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Presentation at the PhUSE Single Day Event (SDE) on Friday the 21st of September, Brussels, Belgium.

Berber Snoeijer consultant at the PHARMO Intitute will present Real-world Patient Treatment Journeys in Combination with Health Assessments at Critical Drug-changing Time Points.

Theme:

Health Technology Assessment Dossiers

Description:

Beyond New Drug Applications, biostatistics and statistical programming professionals across the pharmaceutical industry are now heavily engaged in the preparation of Health Technology Assessment (HTA) dossiers. HTA dossiers are submitted to HTA agencies across Europe and other countries (including Australia, Korea and soon Japan) in support of pricing and reimbursement negotiation of newly approved drugs as well as later on during the drug life cycle.

The German AMNOG Pharmaceuticals Market Reorganization Act requires pharmaceutical companies marketing their products in Germany to submit evidence showing that the new product is more effective than the existing standard of care. In parallel, other HTA agencies (like the UK NICE agency) are rather expecting the presentation of cost-effectiveness modeling as part of HTA dossiers submitted to them. In both cases, the biostatisticians and statistical programmers organisation will be leveraging the analysis and reporting used in support of the compound clinical study reports to contribute to the development of the HTA dossiers, directly with additional clinical data analysis or indirectly by providing clinical data and analysis as input to economic models. The analysis will also go beyond what has been presented in the original clinical study reports, for instance in using methodologies of indirect treatment comparisons and network meta-analysis to allow the comparison of the company’s own drug with existing standard of care on the various markets.

For more information about the PhUSE click here