Pharma job security in 2013

Dear All, just came across this from Luc De Langhe, nice analysis. Merry Christmas Ulf Go to Switzerland  -  Each year some pharma companies move HQs (or at least a part of it) to Switzerland for tax reasons. Even if you lose your job there, you will have plenty of opportunity because this trend will go on for a while. Join a company with a healthy portfolio across all life cycle stages - Your best choice is a company with at least 2 promising compounds in phase 3 for diseases with a high unmet medical need, and with no blockbuster drug approaching its patent cliff. Beware of single-drug companies - Relying on the future sales of one single drug is quite risky in today’s market, with economies that are forced to make tough choices when deciding which new medicines to reimburse. If, however, it is a life-saving drug or one that dramatically increase the QALYs of treated patients vs. the current gold standard, it is worth going for it. Select a company where top management understands what is going on in the market. All too often I hear that good ideas and plans are blocked by marketing executives higher up in the hierarchy who still think pharmaceuticals can be launched the way they did it. Take a job in a function that the pharma industry is currently investing in: business development, licensing, market access, digital marketing, marketing of mature/established brands, emerging markets, etc. Last but not least: equip yourself with the new competencies that pharma companies need in today’s tough business environment. C.E.L.forpharma’s course topics (see below) address those needs and offer a unique opportunity to get face-to-face training by internationally acclaimed experts. You have my very best regards and Season’s greetings – I hope that C.E.L.forpharma may contribute to your success in 2013! Luc Luc De Langhe Co-founder and Managing Director C.E.L.forpharma

A new proposal for the evaluation of orphan drugs?

Dear All,
just read an interesting article: Paying for the Orphan Drug System: break or bend? Is it time for a new evaluation system for payers in Europe to take account of new rare disease treatments?

The authors propose an alternative methodology based on multiple criteria such as rarity, manufacturing complexity, availability of alternatives, disease severity, research undertaken and several others, given that most orphan drugs due to the higher price ranges hardly will meet the traditional cost-effectiveness thresholds imposed by various HTA agencies. Indeed the various countries are having different systems in order to evaluate orphan drugs, for example IQWIG in Germany sees the additional medical benefit as a given for orphan drugs while other authorities have different requirements regarding the need and scope of economic evaluations.  

I think this paper gives some very welcome alternatives as to what assessment criteria to be used. In my view it should ultimately be left with every EU member state, similar to what the authors proposed, to decide which is the best option for their respective healthcare system and assigning the monetary value they would like to place onto an evaluation rather than centralized purchasing procedures as once suggested. Orphan drugs, due to their limited and very specific patient population, are certainly best suited for innovative access agreements linked to real world evidence development in case of uncertainty at launch. 

Cheers
Ulf 

Drug makers discount up to 50% to make it through NICE

Dear All,

just came across an interesting article from Bloomberg on NICE and the discounts offered by manufacturers to pass the cost-effectiveness criterion of the HTA agency in order to get recommended for reimbursement in the UK market.
Of course the confidential discounts offered are nothing new, perhaps the magnitude is surprising to some people not so familiar with the situation. My guess is the higher figures are related to the recent melanoma drugs. In any case I wonder if such articles trigger the desire by some governments of knowing the net prices again, especially those heavily relying on external price referencing.
Interesting also some views from Sir Michael Rawlings on VBP. I am not surprised that he doesn't expect too much difference. There has been a lot of talk about a VBP system, I also have done advisory boards in the past to understand the academic views and theoretical possibilities, but let's face it in order to practically operationalize such a system there are only a limited number of opportunities on the methodological side of things. I guess we are to find out soon what they have come up with.

Cheers
Ulf

2012 Health Economics Blog round up

Dear All,

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.

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

Ulf

The Future of Health Economics 

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

France debating ITR (Index Thérapeutique Relatif)

Dear Readers,

The French HAS, with its representative Jean-Luc Harousseau, outlined at a recent meeting (12. Sep) organized by nile-consulting the move towards the ITR system replacing the ASMR in 2013. The new Index Thérapeutique Relatif, if implemented would be similar to the German system, mainly based on efficacy criteria in a comparative fashion (head to head) consisting of 5 categories:

Each category will be linked to certain rules regarding price.

