Introduction

A regulation that came into effect in Germany in early 2011 now stipulates that the added benefit of most medications containing new active ingredients be assessed as soon as they enter the market. Manufacturers initially set the prices for their new medications, but afterwards prices are based on the results of this assessment, called an “early benefit assessment pursuant to the Act on the Reform of the Market for Medicinal Products (AMNOG).”

When a medication is launched, the manufacturer is required to submit a dossier to the German Federal Joint Committee (G-BA) for early benefit assessment. This dossier must contain the results of all relevant studies on the new drug.

The Institute for Quality and Efficiency in Health Care (IQWiG, Germany) assesses this dossier on behalf of G-BA. Within three months, IQWiG issues a review evaluating the advantages and disadvantages of the new drug in comparison with an appropriate comparator treatment. G-BA and IQWiG both publish the final review.

You can find these drugs in the following table. An alphabetical list is available here.

Blood and blood production

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Apixaban Eliquis Deep vein thrombosis and pulmonary embolism
Edoxaban Lixiana Atrial fibrillation
Edoxaban Lixiana Deep vein thrombosis and pulmonary embolism
Selexipag Uptravi Pulmonary arterial hypertension
Simoctocog alfa Nuwiq Hemophilia A

Heart and circulation

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Lomitapide Lojuxta Familial hypercholesterolemia
Macitentan Opsumit Pulmonary arterial hypertension
Propranolol Hemangiol Hemangioma in infants
Ticagrelor

EU: Brilique
US: Brilinta

High risk of a stroke or heart attack

Skin and hair

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Ingenol mebutate Picato Actinic keratosis

Sexual organs and urinary tract

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Mirabegron Betmiga Overactive bladder
Ospemifene

EU: Senshio

US: Osphena/Ophena

Vaginal atrophy

Infections

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Daclatasvir Daklinza Hepatitis C
Dasabuvir Exviera Hepatitis C
Dolutegravir Tivicay HIV infection
Dolutegravir / abacavir / lamivudine fixed combination Triumeq HIV infection
Emtricitabine / tenofovir alafenamide Descovy HIV infection
Emtricitabine / rilpivirine / tenofovir alafenamide fixed combination Odefsey HIV infection
Ledipasvir / sofosbuvir Harvoni Chronic hepatitis C
Ombitasvir / paritaprevir / ritonavir fixed combination Viekirax Hepatitis C
Rilpivirine Edurant, Eviplera HIV infection
Simeprevir Olysio Chronic hepatitis C
Sofosbuvir / velpatasvir fixed combination Epclusa Chronic hepatitis C

Cancer and the immune system

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Afatinib Giotrif Advanced lung cancer
Afatinib Giotrif Advanced squamous cell lung cancer
Apremilast Otezla Psoriasis
Belatacept Nulojix Following a kidney transplant
Cabozantinib Cabometyx Avanced renal cell cancer
Ceritinib Zykadia Advanced lung cancer
Cobimetinib Cotellic Melanoma
Crizotinib Xalkori Advanced lung cancer
Elotuzumab Empliciti Multiple myeloma
Enzalutamide Xtandi Metastatic prostate cancer
Eribulin Halaven Liposarcoma
Fingolimod Gilenya Multiple slerosis
Ibrutinib Imbruvica Chronic lymphocytic leukemia
Ibrutinib Imbruvica Mantle cell lymphoma
Ibrutinib Imbruvica

Waldenström's macroglobulinemia

Idelalisib Zydelig Chronic lymphocytic leukemia
Idelalisib Zydelig Non-Hodgkin's lymphoma
Lenvatinib

EU: Kisplyx

USA: Lenvima

Advanced renal cell cancer
Necitumumab Portrazza Advanced lung cancer
Nintedanib Vargatef Advanced lung cancer
Nivolumab Opdivo Advanced non-small cell lung cancer
Nivolumab Opdivo Advanced renal cell cancer
Nivolumab Opdivo Melanoma
Osimertinib Tagrisso Advanced lung cancer
Ramucirumab Cyramza Advanced stomach cancer
Ramucirumab Cyramza Advanced lung cancer
Ramucirumab Cyramza Bowel cancer
Ruxolitinib Jakavi Myelofibrosis
Ruxolitinib Jakavi Polycythemia vera
Secukinumab Cosentyx Psoriasis
Secukinumab Cosentyx Ankylosing spondylitis (Bekhtherev's disease)
Sipuleucel-T Provenge Metastatic prostate cancer
Talimogen laherparepvec Imlygic Melanoma
Vedolizumab Entyvio Crohn's disease
Vismodegib Erivedge Basal cell carcinoma

Muscles and skeletal system

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Collagenase extracted from Clostridium histolyticum Xiapex Dupuytren’s contracture

Brain and nervous system

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Brivaracetam Briviact Epilepsy
Dimethyl fumarate Tecfidera Multiple sclerosis
Lurasidone Latuda Schizophrenia
Nalmefene Selincro Alcohol dependency
Opicapone Ongentys Parkinson's disease
Perampanel Fycompa Epilepsy
Safinamide Xadago Parkinson's disease
Vortioxetine Brintellix Depression

Lungs and breathing

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Aclidinium bromide / formoterol Duaklir Genuair, Brimica Genuair Chronic obstructive pulmonary disease (COPD)
Indacaterol and glycopyrronium Ultibro Breezhaler, Xoterna Breezhaler Chronic obstructive pulmonary disease (COPD)
Mepolizumab Nucala Severe asthma
Umeclidinium Incruse Chronic obstructive pulmonary disease (COPD)
Umeclidinium and vilanterol Anoro Chronic obstructive pulmonary disease (COPD)

Sensory organs

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Aflibercept Eylea Age-related macular degeneration
Aflibercept Eylea Diabetic macular edema
Aflibercept Eylea

Macular edema following retinal vein occlusion

Aflibercept Eylea

Myopic choroidal neovascularization

Tafluprost / Timolol Taptiqom Glaucoma

Other

Click on the drug name for more information.

Table: Drugs assessed by IQWiG
Drug name Trade name Condition
Sucroferric oxyhydroxide Velphoro Chronic renal insufficiency

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