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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
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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