Examples
· Benefit assessment/market access/reimbursement/supply chain (AMNOG – IGWiG/G-BA/SHI):
clinical (mortality, morbidity, and surrogate endpoints), economic, and humanistic (patient reported, QoL) outcomes.
for example,
cancer/immuno-oncology (breast cancer, malignant melanoma, pancreas, multiple myeloma),
CV diseases (heart failure, ACS/MI, long QT syndrome, stroke/SEE prevention, lipid disorders),
diabetes,
asthma/COPD (incl. IT devices),
Parkinson’s disease,
meningococcal disease prevention/vaccination,
RDS-CRM,
migraine and cluster headache,
botulinum toxin type A.
· Pharmacological-toxicological expert opinions; eg,
heart failure, atrial fibrillation, anticoagulants, ACS/MI, fibrinolytics, cancer, asthma/COPD, diabetes, depression, sedatives, hypnotics.
· Court expert opinions; eg,
· Legal definitions and pharmaceutical assessment of medicines versus diet supplements, and dietary products.
· Non-prescription medicines – OTC-use, pharmacy-only drugs and GSL; eg,
· New package for drug formulations; eg, suppositories.
· Health promotion in primary health care; eg, general practice and community pharmacy. A European project.
· Registration of traditionally approved herbal medicines.
· Health claims for … in the intended use as a foodstuff.
· Stroke prevention / atrial fibrillation (AF) – NOACs (non-VKA); eg, rivaroxaban, edoxaban;
new VKA.