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Ongoing (preliminary decision published)

Subject:

  • Active Substance: Active Substance: Landiolol hydrochloride
  • Name: Rapibloc©
  • Therapeutic area: Tachykardie
  • Pharmaceutical company: Amomed Pharma GmbH

Time table:

  • Start: 01.06.2017
  • Publication of assessment: 01.09.2017
  • End of public hearing: 22.09.2017
  • Final decision by G-BA: expected for the middle of November 2017

Comparative therapy:

  • Beta blockers (esmolol, metoprolol or propranolol) or calcium antagonists

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo©
  • Therapeutic area: Squamous cell cancer of the head and neck (SCCHN)
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.06.2017
  • Publication of assessment: 01.09.2017
  • End of public hearing: 22.09.2017
  • Final decision by G-BA: expected for the middle of November 2017

Comparative therapy:

  • Patient-individual therapy at the discretion of the physician (chemotherapy, radiotherapy and/or surgery; regarding medicinal therapies in consideration of the respective label)

Subject:

  • Active Substance: Active Substance: Rolapitant
  • Name: Varuby©
  • Therapeutic area: Nausea and vomiting due to chemotherapy
  • Pharmaceutical company: TESARO Bio Germany GmbH

Time table:

  • Start: 01.06.2017
  • Publication of assessment: 01.09.2017
  • End of public hearing: 22.09.2017
  • Final decision by G-BA: expected for the middle of November 2017

Comparative therapy:

  • Highly emetogenic chemotherapy: Triple combination of serotonin agonists (ondansetron or granisetron or tropisetron or palonosetron) + neurokinin-1 receptor antagonist (aprepitant or fosaprepitant) + dexamethasone
  • Moderately emetogenic chemotherapy: Double combination of serotonin agonists (ondansetron or granisetron or tropisetron or palonosetron) + dexamethasone

Subject:

  • Active Substance: Active Substance: Pembrolizumab (new indication: Hodgkin lymphoma)
  • Name: Keytruda©
  • Therapeutic area: Hodgkin lymphoma
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.06.2017
  • Publication of assessment: 01.09.2017
  • End of public hearing: 22.09.2017
  • Final decision by G-BA: expected for the middle of November 2017

Comparative therapy:

  • Therapy at the discretion of the physician in consideration of the respective label and previous therapies.

Subject:

  • Active Substance: Etelcalcetid
  • Name: Parsabiv©
  • Therapeutic area: Secondary hyperparathyroidism
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.06.2017
  • Publication of assessment: 01.09.2017
  • End of public hearing: 22.09.2017
  • Final decision by G-BA: expected for the middle of November 2017

Comparative therapy:

  • Cinacalcet (can be used as part of a therapeutic regimes which can include phosphate binders and/or vitamin D (incl. analogs))

Subject:

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

Time table:

  • Start: 15.06.2017
  • Publication of assessment: 15.09.2017
  • End of public hearing: 06.10.2017
  • Final decision by G-BA: expected for the beginning of December 2017

Comparative therapy:

  • Nivolumab or pembrolizumab

Subject:

  • Active Substance: Blinatumumab (re-assessment)
  • Name: Blincyto©
  • Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.06.2017
  • Publication of assessment: 15.09.2017
  • End of public hearing: 06.10.2017
  • Final decision by G-BA: expected for the beginning of December 2017

Comparative therapy:

  • No comparative therapy because of orphan drug indication

Subject:

  • Active Substance: Nusinersen
  • Name: Spinraza©
  • Therapeutic area: Spinal muscular atrophy
  • Pharmaceutical company: Biogen GmbH

Time table:

  • Start: 01.07.2017
  • Publication of assessment: 02.10.2017
  • End of public hearing: 23.10.2017
  • Final decision by G-BA: expected for the end of December 2017

Comparative therapy:

  • No comparative therapy because of orphan drug status

Subject:

  • Active Substance: Cerliponase alfa
  • Name: Brineura©
  • Therapeutic area: Neuronal ceroid lipofuscinosis type 2 (CLN2 disease)
  • Pharmaceutical company: BioMarin Deutschland GmbH

Time table:

  • Start: 01.07.2017
  • Publication of assessment: 02.10.2017
  • End of public hearing: 23.10.2017
  • Final decision by G-BA: expected for the end of December 2017

Comparative therapy:

  • No comparative therapy because of orphan drug status

Subject:

  • Active Substance: Nivolumab (new indication: urothelial carcinoma)
  • Name: Opdivo©
  • Therapeutic area: Urothelial carcinoma
  • Pharmaceutical company: Bristol-Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.07.2017
  • Publication of assessment: 02.10.2017
  • End of public hearing: 23.10.2017
  • Final decision by G-BA: expected for the end of December 2017

Comparative therapy:

  • Patients with early relapse (≤ 6 months): vinflunine
  • Patients with late relapse (> 6 – 12 months): vinflunine or anew cisplatin-based chemotherapy

Subject:

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

Time table:

  • Start: 15.07.2017
  • Publication of assessment: 16.10.2017
  • End of public hearing: 06.11.2017
  • Final decision by G-BA: expected for the beginning of January 2018

Comparative therapy:

  • No comparative therapy because of orphan drug status

 

Completed (final decision published)

Subject:

  • Active Substance: Dabrafenib (new indication: lung carcinoma)
  • Name: Tafinlar©
  • Therapeutic area: Non-small cell lung cancer
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.05.2017
  • Final decision by G-BA: 16.10.2017

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Trametinib (new indication: lung carcinoma)
  • Name: Mekinist©
  • Therapeutic area: Non-small cell lung cancer
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.05.2017
  • Final decision by G-BA: 16.10.2017

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz©
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.05.2017
  • Final decision by G-BA: 19.10.2017

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Osimertinib (re-assessment)
  • Name: Tagrisso©
  • Therapeutic area: Non-small cell lung cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.05.2017
  • Final decision by G-BA: 16.10.2017

Final decision:

  • With EGFR tyrosine kinase inhibitor pre-treated patients: hint for a major additional benefit

Subject:

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

Time table:

  • Start: 01.05.2017
  • Final decision by G-BA: 16.10.2017

Final decision:

  • therapy with docetaxel or pemetrexed or ceritinib is appropriate: hint for minor additional benefit
  • therapy with docetaxel or pemetrexed or ceritinib is not appropriate: no additional benefit proved

Subject:

  • Active Substance: Axitinib (re-assessment)
  • Name: Inlyta©
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.04.2017
  • Final decision by G-BA: 21.09.2017

Final decision:

  • After first-line therapy with sunitinib: Additional benefit not proved
  • After first-line therapy with a cytokine: Hint for a minor additional benefit

Subject:

  • Active Substance: Tenofovir alafenamide
  • Name: Vemlidy©
  • Therapeutic area: Chronic hepatitis B
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.04.2017
  • Final decision by G-BA: 21.09.2017
  • The decision remains valid until: 01.10.2018

Final decision:

  • Treatment naïve adult patients: Additional benefit not proved
  • Pre-treated adult patients: Additional benefit not proved
  • Treatment naïve adolescent patients (≥ 12 years): Additional benefit not proved
  • Pre-treated adolescent patients (≥ 12 years): Additional benefit not proved

Subject:

  • Active Substance: Dolutegravir (new indication: HIV, age 6 to 12 years)
  • Name: Tivicay©
  • Therapeutic area: HIV infections
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.04.2017
  • Final decision by G-BA: 21.09.2017

Final decision:

  • Treatment naïve patients, from 6 to 12 years: no additional benefit proved
  • Pre-treated patients, from 6 to 12 years: no additional benefit proved

Subject:

  • Active Substance: Active Substance: Baricitinib
  • Name: Olumiant©
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.04.2017
  • Final decision by G-BA: 21.09.2017

Final decision:

  • insufficiently with one standard DMARD pre-treated patients and without unfavorable prognostic factors: additional benefit not proved.
  • bDMARD-naïve patients and baricitinib monotherapy: additional benefit not proved.
  • bDMARD-naïve patients, in combination with methotrexate: additional benefit not proved.
  • insufficiently pre-treated patients with one or more bDMARDs: additional benefit not proved.

