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Ongoing (preliminary decision published)

› Elotuzumab (re-assessment: multiple myeloma, ≥ 2 prior therapies, combination with pomalidomide and dexamethasone)

Subject:

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

Time table:

  • Start: 01.07.2021
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative 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 or
  • Elotuzumab in combination with lenalidomide and dexamethasone or
  • Carfilzomib in combination with lenalidomide and dexamethasone or
  • Carfilzomib in combination with dexamethasone or
  • Daratumumab in combination with lenalidomide and dexamethasone or
  • Daratumumab in combination with bortezomib and dexamethasone

› Osimertinib (new indication: non-small cell lung cancer (NSCLC), EGFR mutations, adjuvant therapy)

Subject:

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

Time table:

  • Start: 01.07.2021
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative therapy:

  • Patients without prior adjuvant platin-based chemotherapy:
    - Patients in stage IB: watchful waiting or a systemic antineoplastic pharmacotherapy at the physician’s discretion
    - Patients in stage II and IIIA: systemic antineoplastic pharmacotherapy at the physician’s discretion
  • Patients with or who are not eligible for prior adjuvant platin-based chemotherapy: Watchful waiting

› Nivolumab (new indication: malignant pleural mesothelioma (MPM), 1st line, combination with ipilimumab)

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
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative therapy:

  • A therapy at the physician's discretion

› Glecaprevir / pibrentasvir (new indication: chronic hepatitis C, patients aged 3 – < 12 years)

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
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative therapy:

  • Patients with genotype 1, 4, 5 or 6: Ledipasvir / sofosbuvir
  • Patients with genotype 2 or 3: Sofosbuvir in combination with ribavirin

› Cabozantinib (re-assessment: thyroid carcinoma)

Subject:

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

Time table:

  • Start: 01.07.2021
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

› Brentuximab vedotin (re-assessment: systemic anaplastic large cell lymphoma (sALCL), 1st line, in combination with cyclophosphamide, doxorubicin and prednisone (CHP))

Subject:

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

Time table:

  • Start: 01.07.2021
  • Publication of assessment: 01.10.2021
  • End of public hearing: 22.10.2021
  • Final decision by G-BA: middle of December 2021

Comparative therapy:

  • No comparative therapy due to orphan drug designation

› Angiotensin II acetate (hypotension)

Subject:

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

Time table:

  • Start: 15.07.2021
  • Publication of assessment: 15.10.2021
  • End of public hearing: 05.11.2021
  • Final decision by G-BA: beginning of January 2022

Comparative therapy:

  • Optimized standard therapy (liquid substitution, vasopressors and antibiotics)

› Tralokinumab (atopic dermatitis)

Subject:

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

Time table:

  • Start: 15.07.2021
  • Publication of assessment: 15.10.2021
  • End of public hearing: 05.11.2021
  • Final decision by G-BA: beginning of January 2022

Comparative therapy:

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

› Empagliflozin (new indication: chronic heart failure)

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
  • Publication of assessment: 15.10.2021
  • End of public hearing: 05.11.2021
  • Final decision by G-BA: beginning of January 2022

Comparative therapy:

  • Optimized standard therapy for the treatment of symptomatic chronic heart failure and underlying conditions such as hypertension, cardiac arrhythmia, coronary heart disease, diabetes mellitus and hypercholesterolemia as well as attendant symptoms

› Satralizumab (neuromyelitis optica spectrum disorders in anti-aquaporin-4 IgG (AQP4-IgG) seropositive patients ≥ 12 years of age)

Subject:

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

Time table:

  • Start: 15.07.2021
  • Publication of assessment: 15.10.2021
  • End of public hearing: 05.11.2021
  • Final decision by G-BA: beginning of January 2022

Comparative therapy:

  • No comparative therapy due to orphan drug designation

› Daratumumab (new indication: multiple myeloma, ≥ previous therapy(ies), in combination with pomalidomide and dexamethasone)

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

› Nivolumab (new indication: colorectal cancer (CRC) with microsatellite-instability-high (MSI-H) or mismatch repair-deficient (dMMR), pre-treated patients, in combination with ipilimumab)

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 wild type) 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 wild type) OR
    - Monotherapy of cetuximab (only for patients with RAS wild type) OR
    - Trifluridine / tipiracil OR
    - Irinotecan + cetuximab (only for patients with RAS wild type) OR
    - Encorafenib + cetuximab (only for patients with BRAF-V600E mutation)

