Health Economics Blog

May 1, 2012
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

February 14, 2012
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

February 10, 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

February 9, 2012

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

February 2, 2012
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.

January 3, 2012
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

November 23, 2011
: Dear Readers,

yesterday the Catalan Department of Health Services announced that it has signed a risk sharing deal involving the Catalan Institute of Oncology and Astra Zeneca. This pioneer project is the first of its kind in Spain in order to balance patients access to new medicines and sustainability of the health care system. This pilot project has a duration of one year and in relation to the results obtained may successively become the standard for market access of innovative drugs in Catalonia from 2012 onward. The current agreement is formed around Astra Zeneca's lung cancer drug Iressa (gefitinib). Patient follow up and evaluations are being performed at the Catalan Institute of Oncology. Further details of the scheme have not been published.

I enclose the link to the original communication (in Catalan).

This is certainly a large step forward in Spain and a consequence to attempt to rationalize costs and to identify patients most likely to benefit from new treatments.

Regards
Ulf

October 26, 2011
Pay for performance contracts for Avastin in Germany: Dear All,

Roche has offered performance based contracts to German hospitals whereby money is paid back when the drug does not work. It appears that the details are not in the public domain. A recent article in the Sueddeutsche Zeitung comments on that news and describes how several stakeholders perceive that strategy as quite problematic as in their view it may set the wrong incentives for hospitals due the potential risk of suboptimal treatment. At the same time the legal basis is questioned as the treatment is paid by the sickness funds and therefore funds shouldn't be given to the hospitals, argue several health insurance representatives. This for sure is a bold move from Roche in order to stop product from loosing ground, but at the same time is not the first pay for performance scheme in Germany. It will be interesting to see how that case unfolds.

best
Ulf

October 12, 2011
German Law Has Companies Weighing Whether to Sell New Drugs in Europe's Largest Market: Dear All,

there is a very interesting podcast on the AMNOG implications and recent developments from the Burrill report.

Cheers
Ulf

October 6, 2011
Market Access: are we mounting the horse from the wrong end?: Dear Readers,

I cannot resist writing one more time about the entire market access discussion currently ongoing everywhere as I believe many of those numerous articles and reports are missing the point. It is sheer amusing - at least to me - to see the continued flood of articles, consultant presentations, blogs, congress announcements, workshops, summits, reorganizations, speeches etc. all over the place basically suggesting as to how the industry just needs to throw a few more people with fancy titles here and there coupled with slight organizational changes onto the problem and involve stakeholders and, guess what, talk actually to patients and perhaps even payers etc. and all of a sudden like Alice in Wonderland everything will be good after all. The uncomfortable truth is it won't be. All this “noise” is only good for one thing, paying the bills of the consultants - which is fine too, as I have been one myself so I can understand, but it will not address the problem the research based pharmaceutical industry and its employees are facing. Without a substantial increase in R&D productivity, the pharmaceutical industry's survival (let alone its continued growth prospects), at least in its current form, is in great jeopardy.

Of course you need experience in areas such as HE, Outcomes Research, Pricing, Economics, Policy, Advocacy etc and all needs to work in sink and early on and with the payer in mind, and yes, most people have understood that by now. So the problem is essentially not in the capabilities, although some are more advanced than others, but rather in the company cultures.

In my view, and in order to get back into business, the industry needs to have a more critical look at itself. Some old fashioned ways of doing things will have to be revisited, most proceses are probably too slow, too bureaucratic, and several companies have cultivated a culture that is not suitable for mistakes or for trial and error. Nobody takes the smallest decision anymore without x t-cons and endless cc lists in the email distribution. We also need to stop looking at the short term financial results only, investors need to be made understood that this is a business model for the long run - in that regard I speculate that some companies that are not registered at the stock exchange might have it easier.

The next important thing is a matter of greater transparency and honesty, internally. How often did you sit in meetings about value stories, and value propositions and this and that and you were thinking this product is actually not up for today’s challenges with the dataset you may have in front of you but nobody wants to be the messenger. Sounds familiar, I thought so. And let's face it if you need a major workshop and intensive external “coaching” to help define the value of your product - well there mostly actually is little to none. If it was really good, it would have been obvious from the start. So maybe we ought to stop beating around the bush and move on if there is nothing to be done anymore... it hurts, understandably, as a lot of sunk cost is associated with it. But this is the same as subsidizing the brown coal in the Ruhrgebiet in Germany over decades…, eventually it was dead, and all knew it was going to be an outdated model, the earlier they would have understood that the better it would have been for all involved.

So how can we get that RD productivity up and bring out the desired and needed (think of cancer, Alzheimer’s etc) next generation products with true distinctive medical benefits? Frankly I don't know, maybe we should ask the scientists. Is it that we have hit the wall with what we can scientifically achieve, is our understanding of human biology and mechanisms simple not sufficient? Or did we organize ourselves in a way that hinders progress?