Subject:

  • Active Substance: Ixekizumab
  • Name: Taltz®
  • Therapeutic area: Plaque-Psoriasis
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.03.2017
  • Final decision by G-BA: 17.08.2017

Final decision:

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

Subject:

  • Active Substance: Secukinumab (re-assessment)
  • Name: Cosentyx®
  • Therapeutic area: Plaque-Psoriasis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.03.2017
  • Final decision by G-BA: 17.08.2017

Final decision:

  • Patients for whom systemic therapy is appropriate: Hint for a considerable additional benefit

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Non-small cell lung cancer (NSCLC), first-line
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.02.2017
  • Final decision by G-BA: 03.08.2017

Final decision:

  • Indication for a considerable additional benefit

Subject:

  • Active Substance: Lonoctocog alfa
  • Name: Afstyla®
  • Therapeutic area: Hemophilia A
  • Pharmaceutical company: CSL Behring GmbH

Time table:

  • Start: 01.02.2017
  • Final decision by G-BA: 20.07.2017

Final decision:

  • No additional benefit benefit proved.

Subject:

  • Active Substance: Vandetanib
  • Name: Caprelsa®
  • Therapeutic area: Thyroid neoplasms (age 5 and older)
  • Pharmaceutical company: Genzyme GmbH

Time table:

  • Start: 15.01.2017
  • Final decision by G-BA: 06.07.2014

Final decision:

  • Non-quantifiable additional benefit

Subject:

  • Active Substance: Reslizumab
  • Name: Cinqaero®
  • Therapeutic area: Asthma
  • Pharmaceutical company: Teva GmbH

Time table:

  • Start: 15.01.2017
  • Final decision by G-BA: 06.07.2014
  • The decision remains valid until: 31.07.2020

Final decision:

  • Patients who are treated with inhaled corticosteroids in case of exacerbations: no additional benefit proved
  • Patients who are regularly treated with inhaled corticosteroids: minor additional benefit

Subject:

  • Active Substance: Ixazomib
  • Name: Ninlaro®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.01.2017
  • Final decision by G-BA: 06.07.2014
  • The decision remains valid until: 01.07.2020

Final decision:

  • Non-quantifiable additional benefit (proven because of orphan drug indication)

Subject:

  • Active Substance: Obeticholic acid
  • Name: Ocaliva®
  • Therapeutic area: Biliary liver cirrhosis
  • Pharmaceutical company: Intercept Pharma Deutschland GmbH

Time table:

  • Start: 15.01.2017
  • Final decision by G-BA: 06.07.2014
  • The decision remains valid until: 31.10.2023

The decision:

  • Non-quantifiable additional benefit (proven because of orphan drug indication)

Subject:

  • Active Substance: Elbasvir/ grazoprevir
  • Name: Zepatier®
  • Therapeutic area: Chronic Hepatitis C
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.12.2016
  • Final decision by G-BA: 15.06.2014

Final decision:

  • Genotype 1, Patients without cirrhosis or with compensated cirrhosis: No additional benefit proved.
  • Genotype 4, Patients without cirrhosis or with compensated cirrhosis: No additional benefit proved.

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Hodgkin disease
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.01.2017
  • Final decision by G-BA: 15.06.2014

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Chronic lymphocytic B cell leukemia
  • Pharmaceutical company: AbbVie Deutschland GmbH

Time table:

  • Start: 01.01.2017
  • Final decision by G-BA: 15.06.2014
  • The decision remains valid until: 15.06.2022

Final decision:

  • Adult patients with CLL with 17p depletion or TP53 mutation who are not suited for treatment with a B cell pathway inhibitor or whose therapy failed: Non-quantifiable additional benefit (proved because of orphan drug designation).
  • Adult patients with CLL without 17p depletion or TP53 mutation who failed chemoimmunotherapy as well as treatment with a B cell pathway inhibitor: Non-quantifiable additional benefit (proved because of orphan drug designation).

