Breadcrumb

IQWiG’s results on AMNOG at a glance

The table below shows the main results of dossier assessments published by IQWiG since 1 January 2017 in accordance with the Act on the Reform of the Market for Medicinal Products (AMNOG). This Act became effective in 2011 and specifies that the benefit and harm of newly approved drugs must be assessed in comparison with conventional treatments. These assessments are based on dossiers submitted by drug manufacturers to the Federal Joint Committee (G-BA).  

 

English-language extracts

An English-language extract is provided for each dossier assessment. If the extract is not yet available and you would like to be informed when it becomes available, please send an e-mail to info@iqwig.de.

 


 

Date of publicationDrugTherapeutic indicationResult of dossier assessmentProject*Comment
19.09.2019Pembrolizumab with pemetrexed and platinum chemotherapyFirst-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutationsPD-L1 expression < 50%: proof of major added benefit for women, indication of minor added benefit for men. PD-L1 expression ≥ 50%: hint of major added benefit for women, hint or lesser benefit for menA19-61Addendum to A19-30
19.09.2019Pembrolizumab with carboplatin and either paclitaxel or nab-paclitaxelFirst-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adultsPD-L1 expression < 50%: indication of major added benefit. PD-L1 expression ≥ 50%: added benefit not provenA19-62Addendum to A19-31
16.09.2019Pomalidomide with bortezomib and dexamethasoneAdults with multiple myeloma who have received at least one prior treatment regimen including lenalidomideDue to negative effects in several side effects hint of lesser benefit than bortezomib and dexamethasone aloneA19-50 
02.09.2019Empagliflozin / linagliptinAdults with type 2 diabetes mellitus when diet and exercise plus at least 2 blood-glucose lowering drugs (except insulin, here metformin/sulphonylurea and empagliflozin/linagliptin) do not provide adequate glycaemic controlAdded benefit not proven due to a lack of suitable study dataA19-49New therapeutic indication. See also as single preparation A14-26 with Addendum A14-50 and A16-12 with Addendum A16-46; in combination with metformin: A16-13 with Addendum A16-47
02.09.2019LorlatinibAdults with ALK-positive advanced NSCLC whose disease has progressed after alectinib or ceritinib as the first ALK tyrosine kinase inhibitor (TKI) therapy, or after crizotinib and at least one other ALK TKIAdded benefit versus appropriate comparator therapy not proven due to a lack of suitable study dataA19-48 
02.09.2019Risankizumab Adults with moderate to severe plaque psoriasisProof of considerable added benefit for patients with inadequate response or intolerance to systemic therapy. Due to a lack of relevant study data, an added benefit is not proven for patients who are not candidates for conventional therapy in the framework of a first systemic therapy.A19-41 
15.08.2019Nivolumab + ipilimumabTreatment-naive adults with intermediate or poor-risk advanced renal cell carcinomaConclusion of dossier assessments A19-11 and A19-12 unchangedA19-54 Addendum to A19-11 and A19-12
15.08.2019FremanezumabMigraine prophylaxis in adult patients with at least 4 migraine days per monthAdded benefit not proven due to a lack of suitable study dataA19-44 
01.08.2019DapagliflozinAdults with type 1 diabetes and body mass index ≥ 27 kg/m2, when insuline alone provides no adequate glycaemic control despite optimum insulin therapy The non-quantifiable advantage in the change of the HbA1c value (surrogate for microvascuolar late complications) is outweighed by disadvantages in the side effects; added benefit not proven.A19-37 
01.08.2019DacomitinibAdult patients with locally advanced or metastatic NSCLC with activating EGFR mutationsPatients with L858R or Del19 mutations: Advantages in overall survival and individual side effects are offset by numerous disadvantages in several outcome categories. Other mutations: No data available. Added benefit not proven for either of both research questions.A19-39 
01.08.2019Lisdexamfetamine Within the overall therapeutic strategy in adults with at least moderate-severity ADHS and symptoms since childhoodAdded benefit not proven due to a lack of suitable study dataA19-40 
01.08.2019ApalutamideAdults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastases Conclusion of dossier assessment A19-09 unchangedA19-51Addendum to A19-09
15.07.2019Radium-223 dichloride (Ra 223) as monotherapy or in combination with an LH-RH analogueAdults with metastatic castration-resistant prostate cancer and symptomatic bone metastases (without visceral metastases) whose disease has progressed after several systemic treatments or for whom no other systemic treatment is suitableAdded benefit is not proven due to a lack of suitable study dataA19-32 
15.07.2019Glecaprevir / pibrentasvirChronic hepatitis C virus infection in adolescents aged 12 to < 18 years Added benefit not proven due to a lack of suitable study dataA19-33 
15.07.2019NintedanibAdults with idiopathic pulmonary fibrosisThe disadvantage regarding the side effects (gastrointestinal disorders) does not completely call into question the advantage in exacerbations; proof of a minor added benefit A19-36 
04.07.2019Ribociclib + fulvestrantPatients with HR-positive, HER2-negative locally advanced or metastatic breast cancerConclusion of dossier assessment A19-06 unchangedA19-45Addendum to A19-06
04.07.2019Ribociclib + aromatase inhibitorPatients with HR-positive, HER2-negative locally advanced or metastatic breast cancerConclusion of dossier assessment A19-06 unchangedA19-46Addendum to A19-06
04.07.2019MelatoninInsomnia in children and adolescents with Autism Spectrum Disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficientConclusion of dossier assessment A19-04 unchangedA19-47Addendum to A19-04
01.07.2019GalcanezumabProphylaxis of migraine in adults who have at least 4 migraine days per monthAdded benefit not proven for 2 of 3 research questions due to lack of study data. Adults with episodic or chronic migraine for whom otherwise best supportive care is the only option: indication of major added benefit.A19-28 
01.07.2019PembrolizumabMonotherapy for the adjuvant treatment of adults with Stage III melanoma and lymph node involvement who have undergone complete resectionDisadvantages in side effects do not completely call into question the advantages in recurrence; overall hint of considerable added benefitA19-29 
01.07.2019Pembrolizumab with pemetrexed and platinum chemotherapyFirst-line treatment of metastatic non-squamous non-small cell lung cancer (NSCLC) in adults whose tumours have no EGFR or ALK positive mutationsAdded benefit not proven for either of both research questions (PD-L1 expression < or ≥ 50%)A19-30 
01.07.2019Pembrolizumab with carboplatin and either paclitaxel or nab-paclitaxelFirst-line treatment of metastatic squamous non-small cell lung cancer (NSCLC) in adultsAdded benefit not proven for either of both research questions (PD-L1 expression < or ≥ 50%)A19-31 
21.06.2019FingolimodChildren and adolescents with highly active or rapidly evolving relapsing-remitting multiple sclerosis (RRMS)In one research question now also hint of added benefit in the category "health-related quality of life"; conclusion of dossier assessment A18-87 nonetheless unchangedA19-42Addendum to A18-87
17.06.2019EmicizumabRoutine prophylaxis of bleeding episodes in patients with severe haemophilia A without factor VIII inhibitorsPresented before-after comparison unsuitable for the assessment of the added benefit; added benefit not provenA19-26New therapeutic indication, see also A18-20
06.06.2019CabozantinibHepatocellular carcinoma after prior sorafenib therapyConclusion of dossier assessment A18-85 unchangedA19-38Addendum to A18-85
03.06.2019RucaparibMonotherapy treatment of adult patients with platinum sensitive, relapsed or progressive, BRCA mutated, high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer, who have been treated with two or more prior lines of platinum based chemotherapy, and who are unable to tolerate further platinum based chemotherapyAdded benefit versus appropriate comparator therapy not proven due to lack of suitable study dataA19-22See also A19-23
03.06.2019RucaparibMaintenance treatment of adult patients with platinumsensitive relapsed high-grade epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in response to platinum-based chemotherapyExclusively negative effects mainly due to different side effects, but no informative results on overall survival. Hence, added benefit not proven.A19-23See also A19-22
16.05.2019EnzalutamideHigh-risk non-metastatic castration-resistant prostate cancerConclusion of dossier assessment A18-80 unchangedA19-34Addendum to A18-80
16.05.2019Venetoclax with rituximabAdult patients with chronic lymphocytic leukaemia with at least one prior therapy and without 17p deletion and/or TP53 mutation who are candidates for chemoimmunotherapyStudy MURANO: effects only in favour of venetoclax with rituximab in comparison with bendamustine with rituximab; derivation of an added benefit not possible due to deviation from appropriate comparator therapy, howeverA19-35Addendum to A18-81
15.05.2019Nivolumab + ipilimumabTreatment-naive adults with intermediate/poor-risk advanced renal cell carcinomaIndication of considerable added benefit for intermediate risk profile; indication of major added benefit for poor risk profileA19-11See also A19-12; see press release
15.05.2019Ipilimumab + nivolumabTreatment-naive adults with intermediate/poor-risk advanced renal cell carcinomaIndication of considerable added benefit for intermediate risk profile; indication of major added benefit for poor risk profileA19-12See also A19-11; see press release
15.05.2019Lumacaftor / ivacaftorCystic fibrosis in patients aged 2 to 5 years who are homozygous for the F508del mutation in the CFTR geneSingle-arm study without very large (dramatic) effects, no data on comparator therapy, transfer from studies in older children unproductive; added benefit not provenA19-13 
15.05.2019LenvatinibProgressive, locally advanced or metastatic, differentiated thyroid carcinoma, refractory to radioactive iodineNo usable data for adjusted indirect comparison with appropriate comparator therapy; added benefit not provenA19-19 
02.05.2019ApalutamideAdults with non-metastatic castration-resistant prostate cancer who are at high risk of developing metastatic diseaseClear advantages in symptomatic progression, disadvantages in some side effects; indication of considerable added benefitA19-09see press release
02.05.2019Abemaciclib with an aromatase inhibitorInitial endocrine therapy in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancerStill indication of lesser benefit in comparison with appropriate comparator therapyA19-24Addendum to A18-72
02.05.2019Abemaciclib with fulvestrantWomen with HR-positive, HER2-negative locally advanced or metastatic breast cancerConclusion of dossier assessment A18-73 unchangedA19-25Addendum to A18-73
02.05.2019Fluticasone furoate / umeclidinium / vilanterol Maintenance treatment in adults with moderate to severe COPD who still have symptoms under a combination of a LABA and a LAMAAdditional analysis of a comparison with a treatment that is not in line with the appropriate comparator therapy; assessment result of A18-79 unchangedA19-27Addendum to A18-79
15.04.2019MelatoninInsomnia in children and adolescents with Autism Spectrum Disorder and/or Smith-Magenis syndrome, where sleep hygiene measures have been insufficientAdded benefit not proven due to lack of informative study dataA19-04 
15.04.2019Doravirine / lamivudine / tenofovir disoproxil fumarateAdults infected with HIV-1Added benefit not proven for treatment-naive or pretreated patientsA19-05 
15.04.2019Ribociclib in combination with an aromatase inhibitor or fulvestrantPatients with HR-positive, HER2-negative locally advanced or metastatic breast cancerPostmenopausal women: survival advantages, but also higher frequency of severe side effects. Overall: added benefit not proven. Pre- and perimenopausal women: indication of lesser benefit than appropriate comparator therapy for one group of patients; other groups: added benefit not proven.A19-06Extension of the therapeutic indication; see also A17-45; see press release
15.04.2019DoravirineAdults infected with HIV-1Added benefit not proven for treatment-naive or pretreated patientsA19-07 
15.04.2019BrigatinibAdult patients with ALK-positive advanced non-small cell lung cancer (NSCLC) previously treated with crizotinibAdded benefit not proven due to lack of suitable study dataA19-08 
04.04.2019OcriplasminVitreomacular traction, including when associated with macular hole of diameter ≤ 400 micronsConclusion of dossier assessment A18-68 unchangedA19-20Addendum to A18-68
04.04.2019DurvalumabLocally advanced, unresectable NSCLCStill hint of considerable added benefitA19-21Addendum to A18-69
01.04.2019Damoctocog alfa pegolTreatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency)Added benefit not proven due to lack of suitable study dataA18-86 
01.04.2019FingolimodChildren and adolescents with highly active or rapidly evolving relapsing-remitting multiple sclerosis (RRMS)If RRMS is highly active and switch of basic therapeutic agents is indicated despite a full and adequate course of treatment with at least one disease-modifying therapy: hint of non-quantifiable added benefit. Other patient groups: added benefit not provenA18-87 
01.04.2019Atezolizumab First-line treatment of adult patients with locally advanced or metastatic urothelial carcinoma who are inelegible for cisplatin-containing first-line treatment and whose tumours have a PD-L1 expression ≥ 5%Added benefit not proven due to lack of suitable study dataA18-88See also A17-51
01.04.2019PembrolizumabLocally advanced or metastatic urothelial carcinoma in adults who are not eligible for cisplatin-containing chemotherapy and whose tumours express PD-L1 with a combined positive score (CPS) ≥ 10Added benefit not proven due to lack of informative study dataA18-89See also A17-46
22.03.2019Palbociclib in combination with fulvestrantWomen with HR-positive, HER2-negative advanced or metastatic breast cancer with progression after endocrine therapyAdded benefit still not proven after analysis of further data from the PALOMA-3 studyA19-14Addendum to A18-63
22.03.2019LenvatinibAdult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapyAdded benefit still not proven for both research questions after analysis of further dataA19-15Addendum to A18-57
22.03.2019Daratumumab in combination with bortezomib, melphalan and prednisoneAdult patients with newly diagnosed multiple myelomaAnalysis of the first data cut-off for the total study population and subpopulation (not eligible for autologous stem cell transplant): both advantages and disadvantages versus appropriate comparator therapyA19-16Addendum to A18-66
22.03.2019Encorafenib in combination with binimetinibAdult patients with unresectable or metastatic melanoma with a BRAF V600 mutationAdded benefit still not proven for pretreated or treatment-naive patients after analysis of further data on adverse events on the adjusted indirect comparison of the studies COLUMBUS and coBRIMA19-17Addendum to A18-61
21.03.2019Binimetinib in combination with encorafenibAdult patients with unresectable or metastatic melanoma with a BRAF V600 mutationAdded benefit still not proven for pretreated or treatment-naive patients after analysis of further data on adverse events on the adjusted indirect comparison of the studies COLUMBUS and coBRIMA19-18Addendum to A18-62
15.03.2019CabozantinibHepatocellular carcinoma after prior sorafenib therapyAdvantage in overall survival, negative effects in severe/serious side effects; overall indication of minor added benefit versus best supportive careA18-85 
01.03.2019EnzalutamideHigh-risk non-metastatic castration-resistant prostate cancerBoth positive and negative effects regarding side effects; added benefit not provenA18-80 
01.03.2019Venetoclax with rituximabAdult patients with chronic lymphocytic leukaemia who have received at least one prior therapyNo adequate implementation of appropriate comparator therapy; added benefit neither proven for patients with 17p deletion or TP53 mutation nor for patients without 17p deletion or TP53 mutationA18-81New therapeutic indication; see A18-82 for monotherapy
01.03.2019Venetoclax (monotherapy)Adult patients with chronic lymphocytic leukaemia who are unsuitable for or have failed treatments with a B-cell receptor pathway inhibitor or chemoimmunotherapyNo comparisons with appropriate comparator therapy presented; added benefit neither proven for patients with 17p deletion or TP53 mutation nor for patients without 17p deletion or TP53 mutationA18-82Orphan drug status lifted; see A18-81 for combination with rituximab
01.03.2019Insulin degludecType 2 diabetes mellitus in adultsIf treatment with at least 2 blood-glucose lowering drugs (except insulin) is insufficient and if the treatment goal is near-normal blood glucose levels: indication of lesser benefit versus appropriate comparator therapy. Other goals or patients pretreated with insulin: added benefit not proven. No suitable analyses of the DEVOTE study.A18-84 
21.02.2019Tofacitinib in combination with methotrexateActive psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a prior DMARD therapyNow hint of minor added benefit after pretreatment with a conventional synthetic DMARD. Added benefit still not proven after pretreatment with a biological DMARDA19-03Addendum to A18-53
21.02.2019Ingenol mebutatePatients with non-hyperkeratotic, non-hypertrophic actinic keratosisConclusion of dossier assessment A18-55 unchangedA19-02Addendum to A18-55
21.02.2019NivolumabAdjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionStage IIIB/C and IV disease: now hint of non-quantifiable added benefit. Stage IIIA disease: added benefit not provenA19-01Addendum to A18-51
15.02.2019Fluticasone furoate/umeclidinium/vilanterolMaintenance treatment in adults with moderate to severe COPD who still have symptoms under a combination of a LABA and a LAMAAdded benefit not proven due to lack of suitable study dataA18-79 
15.02.2019TildrakizumabAdults with moderate to severe plaque psoriasis who are candidates for systemic therapyAdded benefit not proven due to lack of suitable study dataA18-78 
01.02.2019ErenumabProphylaxis of migrainePatients who do not respond to other drug classes, or do not tolerate them, or for whom these are unsuitable: indication of considerable added benefit. Patients with other treatment options: added benefit not proven.A18-71Study data only on episodic migraine, therefore uncertain transferability to patients with chronic migraine according to ICHD-3; see press release
01.02.2019Abemaciclib with an aromatase inhibitorWomen with HR-positive, HER2-negative locally advanced or metastatic breast cancerInitial endocrine therapy in postmenopausal women: indication of lesser benefit in comparison with appropriate comparator therapy. Subsequent endocrine therapy and/or pre- or perimenopausal women: added benefit not proven due to a lack of study data.A18-72See also A18-73
01.02.2019Abemaciclib with fulvestrantWomen with HR-positive, HER2-negative locally advanced or metastatic breast cancerInitial or subsequent therapy in postmenopausal women: hint of lesser benefit in comparison with appropriate comparator therapy. Pre- or perimenopausal women: added benefit not proven due to lack of suitable study data.A18-73See also A18-72
01.02.2019AlirocumabPrimary hypercholesterolaemia or mixed dyslipidaemiaAdded benefit neither proven for patients for whom statin therapy is an option nor for patients with intolerance or contraindication to statin therapyA18-74New assessment due to new scientific findings, see 15-47
01.02.2019SemaglutideType 2 diabetes mellitusAdded benefit neither proven for monotherapy nor in combination with other blood-glucose lowering drugs; analyses of the SUSTAIN 6 study additionally presented not meaningfullly interpretableA18-75 
15.01.2019PembrolizumabHead and neck squamous cell carcinomaAdvantage in overall survival, disadvantages in some side effects; hint of non-quantifiable added benefitA18-67see press release
15.01.2019OcriplasminVitreomacular traction, including when associated with macular hole of diameter ≤ 400 micronsAdded benefit not proven for mild or severe symptomsA18-68New assessment after expiry of decision, see A13-20
15.01.2019DurvalumabLocally advanced, unresectable NSCLCAdvantage in overall survival, disadvantages in some side effects; hint of considerable added benefitA18-69 
02.01.2019LenvatinibAdult patients with advanced or unresectable hepatocellular carcinoma who have received no prior systemic therapyAdded benefit not proven for the 2 subindications (no liver cirrhosis or stage Child-Pugh A, Child-Pugh B)A18-57 