From my experience I have at least some vague ideas in relation to the later:
It comes again back to culture; scientist, like all creative people alike, need an environment that encourages collaboration, which allows for trial and error, that lets you be different if you want to be, have the freedom to investigate, have the possibility of fast and flexible joint ventures with who ever needed. Maybe we need looser and better partnerships, a closer link to Universities, labs, start ups etc... But this all requires a lean, innovative can do culture with an entrepreneurial spirit. However, what we often find is that scientist, and others, are bugged down by inefficiency, over complication, paper stuff, by old style autocratic leadership style, wrong leaders and managers that micromanage every little move and piece of work and therefore will not allow science to flourish. Or as Steve Jobs put it once, “Innovation has nothing to do with how many R&D dollars you have. When Apple came up with the Mac, IBM was spending at least 100 times more on R&D. It’s not about money. It’s about the people you have, how you’re led, and how much you get it.”(Fortune, Nov. 9, 1998)
We might also want to stop seeing our competitors only as that but rather form intelligent partnerships, develop things together when appropriate, occasionally jointly understand which drug and where does mostly benefit the patients rather than only detailing each other out.

New break though medicines are the challenge of the future and as part of it you need business, science, economics savvy and pragmatic people who can understand the advantages and limitations of the science and the payers side in order to lead development and hence the market access strategy of such novel drugs, however once you have a looser in your portfolio it will stay a looser whatever resources you throw at it, that is the big change that has come around. Yet many people, to me sheer surprise, seem to have not yet fully understood that.

Discovery in human biology and medicine needs a flexible and opened minded environment, so why not work on that end first, talk to each other earlier, try to build frameworks of collaborations and organizations that foster scientific progress and find truly promising drug candidates (and be ready to kill those early that are not delivering) rather than wasting time on these endless surface based market access discussions that often jump the horse from the wrong end. Let’s rather talk about how to become an agile, innovative and forward looking industry that will be admired for its break through products. An organization that fosters a culture of true innovation, evolution, entrepreneurship and with a focus on distinctive, head to head evidence generation – that is where I think the “market access” movement should be starting to put the focus on to begin with.

September 27, 2011
AMNOG and its implications in Germany - Webinar: Dear All,

please find below an announcement for a webinar organized by Kakushin group about the changes introduced by the new drug law in Germany and its potential implications. I will give an overview from a pricing perspective.

Cheers
Ulf

September 22, 2011
Executive Summary of the 2011 Health Economics Blog Compensation Survey for Health Economics, Pricing and Market Access Professionals: Dear Readers,

I am pleased to finally announce the results from the compensation survey! I know many of you have been eager to see the data and therefore I would also like to apologize for the slight delay and thank all of you again who have participated and been patient. It took a little longer than anticipted to get through the data but as promised here is the executive summary. I am curious as to your views and comments, please do not hesitate to get in touch - more info as to the survey and possibility to obtain additional data you will find in the post below. Best wishes - Ulf

HealthEconomicsBlog.com International Compensation Survey - Topline Results

The first global anonymous compensation survey for Health Economics, Pricing and Market Access professional conducted by Ulf Staginnus, author of healtheconomicsblog.com in collaboration with HealthEconomics.Com has been completed. A wealth of data from various countries and parts of the world has been obtained via an online questionnaire powered by surveymonkey.com. I therefore would like to sincerely thank everyone who has participated and recommend the survey to friends and colleagues!

I am very delighted to have reached a decent sample size with a total of 212 responses, but I hope we can increase this next time and get an even more precise picture. Below pie chart depicts the distribution among the various occupations.

Where do people work?

The most common place of employment was in a Pharmaceutical Company or a Consultancy, each representing slightly more than one-third of the population. About 10% percent of respondents were from Academia, almost 9% in Medical Device companies and an even split of 3,6% between Biotechnology and HTA/ Governmental agencies.

Seniority

In terms of years of professional experience, most participants had 5-10 (22,4%) or > 15 years of professional experience (27,6%). However, the sample population was limited by a low proportion of responses from individuals at very senior levels (e.g., Executive Director, Vice-President). In addition, there was a lower proportion of respondents with <3 or 3-5 years of experience.

Salary data

Now let’s get down to the most interesting part. Useable salary data were obtained from 193 of the total responses. Data were obtained from a geographically-diverse sample, including the following countries:

Australia, Belgium, Brazil, Canada, China, Denmark, France, Germany, India, Iran, Israel, Italy, Kenya, Lithuania, Luxembourg, Mexico, Netherlands, Pakistan, Poland, Portugal, Romania, Russia, Singapore, South Africa, Spain, Sweden, Switzerland, Turkey, UK and the USA.

Considering the entire international sample, the mean annual salary was US$127.000 and €88.838 respectively, with a median of US$125.000 (€86.895). The lowest salary in the overall sample was US$5.178 (€3.600), a professional from Iran, while the maximum was at US$329.749 (€229.257), a Dir from a Consultancy in the UK. The standard deviations were calculated at US$64.975 and €45.171 respectively. The US dollar numbers for the entire sample have to be interpreted with caution due to the weak US dollar affecting the exchange rates when converting into € (figures from August 23rd 20011 were applied; www.oanda.com).