ITR inférieur (lower): no reimbursement

ITR identique (similar) : lower price

ITR bénéfice minime (marginal benefit): same price

ITR bénéfice moyen (moderate benefit) : price negotiated

ITR bénéfice majeur (major benefir) : European price

For ITR moyen (moderate) and majeur (major) a medico-economic evaluation will be required, initially as a flash report with a full assessment 2-3 years later.

Early dialogue is encouraged in order to establish the right comparator for development programs.

Please find below an interesting transcript and the Q&A session with Jean-Luc Harousseau, in French only. Currently ITR is not yet included in the financial law but at a pilot stage. 

Cheers

Ulf 

Market Access Challenges

Hello Everyone,

finally we are finishing up the holidays, enough of sand and salty water ... Sharing with you a "summer" discussion I have had with the folks from pharmaphorum.com

Curios as to your views on the current matters???

Hope you had a great summer!

Cheers
Ulf

Prices negotiated in Germany most likely are not going to be confidential after all

Dear All,

further to my previous post on the confidentiality of prices in Germany after IQWIG assessment it seems that an agreement of confidentiality could not be reached and it looks like that rebate prices are being published.
If that is the case profound implication on European prices can be expected through external price referencing.
Here is a link to a presentation I gave on the topic
Regards
Ulf

New Tufts study on oncology market access

July 10, 2012

U.S. Cancer Patients Get Faster Access to More Oncology Drugs than European Patients

BOSTON — July 10, 2012 — Cancer patients in the United States get faster access to more oncology drugs to treat their disease than patients in Europe, according to a newly completed study by the Tufts Center for the Study of Drug Development.
In addition, the study found, new oncology drug approvals in the U.S. outpaced European approvals by 33% between 2000 and 2011.
“While greater access to more treatment options is definitely a positive for patients in the U.S., it is not clear if greater access leads to better health outcomes,” noted Joshua P. Cohen, research assistant professor at Tufts CSDD who conducted the analysis.
He said that the growing use of comparative effectiveness research, which provides information on the relative strengths and weaknesses of different medical technologies, could help close the gap between what is known and what is done in pharmaceutical care.
“Although more oncology drugs are available in the U.S., and the costs for a higher share of them are reimbursed, the evidence-based approach adopted by European systems have improved the affordability of drugs in Europe that are considered to be cost-effective,” Cohen said.
The study, reported in the July/August Tufts CSDD Impact Report and released today, also found that:
*Between 2000 and 2011, 40 oncology drugs received market approval in the U.S. compared to 30 in Europe.
*Oncology drug prices in Europe, on average, are 9% lower than in the U.S.
*Patient cost sharing is much lower in Europe than the U.S., where the average co-insurance rate per covered drug is 33%.

About the Tufts Center for the Study of Drug Development
The Tufts Center for the Study of Drug Development (http://csdd.tufts.edu) at Tufts University provides strategic information to help drug developers, regulators, and policy makers improve the quality and efficiency of pharmaceutical development, review, and utilization. Tufts CSDD, based in Boston, conducts a wide range of in-depth analyses on pharmaceutical issues and hosts symposia, workshops, and public forums, and publishes Tufts CSDD Impact Reports, a bi-monthly newsletter providing analysis and insight into critical drug development issues.
—end—
Contacts: Tufts Center for the Study of Drug Development
Sandra Peters — 617-636-2185
sandra.peters@tufts.edu

German prices negotiated with sick funds remain confidential under AMNOG Novelle

Dear All,

as the Deutsche Apothekerzeitung reports, the prices that manufacturers negotiate with association of sick funds (GKV Spitzenverband) after the IQWIG benefit assessment will stay confidential and will not be published in the Lauer Taxe. This is the compromise that now seems to have been reached after long discussions of the AMNOG Novelle. The vfa (Verband forschender Arzneimittelhersteller) commented that confidentiality does not mean secrecy and that private insurers and importers should know about. That would be good news for the pharmaceutical industry as the negative downward pressures on prices due to international price referencing might be avoided.