02.01.2019MepolizumabAdd-on treatment for severe refractory eosinophilic asthma in adolescents and children aged 6 years and olderAdded benefit not proven due to lack of suitable dataA18-58 
02.01.2019Dabrafenib in combination with trametinibAdjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resectionAdvantage in overall survival and recurrence, disadvantages in side effects; indication of considerable added benefitA18-59See press release on A18-59 to A18-62
02.01.2019Trametinib in combination with dabrafenibAdjuvant treatment of adult patients with stage III melanoma with a BRAF V600 mutation, following complete resectionAdvantage in overall survival and recurrence, disadvantages in side effects; indication of considerable added benefitA18-60See press release on A18-59 to A18-62
02.01.2019Encorafenib in combination with binimetinibAdult patients with unresectable or metastatic melanoma with a BRAF V600 mutationAdded benefit not proven for pretreated or treatment-naive patientsA18-61See press release on A18-59 to A18-62
02.01.2019Binimetinib in combination with encorafenibAdult patients with unresectable or metastatic melanoma with a BRAF V600 mutationAdded benefit not proven for pretreated or treatment-naive patientsA18-62See press release on A18-59 to A18-62
02.01.2019Palbociclib in combination with fulvestrantPatients with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer after prior endocrine therapyPALOMA-3 study unsuitable for the derivation of an added benefit due to inadequate implementation of appropriate comparator therapy; added benefit not provenA18-63New assessment after expiry of decision, see A16-74 and A17-15
02.01.2019Tenofovir alafenamideTreatment-naive or treatment-experienced adolescents or adults with chronic hepatitis BAdded benefit not proven for any of the 4 subindicationsA18-64New assessment after expiry of decision, see A17-13
02.01.2019Sitagliptin in oral combination with metforminAdult patients with type 2 diabetes mellitus with inadequate glycaemic control by diet and exercise plus metformin monotherapyComparison with sulfonylurea (glibenclamide or glimepiride) + metformin: hint of non-quantifiable (at most considerable) added benefit. Comparison with glipizide + metformin: treatment goal near-normal blood glucose levels: hint of considerable added benefit; other treatment goal: added benefit not provenA18-65New assessment after expiry of decision, see A16-44; first assessment: A13-02
02.01.2019Daratumumab in combination with bortezomib, melphalan and prednisoneAdult patients with newly diagnosed multiple myeloma who are not eligible for autologous stem cell transplantAdvantage in overall survival, but also disadvantages in side effects; hint of minor added benefitA18-66 
20.12.2018PertuzumabAdjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence, in combination with trastuzumab and chemotherapyConclusion of dossier assessment A18-41 unchangedA18-76Addendum to A18-41
20.12.2018Bictegravir / emtricitabine / tenofovir alafenamideAdults infected with HIV-1Conclusion of dossier assessment A18-43 unchangedA18-77Addendum to A18-43
06.12.2018CabozantinibTreatment-naive adults with advanced renal cell carcinoma (intermediate or poor risk)Conclusion of dossier assessment A18-37 unchangedA18-70Addendum to Commission A18-37
03.12.2018Tofacitinib in combination with methotrexateActive psoriatic arthritis in adults who have had an inadequate response or who have been intolerant to a priorAdded benefit not proven for pretreatment with a conventional synthetic DMARD or with a biological DMARDA18-51 
03.12.2018TofacitinibAdults with moderately to severely active ulcerative colitis who have had an inadequate response or were intolerant to either conventional therapy or a biologic agentAdded benefit not proven due to lack of suitable study dataA18-52 
03.12.2018NivolumabAdjuvant treatment of adults with melanoma with involvement of lymph nodes or metastatic disease who have undergone complete resectionAdded benefit not provenA18-53 
03.12.2018BosutinibPretreated adults with Philadelphia chromosome-positive chronic myelogenous leukaemia (Ph+ CML) and limited treatment optionsDue to a lack of suitable study data, added benefit not proven in the chronic phase or in the accelaterated phase and blast crisisA18-54 
03.12.2018Ingenol mebutatePatients with non-hyperkeratotic, non-hypertrophic actinic keratosisActinic keratosis on face or scalp: hint of non-quantifiable (at most considerable) added benefit; on trunk or extremeties: added benefit not provenA18-55New benefit assessment due to new scientic findings, see A13-04
07.11.2018Tofacitinib in combination with methotrexatebDMARD-naive adults with moderate to severe active rheumatoid arthritis for whom a first treatment with a bDMARD is indicatedBased on the data subsequently submitted on serious infections, the added benefit is now not provenA18-56Addendum to A18-28
02.11.2018BrivaracetamAdjunctive therapy in the treatment of partial-onset seizures with or without secondary generalization in children and adolescents with epilepsyAdded benefit not proven due to a lack of suitable study dataA18-48 
15.10.2018OsimertinibFirst-line treatment of adults with locally advanced or metastatic NSCLC (lung cancer) with activating EGFR mutationsEGFR mutations in exon 21 (L858R) or exon 19 deletion: Hint of non-quantifiable added benefit. Other activating EGFR mutations: added benefit not provenA18-45 
04.10.2018CariprazineAdults with schizophrenia, outcome "akathisia"Long-term treatment: In patients with mostly negative symptoms hint of a non-quantifiable added benefit. Remaining patients as well as acute treatment: added benefit not provenA18-50Addendum to A18-25
01.10.2018PertuzumabAdjuvant treatment of adult patients with HER2-positive early breast cancer at high risk of recurrence, in combination with trastuzumab and chemotherapyPatients < 65 years: added benefit not proven; patients ≥ 65 years: hint of lesser benefit in comparison with the appropriate comparator therapyA18-41 
01.10.2018Bictegravir / emtricitabine / tenofovir alafenamideAdults infected with HIV-1Treatment-naive adults and pretreated adults with indication for a treatment switch: added benefit not proven. Without indication for a treatment switch: added benefit not proven for men; indication of lesser benefit versus the appropriate comparator therapy for women.A18-43 
01.10.2018Ipilimumab + nivolumabAdults with advanced (unresectable or metastatic) melanomaTreatment-naive patients with BRAF V600 mutant tumour and pretreated patients: added benefit not proven. Treatment-naive patients with BRAF V600 WT tumour: indication of lesser benefitA18-44See also A18-40
20.09.2018EmicizumabRoutine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitorsConclusion of dossier assessment A18-20 unchangedA18-49Addendum to A18-20