The mean salary in the US sample was US$145.760 with a minimum of US$19.000 for a Graduate Research Assistant in academia and a maximum annual salary of $US250.000 for a Chief Operating Officer of a consulting company.

The highest salaries are paid in Switzerland, Denmark, Germany and the US. On the bottom of the pay scale ranges were the countries of Spain, Italy and those within the Emerging markets (e.g. Brazil, China) as well as the central Eastern European markets.

Salaries can be considered representative across position level, as there was a relatively even distribution among the various seniority groups collected during the survey. As previously mentioned, we are probably missing more data from the very senior levels (e.g. Executive Director and VPs) due to an under-represented sample, as well as from the very junior entry level positions. The survey indicates that the ranges for very senior level executives can be expected to start at approximately US$250.000 in the US, Swiss Franc 300.000 in Switzerland, and €200.000 in Germany for example.

As outlined above, there were only a few responses from individuals working in HTA agencies and insurance companies, but a relatively reasonable sample (n=20) from academia, mostly from the US. Academia and HTA agency salaries were generally lower than the salary of those employed in the industry, although one has to bear in mind that many have additional income through consulting projects.

Additional benefits

Regarding additional benefits, 73% of respondents had positions which conferred health care benefits. While this is a relatively high percentage, it could have been expected to be somewhat higher. Most (70%) survey respondents are covered with either accidental and/or life insurance by their employers. About a third of respondents have the corporate benefit of a company car. This appears to be most common in Europe due special taxation advantages for employers. More than one-half of the respondents have a private pension plan with their company. Tuition reimbursement or school fees covered by the company represented a small percentage of total benefits and this typically represents a higher proportion for expatriates or for those relocating to positions at corporate headquarters (e.g. mainly when relocating to headquarters in Switzerland, Belgium and the UK).

Other benefits reported by respondents include meal vouchers (especially in Europe), reimbursement for home internet, and the provision of smart phones or other types of IT equipment (e.g. iPads).

It is also interesting to see that more and more companies come around the concept of flexibility on location and allow time from work at home, support home offices and flex time as well as offer specific commuting solutions. This I think becomes even more important for very experienced and senior people in order to attract and retain this talent.

Bonus opportunities

More than one-half (65%) of respondents in the overall sample received a bonus, in addition to their base salary. The data is however more dispersed. Bonuses tend to range from 10% to 20% of the annual gross salary, and this varies substantially with company total sales volume and individual performance. More senior executives stated typical bonus ranges of 25% to 30% of gross salary, while junior positions most typically either had no bonus, or a maximum of 10% to 15% of gross salary. Bonuses for senior professionals in consultancy tend to be somewhat higher.

Stock options and restricted shares

Stock options and restricted share benefits were assessed using an open-ended question, and as a result, the responses were quite varied. However, a broad trend is recognizable. There is a clear distinction on the share option front. In the US, regular and significant restricted shares and stock options are being granted, and form a significant proportion of the overall package; however, this practice is much less common in Europe, suggesting that European based employers need to be more aggressive with this remuneration element in order to remain internationally competitive.

Conclusions and Other Observations

• Remuneration of professionals in this field remains attractive. However, in areas where a substantial proportion of graduates and professionals are coming into the market, such as the UK, salary levels in the entry and middle management positions most likely will slightly decrease, or at least stabilize over time.

• The challenge is to find experienced personnel with relevant country, negotiation, practical health policy and commercial expertise. Professionals that posses that skill set coupled with the ability speak multiple languages will continue to enjoy premium pay.

• Southern European as well as Eastern European countries and Emerging markets are at the lower end of the pay scale. However, with increasing requirements and growth in market size, there will likely be an upward correction on the remuneration side in order to attract and retain experienced professionals.

• Although not specifically analyzed in this survey, headquarter positions typically command a higher pay. This may explain the higher salaries in Switzerland and certain other markets that tend toward a centralized corporate structure, as opposed to field-based professionals.

• US salaries are generally quite attractive, especially with increasing level of seniority. Main additional benefits in Europe include the company car, while the benefit of private health care coverage plays a more important role in the US.

• US employees enjoy stock option and share incentives as a significant part of the annual compensation package

Additional data and analysis

The above data is an executive summary only. Additional data analysis can be conducted, for example:

• Country and Region specific analysis
• Detailed breakdown according to seniority
• Additional graphs & details, box plots etc.
• Some more information on stock and share options
• Data per sector, e.g. Medical device, Pharma, Academia

These analyses can be made available on individual request and are subject to a processing fee to cover data analysis and reporting cost. In addition to that, individuals, human resources departments and recruiters can additionally purchase more detailed data sets. Tiered pricing will be applied with specific discounts for students and HTA and/or governmental agency employees.

