Function: Professional PhD
The motivation for my research begins from using the potential of my professional experience gained so far at governmental HTA agency, public payer, international collaboration and the opportunity of combining it all with academic expertise of Utrecht University while exploring the field of Health Technology Assessment which is growing so rapidly and is also just fascinating for me.
Education and experience:
Iga Lipska MD, acting Director of Control Department National Health Fund (HQ), Warsaw, Poland, former Senior Research Fellow, Center for Innovation in Regulatory Science (CIRS) between 2011-2016, former Director of the Health Technology Assessment Department, Agency for Health Technology Assessment in Poland (AHTAPol) between 2006-2011.
Dr Lipska has broad international and Polish experience in the healthcare sector, with a main focus in recent years on Health Technology Assessment (HTA). She is a medical doctor with a post-graduate diploma in business management and healthcare management and her main field of interest is evidence-based decision making in healthcare.
While she was in charge of the HTA Department in AHTAPol from 2006 through 2011, Dr Lipska was responsible for the drug assessment processes, supervising the review of industry submissions for new active substances and the preparation of full HTA reports. Dr Lipska joined CIRS in 2011 where the scope of her responsibility covered CIRS HTA programme activities, including the HTA Agencies Benchmarking Project. She joint HQ of National Health Fund in January 2017 being responsible for Control Department.
Her research interest include HTA, interactions between HTA bodies and regulatory agencies, drug regulatory science and health policy (both international and Polish perspective).
She is performing doctoral research through the WHO Collaborating Centre for Pharmaceutical Policy and Regulation based in the Utrecht Institute for Pharmaceutical Sciences, Utrecht University, the Netherlands, where he is researching HTA processes and outcomes for new pharmaceuticals.
Title PhD project:
Improving patients’ access to new medicines by understanding variation in Health Technology Assessment processes and outcomes.
PhD project description:
The approaches used by HTA and regulatory agencies differ substantially and they often come to different conclusions. In addition, HTA agencies in different countries come to different conclusions as well. This results in patients being confused with regards to access to new medicines. This thesis investigates HTA processes and outcomes for New Active Substances (NASs), provides the overview of current regulatory and HTA outcomes for NASs in Europe and identifies an overlap between these two functions. It investigates the correlation between the regulatory approval process by European Medicines Agency (EMA) and HTA outcomes and also identifies the reasons for negative and restricted HTA recommendations.
The research aims to understand interactions between Marketing Authorization approval process by EMA and HTA outcomes from chosen European jurisdictions, notably the specific context of conditional and standard MA. It investigates differences between national European HTA recommendations for oncology drugs that received conditional versus those with standard marketing authorization.
This thesis also explores factors influencing HTA recommendations (in particular: clinical indication, therapeutic area, orphan status, active comparator used in clinical trials, regulatory approval process)and the potential for the improvement of predictability of HTA outcomes.
Solutions for further improvement of HTA processes in the context of new medicines will be proposed. Recommendations for future interactions between regulatory agencies and HTA are formulated in order to improve patient access to new and potentially beneficial treatment options.
Teammembers and other people involved: