table:

  • Start: 01.09.2017
  • Final decision by G-BA: 01.03.2018

Final decision:

  • Patients who are candidates for systemic therapy: additional benefit not proven
  • Patients whose response to other systemic therapies, including ciclosporin, methotrexate or PUVA (psoralen and ultraviolet A-light) has been inadequate or who have a contraindication or intolerance for these therapies: indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Ledipasvir/ sofosbuvir
  • Name: Harvoni©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • Treatment-naïve patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
  • Treatment-naïve patients with compensated cirrhosis, genotype 3: additional benefit not proven
  • vPretreated patients, genotypes 1, 4, 5 or 6: hint for a non quantifiable additional benefit
  • Pretreated patients, genotype 3: additional benefit not proven

Subject:

  • Active Substance: Sofosbuvir/ velpatasvir/ voxilarprevir
  • Name: Vosevi©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 1: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 2: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 3: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotype 4: additional benefit not proven
  • DAA naïve patients without cirrhosis or with compensated cirrhosis, genotypes 5 or 6: additional benefit not proven
  • DAA experienced patients without cirrhosis or with compensated cirrhosis: additional benefit not proven

Subject:

  • Active Substance: Carfilzomib
  • Name: Kyprolis©
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • In combination with lenalidomide and dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit
  • In combination with dexamethasone for patients who have received at least one prior therapy: hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • In combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone, for patients who have received at least one prior therapy: hint for a considerable additional benefit
  • As monotherapy for patients with relapsed and refractory multiple myeloma, whose prior therapy included a proteasome inhibitor and an immunomodulatory agent and who have demonstrated disease progression on the last therapy: additional benefit not proven

Subject:

  • Active Substance: Sarilumab
  • Name: Kevzara©
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.08.2017
  • Final decision by G-BA: 15.02.2018

Final decision:

  • As monotherapy or in combination with methotrexate (MTX) for patients who have responded inadequately to, or who are intolerant to one disease modifying anti rheumatic drug (DMARD), and who do not have unfavourable prognostic factors: additional benefit not proven
  • As monotherapy for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time and who are intolerant to MTX or for whom MTX treatment is inappropriate: hint for a considerable additional benefit
  • In combination with MTX for bDMARD naïve patients for whom a bDMARD therapy is indicated for the first time: additional benefit not proven
  • As monotherapy or in combination with MTX for patients who have responded inadequately to, or who are intolerant to one or more bDMARDs: additional benefit not proven

Subject:

  • Active Substance: Certinib
  • Name: Zykadia©
  • Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven

Subject:

  • Active Substance: Glecaprevir/ pibrentasvir
  • Name: Maviret©
  • Therapeutic area: Chronic hepatitis C virus (HCV) infections
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven for any patient population:
    Patients without cirrhosis or with compensated cirrhosis genotype 1
  • Patients without cirrhosis genotype 2
  • Patients with compensated cirrhosis genotype 2
  • Patients without cirrhosis or with compensated cirrhosis genotype 3
  • Patients without cirrhosis or with compensated cirrhosis genotype 4
  • Patients without or with compensated cirrhosis with genotypes 5, 6
  • Patients pre-treated with sofosbuvir + ribavirin

Subject:

  • Active Substance: Saxagliptin/ metformin
  • Name: Komboglyze©
  • Therapeutic area: Diabetes mellitus, type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.08.2017
  • Final decision by G-BA: 01.02.2018

Final decision:

  • Additional benefit not proven

Subject:

  • Active Substance: Inotuzumab ozogamicin
  • Name: Besponsa©
  • Therapeutic area: B cell precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.07.2017
  • Final decision by G-BA: 18.01.2018

Final decision:

  • Minor additional benefit proven (because of orphan drug designation)

 

Ansprechpartner

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