17.09.2018Dolutegravir / rilpivirineHIV-1 infection in adults who are virologically-suppressed on a stable regimen for ≥ 6 months with no history of virological failure and no known or suspected resistance to any NNRTIs or INIsWithout indication for a treatment switch: indication of lesser benefit; with indication for a treatment switch: added benefit not provenA18-34 
17.09.2018OlaparibPatients with platinum-sensitive relapsed high-grade ovarian cancerSerous epithelial ovarian cancer: hint of minor added benefit. Non-serous epithelial ovarian cancer: added benefit not provenA18-36Orphan drug status lifted; therapeutic indication expanded
17.09.2018CabozantinibTreatment-naive adults with advanced renal cell carcinoma (intermediate or poor risk)Intermediate risk: hint of non-quantifiable added benefit in positive MET IHC status; added benefit not proven in other cases; poor risk: added benefit not provenA18-37 
17.09.2018Nivolumab + ipilimumabTreatment-naive adults with advanced (unresectable or metastatic) melanoma with BRAF V600 WT tumourDue to disadvantages in health-related quality of life and side effects, indication of lesser benefit in comparison with the appropriate comparator therapy (nivolomab alone)A18-40See also A18-44
03.09.2018BosutinibAdult patients with newly-diagnosed chronic phase Philadelphia chromosome-positive chronic myelogenous leukaemiaDue to disadvantages regarding severe side effects, hint of lesser benefit in comparison with the appropriate comparator therapyA18-33 
16.08.2018Fluticasone furoate / umeclidinium / vilanterolAdults with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta 2 agonistConclusion of dossier assessment A18-15 unchangedA18-46Addendum to A18-15
16.08.2018IxekizumabPatients with active psoriatic arthritis who have responded inadequately to, or who are intolerant to one or moreNow added benefit not proven for any of the three subindicationsA18-47Addendum to A18-14
15.08.2018HydrocortisoneChildren with adrenal insufficiencyAdded benefit not proven due to lack of suitable study dataA18-29 
15.08.2018Ertugliflozin/sitagliptin (type 2 diabetes mellitus) Adults inadequately controlled by treatment with at least two blood-glucose lowering drugs (except insulin; here: metformin and/or a sulphonylurea and ertugliflozin or sitagliptin)No study data; added benefit not proven in comparison with the appropriate comparator therapyA18-31 
15.08.2018Rurioctocog alfa pegol (haemophilia A)Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency) aged 12 years or olderNo study data; added benefit not proven in comparison with the appropriate comparator therapyA18-32 
02.08.2018OcrelizumabAdults with active relapsing multiple sclerosis (RMS) or with early primary progressive multiple sclerosis (PPMS)Active RMS: proof of considerable (< 40 years) or minor (≥ 40 years) added benefit; highly active RMS: added benefit not proven. PPMS: indication of lesser benefit than appropriate comparator therapyA18-38Addendum to A18-06
02.08.2018Lumacaftor / ivacaftorCystic fibrosis (CF) in 6 to 11 year old children who are homozygous for the F508del mutation in the CFTR geneConclusion of dossier assessment A18-08 unchangedA18-39Addendum to A18-08
02.08.2018BenralizumabAdd-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta agonistsConclusion of dossier assessment A18-11 unchangedA18-42Addendum to A18-11
01.08.2018Extract from Cannabis sativa Adults with moderate to severe spasticity due to multiple sclerosis (MS) who have not responded adequately to other anti-spasticity medication and who demonstrated improvement in spasticity-related symptoms during an initial trial of therapyHint of an added benefit with the extent "non-quantifiable", at most "considerable"A18-27Expiry of the time limit of the G-BA’s decision, see first assessment A12-01
01.08.2018Tofacitinib in combination with methotrexatebDMARD-naive adults with moderate to severe active rheumatoid arthritis for whom a first treatment with a bDMARD is indicatedNegative effect in serious infections; indication of lesser benefit in comparison with the comparator therapyA18-28Expiry of the time limit of the G-BA’s decision, see first assessment A17-18 and addendum A17-43
16.07.2018CariprazineAdults with schizophreniaLong-term treatment: In patients with mostly negative symptoms hint of a non-quantifiable added benefit. Remaining patients as well as acute treatment: added benefit not provenA18-25 
02.07.2018EmicizumabRoutine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitorsAdded benefit not proven due to lack of suitable study dataA18-20 
02.07.2018PatiromerHyperkalaemia in adultsAdded benefit not proven due to lack of suitable study dataA18-21 
02.07.2018Glycopyrronium bromideSevere sialorrhoea (chronic pathological drooling) in children and adolescents aged 3 years and older with chronic neurological disordersAdded benefit not proven as the appropriate comparator therapy (best supportive care) was not implemented in any of the studiesA18-22 
02.07.2018BezlotoxumabPrevention of recurrence of Clostridium difficile infection (CDI) in adults at high risk for recurrence of CDIProof of non-quantifiable (at most considerable) added benefitA18-23 
21.06.2018Alectinib First-line treatment of adults with ALK-positive advanced NSCLC (lung cancer)Conclusion of dossier assessment A17-67 unchangedA18-30Addendum to A17-67
15.06.2018EvolocumabPrimary hypercholesterolaemia (heterozygous familial and non-familial) or mixed dyslipidaemiaAdded benefit not proven for any of the three research questions due to a lack of relevant study dataA18-19See also assessment A15-38
07.06.2018Abiraterone acetate in combination with prednisone / prednisolone and androgen deprivation therapyAdults with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC)Changes both in positive and in negative effects; as a conclusion still proof of a considerable added benefitA18-26Addendum to A17-64
01.06.2018IxekizumabPatients with active psoriatic arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drug (DMARD) therapiesPatients who have responded inadequately to treatment with a conventional DMARD or a bDMARD: added benefit not proven due to lack of data. If first bDMARD treatment is indicated: hint of minor added benefitA18-14 
01.06.2018Fluticasone furoate / umeclidinium / vilanterolAdults with moderate to severe COPD who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta 2 agonistNo statistically significant differences between the treatment groups in the relevant subpopulation of the study included; added benefit not provenA18-15 
01.06.2018Insulin glargine / lixisenatide in combination with metforminAdults with type 2 diabetes mellitus when metformin combined with another oral glucose-lowering medicinal product or with basal insulin does not provide adequate glycaemic controlDepending on therapeutic indication and treatment goal: hint of lesser benefit than under the comparator therapy or added benefit not provenA18-16 