Please contact me (ustaginnus@hotmail.com) in case of additional data needs. We will get back to you with a specific quote and timing in relation to the data consulting request.

Copyright Statement

©2011 healtheconomicsblog.com. All rights reserved. Materials copyrighted by healtheconomicsblog.com may be reprinted for personal use only. Permission to reprint or electronically reproduce any document in part or in its entirety for any other reason is expressly prohibited, unless prior written consent is obtained from www.healtheconomicsblog.com

September 20, 2011
Social Media and Health Event: Dear All,

Chandler Chicco is running a social media and health event. As I posted previously, social media and IT improvements in the pharma sector could become much more important in data collections and connections to patients. Further details on this event from the organizers.

Cheers
Ulf

September 8, 2011
Shire CEO: Pharma must "wake up" to new price reality: Dear All,

I had the pleasure to be on a joint panel with Angus Russell during the 2011 World Health Conference in Brussels about pharmaceutical pricing, where he also stated that pharma needs to start to face reality... I couldn't more agree with this article as many value propositions are unfortunately message heavy and data light.. it's time that true product performance is demonstrated otherwise all that market acess talk and wanting to understand payer perspectices etc. is for nothing..

Cheers
Ulf

Shire CEO: Pharma must "wake up" to new price reality - (Boston Business Journal via NewsPoints Desk)
(Ref: Boston Business Journal)

from WirstWord

Shire CEO Angus Russell said Wednesday that the drugmaker is now initiating head-to-head studies as early as Phase 1, so as to avoid expensive late-stage clinical trials if the potential therapy does not show promise to be best in class, and urged others in the industry to follow suit, Boston Business Journal reported.
Russell said in the future, other markets are likely to follow Germany’s lead in deciding not to pay for drugs that have not been evaluated in head-to-head trials with approved drugs.
The executive said payers and policymakers talk about value, not innovation, and that “if you ignore payers and policymakers, you are not going to be successful in the new world we are entering.”
Russell criticized the lack of coordination between business, regulatory bodies and government health payers, whereby pharmaceutical companies consult with regulators early in the drug development process to design clinical trials, but only after approval, or just before, do they consult with payers about pricing for the drugs.
He noted that “we are all losers at the end of the day if payers don’t want the drugs," or don’t pay a return that is acceptable to shareholders and urged the industry to open up dialogue with regulators, saying “if we don’t get involved ... we’ll end up in a bad place.”

August 30, 2011
Spain: It shouldn't be all about drug expenditure containment: further to the current changes in the Spanish healthcare system, I am pleased to publish a guest post from my good colleague Fernando Aisa, Barcelona.

26 Aug. 2011

Last Thursday, my colleague Ulf posted a message in the blog, regarding the last health cost containment measures of the Spanish Government.

Summarizing, the Royal Decree approved contained the following measures:
• Mandatory prescription by active ingredient
• The physician will prescribe by active ingredient
• The pharmacist will dispense the cheapest drug available
• Changes in the reference price system
• A new reference price will be set immediately when the first generic gets reimbursement authorization by the NHS
• The decrease in the price to be in the reference system -and hence reimbursable- must be done immediately, and not
in two years, as it’s been so far
• 15% rebate for all the drugs manufactured for human use, in the case that: 10 years from the date of reimbursement
authorization by the NHS, 11 years in case of a new indication had been approved

The Government expects savings of around 2.4 billion € with these new measures.

In 2010, two additional Royal Decrees were approved, expecting to save 2.5 billion €:
• 7.5% reduction in manufacturer's price of patented medicines reimbursed by the national health service
• 4% reduction in the price of orphan drugs
• Price of generic medicines cut by 25%

The 2010 measures undertaken provided –for the first time ever- a decrease of -2.36% in the national drug expenditure.
Should the growth deficit of drug expenditure be a goal in itself? Like the spies in the good novels of John Le Carre –Bond used to have more “explicit” means- this is called deflection: Putting one’s attention on a secondary goal while the real one remains undetected.

Aiming to have negative growth in drug expenditure is like trying to freeze salaries. In a country with a more and more ageing population, which is also increasing overall; with high quality of life; with universal healthcare coverage; with innovative medicines coming up that aim to increase life expectancy; just with inflation… with endless etceteras… one cannot expect to keep the drug expenditure growth negative. Of course, it’s good to have a reasonable use of medicines and controlling prescription.

Should we foster the use of generics, as the Spanish government is doing?

Innovative medicines have a life cycle, and it’s protected by a patent, allowing the licensor to have some profits. After that, a reasonable policy of quality generics would allow to divert resources again back to new molecules and research. Hence, yes (for the sake of the post brevity, allow me to simplify here)

Why is this a deflection then?