› Daratumumab (new indication: systemic light-chain amyloidosis, 1st line, in combination with cyclophosphamide, bortezomib and dexamethasone)

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

› Cemiplimab (new indication: basal cell carcinoma, metastatic or locally advanced)

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

› Cemiplimab (new indication: non-small cell lung cancer (NSCLC), 1st line)

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

› Blinatumomab (new indication: B-precursor acute lymphoblastic leukaemia (ALL), high-risk first relapsed, Ph-, CD19+, patients aged ≥ 1 - < 18 years)

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

› Teriflunomide (new indication: relapsing remitting multiple sclerosis (RRMS) in patients aged 10-17 years)

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)

› Selumetinib (neurofibromatosis type 1, patients aged ≥ 3 - < 18 years)

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

› Upadacitinib (new indication: atopic dermatitis, patients aged ≤ 12 years)

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))

› Dapagliflozin (new indication: chronic kidney disease)

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

› Relugolix / estradiol / norethisterone acetate (uterine fibroids)

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

› Tirbanibulin (actinic keratosis (Olsen grade 1))

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

› Tofacitinib (new scientific evidence (§ 13): rheumatoid arthritis, pretreated patients, monotherapy or in combination with methotrexate)

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

› Icosapent ethyl (dislipidemia)

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

› Migalastat (new indication: Fabry disease, patients aged 12 - < 16 years)

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

› Nivolumab (new indication: oesophageal or gastro-oesophageal junction cancer, pretreated patients, adjuvant)

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

› Misoprostol (known substance with new data exclusivity: labour induction)

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

 

Completed (final decision published)

› 02.12.2021: Dostarlimab (endometrial cancer (EC), following prior treatment with a platinum-containing regimen)

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

› 02.12.2021: Tagraxofusp (blastic plasmacytoid dendritic cell neoplasm (BPDCN), 1st line)

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)

› 02.12.2021: Ponesimod (relapsing forms of multiple sclerosis (RMS))

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

› 02.12.2021: Berotralstat (prevention of recurrent attacks of hereditary angioedema (HAE), patients aged ≥ 12 years )

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

› 02.12.2021: Venetoclax (new indication: acute myeloid leukaemia (AML), combination therapy, 1st line)

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

› 19.11.2021: Bosutinib (re-assessment: chronic myelogenous leukemia (CML), Ph+, 1st line)

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

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and other or unknown mutation))

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

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and RF mutation))

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

› 19.11.2021: Ivacaftor / tezacaftor / elexacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor, patients aged ≥ 12 years (heterozygous for F508del and gating mutation (including R117H))

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

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and other or unknown mutation))

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

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and RF mutation))

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

› 19.11.2021: Ivacaftor (new indication, 50 M € limit exceeded: cystic fibrosis, in combination with ivacaftor / tezacaftor / elexacaftor, patients aged ≥ 12 years (heterozygous for F508del and gating mutation (including R117H))

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

› 19.11.2021: Enzalutamide (new indication: prostate cancer, metastatic, hormone-sensitive, combination with androgen deprivation therapy)

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

› 19.11.2021: Cenobamate (epilepsy, focal seizures, ≥ 2 prior therapies)

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

› 19.11.2021: Atezolizumab (new indication: non-small cell lung cancer (NSCLC), PD-L1 expression ≥ 50% on tumour cells (TC) or ≥ 10% on immune cells (IC), EGFR/ALK-negative, 1st line)

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

› 04.11.2021: Atidarsagene autotemcel OTL-200 (metachromatic leukodystrophy with biallelic mutation in ARSA gene)

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

› 04.11.2021: Cannabidiol (new indication: seizures associated with tuberous sclerosis complex (TSC); ≥ 2 years of age)

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)

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: follicular lymphoma (FL))

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

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: chronic lymphocytic leukemia (CLL))

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

› 04.11.2021: Obinutuzumab (re-assessment, 50 M € limit exceeded: follicular lymphoma, 1st line)

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

› 04.11.2021: Onasemnogene abeparvovec (re-assessment, 50 M € limit exceeded: 5q-associated spinal muscular atrophy (SMA))

