Current benefit assessments

These are the current benefit assessments in Germany. For more information follow substances ›› or contact us.

 

Ongoing (preliminary decision published)

Subject:

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

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • Patients with one previous therapy containing a proteasome inhibitor and lenalidomide who became refractory towards lenalidomide:
    - Bortezomib in combination with pegylated liposomal doxorubicin OR
    - Bortezomib in combination with dexamethasone OR
    - Carfilzomib in combination with dexamethasone OR
    - Daratumumab in combination with bortezomib and dexamethasone
  • Patients with ≥ 2 previous therapies containing a proteasome inhibitor and lenalidomide who showed disease progression during or after the last therapy:
    - Bortezomib in combination with pegylated liposomal doxorubicin OR
    - Bortezomib in combination with dexamethasone OR
    - Lenalidomide in combination with dexamethasone OR
    - Pomalidomide in combination with dexamethasone (only for patients with progession during the last therapy) OR
    - Elotuzumab in combination with lenalidomide an dexamethasone OR
    - Elotuzumab in combination with pomalidomide and dexamethasone (only for patients with progression during the last therapy) OR
    - Carfilzomib in combination with lenalidomide and dexamethasone OR
    - Carfilzomib in combination with dexamethasone OR
    - Daratumumab in combination with lenalidomide and dexamethasone OR
    - Daratumumab in combination with bortezomib and dexamethasone

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Colorectal cancer (CRC)
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • A patient-individual therapy, taking into account the number and type of previous therapy(ies), the RAS- and BRAF-mutation status, the localization of the primary tumor, the patient's general health status and the risk of anti-VEGF and anti-VEGFR substances-induced toxicity, choosing from:
    - 5-fluorouracil + folinic acid + irinotecan (FOLFIRI) (optional in combination with bevacizumab or aflibercept or ramucirumab) OR
    - 5-fluorouracil + folinic acid + irinotecan (FOLFIRI) (optional in combination with cetuximab or panitumumab) (only for patients with RAS wildtype) OR
    - 5-fluorouracil + folinic acid + oxaliplatin (FOLFOX) (optional in combination with bevacizumab) OR
    - Capacitabine + oxaliplatin (CAPOX) (optional in combination with bevacizumab) OR
    - 5-fluorouracil (optional in combination with folinic acid or bevacizumab) OR
    - Capecitabine (optional in combination with bevacizumab) OR
    - Monotherapy of irinotecan OR
    - Monotherapy of panitumumab (only for patients with RAS wildtype) OR
    - Monotherapy of cetuximab (only for patients with RAS wildtype) OR
    - Trifluridine / tipiracil OR
    - Irinotecan + cetuximab (only for patients with RAS wildtype) OR
    - Encorafenib + cetuximab (only for patients with BRAF-V600E mutation)

Subject:

  • Active Substance: Daratumumab
  • Name: Darzalex®
  • Therapeutic area: Systemic light-chain amyloidosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • A patient-individual therapy taking into account the general health condition, comorbidity and organ damage of the patient

Subject:

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

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • Best supportive care

Subject:

  • Active Substance: Cemiplimab
  • Name: Libtayo®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • Monotherapy of pembrolizumab

Subject:

  • Active Substance: Blinatumomab
  • Name: Blincyto®
  • Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Teriflunomide
  • Name: Aubagio®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 01.08.2021
  • Publication of assessment: 01.11.2021
  • End of public hearing: 22.11.2021
  • Final decision by G-BA: middle of January 2022

Comparative therapy:

  • Patients who either did not receive disease-modifying therapy or did receive disease-modifying therapy but without highly active disease:
    - Interferon-β 1a OR interferon-β 1b OR glatiramer acetate (considering the approval status)
  • Patients who have a highly active disease despite being treated with a disease-modifying therapy:
    - Fingolimod OR, if indicated, switch of therapy within the basic therapeutic agents (interferon-β 1a, interferon-β 1b, or glatiramer acetate, considering the approval status)

Subject:

  • Active Substance: Selumetinib
  • Name: Koselugo®
  • Therapeutic area: Neurofibromatosis
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 15.08.2021
  • Publication of assessment: 15.11.2021
  • End of public hearing: 06.12.2021
  • Final decision by G-BA: beginning of February 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Dupilumab (if applicable in combination with topical calcineurin inhibitors (TCI) or topical glucocorticoids (TCS))