Ulf very adequately said that these measures focus again on pure price parameters. And he is right. Better use of resources would allow to pay what a medicine is valued (and not over valued) We miss these kind of measures. Spain has 17 regions with a lot of autonomy. The Central Ministry of Health controls hardly 10% of the national healthcare budget. The rest relies on the regions. Due to the specific recent history of Spain, there was an urgency to transfer a lot of competencies to the regions from the central government, without planning or consistency. Hence, we now find 17 regional ministries of health, each of them developing their own health care policies. And very diverse policies: Some regions have overcrowded the hospital population, building and building, under the umbrella of the real-estate boom, creating overlapping of health care areas. Now, some primary care centres are being closed down due to the lack of patients. The population of doctors per 1000 inhabitants is one of the highest of the OCDE. In contrast, nursery services are below any average –OCDE or EU. Other region tried to create its own reimbursement list, trying to supplant one of the last competencies of the central government: Approval a single price and reimbursement of the same drugs across the territory, to ensure all citizens have access to the same level of health care. Again, the etcetera of non-sense policies becomes incredibly high. Guess what: The famous Spanish debt –not that high, anyhow- mainly comes from the regions and their policies. Regional healthcare debt is huge and pharma companies are sustaining a lot of effort. Some of the reasons are named above.

In the absence of a central HTA agency –last Royal Decree approved tries to create kind of embryo- we may find, currently, around 10 regional HTA agencies. Again, each of these agencies has its own assessment criteria. Surprisingly, none of them has criteria of value based evidence. They stay in mere cost-effectiveness or YTC vs. standards of care. Again, they just look for savings, instead of increasing the quality of the medicines available and the service to the patient. And then we’ve got the hospitals. In an attempt to control the prescription and dispensation of specialty drugs, the government transferred a significant number of these drugs to be dispensed from the hospital pharmacy. This resulted in a huge increase in the number of hospital pharmacy commissions, which obviously overlap and duplicate competencies with the regional HTA agencies and diverse bodies.

Drugs should be priced and paid what they are worth -It’s true that some of them may be over-priced, but that’s a topic for another article- and we must ensure we have the right mechanisms in place to make the fair assessments. But we cannot simply focus on trying to reduce the bill. After having put in place reasonable measures to ensure right use and prescription of drugs, we should stop shrinking innovation and put our efforts in increasing the efficiency of healthcare expenditure and resources, reducing the bureaucracy and layers, standardizing assessment criteria. The opposite would lead to an unequal healthcare coverage and lower quality of drugs available, emphasising the inequities of the country.

August 25, 2011
New Royal Decree further tightening drug funding in Spain: The Spanish cabinet just approved the new Real Decreto - ley 9/2011 – another set of measures in the fight to tighten the state’s budget. Among the updated rules in the new law is that doctors only can prescribe drugs (with a few exceptions) according to the active substance (principio activo (PPA)) rather than by brand. This, according to the Spanish government, should ensure that only the cheapest available medicine is being dispensed within the national health system. On the other hand the therapeutic price referencing system, article 93, will be once again altered - the second time in a year - whereby the system will now be converted into a low price mechanism that only looks at the financing of the cheapest drug in the class.

This new set of cost containment measures come not really as a big surprise but the implications are most likely to further negatively affect the pharmaceutical sector in Spain in terms of employments and investments in R and D says Farmindustria, the Spanish industry organization.

Here is the link to the full text of the decree.

July 14, 2011
First Global HE, Pricing and Market Access compensation and benefits survey closing soon...: Folks,

I would like to remind you to check out the salary survey.. so far with the joint effort of Patti from healtheconomics.com and I we have hit the 200 responder mark today! It will be quite some work to shuffle through the data therefeore I would like to close that survey by the end of July in order to do some stats and writing up of the top line results during the upcoming travels in August.. so who has not participated, or has but has not yet encouraged friends and colleagues, please do so - it is of course entirely anonymous.

Here the initial post with the link to the survey again.

Many thanks and happy holidays to those already somewhere at the beach or in the montains.

Cheers
Ulf

July 14, 2011
Jeroen Luyten is this year’s winner of Pfizer’s European HTAcademy scholarship of €40,000: Amsterdam, July 5, 2011 – Jeroen Luyten, a PhD student at the University of Antwerp in Belgium, was selected this year’s winner of the European HTAcademy scholarship by an independent expert committee – in tough competition with Dutch and German national winners. His research project aims to investigate the moral relevance of medical effectiveness and intangible costs for the societal valuation of QALY-gains; dimensions that are so far under-explored within the QALY framework. Mentor for this project is Professor Philippe Beutels of the Centre for Health Economics Research and Modelling Infectious Diseases at the University of Antwerp.

From left: Clare McGrath, Pfizer, Jeroen Luyten, HTAcademy European Scholarship winner and Professor Maarten J. Postma, Chairman of the European Expert Committee

The HTAcademy aims to promote the further development of Health Technology Assessment (HTA) as an important tool for the systematic evaluation of healthcare technologies by supporting up-and-coming scholars in the HTA field. The European HTAcademy scholarship of €40,000 is awarded once a year for the realization of the winning research proposal. National level winners receive a travel stipend of €5,000–€10,000. The HTAcademy is sponsored by Pfizer Ltd.

