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Ongoing (preliminary decision published)

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

Subject:

  • Active Substance: Certinib (new indication: 1st line)
  • Name: Zykadia©
  • Therapeutic area: Non-small-cell lung cancer (NSCLC)
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.08.2017
  • Publication of assessment: 01.11.2017
  • End of public hearing: 22.11.2017
  • Final decision by G-BA: expected for the beginning of February 2018

Comparative therapy:

  • Crizotinib

Subject:

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

Time table:

  • Start: 01.08.2017
  • Publication of assessment: 01.11.2017
  • End of public hearing: 22.11.2017
  • Final decision by G-BA: expected for the beginning of February 2018

Comparative therapy:

  • Patients without cirrhosis:
    • Genotype 1: combination of ledipasvir/sofosbuvir or combination of ombitasvir/paritaprevir/ritonavir + dasabuvir + ribavirin (if appropriate for genotype 1)
    • Genotype 4 without cirrhosis: combination of ledipasvir/sofosbuvir or combination of ombitasvir/paritaprevir/ritonavir + ribavirin
  • Patients with decompensated cirrhosis:
    • Genotype 1 and 4 with decompensated cirrhosis: combination of ledipasvir/sofosbuvir
  • Patients without cirrhosis or decompensated cirrhosis
    • Genotype 2 and 3: combination of sofosbuvir + ribavirin or sofosbuvir/velpatasvir
    • Genotype 5 and 6: combination of ledipasvir/sofosbuvir
  • Pre-treated patients with sofosbuvir + ribavirin: patient individual

Subject:

  • Active Substance: Saxagliptin/ metformin (new indication: combination with other antidiabetic drugs)
  • Name: Komboglyze©
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.08.2017
  • Publication of assessment: 01.11.2017
  • End of public hearing: 22.11.2017
  • Final decision by G-BA: expected for the beginning of February 2018

Comparative therapy:

  • human insulin + metformin OR
  • human insulin + empagliflozin OR
  • human insulin + liraglutide OR
  • human insulin if metformin, empagliflozin and liraglutide are not appropriate

Subject:

  • Active Substance: Ledipasvir/ sofosbuvir (new indication: juvenile patients (12-17 years))
  • Name: Harvoni©
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Publication of assessment: 15.11.2017
  • End of public hearing: 06.12.2017
  • Final decision by G-BA: expected for the middle of February 2018

Comparative therapy:

  • Therapy-naïve patients: combination of ribavirin and peginterferon alfa
  • Pre-treated patients: Best supportive care

Subject:

  • Active Substance: Sofosbuvir/ velpatasvir/ voxilaprevir
  • Name: Vosevi©
  • Therapeutic area: Chronic hepatitis C
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.08.2017
  • Publication of assessment: 15.11.2017
  • End of public hearing: 06.12.2017
  • Final decision by G-BA: expected for the middle of February 2018

Comparative therapy:

  • Genotype 1 without cirrhosis: ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir plus dasabuvir (plus ribavirin if appropriate)
  • Genotype 1 with compensated cirrhosis: Ledipasvir/sofosbuvir
  • Genotype 2 with or without cirrhosis: sofosbuvir plus ribavirin or sofosbuvir/velpatasvir
  • Genotype 3 with or without cirrhosis: sofosbuvir plus ribavirin or sofosbuvir/velpatasvir
  • Genotype 4 without cirrhosis: ledipasvir/sofosbuvir or ombitasvir/paritaprevir/ritonavir plus ribavirin
  • Genotype 4 with compensated cirrhosis: Ledipasvir/sofosbuvir
  • Genotype 5 with or without compensated cirrhosis: Ledipasvir/sofosbuvir
  • Genotype 6 with or without compensated cirrhosis: Ledipasvir/sofosbuvir
  • DAA-pre-treated patients: patient-individual therapy

Subject:

  • Active Substance: Carfilzomib (re-assessment)
  • Name: Kyprolis©
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.08.2017
  • Publication of assessment: 15.11.2017
  • End of public hearing: 06.12.2017
  • Final decision by G-BA: expected for the middle of February 2018

Comparative therapy:

  • Re-assessment of orphan drug due to exceedance of turnover limit of 50 million euros
  • Bortezomib in combination with pegylated, liposomal doxorubicine or bortezomib in combination with dexamethasone or lenalidomide in combination with dexamethasone or elotuzumab in combination with lenalidomide and dexamethasone

Subject:

  • Active Substance: Daratumumab (re-assessment)
  • Name: Darzalex©
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 15.08.2017
  • Publication of assessment: 15.11.2017
  • End of public hearing: 06.12.2017
  • Final decision by G-BA: expected for the middle of February 2018

Comparative therapy:

  • Re-assessment of orphan drug due to exceedance of turnover limit of 50 million euros
  • Patients with pre-treatment and progression: patient-individual therapy
  • Patients who were treated with at least one therapy: Bortezomib in combination with pegylated, liposomal doxorubicine or bortezomib in combination with dexamethasone or lenalidomide in combination with dexamethasone or elotuzumab in combination with lenalidomide and dexamethasone

Subject:

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

Time table:

  • Start: 15.08.2017
  • Publication of assessment: 15.11.2017
  • End of public hearing: 06.12.2017
  • Final decision by G-BA: expected for the middle of February 2018

Comparative therapy:

  • insufficiently pre-treated patients with one DMARD (incl. MTX) and without unfavorable prognostic factors: alternative DMARDs (such as MTX, leflunomid) as mono or combination therapy
  • bDMARD-naïve patients for whom a bDMARD therapy is indicated: bDMARDs in combination with MTX (adalimumab or etanercept or certolizumab pegol or golimumab or abatacept or tocilizumab), in monotherapy only if appropriate and if MTX is not appropriate
  • insufficiently pre-treated patients with one or more bDMARDs: change of bDMARD(s) (adalimumab or etanercept or certolizumab pegol or golimumab or abatacept or tocilizumab in combination with MTX (as monotherapy if appropriate) or ritixumab for patients with severe rheumatoid arthritis) in consideration of pre-treatment.

Subject:

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

Time table:

  • Start: 01.09.2017
  • Publication of assessment: 01.12.2017
  • End of public hearing: 22.12.2017
  • Final decision by G-BA: expected for the beginning of March 2018

Comparative therapy:

  • Patients for whom systemic is appropriate: fumaric acid ester or ciclosporin or methotrexate or phototherapy (balneophototherapy, oral PUVA, NB-UVB) or secukinumab
  • 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: adalimumab or infliximab or ustekinumab or secukinumab

 

Completed (final decision published)

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
  • Final decision by G-BA: 07.12.2017
  • The decision remains valid until: 15.06.2018

Final decision:

  • Additional benefit not proved.

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
  • Final decision by G-BA: 07.12.2017

Final decision:

  • Considerable additional benefit (proven because of orphan drug indication).

Subject:

  • Active Substance: Nivolumab (new indication: SCCHN
  • 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
  • Final decision by G-BA: 17.11.2017

Final decision:

  • Patients with early progression during or after a platin-based therapy: Hint for a considerable additional benefit
  • Patients with late progression after a platin-based therapy and for whom another platin-based therapy is appropriate: No additional benefit proved.

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
  • Final decision by G-BA: 17.11.2017

Final decision:

  • Patients with highly emetogenic chemotherapy: no additional benefit proved.
  • Patients with moderately emetogenic chemotherapy: no additional benefit proved.

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
  • Final decision by G-BA: 17.11.2017

Final decision:

  • No additional benefit proved.

Subject:

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

Time table:

  • Start: 01.06.2017
  • Final decision by G-BA: 17.11.2017

Final decision:

  • No additional benefit proved.

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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