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Chronic kidney diaease
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Optimized standard of care for the treatment of CKD taking into consideration the underlying disease and frequent comorbidities (diabetes mellitus, hypertension, dyslipoproteinemia, anemia) or secondary diseases

Subject:

  • Active Substance: Relugolix / estradiol / norethisterone acetate
  • Name: Ryeqo®
  • Therapeutic area: Uterine fibroids
  • Pharmaceutical company: Gedeon Richter Pharma GmbH

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Patient-individual therapy choosing from:
    - watchful waiting
    - treating of symptoms with gestagens (for patients for whom symptomatic treatment of prolonged and/or heavy menstruation (menorrhagia, hypermenorrhea) is sufficient) or ulipristal acetate (for patients who have not yet reached menopause and for whom uterine fibroid embolization and/or surgery are not suitable or have failed), and
    - invasive treatment options

Subject:

  • Active Substance: Tirbanibulin
  • Name: Klisyri®
  • Therapeutic area: Actinic keratosis
  • Pharmaceutical company: Almirall Hermal GmbH

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Diclofenac / hyalurenic acid gel (3 %) or
  • 5-fluorouracil or
  • imiquimod or
  • (surgical) cryotherapy for the treatment of single lesions

Subject:

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

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Patients who do not show unfavorable prognostic factors and for whom previous treatment with disease-modifying antirheumatic drugs (DMARDs) proved inadequate or was not tolerated (classical DMARDs, inclusive methotrexate (MTX):
    - Alternative classical DMARDs if applicable (MTX, leflunomide, sulfasalazine) as monotherapy or combination therapy
  • Patients for whom first line therapy with biotechnological manufactured DMARDs (bDMARDs) or targeted synthetic DMARDs (bDMARDs) is indicated:
    - bDMARDs or tsDMARDs (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or upadacitinib) in combination with MTX; if applicable as monotherapy taking into consideration the individual approval status if MTX is unsuitable or an intolerance is apparent
  • Patients for whom previous treatment with one or more bDMARDs and/or tsDMARDs proved inadequate or was not tolerated:
    - Change of the bDMARD or tsDMARD therapy (abatacept or adalimumab or baricitinib or certolizumab pegol or etanercept or golimumab or infliximab or sarilumab or tocilizumab or upadacitinib in combination with MTX; if applicable as monotherapy taking into consideration the individual approval status if MTX is unsuitable or an intolerance is apparent; or for patients with severe rheumatoid arthritis rituximab) taking into consideration previous therapies

Subject:

  • Active Substance: Icosapent ethyl
  • Name: Vazkepa®
  • Therapeutic area: Dyslipidemia
  • Pharmaceutical company: Amarin Pharmaceuticals Ireland Limited

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Maximum tolerated drug therapy at the physician's discretion taking into consideration statins and cholesterol reabsorption inhibitors

Subject:

  • Active Substance: Migalastat
  • Name: Galafold®
  • Therapeutic area: Fabry disease
  • Pharmaceutical company: Amicus Therapeutics GmbH

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Oesophageal or gastro-oesophageal junction cancer
  • Pharmaceutical company: Bristol Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Watchful waiting

Subject:

  • Active Substance: Misoprostol
  • Name: Angusta®
  • Therapeutic area: Labour induction
  • Pharmaceutical company: Norgine GmbH

Time table:

  • Start: 01.09.2021
  • Publication of assessment: 01.12.2021
  • End of public hearing: 22.12.2021
  • Final decision by G-BA: middle of February 2022

Comparative therapy:

  • Dinoprostone

Subject:

  • Active Substance: Roxadustat
  • Name: Evrenzo®
  • Therapeutic area: Anaemia
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • An erythropoetin-stimulating drug

Subject:

  • Active Substance: Bimekizumab
  • Name: Bimzelx®
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: UCB Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • Patients with moderate to severe plaque psoriasis who are not eligible for conventional therapy in the setting of initial systemic therapy:
    - Adalimumab or
    - Guselkumab or
    - Ixekizumab or
    - Secukinumab
  • Patients with moderate to severe plaque psoriasis who have had an indaquate response to or have not tolerated systemic therapy:
    - Adalimumab or
    - Brodalumab or
    - Guselkumab or
    - Infliximab or
    - Ixekizmab or
    - Risankizumab or
    - Secukinumab or
    - Ustekinumab

