Skiplinks


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).

Until the end of 2016 IQWiG published a press release for each benefit assessment (except for orphan drugs). From 2017 onwards a press release will only be published in special cases.


*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 publication Drug Therapeutic indication Result of dossier assessment Project* Comment
17.11.2017 Nivolumab Adult patients with squamous-cell carcinoma of the head and neck with progression during/after platinum-based therapy Conclusion of dossier assessment A17-24 unchanged A17-54 Addendum to A17-24
17.11.2017 Etelcalcetide Secondary hyperparathyroidism Study 20120360: neither advantage nor disadvantage proven for etelcalcetide in comparison with cinacalcet A17-53 Addendum to A17-25
15.11.2017 Ledipasvir/Sofosbuvir Chronic hepatitis C in pretreated and treatment-naive adolescents Genotype 1 with and without pretreatment: hint of a non-quantifiable added benefit; other genotypes: added benefit not proven A17-41
15.11.2017 Daratumumab Adult patients with multiple myeloma who have received at least one previous treatment Monotherapy 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 women A17-40
15.11.2017 Sarilumab Moderate to severe active rheumatoid arthritis Hint 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 proven A17-39
15.11.2017 Carfilzomib Adult patients with multiple myeloma who have received at least one previous treatment Combination 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 mit dexamethasone: added benefit not proven A17-38
15.11.2017 Sofosbuvir/velpatasvir/voxilaprevir Chronic hepatitis C Added benefit not proven for 12 of 13 research questions. Hint of lesser benefit for DAA-naive adult patients with CHC genotype and compensated cirrhosis A17-35
02.11.2017 Ceritinib First-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
02.11.2017 Saxagliptin/metformin Type 2 diabetes mellitus Due to a lack of data, an added benefit is not proven for the combination with other drugs except insulin and sulfonylureas A17-33
02.11.2017 Glecaprevir/Pibrentasvir Chronic hepatitis C Due to a lack of data, an added benefit is not proven for any of the 7 therapeutic indications (genotypes, pretreatment) A17-34
19.10.2017 Tofacitinib Moderate to severe rheumatoid arthritis in adult patients with insufficient response to prior treatment For patients ≤ 65 years with unfavourable prognosis pretreated once no hint of lesser benefit versus adalimumab. For 4 questions added benefit therefore not proven. A17-43 Addendum to A17-18
19.10.2017 Alectinib Advanced ALK-positive NSCLC (lung cancer) Hint of considerable added benefit for crizotinib and chemotherapy-pretreated adults who are eligible for treatment with docetaxel or pemetrexed A17-44 Addendum to A17-19
19.10.2017 Osimertinib Advanced NSCLC (lung cancer) with T790M mutation after pretreatment with EGFR-TKI Unchanged hint of non-quantifiable, at least considerable added benefit versus cisplatin + pemetrexed A17-47 Addendum to A17-20
02.10.2017 Nivolumab Locally advanced unresectable or metastatic urothelial carcinoma in adults after failure of prior platinum-containing therapy Added benefit not proven due to lack of suitable study data A17-29
21.09.2017 Baricitinib Moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to pretreatment Neither 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 A17-14 A17-36 Addendum to A17-14
21.09.2017 Dolutegravir HIV infection in children with antiretroviral pretreatment or in treatment-naive children Added benefit still not proven: data from studies in adults not transferable to children A17-37 Addendum to A17-11
15.09.2017 Nivolumab (in combination with ipilimumab) Treatment-naive adult patients with advanced (unresectable or metastatic) BRAF V600 WT melanoma Hint of lesser benefit of nivolumab + ipilimumab versus nivolumab A17-27 Expiry of the G-BA decision, see first assessment A16-35
01.09.2017 Pembrolizumab Relapsed/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 option Added benefit not proven due to a lack of suitable data A17-23
01.09.2017 Nivolumab Adults with squamous-cell carcinoma of the head and neck and progression during/after platinum-based therapy Indication of considerable added benefit for patients with progression up to 6 months after platinum-based therapy; added benefit not proven for progression occurring later A17-24
01.09.2017 Etelcalcetide Secondary hyperparathyroidism Added benefit not proven due to a lack of suitable data A17-25
01.09.2017 Rolapitant Prevention of nausea and vomiting in chemotherapy Added benefit not proven due to a lack of suitable data A17-26
17.08.2017 Ixekizumab Adults with moderate to severe plaque psoriasis Indication of considerable added benefit now also for patients who are eligible for systemic and/or phototherapy A17-30 Addendum to A17-07
17.08.2017 Secukinumab Adults with moderate to severe plaque psoriasis Conclusion of dossier assessment A17-08 unchanged A17-31 Addendum to A17-08
04.08.2017 Pembrolizumab First-line therapy in patients with metastasizing NSCLC with PD-L1 expressing tumours and without activating EGFR or ALK mutation Unchanged hint of considerable added benefit A17-28 Addendum to A17-06
01.08.2017 Trametinib Advanced NSCLC (lung cancer) with BRAF-V600 mutation Added benefit not proven due to a lack of suitable data A17-16
01.08.2017 Dabrafenib Advanced NSCLC (lung cancer) with BRAF-V600 mutation Added benefit not proven due to a lack of suitable data A17-17
01.08.2017 Osimertinib Advanced NSCLC (lung cancer) with T790M mutation after pretreatment with EGFR-TKI Hint for non-quantifiable, at least considerable added benefit versus cisplatin + pemetrexed A17-20 Expiry of the time limit of the G-BA’s decision; see first assessment A16-14