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

› 04.11.2021: Lanadelumab (re-assessment, 50 M € limit exceeded: hereditary angioedema (HAE), prophylaxis, ≥ 12 years of age)

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

› 04.11.2021: Isatuximab (multiple myeloma, after ≥ 2 previous therapies, combination with pomalidomide and dexamethasone)

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

› 04.11.2021: Isatuximab (multiple myeloma, after ≥ 1 previous therapy, combination with carfilzomib and dexamethasone)

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

› 21.10.2021: Cabotegravir (HIV-1 infection, in combination with rilpivirine, for patients on a stable antiretroviral therapy)

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

› 21.10.2021: Rilpivirine (HIV-1 infection, in combination with cabotegravir, for patients on a stable antiretroviral therapy)

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

› 21.10.2021: Erenumab (new scientific evidence (§ 14): migraine prophylaxis)

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

› 21.10.2021: Risdiplam (5q-associated spinal muscular atrophy (SMA))

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

› 21.10.2021: Cabozantinib (new indication: renal cell carcinoma, in combination with nivolumab, 1st line)

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

› 21.10.2021: Nivolumab (new indication: renal cell carcinoma in combination with cabozantinib, 1st line)

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

› 07.10.2021: Pemigatinib (cholangiocarcinoma with FGFR2 fusion or rearrangement, at least one prior therapy)

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)

› 16.09.2021: Bedaquiline (new indication: multidrug-resistant pulmonary tuberculosis (MDR-TB), patients aged 5-11 years)

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)

› 16.09.2021: Pembrolizumab (new indication: colorectal cancer, MSI-H or dMMR, 1st line)

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

› 16.09.2021: Pembrolizumab (new indication: urothelial cancer, CPS ≥ 10, 1st line)

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

› 16.09.2021: Pembrolizumab (new indication: Hodgkin lymphoma, pre-treated patients, aged ≥ 3 years)

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

› 16.09.2021: Fostemsavir (multidrug-resistant HIV infection)

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

› 16.09.2021: Avatrombopag (thrombocytopenia with chronic liver disease)

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

› 16.09.2021: Avatrombopag (immune thrombocytopenia (ITP))

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

› 16.09.2021: Remdesivir (COVID-19, patients aged ≥ 12 years, requirement of supplemental oxygen)

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

› 16.09.2021: Sodium zirconium cyclosilicate (hyperkalaemia)

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

› 16.09.2021: Nivolumab (re-assessment: melanoma, adjuvant therapy)

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

› 02.09.2021: Selpercatinib (thyroid cancer, RET fusion+, prior treatment with sorafenib and/or lenvatinib)

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

› 02.09.2021: Selpercatinib (medullary thyroid cancer, RET-mutated, prior treatment with cabozantinib and/or vandetanib, patients aged ≥ 12 years)

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

› 02.09.2021: Selpercatinib (NSCLC, RET fusion+, prior treatment with platinum-based chemo- and/or immunotherapy)

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

› 02.09.2021: Tucatinib (breast cancer, HER2+, ≥ 2 prior therapies, combination with trastuzumab and capecitabine)

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

› 02.09.2021: Fedratinib (myelofibrosis)

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)

› 02.09.2021: Imlifidase (desensitization treatment of kidney transplant patients)

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)

› 19.08.2021: Esketamine (depression, acute short-term treatment, combination therapy)

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

› 19.08.2021: Esketamine (depression, treatment resistant, in combination with SSRI or SNRI)

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

› 19.08.2021: Avelumab (new indication: urothelial carcinoma, 1st line)

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

› 05.08.2021: Acalabrutinib (chronic lymphocytic leukaemia (CLL); at least one prior therapy)

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

› 05.08.2021: Autologous anti-CD19-transduced CD3+ cells (mantle cell lymphoma (MCL), pre-treated patients)

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)

› 05.08.2021: Baloxavir marboxil (influenza, post-exposure prophylaxis, ≥ 12 years of age)

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

› 05.08.2021: Baloxavir marboxil (influenza, ≥ 12 years of age)

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

› 05.08.2021: Beclometasone / formoterol / glycopyrronium bromide (obligation for benefit assessment for the first time: asthma)

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

› 15.07.2021: Carfilzomib (new indication: multiple myeloma; at least 1 prior treatment; combination with daratumumab and dexamethasone)

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

› 15.07.2021: Upadacitinib (new indication: ankylosing spondylitis)