Cheers
Ulf

Is the price disparity in Europe going to end?

Dear Readers,

Medaxial sent me a good paper on the issue of pharmaceutical price disparity and describes in a simple and explicit way why price differences are not going to disappear between countries. It examines the role of international price referencing and parallel trade and I especially liked the notion that they picked up on the fact that price differentiation might actually be the better solution for the development of a respective country.
Interesting read for those interested in the topic: why not having a single price...?

Cheers
Ulf

Spain - yet another Royal Decree to cut costs

Dear Readers,

the financial situation in Spain gets worse by the day and the household deficit has led the government in Madrid again to issue a new package of measures to achieve additional savings in the health care sector. The new Real Decree RDL 16/2012 that was published on April 24th once again, although this time patients are directly affected as well with co payments etc, will heavily impact the pharmaceutical sector. Among the changes are modifications to the reference pricing system (selective financing via maximum prices, consideration of generics and biosimilar price levels in class etc) as well as to the price setting process in general. The Spanish organization of pharmaceutical manufacturers called the significance of the decree "without precedence" and an attack against innovation.

There will also be an advisory committee of responsible for pharmacoeconomic considerations as part of the price setting process. It looks like Spain is getting more serious now on cost-effectiveness and budget impact evaluations on national level.

I haven't fully digested the heavy pamphlet myself yet but will be reporting here on the developments.

Cheers
Ulf

Abacus International: Business development manager – USA

WANTED: Pioneer to extend Abacus International’s innovative market access solutions within the USA.

Abacus International

For over 16 years, Abacus International has pioneered the development of evidence-based market access solutions for many of the world’s leading healthcare companies. In the 1990’s, Abacus were the first to develop cost effectiveness and budget impact models for use by key account teams with payers. Abacus were also involved in the development of the first HTA submission. More recently we have developed a value platform tool, a unique web-based method for communicating value messages in a layered and transparent fashion. Abacus remain at the cutting edge of health economic modelling and systematic review with associated meta-analysis techniques. Most recently, we have developed the first economic models for iPad and have introduced a strategic market access offering, analyzing global HTA & reimbursement decisions to provide key learnings for new product launches.

Abacus’ ethos is to combine technical excellence with commercial clarity and we strive to evolve our services in order to meet the needs of our customers in a constantly changing environment. Our experienced and expert team of health economic and market access specialists is one of the largest in Europe.

About 20% of our business is commissioned by the US-based global departments of major healthcare companies. We want to establish a US based office to accelerate the rate of growth of our North American business and seek a manager who will drive this business, taking the lead on selling the range of our services to prospective clients. This manager will become a key individual in our international growth and, ultimately, their success will determine the rate of recruitment of other local staff to deliver the projects. Currently our team of 60 UK-based staff are delivering all projects, irrespective of client geography.

The role

Ideally based in New York/New Jersey, you will take ultimate responsibility for selling Abacus services to the healthcare industry in North America. You will be responsible for generating leads, booking meetings and presenting our specialist services to a range of potential customers including market access, health economics and marketing. You will need to liaise with our 6 business unit directors, and the commercial and finance directors, in order to fully understand our deliverables and the selling proposition for each service offering. Abacus consultants in the UK manage projects but also have a business development role by key account. You will therefore need to develop relationships with the consultants to coordinate business development activities across key accounts. As the first member of our US-based office you will eventually become a senior figure, potentially involved in general management issues such as recruitment and office site management (supported by members from the UK team).

This is an exciting opportunity to build upon the excellent reputation of Abacus in Europe and establish us as a market access and health economic force in North America. Abacus have 60-70 active clients each year, including 19 of the top 25 pharma companies. We are preferred suppliers to many organisations with a very broad range of innovative deliverables. You would have the advantage of presenting the European credibility of Abacus, often with a history of working on the products in the portfolio of the client you are presenting to.  The products that we would see you selling as a focus would include:

1)      Payer landscaping: A strategic analysis of global payer decisions; this includes the development of an online database of payer decisions, linking the evidence they reviewed to the ultimate approval decision. This product is unique to Abacus and receives a very positive reception when presented to customers.