17.05.2018GuselkumabAdults with moderate to severe plaque psoriasis with inadequate response to other systemic treatments or with contraindication or intoleranceBased on the study data subsequently submitted, there is now proof of a major added benefit in this therapeutic indicationA18-24Addendum to A17-60
15.05.2018IpilimumabAdvanced (unresectable or metastatic) melanoma in adolescents aged between 12 and 18 yearsInadequate transfer of results from study with adults; added benefit not provenA18-12 
15.05.2018SonidegibAdults with locally advanced basal cell carcinoma who are not amenable to curative surgery or radiation therapyAdded benefit not proven due to lack of suitable study dataA18-10 
15.05.2018BenralizumabAdd-on maintenance treatment in adults with severe eosinophilic asthma inadequately controlled despite high-dose inhaled corticosteroids plus long-acting beta agonistsAdded benefit not proven due to lack of suitable study dataA18-11 
02.05.2018Lumacaftor/ivacaftorCystic fibrosis (CF) in children aged between 6 and 11 years who are homozygous for the F508del mutation in the CFTR geneNeither positive nor negative effects in comparison with the best possible symptomatic treatment; added benefit not provenA18-08 
02.05.2018OcrelizumabAdults with active relapsing multiple sclerosis (RMS) or with early primary progressive multiple sclerosis (PPMS)Active RMS: proof of considerable (< 40 years) or minor (≥ 40 years) added benefit; highly active RMS: indication of considerable added benefit. PPMS: indication of lesser benefit than appropriate comparator therapyA18-06 
19.04.2018TivozanibRenal cell carcinomaNo change in the conclusion compared with A17-58A18-17Addendum to A17-58
16.04.2018Elvitegravir / cobicistat / emtricitabine / tenofovir alafenamideChildren aged 6 to 12 years who are infected with HIV-1No study data; added benefit not proven in comparison with the appropriate comparator therapyA18-01See also A17-59
05.04.2018CabozantinibAdults with advanced renal cell carcinoma after targeted therapy against vascular endothelial growth factor (VEGF)No change in the conclusion compared with A17-56A18-13Addendum to A17-56
05.04.2018CabozantinibAdults with advanced renal cell carcinoma after targeted therapy against vascular endothelial growth factor (VEGF)No change in the conclusion compared with A17-56A18-18Second addendum to A17-56, see also A18-13
03.04.2018Dapagliflozin (add-on to metformin)Diabetes mellitus type 2Added benefit not provenA17-65Renewed benefit assessment due to new scientic findings, see A12-18 and A13-18
03.04.2018Dapagliflozin/metformin (fixed combination)Diabetes mellitus type 2Added benefit not provenA17-66Renewed benefit assessment due to new scientic findings, see A14-07
03.04.2018AlectinibFirst-line treatment of adults with ALK-positive advanced NSCLC (lung cancer)Hint of a non-quantifiable added benefitA17-67 
15.03.2018Abiraterone acetate in combination with prednisone/prednisolone and androgen deprivation therapyAdults with newly diagnosed high-risk metastatic hormone-sensitive prostate cancer (mHSPC)Proof of considerable added benefitA17-64 
15.03.2018RibociclibInitial endocrine therapy in postmenopausal women with HR-positive, HER2-negative locally advanced or metastatic breast cancerUnchanged conclusion compared with dossier assessment A17-45A18-07Addendum to A17-45
15.03.2018AtezolizumabAdults with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapyNo change in the conclusion compared with the dossier assessment A17-50A18-09Addendum to A17-50
01.03.2018GuselkumabAdults with moderate to severe plaque psoriasisIndication of considerable added benefit in both subindications (systemic therapy suitable/not suitable)A17-60 
01.03.2018PerampanelAdjunctive treatment of primary generalized tonic-clonic seizures in adults and adolescents with idiopathic generalized epilepsyAppropriate comparator therapy not implemented; added benefit not provenA17-61 
01.03.2018CladribineAdults with highly active relapsing multiple sclerosisAdded benefit not proven for any of the 3 relevant patient groupsA17-62 
01.03.2018DupilumabAdults with moderate to severe atopic dermatitis who are candidates for systemic treatmentIndication of a non-quantifiable added benefitA17-63 
01.03.2018BrodalumabAdults with moderate to severe plaque psoriasisUnchanged compared with A17-42 A18-02Addendum to A17-42
15.02.2018Elvitegravir / cobicistat / emtricitabine / tenofovir disoproxilHIV-1-infected adolescentsNo study data; added benefit not proven in comparison with the appropriate comparator therapyA17-59 
15.02.2018DaratumumabAdults with multiple myeloma who have received at least one previous treatmentCombination with lenalidomide and dexamethasone or with bortezomib and dexamethasone: proof of considerable added benefit. Monotherapy: added benefit not provenA18-03Addendum to A17-40
15.02.2018CarfilzomibAdults with multiple myeloma who have received at least one previous treatmentCombination with lenalidomide and dexamethasone: indication of a considerable added benefit for patients < 65 years and hint of minor added benefit for patients ≥ 65 years. Combination with dexamethasone: indication of minor added benefit.A18-04Addendum to A17-38
15.02.2018Sofosbuvir / velpatasvir / voxilaprevirChronic hepatitis CDAA-naive adults with CHC genotype 3 without cirrhosis: hint of non-quantifiable, at most minor added benefit. Remaining 12 research questions: unchangedA18-05Addendum to A17-35
01.02.2018TivozanibRenal cell carcinoma Due to a lack of usable study data, an added benefit is neither proven for first-line treatment nor for disease progression after cytokine treatment.A17-58 
01.02.2018Nonacog beta pegolTreatment and prophylaxis of bleeding in patients with haemophilia B who are at least 12 years of ageNo relevant data; added benefit not provenA17-57 
15.01.2018Sofosbuvir (in combination with ribavirin)Adolescents with genotype 2 or 3 chronic hepatitis CPretreated adolescents: hint of a non-quantifiable added benefit; treatment-naïve adolescents: added benefit not provenA17-55 
15.01.2018CabozantinibAdult patients with advanced renal cell carcinoma following prior vascular endothelial growth factor (VEGF)-targeted therapyAdvantage in overall survival and disadvantages regarding side effects; overall indication of minor added benefitA17-56Expiry of the limitation period of the G-BA decision, see first assessment A16-69 and addendum A17-10
02.01.2018Darunavir / cobicistat / -emtricitabine / -tenofovir alafenamidHIV-1-infected adults and adolescentsPretreated adults without indication for a treatment switch: hint of lesser benefit in comparison with the comparator therapy. Further indications: added benefit not provenA17-48 
02.01.2018Dimethyl fumarateAdult patients with moderate to severe psoriasis vulgaris who require systemic drug therapy No added benefit proven because of a lack of suitable study dataA17-49 