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

› 15.07.2021: Upadacitinib (new indication: psoriatic arthritis)

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

› 15.07.2021: Inclisiran (primary hypercholesterolaemia or mixed dyslipidaemia)

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

› 15.07.2021: Fenfluramine (Dravet syndrome; age ≥ 2 years)

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)

› 15.07.2021: Niraparib (re-assessment: ovarian, fallopian tube, or primary peritoneal cancer)

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)

› 15.07.2021: Dolutegravir (new indication: HIV infection, children at the age of ≥ 4 weeks up to < 6 years)

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

› 15.07.2021: Levofloxacin / dexamethasone (infections and inflammation associated with cataract surgery)

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

› 15.07.2021: Pertuzumab / trastuzumab (breast cancer, HER2+, early with high risk of recurrence, adjuvant)

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

› 15.07.2021: Pertuzumab / trastuzumab (breast cancer, HER2+, locally advanced or inflammatory or early with high risk of recurrence, neo-adjuvant)

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

› 15.07.2021: Pertuzumab / trastuzumab (breast cancer, HER2+, metastasized or with local recurrence (inoperable), 1st line, combination with docetaxel)

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

› 15.07.2021: Blinatumomab (B-precursor acute lymphoblastic leukaemia (ALL), relapsed or refractory, Ph+ CD19+)

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)

› 01.07.2021: Lumasiran (hyperoxaluria)

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)

› 01.07.2021: Lenvatinib (re-assessment: renal cell carcinoma)

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

› 01.07.2021: Dupilumab (new indication: atopic dermatitis, children aged 6-11 years)

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

› 01.07.2021: Afamelanotide (re-assessment: erythropoietic protoporphyria)

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)

› 01.07.2021: Nivolumab (new indication: squamous oesophageal cancer; pre-treated patients)

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

› 03.06.2021: Olaparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stages III + IV, HRD-positive, maintenance therapy, combination with bevacizumab)

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

› 03.06.2021: Olaparib (new indication: prostate cancer, BRCA 1/2 mutations, progress after hormonal treatment)

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

› 03.06.2021: Olaparib (new indication: pancreatic cancer, BRCA 1/2 mutations, maintenance therapy)

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

› 03.06.2021: Acalabrutinib (chronic lymphocytic leukaemia (CLL); combination with obinutuzumab, 1st line)

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

› 03.06.2021: Acalabrutinib (chronic lymphocytic leukaemia (CLL); monotherapy, 1st line)

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

› 03.06.2021: Sucroferric oxyhydroxide (new indication: control of blood-phosphate levels in patients with chronic kidney disease, aged ≥ 2 – 18 years)

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

› 03.06.2021: Perampanel (new indication: epilepsy, primary generalised seizures, patients aged 7 – < 12 years)

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

› 03.06.2021: Perampanel (new indication: epilepsy, partial seizures, patients aged 4 – < 12 years)

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

› 03.06.2021: Nivolumab (new indication: non-small cell lung cancer (NSCLC), combination with ipilimumab and platinum-based chemotherapy, 1st line)

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

› 03.06.2021: Ipilimumab (new indication: non-small cell lung cancer (NSCLC), combination with nivolumab and platinum-based chemotherapy, 1st line)

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

› 03.06.2021: Sebelipase alfa (re-assessment: lysosomal acid lipase deficiency)

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)

› 20.05.2021: Guselkumab (new indication: psoriatic arthritis)

Subject:

  • Active Substance: Guselkumab
  • Name: Tremfya®
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: Janssen-Cilag GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • Patients who have responded insufficiently to or have not tolerated prior disease-modifying antirheumatic drug (DMARD) therapy: no additional benefit proved
  • Patients who have responded insufficiently to or have not tolerated prior biological DMARD (bDMARD) therapy: no additional benefit proved

› 20.05.2021: Nusinersen (re-assessment, 50 Mio. € limit exceeded: spinal muscular atrophy)

Subject:

  • Active Substance: Nusinersen
  • Name: Spinraza®
  • Therapeutic area: Spinal muscular atrophy (SMA)
  • Pharmaceutical company: Biogen GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • a) Type 1: indication for a major additional benefit
  • b) Type 2: hint for a considerable additional benefit
  • c) Type 3/4: no additional benefit proved
  • d1) Pre-symptomatic and 2 SMN2 gene copies: hint for a major addiitional benefit
  • d2) Pre-symptomatic and 3 SMN2 gene copies: hint for a non-quantifiable addiitional benefit
  • d3) Pre-symptomatic and more than 3 SMN2 gene copies: no additional benefit proved