01.08.2017 Alectinib Advanced ALK-positive NSCLC (lung cancer) Added benefit not proven, as no (or no suitable) data available A17-19
01.08.2017 Tofacitinib Moderate to severe rheumatoid arthritis in adult patients with insufficient response to prior treatment For 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
06.07.2017 Reslizumab Severe eosinophilic asthma Additional study data unsuitable for the derivation of an added benefit; still no added benefit proven A17-22 Addendum to A17-02
03.07.2017 Baricitinib Moderate to severe rheumatoid arthritis in adult patients who have responded inadequately to pretreatment Added 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
03.07.2017 Tenofovir alafenamide Chronic hepatitis B Added benefit not proven for adolescents or adults: partly no data, partly data incomplete with regard to content A17-13 See press release
03.07.2017 Axitinib Advanced renal cell carcinoma after failure of prior treatment Hint of considerable added benefit in comparison with sorafenib for cytokine-pretreated patients; added benefit not proven for sunitinib-pretreated patients A17-12 Expiry of the G-BA decision, see first assessment A12-14
03.07.2017 Dolutegravir HIV infection in children with antiretroviral pretreatment or in treatment-naive children Added benefit not proven: data from studies in adults not transferable to children A17-11 See first assessment of dolutegravir for adults, A14-08
16.06.2017 Nivolumab Hodgkin lymphoma Conclusion of dossier assessment A16-76 unchanged A17-21 Addendum to A16-76
01.06.2017 Ixekizumab Adults with moderate to severe plaque psoriasis Indication of considerable added benefit for patients with inadequate response to previous systemic treatment A17-07 See press release on secukinumab and ixekizumab
01.06.2017 Secukinumab Adults with moderate to severe plaque psoriasis Indication of considerable added benefit for patients who are candidates for systemic treatment A17-08 See press release on secukinumab and ixekizumab
18.05.2017 Palbociclib Advanced breast cancer, HR-positive, HER2-negative Conclusion of dossier assessment A16-74 unchanged A17-15 Addendum to A16-74
15.05.2017 Pembrolizumab First-line treatment of patients with metastatic NSCLC with PD-L1-expressing tumours and without activating EGFR or ALK mutation Hint of considerable added benefit, particularly due to prolonged overall survival A17-06 See press release; see A16-55 for second-line treatment
02.05.2017 Lonoctocog alfa Haemophilia A Added benefit not proven due to a lack of suitable data A17-03
20.04.2017 Cabozantinib Advanced renal cell carcinoma after targeted treatment against VEGF No change in the conclusion compared with dossier assessment A16-69 A17-10 Addendum to A16-69
18.04.2017 Vandetanib Medullary 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 inadequate A17-01
18.04.2017 Reslizumab Severe eosinophilic asthma Added benefit not proven due to a lack of suitable data A17-02
03.04.2017 Nivolumab Hodgkin lymphoma Added benefit not proven for patients who are eligible for further stem cell transplantation or for patients for whom this is not the case A16-76
16.03.2017 Opicapone Parkinson disease Neither positive nor negative effects on Parkinson-specific outcomes and side effects in comparison with entacapone A17-04 Addendum to A16-61
16.03.2017 Ceritinib ALK-positive advanced NSCLC (lung cancer) Hint of considerable added benefit for crizotinib-pretreated patients for whom treatment with docetaxel or pemetrexed is an option A17-05 Addendum to A16-62
15.03.2017 Elbasvir/grazoprevir Chronic hepatitis C Added benefit neither proven in genotype 1 nor in genotype 4 of the virus due to lack of suitable data A16-75
01.03.2017 Palbociclib Advanced breast cancer, HR-positive, HER2-negative Indication of lesser benefit in first-line treatment after menopause for palbociclib in combination with letrozole; no (suitable) data for further groups A16-74 See press release
02.02.2017 Trifluridine/tipiracil Colorectal cancer No added benefit proven in patients with 2 prior treatment regimens; hint of minor added benefit in patients with more than 2 A16-77 Addendum to A16-54
01.02.2017 Cabozantinib Advanced renal cell carcinoma after targeted treatment against VEGF Indication of non-quantifiable added benefit: advantage for mortality; lack of data for other outcomes A16-69
16.01.2017 Macitentan Pulmonary arterial hypertension Added benefit not proven due to lack of suitable data A16-67 Orphan drug; revenue threshold (€50 million) exceeded
05.01.2017 ofosbuvir/velpatasvir Chronic hepatitis C No conclusions on added benefit in patients with HIV co-infection possible A16-73 Addendum to A16-48
02.01.2017 Crizotinib ROS1-positive advanced lung cance Added benefit neither proven for pretreated nor for non-pretreated patients A16-59 See press release
02.01.2017 Ibrutinib Chronic lymphocytic leukaemia after pretreatment Indication of considerable added benefit for certain patients (patients with at least 2 pretreatments); comparison with bendamustine + rituximab A16-60
02.01.2017 Opicapone Parkinson disease Added benefit not proven A16-61
02.01.2017 Ceritinib Advanced ALK-positive non-small cell lung cancer after pretreatment with crizotinib Added benefit neither proven versus docetaxel or pemetrexed nor versus best supportive care A16-62 Expiry of time limit
02.01.2017 Lenvatinib Advanced renal cell carcinoma after pretreatment against VEGF Hint of a minor added benefit, as mortality advantage outweighs disadvantages regarding side effects A16-63
02.01.2017 Idelalisib Chronic lymphocytic leukaemia Added benefit neither proven for pretreated nor for non-pretreated patients A16-64 See also A16-18

to top

Glossary entries