02.01.2018AtezolizumabAdult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after prior chemotherapyPatients for whom treatment with docetaxel, pemetrexed or nivolumab is indicated: indication of a major added benefit (PD-L1 high) or non-quantifiable added benefit (PD-L1 low) Other patients: added benefit not proven.A17-50 
02.01.2018AtezolizumabAdult patients with locally advanced or metastatic urothelial cell carcinoma, for whom cisplatin-based chemotherapy is not suitable (first-line treatment)Due to a lack of suitable data, added benefit versus chemotherapy specified by the physician not provenA17-51for information on second-line treatment see A17-52
02.01.2018AtezolizumabAdult patients with locally advanced or metastatic urothelial carcinoma after pretreatment with platinum-based chemotherapy (second-line treatment)Hint of a considerable added benefitA17-52for information on second-line treatment see A17-51
15.12.2017RibociclibInitial endocrine therapy of HR-positive, HER2-negative, locally advanced or metastatic breast cancer in postmenopausal women Surrogate outcome "progression-free survival" not validated; side effects: indication of greater harm. Overall, there is an indication of lesser benefit versus the comparator therapyA17-45 
15.12.2017PembrolizumabAdult patients with locally advanced or metastatic urothelial cell carcinoma First-line, cisplatin-based therapy unsuitable: added benefit not proven. After pretreatment with platinum-based chemotherapy: indication of considerable added benefit. A17-46 
01.12.2017BrodalumabAdult patients with moderate to severe plaque psoriasis for whom systemic treatment is an optionIn case of contraindication, intolerance or inadequate response to other systemic treatments including ciclosporin, methotrexate or PUVA: hint of non-quantifiable added benefit. Other patients: lesser benefit or added benefit not provenA17-42 
17.11.2017NivolumabAdult patients with squamous-cell carcinoma of the head and neck with progression during/after platinum-based therapyConclusion of dossier assessment A17-24 unchangedA17-54Addendum to A17-24
17.11.2017EtelcalcetideSecondary hyperparathyroidism Study 20120360: neither advantage nor disadvantage proven for etelcalcetide in comparison with cinacalcetA17-53Addendum to A17-25
15.11.2017Ledipasvir / SofosbuvirChronic hepatitis C in pretreated and treatment-naive adolescentsGenotype 1 with and without pretreatment: hint of a non-quantifiable added benefit; other genotypes: added benefit not provenA17-41 
15.11.2017DaratumumabAdult patients with multiple myeloma who have received at least one previous treatmentMonotherapy following progression during pretreatment: added benefit not proven. Combination with bortezomib and dexamethasone: added benefit not proven. With lenalidomide and dexamethasone: added benefit not proven for men, hints of major added benefit for womenA17-40 
15.11.2017SarilumabModerate to severe active rheumatoid arthritisHint of an added benefit for patients for whom treatment with biologic disease-modifying antirheumatic drugs (bDMARD) is indicated for the first time and who do not tolerate MTX. Other patient groups: added benefit not provenA17-39 
15.11.2017CarfilzomibAdult patients with multiple myeloma who have received at least one previous treatmentCombination with lenalidomide and dexamethasone: for patients < 65 years hint of non-quantifiable added benefit. An added benefit is not proven for patients ≥ 65 years. Combination with dexamethasone: added benefit not provenA17-38 
15.11.2017Sofosbuvir / velpatasvir / voxilaprevirChronic hepatitis CAdded benefit not proven for 12 of 13 research questions. Hint of lesser benefit for DAA-naive adult patients with CHC genotype and compensated cirrhosisA17-35 
02.11.2017CeritinibFirst-line treatment of adult patients with advanced ALK-positive NSCLC Added benefit not proven due to the lack of similarity of the indirectly compared studies A17-32 
02.11.2017Saxagliptin/metformin Type 2 diabetes mellitusDue to a lack of data, an added benefit is not proven for the combination with other drugs except insulin and sulfonylureas A17-33 
02.11.2017Glecaprevir/PibrentasvirChronic hepatitis CDue to a lack of data, an added benefit is not proven for any of the 7 therapeutic indications (genotypes, pretreatment)A17-34 
19.10.2017TofacitinibModerate to severe rheumatoid arthritis in adult patients with insufficient response to prior treatmentFor patients ≤ 65 years with unfavourable prognosis pretreated once no hint of lesser benefit versus adalimumab. For 4 questions added benefit therefore not proven. A17-43Addendum to A17-18
19.10.2017AlectinibAdvanced ALK-positive NSCLC (lung cancer) Hint of considerable added benefit for crizotinib and chemotherapy-pretreated adults who are eligible for treatment with docetaxel or pemetrexedA17-44Addendum to A17-19
19.10.2017OsimertinibAdvanced NSCLC (lung cancer) with T790M mutation after pretreatment with EGFR-TKIUnchanged hint of non-quantifiable, at least considerable added benefit versus cisplatin + pemetrexedA17-47Addendum to A17-20
02.10.2017NivolumabLocally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapyAdded benefit not proven due to lack of suitable study dataA17-29 
21.09.2017BaricitinibModerate to severe rheumatoid arthritis in adult patients who have responded inadequately to pretreatmentNeither advantage nor disadvantage proven from the consideration of the total study population of the JADV study for research questions 2 and 3 of dossier assessment A17-14A17-36Addendum to A17-14
21.09.2017DolutegravirHIV infection in children with antiretroviral pretreatment or in treatment-naive childrenAdded benefit still not proven: data from studies in adults not transferable to childrenA17-37Addendum to A17-11
15.09.2017Nivolumab (in combination with ipilimumab)Treatment-naive adult patients with advanced (unresectable or metastatic) BRAF V600 WT melanomaHint of lesser benefit of nivolumab + ipilimumab versus nivolumabA17-27Expiry of the G-BA decision, see first assessment A16-35
01.09.2017PembrolizumabRelapsed/refractory Hodgkin lymphoma after autologous stem cell transplantation (ASCT) and treatment with brentuximab vedotin (BV) or after failure of BV therapy if ASCT is not an optionAdded benefit not proven due to a lack of suitable dataA17-23 
01.09.2017NivolumabAdults with squamous-cell carcinoma of the head and neck and progression during/after platinum-based therapyIndication of considerable added benefit for patients with progression up to 6 months after platinum-based therapy; added benefit not proven for progression occurring laterA17-24 
01.09.2017EtelcalcetideSecondary hyperparathyroidismAdded benefit not proven due to a lack of suitable dataA17-25 
01.09.2017RolapitantPrevention of nausea and vomiting in chemotherapyAdded benefit not proven due to a lack of suitable dataA17-26 
17.08.2017IxekizumabAdults with moderate to severe plaque psoriasisIndication of considerable added benefit now also for patients who are eligible for systemic and/or phototherapyA17-30Addendum to A17-07