› 20.05.2021: Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and CF mutation))

Subject:

  • Active Substance: Tezacaftor / ivacaftor
  • Name: Symkevi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Tezacaftor / ivacaftor (new indication: cystic fibrosis, in combination with ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and CF mutation))

Subject:

  • Active Substance: Tezacaftor / ivacaftor
  • Name: Symkevi®
  • Therapeutic area: Cystic fibrosis
  • Pharmaceutical company: Vertex Pharmaceuticals (Ireland) Limited

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with cardiomyopathy)

Subject:

  • Active Substance: Tafamidis
  • Name: Vyndaqel®
  • Therapeutic area: Amyloidosis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • Indication for a considerable additional benefit

› 20.05.2021: Tafamidis (re-assessment, 50 Mio. € limit exceeded: amyloidosis with polyneuropathy)

Subject:

  • Active Substance: Tafamidis
  • Name: Vyndaqel®
  • Therapeutic area: Amyloidosis
  • Pharmaceutical company: Pfizer Pharma GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Niraparib (new indication: ovarian, fallopian tube, or primary peritoneal cancer, FIGO stage III and IV, maintenance therapy)

Subject:

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

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (heterozygous for F508del and RF mutation))

Subject:

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

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, in combination with tezacaftor/ ivacaftor, patients aged 6 to < 12 years (homozygous for F508del and RF mutation))

Subject:

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

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • No additional benefit proved

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, R117H mutation)

Subject:

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

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • Hint for a non-quantifiable additional benefit

› 20.05.2021: Ivacaftor (new indication: cystic fibrosis, patients aged 4 to < 6 months, gating mutations)

Subject:

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

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • Hint for a non-quantifiable additional benefit

› 20.05.2021: Dapagliflozin (new indication: chronic heart failure)

Subject:

  • Active Substance: Dapagliflozin
  • Name: Forxiga®
  • Therapeutic area: Heart failure
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • Hint for a considerable additional benefit

› 20.05.2021: Crizanlizumab (prevention of recurrent vaso-occlusive crises in sickle cell disease, patients aged ≥ 16 years)

Subject:

  • Active Substance: Crizanlizumab
  • Name: Adakevo®
  • Therapeutic area: Sickle cell disease
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021
  • This decision remains valid until: 01.12.2025

Final decision:

  • Hint for a minor additional benefit

› 20.05.2021: Atezolizumab (new indication: hepatocellular carcinoma, in combination with bevacizumab)

Subject:

  • Active Substance: Atezolizumab
  • Name: Tecentriq®
  • Therapeutic area: Hepatocellular carcinoma (HCC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

  • a) Patients with HCC with Child-Pugh A or no liver cirrhosis without prior systemic therapy: indication for a considerable additional benefit
  • b) Patients with HCC with Child-Pugh B without prior systemic therapy: no additional benefit proved

› 20.05.2021: Amikacin sulfate (liposomal) (lung infection caused by Mycobacterium avium Complex (MAC))

Subject:

  • Active Substance: Amikacin sulfate
  • Name: Arikayce liposomal®
  • Therapeutic area: MAC lung infection
  • Pharmaceutical company: Insmed Germany GmbH

Time table:

  • Start: 01.12.2020
  • Final decision by G-BA: 20.05.2021

Final decision:

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

› 06.05.2021: Eszopiclone (insomnia)

Subject:

  • Active Substance: Eszopiclone
  • Name: Lunivia®
  • Therapeutic area: Insomnia
  • Pharmaceutical company: Henning Arzneimittel GmbH & Co. KG

Time table:

  • Start: 15.02.2021
  • Final decision by G-BA: beginning of August 2021

Final decision:

  • No additional benefit proved since there has not been submitted any dossier. The drug is subject to reference pricing.