Runners-up

Dr. Barbara Buchberger of the University Duisburg-Essen was the winner of the German HTAcademy scholarship 2011/12. Her project proposal entitled “Descriptive and analytic comparison of component systems for the assessment of interventional studies” aims to research quality assessment tools (QAT) used to test the internal validity of single interventional studies. Supporting this work is Professor Jürgen Wasem of the Institute for Health Care Management and Research at the University of Duisberg-Essen.

The Dutch HTAcademy expert committee selected Reina de Kinderen, a PhD student at the University of Maastricht, this year’s national winner. Her research project aims to explore differences between condition-specific and generic instruments for health valuation in epilepsy; hypothesized to be lower due to the non-constant health state of epilepsy patients. Mentor for this project is Dr. Silvia Evers of the University of Maastricht.

HTAcademy national winners: Barbara Buchberger, Reina de Kinderen and Jeroen Luyten

About HTAcademy

Pfizer’s annual HTAcademy scholarship program aims to support graduates at the start of their academic careers who want to contribute to the further development and application of HTA concepts. Eligible candidates may come from, for example, the fields of medicine, health sciences, health economics, psychology or medical ethics. The European scholarship of €40,000 is awarded to the candidate with the most promising research proposal, as selected by an independent expert committee. Eligible candidates for the European scholarship are the national level HTAcademy scholarship winners; each awarded a travel stipend of €5,000 – €10,000. For the cycle 2011/12, applications from Belgium, Germany, the Netherlands and Switzerland were accepted. The European expert committee is chaired by Dr. Maarten J. Postma, Professor of Pharmacoeconomics at the University of Groningen.

Further information about the HTAcademy scholarship program and contact details can be found at www.htacademy.eu

July 8, 2011
Lilly CEO Calls for Improved Dialogue in Germany Between Industry and the Government and Health Care System: from www.lilly.com

Speech to Federation of German Industries Conference focuses on Germany's legacy as a pharmaceutical powerhouse and the need for greater collaboration and communication to advance medical innovation

BERLIN, July 7, 2011 /PRNewswire/ -- In an address to the Federation of German Industries Conference in Germany today, John C. Lechleiter, Ph.D., chairman, president and chief executive officer of Eli Lilly and Company, offered to help build a new level of trust between the biopharmaceutical industry and government health care regulators. Lechleiter said collaboration can harness innovation to help meet growing health care demands within increasingly constrained budgets, create an environment where biopharmaceutical innovation can thrive, and achieve victories on behalf of the people who are counting on medical advances to live longer healthier lives.

Lechleiter, who in 2012 will serve as the chairman of PhRMA, the U.S.-based association of global pharmaceutical research and biotechnology companies, noted that Germany is the third-largest market in the world for most of the industry, including Lilly.

"Although Lilly is based in the U.S., we have deep roots here in Germany and enormous respect for this country's legacy as a pharmaceutical powerhouse," said Lechleiter. "However, in no other place in the world has the environment for innovative pharmaceuticals changed more in the last 12 months than it has in Germany." He noted that "recent health care reforms are jeopardizing the country's legacy of pharmaceutical innovation," but added: "At the same time, I see Germany as a place where the pharmaceutical industry can achieve a breakthrough — a fresh start if you will — to develop more constructive and collaborative relationships."

Lechleiter said government and industry are on the same side in the fight against disease. "We are collaborators, not competitors. We need to work together in a spirit of openness and trust, and our industry bears responsibility for helping to build — or rebuild — that trust."

To open the dialogue, Lechleiter discussed recent health care reforms in Germany that have created barriers for innovation. He cited action last year by the German government to freeze prices for pharmaceuticals already in the market and to increase significantly the mandatory rebates that industry must pay to the health system on sales of its products. As well, in a law known by its German acronym AMNOG, parliament imposed a complex new regulatory mechanism to assess the added benefit of new pharmaceutical products entering the German market, linking future net prices to the outcomes of this assessment.

"No other country in the world has a set of requirements quite like those imposed by AMNOG. The potential effects are serious: launches of new medicines that can benefit patients delayed or withdrawn, erosion of Germany's strength in pharmaceutical innovation, and the loss of high-paying jobs in research and development."

He said that AMNOG proposes to determine the value of a medicine in "a wholly unnatural way: at the time it is launched in the market, before any real-world experience with the new product is available." In addition, he said, the understanding of innovation reflected in German regulation fails to account for the full value of innovation, with too much short-term focus on holding down costs "by imposing impossible standards on new treatments that some of the most effective medicines of the past never would have met."

"Given that AMNOG is now the framework we have for assessing the value of new medicines," he said, "I believe it's vitally important to find ways within that framework to allow patients and the health care system to benefit from pharmaceutical innovation." He suggested, for example, that "the 'Early Assessment' could be used not to define the potential of a new medicine as low as possible to save money, but rather to take a comprehensive view of its potential value for patients."