Subject:

  • Active Substance: Vericiguat
  • Name: Verquvo®
  • Therapeutic area: Chronic heart failure
  • Pharmaceutical company: Bayer Vital GmbH

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • Optimized standard of care for the treatment of symptomatic chronic heart failure and underlying conditions, such as hypertension, arrhythmias, coronary artery disease, diabetes mellitus, hypercholesterolaemia, and associated symtoms

Subject:

  • Active Substance: Odevixibat
  • Name: Bylvay®
  • Therapeutic area: Cholestasis
  • Pharmaceutical company: Albireo Pharma AB

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Tafasitamab
  • Name: Minjuvi®
  • Therapeutic area: Diffuse large B-cell lymphoma
  • Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Tofacitinib
  • Name: Xeljanz®
  • Therapeutic area: Polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 15.09.2021
  • Publication of assessment: 15.12.2021
  • End of public hearing: 05.01.2022
  • Final decision by G-BA: beginning of March 2022

Comparative therapy:

  • Patients with active PJIA
    - a1) Patients who have had an inadequate response to prior treatment with classical DMARDs (including MTX):

    A bDMARD (adalimumab or etanercept or golimumab or tocilizumab) in combination with MTX; if appropriate in the case of MTX intolerance or incompatibility as monotherapy under consideration of the respective authorization status
    - a2) Patients who have had an inadequate response to prior treatment with one or more bDMARDs:
    A switch of the bDMARD therapy (abatacept or adalimumab or etanercept or golimumab or tocilizumab)
  • Patients with (active) juvenile PsA who have had an inadequate response to prior treatment with DMARDs: Therapy at the physician's discretion

Subject:

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

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • 1) Paediatric patients with high disease activity characterized by clinical symptoms of hemolysis: eculizumab
  • 2) Paediatric patients who have been receiving eculizumab for ≥ 6 months and are clinically stable: eculizumab

Subject:

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

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • Best supportive care

Subject:

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

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • Daratumumab in combination with melphalan and prednisone or
  • Bortezomib in combination with melphalan and prednisone or
  • Bortezomib in combination with lenalidomide and dexamethasone or
  • Thalidomide in combination with melphalan and prednisone or
  • Lenalidomide in combination with dexamethasone

Subject:

  • Active Substance: Vosoritide
  • Name: Voxzogo®
  • Therapeutic area: Achondroplasia
  • Pharmaceutical company: BioMarin International Limited

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

Subject:

  • Active Substance: Vandetanib
  • Name: Caprelsa®
  • Therapeutic area: Medullary thyroid cancer
  • Pharmaceutical company: Sanofi Aventis Deutschland GmbH

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • Cabozantinib

Subject:

  • Active Substance: Solriamfetol
  • Name: Sunosi®
  • Therapeutic area: Obstructive sleep apnoea (OSA)
  • Pharmaceutical company: Jazz Pharmaceuticals Ireland Ltd.

Time table:

  • Start: 01.10.2021
  • Publication of assessment: 03.01.2022
  • End of public hearing: 24.01.2022
  • Final decision by G-BA: middle of March 2022

Comparative therapy:

  • Optimized standard of care for the treatment of the underlying obstructive sleep apnoea
    (standard therapy includes, in particular, continuous positive airway pressure (CPAP) therapies; weight-reducing measures can be accompanying strategies)

Subject:

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

Time table:

  • Start: 15.10.2021
  • Publication of assessment: 17.01.2022
  • End of public hearing: 07.02.2022
  • Final decision by G-BA: beginning of April 2022

Comparative therapy:

  • Genotype 1, 4, 5 or 6: ledipasvir / sofosbuvir OR glecaprevir / pibrentasvir
  • Genotype 2 or 3: sofosbuvir + ribavirin OR glecaprevir / pibrentasvir

Subject:

  • Active Substance: Albutrepenonacog alfa
  • Name: Idelvion®
  • Therapeutic area: Hemophilia B
  • Pharmaceutical company: CSL Behring GmbH