› 06.05.2021: Baricitinib (new indication: atopic dermatitis)

Subject:

  • Active Substance: Baricitinib
  • Name: Olumiant®
  • Therapeutic area: Atopic dermatitis
  • Pharmaceutical company: Lilly Deutschland GmbH

Time table:

  • Start: 15.11.2020
  • Final decision by G-BA: 06.05.2021

Final decision:

  • No additional benefit proved

› 15.04.2021: Filgotinib (rheumatoid arthritis)

Subject:

  • Active Substance: Filgotinib
  • Name: Jyseleca®
  • Therapeutic area: Rheumatoid arthritis
  • Pharmaceutical company: Gilead Sciences GmbH

Time table:

  • Start: 15.10.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

  • a1) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. methotrexate (MTX)): no additional benefit proved
  • a2) Patients without unfavourable prognostic factors and who have responded insufficiently or did not tolerate prior treatment with a disease-modifying agent (classical DMARDs, incl. MTX); filgotinib as in combination with MTX: no additional benefit proved
  • b1) Patients for whom treatment with biological DMARDs (bDMARDs) or targeted synthetic DMARDs (tsDMARDs) is indicated for the first time; filgotinib as monotherapy: no additional benefit proved
  • b2) Patients for whom treatment with bDMARDs or tsDMARDs is indicated for the first time; filgotinib in combination with MTX: hint for a minor additional benefit
  • c1) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib as monotherapy: no additional benefit proved
  • c2) Patients who have responded insufficiently or did not tolerate prior treatment with one or several bDMARDs and/or tsDMARDs; filgotinib in combination with MTX: no additional benefit proved

› 15.04.2021: Cannabidiol (reassessment: Dravet syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Dravet syndrome
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.10.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

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

› 15.04.2021: Cannabidiol (reassessment: Lennox-Gastaut syndrome, patients ≥ 2 years of age, in combination with clobazam)

Subject:

  • Active Substance: Cannabidiol
  • Name: Epidyolex®
  • Therapeutic area: Lennox-Gastaut syndrome
  • Pharmaceutical company: GW Pharmaceuticals plc

Time table:

  • Start: 15.10.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

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

› 15.04.2021: Semaglutide (new scientific evidence (§13): diabetes mellitus type 2)

Subject:

  • Active Substance: Semaglutide
  • Name: Rybelsus® / Ozempic®
  • Therapeutic area: Diabetes mellitus type 2
  • Pharmaceutical company: Novo Nordisk Pharma GmbH

Time table:

  • Start: 01.11.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

  • a) monotherapy:
    - a1) patients with high CV risk: no additional benefit proved)
    - a2) patients without high CV risk: no additional benefit proved
  • b) in combination with another antidiabetic (except for insulin, here: metformin):
    - b1) patients with high CV risk: no additional benefit proved
    - b2) patients without high CV risk: no additional benefit proved
  • c) in combination with two other antidiabetics (except for insulin):
    - c1) patients with high cardiovascular risk: no additional benefit proved
    - c2) patients without high CV risk: no additional benefit proved
  • d) in combination with insulin (with or w/o metformin or empagliflozin* or liraglutide*, if appropriate):
    - d1) patients with high CV risk: no additional benefit proved
    - d2) patients without high CV risk: no additional benefit proved

› 15.04.2021: Bempedoic acid / ezetimibe (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

  • Active Substance: Bempedoic acid / ezetimibe
  • Name: Nustendi®
  • Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
  • Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

  • Start: 01.11.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

  • a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
  • b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
    no additional benefit proved

› 15.04.2021: Bempedoic acid (primary hypercholersterolaemia and mixed dyslipidaemia)

Subject:

  • Active Substance: Bempedoic acid
  • Name: Nilemdo®
  • Therapeutic area: Primary hypercholesterolaemia and mixed dyslipidaemia
  • Pharmaceutical company: Daiichi Sankyo Deutschland GmbH

Time table:

  • Start: 01.11.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

  • a) Patients whose maximum tolerated lipid-lowering medicinal and dietary options have not been exhausted yet: no additional benefit proved
  • b) Patients whose maximum tolerated lipid-lowering medicinal (except of evolocumab) and dietary options have already been exhausted:
    no additional benefit proved

› 15.04.2021: Burosumab (new indication: X-linked hypophosphataemia, ≥ 18 years of age)

Subject:

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

Time table:

  • Start: 01.11.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

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

› 15.04.2021: Avapritinib (gastrointestinal stromal tumors (GIST))

Subject:

  • Active Substance: Avapritinib
  • Name: Ayvakyt®
  • Therapeutic area: Gastrointestinal stromal tumors (GIST)
  • Pharmaceutical company: Blueprint Medicines (Germany) GmbH