17.08.2017SecukinumabAdults with moderate to severe plaque psoriasisConclusion of dossier assessment A17-08 unchangedA17-31Addendum to A17-08
04.08.2017PembrolizumabFirst-line therapy in patients with metastasizing NSCLC with PD-L1 expressing tumours and without activating EGFR or ALK mutationUnchanged hint of considerable added benefitA17-28Addendum to A17-06
01.08.2017TrametinibAdvanced NSCLC (lung cancer) with BRAF-V600 mutationAdded benefit not proven due to a lack of suitable dataA17-16 
01.08.2017DabrafenibAdvanced NSCLC (lung cancer) with BRAF-V600 mutationAdded benefit not proven due to a lack of suitable dataA17-17 
01.08.2017OsimertinibAdvanced NSCLC (lung cancer) with T790M mutation after pretreatment with EGFR-TKIHint for non-quantifiable, at least considerable added benefit versus cisplatin + pemetrexedA17-20Expiry of the time limit of the G-BA’s decision; see first assessment A16-14
01.08.2017AlectinibAdvanced ALK-positive NSCLC (lung cancer) Added benefit not proven, as no (or no suitable) data availableA17-19 
01.08.2017Tofacitinib Moderate to severe rheumatoid arthritis in adult patients with insufficient response to prior treatmentFor 4 questions added benefit not proven. In one subgroup (patients with unfavourable prognosis pretreated once, ≤ 65 years) hint of lesser benefit versus adalimumab)A17-18 
06.07.2017ReslizumabSevere eosinophilic asthmaAdditional study data unsuitable for the derivation of an added benefit; still no added benefit provenA17-22Addendum to A17-02
03.07.2017BaricitinibModerate to severe rheumatoid arthritis in adult patients who have responded inadequately to pretreatmentAdded benefit not proven for 3 research questions. Hint of lesser benefit in comparison with adalimumab for patients with unfavourable prognosis and 1 prior therapy.A17-14 
03.07.2017Tenofovir alafenamideChronic hepatitis BAdded benefit not proven for adolescents or adults: partly no data, partly data incomplete with regard to contentA17-13See press release
03.07.2017AxitinibAdvanced renal cell carcinoma after failure of prior treatmentHint of considerable added benefit in comparison with sorafenib for cytokine-pretreated patients; added benefit not proven for sunitinib-pretreated patientsA17-12Expiry of the G-BA decision, see first assessment A12-14
03.07.2017DolutegravirHIV infection in children with antiretroviral pretreatment or in treatment-naive childrenAdded benefit not proven: data from studies in adults not transferable to childrenA17-11See first assessment of dolutegravir for adults, A14-08
16.06.2017NivolumabHodgkin lymphomaConclusion of dossier assessment A16-76 unchangedA17-21Addendum to A16-76
01.06.2017IxekizumabAdults with moderate to severe plaque psoriasisIndication of considerable added benefit for patients with inadequate response to previous systemic treatmentA17-07See press release on secukinumab and ixekizumab
01.06.2017SecukinumabAdults with moderate to severe plaque psoriasisIndication of considerable added benefit for patients who are candidates for systemic treatmentA17-08See press release on secukinumab and ixekizumab
18.05.2017PalbociclibAdvanced breast cancer, HR-positive, HER2-negativeConclusion of dossier assessment A16-74 unchangedA17-15Addendum to A16-74
15.05.2017PembrolizumabFirst-line treatment of patients with metastatic NSCLC with PD-L1-expressing tumours and without activating EGFR or ALK mutationHint of considerable added benefit, particularly due to prolonged overall survivalA17-06See press release; see A16-55 for second-line treatment
02.05.2017Lonoctocog alfaHaemophilia AAdded benefit not proven due to a lack of suitable data A17-03 
20.04.2017CabozantinibAdvanced renal cell carcinoma after targeted treatment against VEGFNo change in the conclusion compared with dossier assessment A16-69A17-10Addendum to A16-69
18.04.2017VandetanibMedullary thyroid carcinoma in adolescents and children from the age of 5 Added benefit not proven due to a lack of suitable data for children and adolescents; implementation of extrapolation of adult data is inadequateA17-01 
18.04.2017ReslizumabSevere eosinophilic asthma Added benefit not proven due to a lack of suitable data A17-02 
03.04.2017NivolumabHodgkin lymphomaAdded benefit not proven for patients who are eligible for further stem cell transplantation or for patients for whom this is not the caseA16-76 
16.03.2017OpicaponeParkinson diseaseNeither positive nor negative effects on Parkinson-specific outcomes and side effects in comparison with entacaponeA17-04Addendum to A16-61
16.03.2017CeritinibALK-positive advanced NSCLC (lung cancer)Hint of considerable added benefit for crizotinib-pretreated patients for whom treatment with docetaxel or pemetrexed is an optionA17-05Addendum to A16-62
15.03.2017Elbasvir/grazoprevirChronic hepatitis CAdded benefit neither proven in genotype 1 nor in genotype 4 of the virus due to lack of suitable dataA16-75 
01.03.2017PalbociclibAdvanced breast cancer, HR-positive, HER2-negativeIndication of lesser benefit in first-line treatment after menopause for palbociclib in combination with letrozole; no (suitable) data for further groupsA16-74See press release
02.02.2017Trifluridine/tipiracilColorectal cancerNo added benefit proven in patients with 2 prior treatment regimens; hint of minor added benefit in patients with more than 2A16-77Addendum to A16-54
01.02.2017CabozantinibAdvanced renal cell carcinoma after targeted treatment against VEGFIndication of non-quantifiable added benefit: advantage for mortality; lack of data for other outcomesA16-69 
16.01.2017MacitentanPulmonary arterial hypertensionAdded benefit not proven due to lack of suitable dataA16-67Orphan drug; revenue threshold (€50 million) exceeded
05.01.2017ofosbuvir/velpatasvir Chronic hepatitis CNo conclusions on added benefit in patients with HIV co-infection possibleA16-73Addendum to A16-48
02.01.2017Crizotinib ROS1-positive advanced lung canceAdded benefit neither proven for pretreated nor for non-pretreated patientsA16-59See press release
02.01.2017Ibrutinib Chronic lymphocytic leukaemia after pretreatmentIndication of considerable added benefit for certain patients (patients with at least 2 pretreatments); comparison with bendamustine + rituximabA16-60 
02.01.2017Opicapone Parkinson diseaseAdded benefit not provenA16-61 
02.01.2017CeritinibAdvanced ALK-positive non-small cell lung cancer after pretreatment with crizotinibAdded benefit neither proven versus docetaxel or pemetrexed nor versus best supportive careA16-62Expiry of time limit
02.01.2017LenvatinibAdvanced renal cell carcinoma after pretreatment against VEGFHint of a minor added benefit, as mortality advantage outweighs disadvantages regarding side effectsA16-63 
02.01.2017Idelalisib Chronic lymphocytic leukaemiaAdded benefit neither proven for pretreated nor for non-pretreated patientsA16-64See also A16-18

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