2)      iPad and web versions of local budget impact and HE models. Again, an innovative approach by Abacus and one that excites potential customers.

3)      Value platform tool: An online hosting system presenting layered and interactive value dossiers linked to source material, such as the HE model.

4)      Technical HE modelling: Abacus teach Excel® modelling at Masters level and our technical models are truly impressive. You would probably co-present at pitches with one of our health economists.

5)      Systematic review and meta-analysis, a core element of comparative  effectiveness research.

The candidate

·         Ideally from a consultancy or industry background, with a good grounding in market access and health economics

·         Driven by meeting sales targets and motivated by success

·         A good network of North American industry contacts

·         Tenacity at seeking out leads and finding opportunities to present services

·         Exceptional communication skills and the ability to present market access and health economic services with authority and understanding

·         An organised, presentable and approachable individual

The package

Abacus is an exceptional place to work with a very low staff turnover. Although a company of around 60 staff, we strive to maintain our family-centric ethos. We believe in a good work life balance and this contract, although US-based, will be based upon our UK structure, including a holiday package of around 28 days, rising to 30 days after 5 years. The general remuneration package will be competitive and commensurate with experience; bonus will be linked to sales success.

Please send your CV to simon.howard@abacusint.com or call +44 (0)1869 241281 for an informal discussion.

Closing date: 29^th of February, 2012

New Drugs in Germany under AMNOG – initial considerations

Dear All,

AMNOG has issues the first assessment reports on a variety of drugs with mixed results. An interview with Dr. Cornelius Erbe from the DAK has been published recently. It is interesting to see that when he has been asked about the future developments in Germany he stated that, “I think the pharmaceutical industry is currently faced with a very important change in the legal framework and the market environment. We are a little bit concerned about the thoroughness of this change, and politicians are thinking about readjusting the laws they have taken. So it might be that the future looks a little bit more positive than it does today.” Given that he is close to health policy making I am curious how things unfold. We will be getting back to this during the year.

IHS Global insights have also done a nice job in summarizing the ratings obtained so far. 

To remind you the scoring system applied in Germany is:

1: Major added benefit over comparator
2: Significant added benefit
3: Slight added benefit
4: Unquantifiable added benefit
5: No added benefit proven
6: Less than comparator


Pricing of drugs in Germany will be related to the scores. According to their review about 60% percent of new therapies have been rated between 4 to 1 and therefore are eligible for price negotiations with the association of the statuary sickness funds. Those scored below will only be able to obtain a referenced price in Germany.


These results clearly show the changed course that pricing and reimbursement for medicines has taken in Germany. Stay tuned for further follow up on the topic.


Cheers
Ulf

Future of R&D

Hi Everyone,


eyeforpharma is putting together what looks like to become an interesting conference. I will be participating in a panel discussion as well. Check it out.


Cheers
Ulf 


May 8th – 9th top payers: HAS, IQWIG, EUnetHTA, NICE and SanteSuisse are meeting big pharma at the Clinical Commercial Conference in Zurich .

The Super Early Bird discounted rate ends this week! To speak with big pharma and the payers that matter -  Book now and save €400

Join us and learn:

• Build commercial endpoints into clinical trials – BMS and the best of big pharma share how payer insight has provided robust development plans.

• Enhance your solutions for unmet need with Real World Data. Google and the ABPI will present solutions.

• Comparative Effectiveness Research – hear what payers can do to help you prove value and align to un-met need.