Time table:

  • Start: 15.10.2021
  • Publication of assessment: 17.01.2022
  • End of public hearing: 07.02.2022
  • Final decision by G-BA: beginning of April 2022

Comparative therapy:

  • Recombinant or human plasma-derived coagulation factor IX products

Subject:

  • Active Substance: Peanut protein as defatted powder of Arachis hypogaea L., semen (peanuts)
  • Name: Palforzia®
  • Therapeutic area: Peanut allergy
  • Pharmaceutical company: Aimmune Therapeutics Germany GmbH

Time table:

  • Start: 15.10.2021
  • Publication of assessment: 17.01.2022
  • End of public hearing: 07.02.2022
  • Final decision by G-BA: beginning of April 2022

Comparative therapy:

  • Watchful waiting (note: peanut-avoiding diet is expected in both study arms; rescue medication should be possible when clinically indicated for accidental peanut exposition)

 

Completed (final decision published)

Subject:

  • Active Substance: Angiotensin II acetate
  • Name: Giapreza®
  • Therapeutic area: Hypotension
  • Pharmaceutical company: PAION Deutschland GmbH

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tralokinumab
  • Name: Adtralza®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: Leo Pharma A/S

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Empagliflozin
  • Name: Jardiance®
  • Therapeutic area: Chronic heart failure
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Satralizumab
  • Name: Enspryng®
  • Therapeutic area: Neuromyelitis optica spectrum disorders
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.07.2021
  • Final decision by G-BA: 06.01.2022

Final decision:

  • Hint for a minor additional benefit (orphan drug)

Subject:

  • Active Substance: Elotuzumab
  • Name: Empliciti®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Bristol Myers-Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021
  • This resolution remains valid until: 01.07.2024

Final decision:

  • Patients without prior adjuvant platin-based chemotherapy: No additional benefit proved
  • Patients with or who are not eligible for prior adjuvant platin-based chemotherapy: Indication for a non-quantifiable additional benefit

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Malignant pleural mesothelioma (MPM)
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KGaA

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Patients with epithelioid tumor histology: No additional benefit proved
  • Patients without epithelioid tumor histology: Indication for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

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

Subject:

  • Active Substance: Cabozantinib
  • Name: Cometriq®
  • Therapeutic area: Thyroid carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

  • Active Substance: Brentuximab
  • Name: Adcetris®
  • Therapeutic area: Anaplastic large cell lymphoma
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 01.07.2021
  • Final decision by G-BA: 16.12.2021

Final decision:

  • Hint for a minor additional benefit (orphan drug)

Subject:

  • Active Substance: Dostarlimab
  • Name: Jemperli®
  • Therapeutic area: Endometrial cancer (EC)
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Tagraxofusp
  • Name: Elzonris®
  • Therapeutic area: Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
  • Pharmaceutical company: Stemline Therapeutics B.V.

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

  • Active Substance: Ponesimod
  • Name: Ponvory®
  • Therapeutic area: Multiple sclerosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • Patients who did not yet receive disease modifying therapeutics or who did receive disease modifying therapeutics but have not a highly active disease:
    - No decision on additional benefit yet. G-BA updated the comparative therapy and assigned IQWiG to assess the now relevant study. The final decision on additional benefit is due in 6 months.
  • Patients who received disease modifying therapeutics but still have a highly active disease: No additional benefit proved

Subject:

  • Active Substance: Berotralstat
  • Name: Orladeyo®
  • Therapeutic area: Hereditary angioedema (HAE)
  • Pharmaceutical company: BioCryst Pharma Deutschland GmbH

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Venetoclax
  • Name: Venclyxto®
  • Therapeutic area: Acute myeloid leukaemia (AML)
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 15.06.2021
  • Final decision by G-BA: 02.12.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

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

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Ivacaftor / tezacaftor / elexacaftor
  • Name: Kaftrio®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Germany) GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Enzalutamide
  • Name: Xtandi®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: Astellas Pharma GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Cenobamate
  • Name: Ontozry®
  • Therapeutic area: Epilepsy
  • Pharmaceutical company: Angelini Pharma Deutschland GmbH

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Lung cancer, non-small cell
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.06.2021
  • Final decision by G-BA: 19.11. 2021

Final decision:

  • Patients with PD-L1 expression ≥ 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved
  • Patients with PD-L1 expression < 50% on tumour cells (TC) or ≥10% on immune cells (IC), EGFR/ALK-negative: No additional benefit proved

Subject:

  • Active Substance: Atidarsagene autotemcel OTL-200
  • Name: Libmeldy®
  • Therapeutic area: Metachromatic leukodystrophy
  • Pharmaceutical company: Orchard Therapeutics GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 04.11.2021
  • The decision remains valid until: 01.07.2024

Final decsion:

  • Children with late infantile or early juvenile stage of MLD without clinical manifestation of the disease:: Hint for a major additional benefit
  • Children with early juvenile stage of MLD with untimely clinical manifestation of the disease, who are able to walk independently, before cognitive deterioration:: Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Seizures associated with tuberous sclerosis complex (TSC)
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro®
  • Therapeutic area: Follicular lymphoma
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Obinutuzumab
  • Name: Gazyvaro®
  • Therapeutic area: Chronic lymphocytic leukemia (CLL)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Onasemnogene abeparvovec
  • Name: Zolgensma®
  • Therapeutic area: Spinal muscular atrophy (SMA)
  • Pharmaceutical company: Novartis Gene Therapies EU Limited

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • Symptomatic patients with 5q-associated SMA type I: No additional benefit proved
  • Symptomatic patients with 5q-associated SMA type II (up to 3 copies of SMN2 gene: No additional benefit proved
  • Symptomatic patients with 5q-associated SMA type III (up to 3 copies of SMN2 gene: No additional benefit proved
  • Pre-symptomatic patients with 5q-associated SMA (up to 3 copies of SMN2 gene: No additional benefit proved

Subject:

  • Active Substance: Lanadelumab
  • Name: Takhzyro®
  • Therapeutic area: Hereditary angioedema
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Isatuximab
  • Name: Sarclisa®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: Sanofi-Aventis Deutschland GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Isatuximab
  • Name: Sarclisa®
  • Therapeutic area: Hereditary angioedema
  • Pharmaceutical company: Takeda GmbH

Time table:

  • Start: 15.05.2021
  • Final decision by G-BA: 04.11.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Cabotegravir
  • Name: Vocabria®
  • Therapeutic area: HIV-1 infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Rilpivirine
  • Name: Rekambys®
  • Therapeutic area: HIV-1 infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Erenumab
  • Name: Aimovig®
  • Therapeutic area: Migraine prophylaxis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Risdiplam
  • Name: Evrysdi®
  • Therapeutic area: Spinal muscular atrophy
  • Pharmaceutical company: Roche Pharma GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • a) Patients with a 5q-associated SMA type I: Hint for a non-quantifiable additional benefit
  • b) Patients with a 5q-associated SMA type II: No additional benefit proved
  • c1) Patients with a 5q-associated SMA type III, intrathecal administration of nusinersen possible: No additional benefit proved
  • c2) Patients with a 5q-associated SMA type III, intrathecal administration of nusinersen not possible: Hint for a non-quantifiable additional benefit
  • d1) Presymptomatic patients with a 5q-associated SMA and ≤ 3 copies of the SMN2 gene: No additional benefit proved
  • d2) Presymptomatic patients with a 5q-associated SMA and 4 copies of the SMN2 gene: No additional benefit proved

Subject:

  • Active Substance: Cabozantinib
  • Name: Cabometyx®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Ipsen Pharma GmbH

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • a) Patients with a favorable risk profile (IMDC-Score 0): No additional benefit proved
  • b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3): No additional benefit proved

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Renal cell carcinoma
  • Pharmaceutical company: Bristol-Myers Squibb GmbH & Co. KG

Time table:

  • Start: 01.05.2021
  • Final decision by G-BA: 21.10.2021

Final decision:

  • a) Patients with a favorable risk profile (IMDC-Score 0): No additional benefit proved
  • b) Treatment-naïve patients with advanced renal cell carcinoma with an intermediate (IMDC-Score 1–2) or unfavorable risk profile (IMDC-Score ≥ 3): No additional benefit proved

Subject:

  • Active Substance: Pemigatinib
  • Name: Pemazyre®
  • Therapeutic area: Cholangiocarcinoma
  • Pharmaceutical company: Incyte Biosciences Germany GmbH

Time table:

  • Start: 15.04.2021
  • Final decision by G-BA: 07.10.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Bedaquiline
  • Name: Sirturo®
  • Therapeutic area: Tuberculosis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Colorectal cancer
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • Patients for whom an intensive therapy is indicated: Hint for a minor additional benefit
  • Patients for whom an intensive therapy is not indicated: No additional benefit proved

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Urothelial cancer
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Pembrolizumab
  • Name: Keytruda®
  • Therapeutic area: Hodgkin lymphoma
  • Pharmaceutical company: MSD Sharp & Dohme GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • Adults:
    • Brentuximab vedotin is the appropriate therapy: Hint for a considerable additional benefit
    • Brentuximab vedotin is not the appropriate therapy: No additional benefit proved
  • Children and adolescents aged 3 years and older: No additional benefit proved

Subject:

  • Active Substance: Fostemsavir
  • Name: Rukobia®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Avatrombopag
  • Name: Doptelet®
  • Therapeutic area: Thrombocytopenia with chronic liver disease
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Avatrombopag
  • Name: Doptelet®
  • Therapeutic area: Immune thrombocytopenia
  • Pharmaceutical company: Swedish Orphan Biovitrum GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Remdesivir
  • Name: Veklury®
  • Therapeutic area: Coronavirus disease 2019 (COVID-19)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • Adults:
    • Receiving low-flow oxygen at the beginning of the therapy: Hint for a minor additional benefit
    • Receiving high-flow oxygen at the beginning of the therapy: No additional benefit proved
  • Adolescents aged 12 years and older: No additional benefit proved

Subject:

  • Active Substance: Sodium zirkonium cyclosilicate
  • Name: Lokelma®
  • Therapeutic area: Hyperkalaemia
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.04.2021
  • Final decision by G-BA: 16.09.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: Thyroid cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021

Final decision:

  • Patients with an advanced, differentiated thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved
  • Patients with an advanced, anaplastic thyroid cancer (RET+, systemic therapy indicated, prior treatment with sorafenib and/or lenvatinib): No additional benefit proved

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: Thyroid cancer
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Selpercatinib
  • Name: Retsevmo®
  • Therapeutic area: NSCLC
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021

Final decision:

  • a) After first-line therapy with a PD-1/PD-L1 antibody as monotherapy: No additional benefit proved
  • b) After first-line therapy with a cytotoxic chemotherapy: No additional benefit proved
  • c) After first-line therapy with a PD-1/PD-L1 antibody in combination with a platin-based chemotherapy or after sequential therapy with a PD-1/PD-l1 antibody and a platin-based chemotherapy:No additional benefit proved

Subject:

  • Active Substance: Tucatinib
  • Name: Tukysa®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Seagen Germany GmbH

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Fedratinib
  • Name: Inrebic®
  • Therapeutic area: Chronic myeloproliferative diseases
  • Pharmaceutical company: Celgene GmbH

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021
  • The resolution remains valid until: 01.03.2025

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Imlifidase
  • Name: Idefirix®
  • Therapeutic area: Desensitization of kidney transplant
  • Pharmaceutical company: Hansa Biopharma AB

Time table:

  • Start: 15.03.2021
  • Final decision by G-BA: 02.09.2021
  • The resolution remains valid until: 01.04.2026

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Esketamine
  • Name: Spravato®
  • Therapeutic area: Depression
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.03.2021
  • Final decision by G-BA: 19.08.2021

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Esketamine
  • Name: Spravato®
  • Therapeutic area: Depression
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.03.2021
  • Final decision by G-BA: 19.08.2021
  • The decision is limited until: 15.06.2023

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Avelumab
  • Name: Bavencio®
  • Therapeutic area: Urothelial carcinoma
  • Pharmaceutical company: Merck Serono GmbH and Pfizer Pharma GmbH

Time table:

  • Start: 01.03.2021
  • Final decision by G-BA: 19.08.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Acalabrutinib
  • Name: Calquence®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 05.08.2021

Final decision:

  • a1) Patients with neither 17p deletion nor TP53 mutation and who can be treated with a chemo-immunotherapy and for whom the patient-individual therapy is rituximab in combination bendamustine (BR): No additional benefit proved
  • a2) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with chemo-immunotherapy and for whom the patient-individual therapy is not rituximab in combination with BR: No additional benefit proved
  • b) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemo-immunotherapy due to other reasons: Hint for a considerable additional benefit
  • c1) Patients with at least 2 prior therapies and for whom the patient-individual therapy is idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: Hint for a minor additional benefit
  • c2) Patients with at least 2 prior therapies and for whom the patient-individual therapy is not idelalisib in combination with rituximab or rituximab or rituximab in combination with BR: No additional benefit proved

Subject:

  • Active Substance: Autologous anti-CD19-transduced CD3+ cells
  • Name: Tecartus®
  • Therapeutic area: Mantle cell lymphoma (MCL)
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.02.2021
  • Final decision by G-BA: 05.08.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Baloxavir marboxil
  • Name: Xofluza®
  • Therapeutic area: Influenza
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.02.2021
  • Final decision by G-BA: 05.08.2021

Final decision:

  • Without risk for complications due to influenza: Indication for a considerable additional benefit
  • With risk for complications due to influenza: No additional benefit proved

Subject:

  • Active Substance: Baloxavir marboxil
  • Name: Xofluza®
  • Therapeutic area: Influenza
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 15.02.2021
  • Final decision by G-BA: 05.08.2021

Final decision:

  • Without risk for complications due to influenza: No additional benefit proved
  • With risk for complications due to influenza: No additional benefit proved

Subject:

  • Active Substance: Beclometasone / formoterol / glycopyrronium bromide
  • Name: Trimbow®
  • Therapeutic area: Asthma
  • Pharmaceutical company: Chiesi GmbH

Time table:

  • Start: 15.02.2021
  • Final decision by G-BA: 05.08.2021

Final decision:

  • Patients who are insufficiently treated with a medium-dosed ICS / LABA therapy: No additional benefit proved
  • Patients who are insufficiently treated with a high-dosed ICS / LABA therapy: No additional benefit proved

Subject:

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

Time table:

  • Start: 15.01.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Ankylosing spondylitis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • a1) Patients who have responded inadequately to conventional therapy: No additional benefit proved
  • a2) Patients who have responded inadequately or who are intolerant to biological disease-modifying antirheumatic drugs (bDMARDs): No additional benefit proved

Subject:

  • Active Substance: Upadacitinib
  • Name: Rinvoq®
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: AbbVie Deutschland GmbH & Co. KG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • a1) Patients who have responded inadequately to or did not tolerate conventional disease-modifying antirheumatic drugs (DMARDs): Hint for a considerable additional benefit
  • a2) Patients who have responded inadequately to or did not tolerate biological disease-modifying antirheumatic drugs (bDMARDs):: No additional benefit proved

Subject:

  • Active Substance: Inclisiran
  • Name: Leqvio®
  • Therapeutic area: Primary hypercholesterolaemia or mixed dyslipidaemia
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • Patients who have not already exhausted all available dietary and medicinal lipid-lowering options: No additional benefit proved
  • Patients who have already exhausted all available dietary and medicinal lipid-lowering options (except for evolocumab or alirocumab): No additional benefit proved

Subject:

  • Active Substance: Fenfluramine
  • Name: Fintepla®
  • Therapeutic area: Dravet syndrome
  • Pharmaceutical company: Zogenix GmbH

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

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

Subject:

  • Active Substance: Niraparib
  • Name: Zejula®
  • Therapeutic area: Ovarian, fallopian tube, or primary peritoneal cancer
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • No additional benefit proved (orphan drug)

Subject:

  • Active Substance: Dolutegravir
  • Name: Tivicay®
  • Therapeutic area: HIV-1 infection
  • Pharmaceutical company: ViiV Healthcare GmbH

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • Therapy-naïve children: No additional benefit proved
  • Pre-treated children: No additional benefit proved

Subject:

  • Active Substance: Levofloxacin / dexamethasone
  • Name: Ducressa®
  • Therapeutic area: Infections and inflammation associated with cataract surgery
  • Pharmaceutical company: Santen GmbH

