it is amazing how quickly the time went and we are soon getting to the end of the year, so its time for a brief resume. It certainly has been a busy year in the sector and one with many changes. The economic crisis has hit hard on all parts of the pharmaceutical and biotech industry. Many countries are affected with severe cost containment measures, health policy changes, increased competition through biosimilars and generics as well as by mounting pricing pressures. The recovery does not seem on the horizon so quickly. Especially the CEE Region as well Southern European are going through some very tough times. In Spain, the president of the Catalan company Grifols, Victor Grifols summed up the situation quite drastically in a recent meeting. He stated, before investing in Madrid "I am rather going to Gibraltar... one cannot depend on a central government that fixes prices and than does not pay." There is a lot to be done in Spain to fix the problems in the healthcare system and the latest real decree leaves a lot open to interpretation but it seems the way is paved for more economic evaluations as part of P&R approvals. As always the devil will be in the detail and in Spain in the way that will or can be implemented in practice considering the strong decentralized structures and decision making of the 17 communities.
In 2012 we also have gotten a good flavor of what the IQWIG process in Germany is like. There has been a pricing arbitration but so far little taste of what the outcome of economic evaluations will bring in case of disagreements on the pricing negotiations. France is equally increasing hurdles to market access and also here the train of medico economic evaluations, whatever that will be in practice, has left the station.
I am wondering if someone in the Uk is actually understanding what is going on, a lot of talk about value based pricing and different processes for the assessment of orphan drugs but there seems to be a lot of haze around the issues.
International price referencing also remains a persistent issue, many companies trying to tackle this by improving capabilities and better analytical tools to manage the situation as well as the implementation of risk sharing/market access agreements is expected to continue to increase throughout 2013.
I am wondering if someone in the Uk is actually understanding what is going on, a lot of talk about value based pricing and different processes for the assessment of orphan drugs but there seems to be a lot of haze around the issues.
International price referencing also remains a persistent issue, many companies trying to tackle this by improving capabilities and better analytical tools to manage the situation as well as the implementation of risk sharing/market access agreements is expected to continue to increase throughout 2013.
This year has undoubtedly been the year of the term "market access", although I have the feeling the winner of 2013 will be real world evidence (RWE). Indeed more and more stakeholders came to realize that additional real life data needs to be created and that an assessment of a new medicine does not stop at launch but rather seems to begin at that point. Many of the big consulting companies have geared up and dedicated capabilities toward this topic. The most prominent was the announcement of Astra Zeneca at the beginning of the year to partner with IMS on a three year contract of RWE creation. Others are to follow for sure. Optum insight picked up the topic at this years ISPOR conference in Berlin with various presentations on available databases throughout Europe for potential RWE research. Obviously many methodological and technical aspects are to be resolved and the area is still in its infancy but I am convinced that this is an area we will hear much more about.
I don't now yet exactly how but I cant help the feeling the key to success on this front is the internet and IT. Having managed various observational research studies myself throughout my professional life in the industry I cant help wondering the way we implemented and actually do the data collections is an outmoded way of going about that and with the technology at hand these days we should be able to innovate and do that very different, much more efficient and faster. I think some of the online patient networks that exist, for example for rare diseases (thinking here of sites like www.patientslikeme.com), are going into the right direction and are already somewhat ahead of the curve. They are now employing outcomes research scientists that I suppose will help to overcome some of the potential limitations on the methodological side (e.g. selection bias etc) and to analyze the wealth of data.
I am closing our little review with a big thank you to you, the readers, for the numerous comments, suggestions and interesting discussions on the topics raised. We have grown steadily in 2012 again, something I am very happy about as the posting was a little slower due to the work load this year. Maybe I get a round in 2013 to brush up the blog a little in terms of layout and functionality and maybe add some sections but I do not want to over promise ;)
Last but not least a little advertising of an important project kicked off in 2012 jointly with my friend Olivier Ethgen. We are putting together a book (see bottom of the page) on the future of health economics to be published in summer of 2013. It was a busy undertaking but we managed to get a great selection of authors together to write about the important matters in our field. I would like to thank all of you who contributed.
Wishing you all the best for the upcoming holiday season.
Warm regards
I am closing our little review with a big thank you to you, the readers, for the numerous comments, suggestions and interesting discussions on the topics raised. We have grown steadily in 2012 again, something I am very happy about as the posting was a little slower due to the work load this year. Maybe I get a round in 2013 to brush up the blog a little in terms of layout and functionality and maybe add some sections but I do not want to over promise ;)
Last but not least a little advertising of an important project kicked off in 2012 jointly with my friend Olivier Ethgen. We are putting together a book (see bottom of the page) on the future of health economics to be published in summer of 2013. It was a busy undertaking but we managed to get a great selection of authors together to write about the important matters in our field. I would like to thank all of you who contributed.
Wishing you all the best for the upcoming holiday season.
Warm regards
Ulf
Edited by Ulf Staginnus and Olivier Ethgen
July 2013 200 pages 978-1-4094-4543-2
244 x 172 mm Hardback £85.00
The pharmaceutical industry faces a well-documented perfect storm: on the one hand, the patent cliff; the lack of new blockbusters and, on the other, economic pressure on pricing from markets with growing expectations and shrinking budgets. In the face of such pressure, traditional health economics models no longer seem appropriate and yet what do we have to replace them? The growing focus on 'value' and 'cost effectiveness' are evidence of new emerging thinking although, even here, with the shift from medicine as cure to medicine as palliative, as a treatment for chronic illness and with the growing emphasis on preventative approaches, the landscape is complex and challenging.
The Future of Health Economics offers a window into some of the most influential emerging issues in pharmacoeconomics; issues such as risk-sharing and alternative pricing models or the potential impact of radical new approaches such as personalized medicine; as well as exploring the changing role of government and regulators.
Ulf Staginnus and Olivier Ethgen, themselves two of the most well-regarded practitioners in this field, have brought together some leading-edge thinkers from industry and academia around the world to provide the industry, policy-makers, regulators, health practitioners and academics with the raw material for their future scenarios.
www.gowerpublishing.com/isbn/9781409445432