Time table:

  • Start: 01.11.2020
  • Final decision by G-BA: 15.04.2021

Final decision:

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

› 01.04.2021: Ibrutinib (new indication: chronic lymphatic leukemia (CLL), 1st line, combination with rituximab)

Subject:

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

Time table:

  • Start: 01.10.2020
  • Final decision by G-BA: 01.04.2021
  • This decision remains valid until: 01.04.2024

Final decision:

  • a) Patients who can be treated with fludarabine in combination with cyclophosphamide and rituximab (FCR): hint for a considerable additional benefit
  • b) Patients who cannot be treated with FCR: no additional benefit proved
  • c) Patients with 17p-deletion and/or T53-mutation or for whom a chemoimmunotherapy is not indicated due to other reasons: no additional benefit proved

› 01.04.2021: Durvalumab (new indication: small-cell lung cancer (SCLC), 1st line, combination with etoposide and either carboplatin or cisplatin

Subject:

  • Active Substance: Durvalumab
  • Name: Imfinzi®
  • Therapeutic area: Small-cell lung cancer (SCLC)
  • Pharmaceutical company: AstraZeneca GmbH

Time table:

  • Start: 01.10.2020
  • Final decision by G-BA: 01.04.2021

Final decision:

  • Hint for a minor additional benefit

› 01.04.2021: Sofosbuvir / velpatasvir (new indication: chronic hepatitis C, patients aged ≥ 6 and < 18 years)

Subject:

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

Time table:

  • Start: 01.10.2020
  • Final decision by G-BA: 01.04.2021

Final decision:

  • a) Patients aged 6 up to < 12 years (genotype 1, 4, 5, or 6): no additional benefit proved
  • b) Patients aged 6 up to < 12 years (genotype 2 or 3): no additional benefit proved
  • c) Patients aged 12 up to < 18 years (genotype 1, 4, 5, or 6): no additional benefit proved
  • d) Patients aged 12 up to < 18 years (genotype 2 or 3): no additional benefit proved

› 04.03.2021: Belantamab mafodotin (multiple myeloma, at least 4 prior therapies, monotherapy)

Subject:

  • Active Substance: Belantamap mafodotin
  • Name: Blenrep®
  • Therapeutic area: Multiple myeloma
  • Pharmaceutical company: GlaxoSmithKline GmbH & Co. KG

Time table:

  • Start: 15.09.2020
  • Final decision by G-BA: 04.03.2021
  • This decision remains valid until: 01.09.2022

Final decision:

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

› 18.02.2021: Alpelisib (breast cancer, PIK3CA-mutation, pre-treated patients, combination with fulvestrant)

Subject:

  • Active Substance: Alpelisib
  • Name: Piqray®
  • Therapeutic area: Breast cancer
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • A1) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: Indication for less benefit
  • A2) Postmenopausal women with progress after (neo)adjuvant endocrine monotherapy without lung or liver metastasis: No additional benefit proved
  • A2) Men with progress after (neo)adjuvant endocrine monotherapy: No additional benefit proved
  • B1) Postmenopausal women with progress after endocrine monotherapy in locally advanced setting or metastasized stage: Indication for less benefit
  • B2) Men with progress after endocrine monotherapy in locally advanced setting or metastasized stage: No additional benefit proved

› 18.02.2021: Bulevirtide (chronic hepatitis delta virus (HDV) infection, HDV-RNA-positive)

Subject:

  • Active Substance: Bulevirtide
  • Name: Hepcludex®
  • Therapeutic area: Chronic hepatitis D
  • Pharmaceutical company: MYR GmbH

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021
  • The decision remains valid until: 01.06.2025

Final decision:

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

› 18.02.2021: Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

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

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • Hint for a major additional benefit

› 18.02.2021: Ivacaftor / tezacaftor / elexacaftor (cystic fibrosis, combination with ivacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

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

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • Indication for a major additional benefit

› 18.02.2021: Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (heterozygous for F508del and MF mutation)

Subject:

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

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • Hint for a major additional benefit

› 18.02.2021: Ivacaftor (cystic fibrosis, combination with ivacaftor / tezacaftor / elexacaftor for patients aged ≥ 12 years (homozygous for F508del and MF mutation)

Subject:

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

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • Indication for a major additional benefit

› 18.02.2021: Entrectinib (NSCLC, ROS1-positive, advanced, 1st line)

Subject:

  • Active Substance: Entrectinib
  • Name: Rozlytrek®
  • Therapeutic area: Non-small cell lung cancer (NSCLC)
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021
  • This decision remains valid until: 31.12.2027

Final decision:

  • No additional benefit proved

› 18.02.2021: Entrectinib (solid tumors, neurotrophin tyrosine receptor kinase (NTRK) gene fusion, histology-independent)

Subject:

  • Active Substance: Entrectinib
  • Name: Rozlytrek®
  • Therapeutic area: Tumors with neurotrophin tyrosine receptor kinase (NTRK) gene fusion
  • Pharmaceutical company: Roche Pharma AG

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • No additional benefit proved

› 18.02.2021: Ibalizumab (multi-resistant HIV infection)

Subject:

  • Active Substance: Ibalizumab
  • Name: Trogarzo®
  • Therapeutic area: HIV infection
  • Pharmaceutical company: Theratechnologies Europe limited

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • No additional benefit proved

› 18.02.2021: Secukinumab (new scientific evidence (§14): psoriatic arthritis)

Subject:

  • Active Substance: Secukinumab
  • Name: Cosentyx®
  • Therapeutic area: Psoriatic arthritis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • A1) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy with concurrent moderate to severe plaque psoriasis: Indication for a minor additional benefit
  • A2) Patients who did not benefit sufficiently from or who did not tolerate a previous DMARD therapy without concurrent moderate to severe plaque psoriasis: No additional benefit proved
  • B) Patients who did not benefit sufficiently from or who did not tolerate a previous bDMARD therapy: No additional benefit proved

› 18.02.2021: Secukinumab (new indication: Plaque psoriasis, patients aged > 6 years)

Subject:

  • Active Substance: Secukinumab
  • Name: Cosentyx®
  • Therapeutic area: Plaque psoriasis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • Hint for a minor additional benefit

› 18.02.2021: Secukinumab (new indication: axial spondyloarthritis)

Subject:

  • Active Substance: Secukinumab
  • Name: Cosentyx®
  • Therapeutic area: Axial spondyloarthritis
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 01.09.2020
  • Final decision by G-BA: 18.02.2021

Final decision:

  • No additional benefit proved

› 04.02.2021: Nintedanib (new indication: systemic sclerosis associated interstitial lung disease (SSc-ILD))

Subject:

  • Active Substance: Nintedanib
  • Name: Ofev®
  • Therapeutic area: Systemic sclerosis associated interstitial lung disease (SSc-ILD)
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.08.2020
  • Final decision by G-BA: 04.02.2021

Final decision:

  • No additional benefit proved (orphan drug, 50 M € sales exceeded)

› 04.02.2021: Nintedanib (new indication: chronic fibrosing interstitial lung disease (ILD) with progressive phenotype)

Subject:

  • Active Substance: Nintedanib
  • Name: Ofev®
  • Therapeutic area: Chronic fibrosing interstitial lung disease (ILD) with progressive phenotype
  • Pharmaceutical company: Boehringer Ingelheim Pharma GmbH & Co. KG

Time table:

  • Start: 15.08.2020
  • Final decision by G-BA: 04.02.2021

Final decision:

  • Hint for a minor additional benefit (orphan drug, 50 M € sales exceeded)

› 04.02.2021: Trifarotene (acne vulgaris, ≥ 12 years of age)

Subject:

  • Active Substance: Trifarotene
  • Name: Selgamis®
  • Therapeutic area: Acne vulgaris
  • Pharmaceutical company: Galderma Laboratorium GmbH

Time table:

  • Start: 15.08.2020
  • Final decision by G-BA: 04.02.2021

Final decision:

  • No additional benefit proved

› 04.02.2021: Indicaterol acetate / glycopyrronium bromide / mometasone furoate (asthma bronchiale)

Subject:

  • Active Substance: Indicaterol acetate
  • Name: Enerzair Breezhaler®
  • Therapeutic area: Asthma bronchiale
  • Pharmaceutical company: Novartis Pharma GmbH

Time table:

  • Start: 15.08.2020
  • Final decision by G-BA: 04.02.2021

Final decision:

  • No additional benefit proved

 

Ansprechpartner

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