Lechleiter will be in Germany for the next 7 days meeting with government officials, members of parliament, and regulators to make a case for greater dialogue and trust between industry and health care regulators. "For companies like Lilly to make the enormous investments necessary to develop new medicines, we need predictability and certainty in the regulatory process that will determine whether or not those medicines will ever reach patients. We in industry are prepared to work with regulators to help define clear, transparent, and workable approaches to regulation, and we want to work in the same way with health care policy makers to lay out the process that determines the value of innovation."

"We're on the same side in this fight. We have a common enemy — disease, disability, and premature death," said Lechleiter. "And we have a common interest in the only means by which our health system can help more people live longer and healthier within constrained budgets — and that's innovation."

"I know I speak for colleagues in the biopharmaceutical industry when I say that we seek a regular, open, and structured dialogue in Germany with the government and the health care system," Lechleiter concluded.

June 28, 2011
Preparing For A Pricing Shift: Roche Admits Cost Is An Issue In Oncology And Beyond: From The Pink Sheet
Preparing For A Pricing Shift: Roche Admits Cost Is An Issue In Oncology And Beyond
Pricing by indication could be one approach to the growing problem of the cost of oncology drugs, Roche Pharmaceuticals Chief Operating Officer Pascal Soriot suggested at the firm's analyst event at the recent American Society of Clinical Oncology annual meeting.
"It is clear that cost is going to be an issue," Soriot said. "We are certainly starting to think about it, and over the next few years we will develop strategies for this."
Though it has come up with increasing frequency in recent years, the need to address oncology pricing was a clear takeaway from the ASCO annual meeting, where mentions of emerging data on Avastin (bevacizumab) in ovarian cancer were paired with comments about the cost of the therapy.
Genentech was pioneering with its payment assistance program for Avastin, which caps the price for on-label uses at $58,000 a year (after a patient hits 10,000 mg of use, the company provides the drug free for the remainder of the year). But ovarian cancer holds the potential for longer durations of use, as evidence suggests Avastin could play a role as a maintenance therapy ("Roche's Long View: ASCO Marks Progress In Shifting To Lengthier Treatment Duration For Avastin, Rituxan," "The Pink Sheet," June 14, 2010).
Beyond Roche, Dendreon's $90,000 price tag for Provenge and Bristol-Myers Squibb's $120,000 for Yervoy – the most expensive oncology therapies to date – have cost considerations moving up the agenda. Pharmacy benefit manager Medco highlighted growth of oncology drug and companion diagnostic costs in its "2011 Drug Trend Report" ("Payers Are Preparing For Coming Companion Diagnostics, Medco Notes," "The Pink Sheet," June 20, 2011). And some payers are exploring "clinical pathway" programs to establish standards of care for high-cost cancers (“What New Cancer Pathway Programs Mean For The Drug Industry,” IN VIVO, May 2011).
Soriot noted that the cost problem transcends oncology, pointing to rheumatology as an example.
"Over the next few years, the payers of course are going to be helped a little bit by the fact that some other drugs will lose patent protection, but it is not going to be enough, I think," he said. "We have to definitely tackle this issue, and I believe … more and more we will have to start thinking of pay-for-performance but also pricing for an indication."
The executive did not elaborate but mentioned that he had been meeting with opinion leaders and decision-makers from European countries to talk about setting up a different approach where pricing is done by treatment of cancer type.
While such talk is in the early stages, the groundwork needs to be laid now. "We need to put in place the tools," Soriot concluded. "That's why we need to partner with payers and decision-makers in various countries, to put in place the tools so we can do that."
But, he added, "we have an incentive and we are in a very good position as a company to do it because we have a very broad portfolio. So we have various products that we can leverage to do that."
Price also came up as part of Roche's business rationale for personalized medicine: a slide on the benefits of patient stratification listed pricing power alongside increased market share, time to market, lower development costs and higher probability of success.
Personalized health care, and its advantages for R&D productivity, was the theme as Roche/Genentech talked up its oncology prowess for investors.
Protecting Its Dominance
"We are a leader in oncology today, and we intend to remain one," Soriot pronounced at the on-site analyst event. The firm has a comfortable margin, with 31% of the global market in 2010 followed by Novartis with 11% ("Global Oncology Rankings: It’s A Long Way To The Top," "The Pink Sheet," June 6, 2011).
Oncology has a high profile within Roche's overall business as well. "Half of our investment and half of our projects are in oncology," Soriot noted, with 52% of the big pharma's new molecular entities in clinical development for cancer. There is a move to do more in other areas, like inflammation/immunology and CNS. "But oncology remains, clearly, the mainstay of our research and development investment."
The execs also touted Roche/Genentech's above-average success rate in development, although 2010 was dogged by a series of failures. "We actually dropped to an average success rate like the rest of the industry," Karl Mahler, head of investor relations, boasted. But since October, the firm has now had 18 trials in a row that were positive, he noted.

