Medicine | Indication | Primary endpoint (PEP) | Therapeutic expert panel present at oral hearing |
---|---|---|---|
Oncological diseases | |||
Abiraterone acetate | Prostate carcinoma | OS | BDU, DGHO, DVPZ |
Abiraterone acetatea | Prostate carcinoma | OS, rPFS | DGHO |
Afatinibc | Non-small cell lung cancer | PFS | DGHO, DKG (Working Group on Thoracic Oncology of the AIO) |
Aflibercept | Metastatic colorectal cancer | OS | DGVS |
Axitinib | Renal cell carcinoma | PFS | DGHO |
Bosutinib | Chronic myeloid leukaemia | MCR | DGHO |
Brentuximab vedotin | Hodgkin-Lymphoma, anaplastic large cell lymphoma | ORR | DGHO |
Cabazitaxel | Prostate carcinoma | OS | DGHO, DKG |
Cabozantinib | Thyroid gland neoplasia | PFS | DGE (thyroid gland section), DGHO, DGN |
Crizotinib | Non-small cell lung cancer | PFS, ORR | DGHO, POA, representatives from leading oncology centres |
Decitabine | Myeloid leukaemia | OS | DGHO |
Enzalutamide | Prostate carcinoma | OS | DGHO, DGU |
Enzalutamidea | Prostate carcinoma | OS, rPFS | DGHO |
Eribulin | Breast cancer | OS | DGHO |
Eribulinac | Breast cancer | OS, rPFS | DGHO |
Ibrutinib | Chronic lymphocytic leukaemia, relapsed or refractory mantle cell lymphoma (MCL) | ORR | DGHO |
Idelalisib | Chronic lymphocytic leukaemia, follicular lymphoma | PFS | DGHO, GLSG, representative from the University Hospital Gießen |
Ipilimumab | Melanoma | OS | DGHO |
Lenvatinib | Thyroid gland neoplasia | PFS | DGHO |
Nintedanib | Non-small cell lung cancer | PFS | DGHO, DKG (Working Group on Thoracic Oncology of the AIO), representative from the LungenClinic Grosshansdorf |
Nivolumab | Melanoma | OS, PFS | ADO, DGHO |
Obinutuzumab | Chronic lymphocytic leukaemia | PFS | DGHO |
Olaparib | Ovarian cancer | PFS | DGHO |
Pertuzumab | Breast cancer | PFS, ORR | AGO, DGHO |
Pomalidomide | Multiple myeloma | PFS | DGHO, representatives from the University Hospitals of Heidelberg, Tübingen and Würzburg |
Radium-223-dichloride | Prostate carcinoma | OS | DGHO |
Ramucirumab | Stomach cancer | OS | DGHO, DGVS |
Regorafenib | Colorectal cancer | OS | DGHO |
Ruxolitinibd | Chronic myeloproliferative diseases | ≥35 % reduction in spleen volume | DGHO |
Ruxolitiniba | Polycythaemia vera | Haematocrit control without phlebotomy and ≥35 % reduction in spleen volume | DGHO |
Siltuximab | Multicentric Castleman’s disease | Durable tumour & symptomatic response (complete and partial response) | DGHO |
Sipuleucel-T | Prostate carcinoma | OS | DGHO, representative from the University Hospital Tübingen, Department of Urology |
Trastuzumab emtansine | Breast cancer | OS, PFS | AGO, DGHO |
Vandetanibb | Thyroid gland neoplasia | PFS | DGHO |
Vemurafenibc | Melanoma | OS, PFS | ADO, DGHO |
Vismodegib | Basal cell cancer | ORR | DGHO, DGMKG, German Society of Dermatology |
Metabolic diseases | |||
Albiglutide | Diabetes mellitus type 2 | HbA1c | DDG, Diabetes Research Group HZM, representative from the University Hospital Carl Gustav Carus (Dresden) |
Dulaglutide | Diabetes mellitus type 2 | HbA1c | BVND, DDG, Diabetes Research Group HZM |
Eliglustat | Gaucher disease type 1 | Stable health status (decrease in spleen and liver volume, Hb, thrombocytes) and %-change in spleen volume | ASIM, DGVS, representative from the Charité University Medicine Berlin |
Elosulfase alfa | Mucopolysaccharidose type IVA (Morquio A syndrome) | 6MWT | ZSE Wiesbaden |
Insulin degludeca | Diabetes mellitus type 1 | HbA1c | DDG |
Ivacaftor | Cystic fibrosis | FEV1% | - |
Ivacaftora | Cystic fibrosis | FEV1% | - |
Linagliptinb | Diabetes mellitus type 2 | HbA1c | BVND, DDG, Diabetes Research Group HZM |
Pasireotide | Pituitary gland dysfunction | mUFC ≤ ULN | - |
Pasireotidea | Acromegaly | Biochemical control | - |
Saxagliptin | Diabetes mellitus type 2 | HbA1c | DDG, Working Group on Pharmacoepidemiology, Diabetes Research Group HZM, Diabetes Centre Bad Lauterberg |
Saxagliptin/metformin | Diabetes mellitus type 2 | HbA1c | BVND |
Sitagliptin | Diabetes mellitus type 2 | HbA1c | DDG, Working Group on Pharmacoepidemiology, Diabetes Research Group HZM, Diabetes Centre Bad Lauterberg |
Sitagliptin/metformin | Diabetes mellitus type 2 | HbA1c | DDG, Diabetes Centre Bad Lauterberg, Diabetes Research Group HZM, Working Group on Pharmacoepidemiology |
Vildagliptinb | Diabetes mellitus type 2 | HbA1c | BVND, DDG |
Infectious diseases | |||
Boceprevir | Chronic hepatitis C | SVR | bng, DGVS, German Liver Foundation |
Daclatasvir | Chronic hepatitis C | SVR | bng, dagnä, DGIM, DGVS |
Dasabuvir | Chronic hepatitis C | SVR | bng, dagnä, DGIM, DGVS |
Dolutegravir | HIV infection | VR | dagnä, DAIG |
Dolutegravir/abacavir/lamivudine | HIV infection | VR | - |
Elvitegravir/cobicistat/emtricitabin/tenofovir-disoproxil | HIV infection | VR | dagnä, DAIG |
Emtricitabine/rilpivirine/tenofovirdisoproxil | HIV infection | VR | dagnä, DAIG |
Fidaxomicin | Clostridium infection | Overall cure | DGHO, DGVS |
Ledipasvir/sofosbuvir | Chronic hepatitis C | SVR | bng, dagnä, DGIM, DGVS |
Ombitasvir/paritaprevir/ritonavir | Chronic hepatitis C | SVR | bng, dagnä, DGIM, DGVS |
Rilpivirine | HIV infection | VR | DAIG, dagnä |
Simeprevir | Chronic hepatitis C | SVR | bng, dagnä, DGI, DGIM, DGVS |
Sofosbuvir | Chronic hepatitis C | SVR | bng, dagnä, DGIM |
Telaprevir | Hepatitis C | SVR | bng, DGVS, German Liver Foundation |