Theo Fellgett
VP Europe – eyeforpharma
theo@eyeforpharma.com
+44(0) 207 375 7591
eyeforpharma is part of FC Business Intelligence Ltd.
FC Business Intelligence Ltd is a registered company in England and Wales - Registered number 04388971, 7-9 Fashion Street, London, E1 6PX, UK

Market Access jobs @ Biogen Idec

Join Biogen Idec!
Biogen Idec is expanding its Market Access team with special focus on Public Affairs, Patient Advocacy and Eastern Europe. We are looking forward to receiving your application at europe.careers@biogenidec.com
Biogen Idec creates new standards of care in therapeutic areas with high unmet medical needs. Founded in 1978, Biogen Idec is a global leader in the biotechnology industry in the discovery, development, manufacturing, and commercialization of innovative therapies. Patients in more than 90 countries benefit from Biogen Idec's significant products that address diseases such as lymphoma, multiple sclerosis, and rheumatoid arthritis.

Health economics blog - 2011 round up

Dear Readers,

first of all I would like to wish everyone a happy and successful 2012! This is also a good opportunity to look back - I wanted to do this earlier but with the usual year end stuff and Christmas etc I didn't manage -  and especially thank you for the comments, discussions, helpful links etc throughout 2011. It has been a good year, we hit the 10.000 page views a month in June and also more than 500 regular followers, so I thank you for your continued interest.

It has been a turbulent year in the industry without any doubt. It is not easy to keep up with the daily news flow and to pick the interesting and important things. In that regard I am delighted that my last blog entry about new market access models created so much attention, I guess that shows the topic is on most people's mind and many of you strongly agreed with the majority of points. I guess the challenge remains to put thoughts into practice and become lean and agile. Anyhow the article has been reposted by eyeforpharma.com, healtheconomics.com as well as by The Healthcareblog and I have received a lot of good words for that piece.

It has been the year of reforms and cost containments and the news flow continues in the new year with new pressures in Portugal (always a problem child) as well the Czech Republik -  someone there announced that the Ministry plans to introduce formal cost effectiveness assessments (already done to some extent) as of 2013.  I had hoped they would learn from the mistakes somewhere else and wouldn't go the same way but I suppose everyone needs to make their own mistakes first before understanding that cost-effectiveness analysis doesn't solve the issues at hand.

It has also been the year of generics, in that regard I had a little deja vu experience when Pfizer announced the own marketing of a generic version of Lipitor.  I remember sitting one morning in the worldwide team meeting at Pfizer's 42nd street NY headquarters and responding just that when we were asked to think about generic life cycle management: "sell the generic stuff yourself". I still remember the outcast looks I earned for that comment, mind you it was 2004/5 when things still looked more bullish in pharma world. But to me that seemed and still is the most logical thing to do, as others such as Novartis have already been doing, instead of the useless differentiation efforts - at least in the small molecule arena. There prices go only into one direction - down, there is no magic, no big strategy the main decision is how much and how fast and until what level the originator would like to compete. I always called this, using a military term, an "organized retreat".  Biosimilars on the other hand might be another story, here - and I remember that well from my vaccine time - quality in manufacturing etc matters tremendously and not every company has the capability to produce good and consistent lots.

All in all however with a still weak economy in most parts of Europe pricing pressures will continue to mount throughout 2012.

So what else was going on? With your help we completed the first compensation survey, which was a good success. Many of you emailed me and should I have forgotten to answer some requests please remind me again.

We (Olivier Ethgen and I) have also taken on the challenging task to put together a book on the future of health economics. Have a look at the link and let me know if there are any interesting topics that you think are worth exploring or of anyone would like to contribute a chapter. We have already a good draft of potential chapters and will try to cover new stuff as well as spend some time on organizational matters around market access etc.

Last but not least most of us start the new year with a whole lot of new ideas and principles and stop, start continue considerations. Well my 'magic' word for 2012 is Prioritization. I feel I spent far too much time on things that didn't really matter in the big scheme of things, so lets see how I do this year. Steve jobs famous words from the Stanford graduation speech come to mind: reminding one selves (without being overly dramatic of course) of the finity of life helps doing the right things and stop wasting time. So for example, before we write yet another useless email cc ing the world, we should think about if that really is required...or if that personal chat or phone call isn't simple the better thing to do ;)

Wishing everyone a great year and looking forward to hearing from you!

Cheers
Ulf