Subject:

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

Time table:

  • Start: 01.12.2016
  • Final decision by G-BA: 18.05.2017
  • The decision remains valid until: 01.03.2019 (slice A1) / 01.10.2018 (slice B1/B2)

Final decision:

A) Women with HR+, HER2-, advanced/metastasized breast cancer and as initial endocrine therapy

  • A1) Postmenopausal women: No additional benefit proved.
  • A2) Pre- and postmenopausal women: tamoxifene in combination with depletion of ovarian function

B) Pre-treated women with HR+, HER2-, advanced/metastasized breast cancer who had progression with an endocrine therapy

  • B1) Postmenopausal women: No additional benefit proved.
  • B2) Pre- and postmenopausal women: No additional benefit proved.

Subject:

  • Active Substance: Olaratumab
  • Name: LartruvoTM
  • Therapeutic area: Sarcoma
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 01.12.2016
  • Final decision by G-BA: 18.05.2017
  • The decision remains valid until: 01.05.2020

Final decision:

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

Subject:

  • Active Substance: Cabozantinib (Advanced renal cell carcinoma)
  • Name: Cabometyx®
  • Therapeutic area: Advanced renal cell carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 01.11.2016
  • Final decision by G-BA: 20.04.2017
  • The decision remains valid until: 15.10.2017

Final decision:

  • Hint for a non-quantifiable additional benefit.

Subject:

  • Active Substance: Macitentan (re-assessment (50m euros limit exceeded))
  • Name: Opsumit®
  • Therapeutic area: Pulmonary arterial hypertension
  • Pharmaceutical company: Actelion Pharmaceuticals Deutschland GmbH

Time table:

  • Start: 15.10.2016
  • Final decision by G-BA: 06.04.2017

Final decision:

  • Additional benefit not proved.

Subject:

  • Active Substance: Ibrutinib (new indication: new combination)
  • Name: Imbruvica®
  • Therapeutic area: Chronic lymphatic leukemia (CLL)
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017

Final decision:

  • Patients with at least 2 prior therapies for whom Bendamustin in combination with Rituximab is the patient individual optimized therapy: Hint for a considerable additional benefit.
  • Patients with a prior treatment for whom Bendamustin in combination with Rituximab is not the patient individual optimized therapy: No additional benefit proved.

Subject:

  • Active Substance: Ceritinib (new assessment)
  • Name: Zykadia®
  • Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Novartis Pharma Gm

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017

Final decision:

  • Patients eligible for a therapy with docetaxel or pemetrexed: Hint for considerable additional benefit
  • Patients not eligible for a therapy with docetaxel or pemetrexed: No additional benefit proved

Subject:

  • Active Substance: Idelalisib (new indication: new combination partner)
  • Name: Zydelig®
  • Therapeutic area: Chronic lymphatic leukemia (CLL)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017

Final decision:

In combination with Rituximab:

  • Hint for non-quantifiable additional benefit

In combination with Ofatumumab:

  • Patients with at least one prior therapy and with relapsing and refractory CLL for whom chemotherapy is indicated: No additional benefit proved.
  • Patients with at least one prior therapy and with relapsing and refractory CLL for whom chemotherapy is not indicated: No additional benefit proved.
  • First-line therapy for patients with 17p deletion or TP53 mutation, for whom no other therapy is indicated: No additional benefit proved.

Subject:

  • Active Substance: Crizotinib (new indication: ROS1 positive)
  • Name: Xalkori®
  • Therapeutic area: Non-small-cell lung carcinoma (NSCLC)
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017

Final decision:

Previously untreated patients with ROS1-positive, advanced non-small-cell lung cancer (NSCLC):

  • Patients with ECOG performance status 0, 1 or 2 and patients with ECOG performance status 2: No additional benefit proved.

Pretreated patients with ROS1-positive, advanced non-small-cell lung cancer (NSCLC):

  • Patients eligible for a treatment with docetaxel or pemetrexed: No additional benefit proved.
  • Patients not eligible for a treatment with docetaxel or pemetrexed: No additional benefit proved.

Subject:

  • Active Substance: Lenvatinib (Renal cell carcinoma)
  • Name: Kisplyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Eisei GmbH

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017
  • The decision remains valid until: 31.12.2020

Final decision:

  • Hint for minor additional benefit

Subject:

  • Active Substance: Opicapone
  • Name: Ongentys®
  • Therapeutic area: Parkinson’s disease
  • Pharmaceutical company: Bial Portela

Time table:

  • Start: 01.10.2016
  • Final decision by G-BA: 16.03.2017

Final decision:

  • No additional benefit proved.