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021
  • The decision remains valid until: 01.10.2022

Final decision:

  • Hint for a minor additional benefit

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Pertuzumab / trastuzumab
  • Name: Phesgo®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Blinatumomab
  • Name: Blincyto®
  • Therapeutic area: B-precursor acute lymphoblastic leukaemia (ALL)
  • Pharmaceutical company: Amgen GmbH

Time table:

  • Start: 01.02.2021
  • Final decision by G-BA: 15.07.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug designation)

Subject:

  • Active Substance: Lumasiran
  • Name: Oxlumo®
  • Therapeutic area: Hyperoxaluria
  • Pharmaceutical company: Alnylam Germany GmbH

Time table:

  • Start: 01.01.2021
  • Final decision by G-BA: 01.07.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

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

Time table:

  • Start: 01.01.2021
  • Final decision by G-BA: 01.07.2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 01.01.2021
  • Final decision by G-BA: 01.07.2021

Final decision:

  • Hint for a non-quantifiable additional benefit

Subject:

  • Active Substance: Afamelanotide
  • Name: Scenesse®
  • Therapeutic area: Erythropoietic protoporphyria (EPP)
  • Pharmaceutical company: Clinuvel UK Limited

Time table:

  • Start: 01.01.2021
  • Final decision by G-BA: 01.07.2021

Final decision:

  • Hint for a non-quantifiable additional benefit (orphan drug)

Subject:

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

Time table:

  • Start: 01.01.2021
  • Final decision by G-BA: 01.07.2021

Final decision:

  • Patients for whom chemotherapy is an option: Hint for a minor additional benefit
  • Patients for whom chemotherapy is not an option: No additional benefit proved

Subject:

  • Active Substance: Olaparib
  • Name: Lynparza®
  • Therapeutic area: Ovarian cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021
  • This decision remains valid until: 01.10.2022

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Olaparib
  • Name: Lynparza®
  • Therapeutic area: Prostate cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • Hint for a considerable additional benefit

Subject:

  • Active Substance: Olaparib
  • Name: Lynparza®
  • Therapeutic area: Pancreatic cancer
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Acalabrutinib
  • Name: Calquence®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
  • b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
  • c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

Subject:

  • Active Substance: Acalabrutinib
  • Name: Calquence®
  • Therapeutic area: Chronic lymphocytic leukaemia (CLL)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • a) Patients with neither 17p deletion nor TP53 mutation and who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): no additional benefit proved
  • b) Patients with neither 17p deletion nor TP53 mutation and who cannot be treated with FCR: hint for a minor additional benefit
  • c) Patients with 17p deletion or TP53 mutation or who cannot be treated with chemotherapy due to other reasons: no additional benefit proved

Subject:

  • Active Substance: Sucroferric oxyhydroxide
  • Name: Velphoro®
  • Therapeutic area: To control blood-phosphate levels in patients with chronic kidney disease
  • Pharmaceutical company: Fresenius Medical Care Deutschland GmbH

Time table:

  • Start: 15.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • No additional benefit proved

Subject:

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

Time table:

  • Start: 15.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • No additional benefit proved

Subject:

  • Active Substance: Nivolumab
  • Name: Opdivo®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

  • Start: 15.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
  • Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit

Subject:

  • Active Substance: Ipilimumab
  • Name: Yervoy®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Bristol-Myers Squibb Pharma EEIG

Time table:

  • Start: 15.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • Patients with a Tumor Proportion Score [TPS] ≥ 50 % (PD-L1 expression): no additional benefit proved
  • Patients with a Tumor Proportion Score [TPS] < 50 % (PD-L1 expression): indication for a minor additional benefit proved

Subject:

  • Active Substance: Sebelipase alfa
  • Name: Kanuma®
  • Therapeutic area: Lysosomal acid lipase (LAL) deficiency
  • Pharmaceutical company: Alexion Pharma Germany GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 03.06.2021

Final decision:

  • Patients with rapidly progressing LAL deficiency during infancy (≥ 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)
  • Patients with LAL deficiency not already rapidly progressing during infancy (< 6 months): hint for a non-quantifiable additional benefit (orphan drug designation)

 

Please contact

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