Subject:

  • Active Substance: Pembrolizumab (new indication)
  • Name: KEYTRUDA®
  • Therapeutic area: Non-small lung cancer (NSCLC)
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 15.08.2016
  • Final decision by G-BA: 02.02.2017

Final decision:

  • Patients for whom a therapy with docetaxel, pemetrexed or nivolumab is appropriate: Indication for a considerable additional benefit.
  • Patients for whom the above therapy is not appropriate: No additional benefit proved.

Subject:

  • Active Substance: Trifluridine/tipiracil
  • Name: Lonsurf®
  • Therapeutic area: Colorectal cancer
  • Pharmaceutical company: Servier Deutschland GmbH

Time table:

  • Start: 15.08.2016
  • Final decision by G-BA: 02.02.2017
  • The decision remains valid until: 31.01.2019

Final decision:

  • Hint for a minor additional benefit.

Subject:

  • Active Substance: Carfilzomib (new indication)
  • Name: Kyprolis®
  • Therapeutic area: Multiple Myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.08.2016
  • Final decision by G-BA: 19.01.2017

Final decision:

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

Subject:

  • Active Substance: Brentuximab vedotin (new indication)
  • Name: Adcetris®
  • Therapeutic area: Hodgkin Lymphoma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.08.2016
  • Final decision by G-BA: 19.01.2017

Final decision:

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

Subject:

  • Active Substance: Pitolisant
  • Name: Wakix®
  • Therapeutic area: Narcolepsy
  • Pharmaceutical company: Bioprojet Pharma SARL

Time table:

  • Start: 01.08.2016
  • Final decision by G-BA: 19.01.2017

Final decision:

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

Subject:

  • Active Substance: Tasimelteon
  • Name: Hetlioz®
  • Therapeutic area: Sleep Disorders, Circadian Rhythm
  • Pharmaceutical company: Vanda Pharmaceuticals Inc.

Time table:

  • Start: 01.08.2016
  • Final decision by G-BA: 19.01.2017

Final decision:

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

Subject:

  • Active Substance: Teduglutide (new indication)
  • Name: Revestive®
  • Therapeutic area: Malabsorption Syndromes
  • Pharmaceutical company: Shire Deutschland GmbH

Time table:

  • Start: 01.08.2016
  • Final decision by G-BA: 19.01.2017

Final decision:

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

Subject:

  • Active Substance: Sofosbuvir/velpatasvir
  • Name: Epclusa®
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.07.2016
  • Final decision by G-BA: 05.01.2017

Final decision:

  • Patients without cirrhosis, genotype 1: No additional benefit proved.
  • Patients with compensated cirrhosis, genotype 1: No additional benefit proved.
  • Patients without cirrhosis or with compensated cirrhosis, genotype 2: Hint for a minor additional benefit.
  • Patients without cirrhosis or with compensated cirrhosis, genotype 3: Hint for a considerable additional benefit.
  • Patients without cirrhosis, genotype 4: No additional benefit proved.
  • Patients with compensated cirrhosis, genotype 4: No additional benefit proved.
  • Patients without cirrhosis or with compensated cirrhosis, genotype 5 or 6: No additional benefit proved.
  • Patients with decompensated cirrhosis, genotype 1: No additional benefit proved.
  • Patients with decompensated cirrhosis, genotype 2, 3, 4, 5 or 6: Hint for a non-quantifiable additional benefit.

Subject:

  • Active Substance: Emtricitabine/rilpivirine/tenofovir alafenamide
  • Name: Odefsey®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.07.2016
  • Final decision by G-BA: 05.01.2017

Final decision:

  • Therapy-naïve adults: No additional benefit proved.
  • Therapy-naive patients, 12 years or older: No additional benefit proved.
  • Pre-treated adults: No additional benefit proved.
  • Pre-treated patients, 12 years or older: No additional benefit proved.

 

Ansprechpartner

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