The combined company currently has 32 new molecular entities in oncology, including four in Phase III and four in Phase II (see chart).
Hal Barron, chief medical officer and head of global product development, pointed out that the company is moving outside of its core area of expertise – monoclonal antibodies – to an "increasingly large portfolio of molecules" that include small molecules, oral agents and combinations of antibodies and small molecules.
Antibody-drug conjugates, which link an antibody to a small molecule cytotoxic, make up the lion's share of Roche/Genentech's oncology pipeline. Behind the lead project, trastuzumab-DM1 (which stalled after the company tried an early submission in breast cancer), the company has 37 additional ADCs.
The company believes ADCs will change the way cancer is treated, and having that platform technology with a wide stable of molecules (now targeting 11 cancers) could be very good positioning. But although the company's attempt to be first to market may have backfired with the "refuse to file" action on its T-DM1 submission, it continues to accrue evidence. At ASCO it presented data showing T-DM1 was effective in Herceptin-refractory patients, "highlighting the fact that not only can these molecules be safer, they can have activity that might be in excess of what you would see with a naked antibody," Barron said.
Like most of the pharmaceutical industry, Roche espouses the personalized health care movement. Most of its development projects have a biomarker program, and the theme of the oncology pipeline is "really to develop drugs in a very targeted way, to identify which patients need which drugs and ensure that we study them in a robust manner," Barron said, noting that this means a more pronounced treatment effect and more accentuated benefit/risk profile.
Taking Advantage Of In-House Assets
It also means an evolving business model. "In the future, more and more what we actually will be commercializing is not a medicine; it's actually a solution, a medicine and a test," Soriot said. "It sounds easy when you talk about it, but I can tell you it is not that easy to engineer and operationalize that."
That's where the company thinks it has an advantage: Roche's legacy diagnostics business gives it an in-house source for the companion diagnostic work to go along with the personalized therapies. It is "a great advantage in the marketplace," Soriot said, "because both teams are in the same company and have the same rules and [are] able to cooperate and coordinate their activities much better than we would if we were two separate companies."
"We are trying to leverage the strengths of having pharma and diagnostics under the same roof and across the entire value chain," he continued. In the research stage, that involves sharing knowledge from the beginning and working together to understand the biology and the pathways, "by making sure that the teams share data very early on, in a very free fashion, and hopefully leveraging IP each time we can." In development, it means prospectively identifying biomarkers and doing the right sample collection. And, "from a commercialization viewpoint, we are working hard on defining the label at launch and coordinating the launch of the two products."
Soriot acknowledged that the company has been talking the personalized medicine talk for awhile. "And I must say, for a number of years we didn't have a lot to show for it." But he argues that in the last year the company has come closer to turning the strategic vision into reality.
"In particular, since the merger of the two companies, you can see an enormous acceleration of [the] number of projects [and] collaborations that exist between our diagnostics unit and the pharma team." And over the next three to four years, he expects an acceleration of that trend and multiplication of the number of joint projects.

.
It is a costly process, but Soriot thinks it will pay off in terms of increased R&D productivity. Nodding to analyst criticism that big pharma has been spending too much on R&D with little to show for it, he admitted that "we haven't been very popular … because we are one of the highest spenders in the industry."
"The way we see it is that it's not a question of cutting investment, it's a question of increasing productivity of the investment," Soriot said. "And clearly personalized health care is a massive lever to improve this productivity by reducing attrition rates and identifying biomarkers prospectively." It will also help with development costs by enabling shorter studies in smaller sample sizes because of patient selection. It can also mean a quicker path to market, he said, pointing to the BRAF inhibitor vemurafenib under FDA review for treatment of metastatic melanoma in patients with a certain BRAF mutation.
The Saving Grace Of A Biomarker
Roche will get a test of the benefits of starting out with a personalized medicine from day one with MetMAb. The monoclonal antibody is in development for lung and triple-negative breast cancers and shortly in colorectal cancer, all stratified by levels of the MET protein. "If you look at MetMAb, it would not be a product without the biomarker," Soriot said.
The initial Phase II trial in lung cancer did not show a benefit in the overall population; a retrospective analysis showed advantage in the cohort of patients with high levels of MET, and a survival analysis of this group was presented at ASCO ("Roche's Diagnostic Foothold Gives Genentech A Leg Up In Oncology," "The Pink Sheet" DAILY, June 2, 2011). Phase III is slated to begin later in the year.
The company is also attempting to retrofit some of its marketed products with a personalized health care strategy. With the lung cancer therapy Tarceva (erlotinib), Roche has taken research about EGFR mutations and re-run studies ("NSCLC Market Snapshot: Promising Biomarkers, Testing Challenges," "The Pink Sheet," May 30, 2011). The EURTAC trial presented at ASCO gave proof that erlotinib has better effect in patients with EGFR mutations and is helping move the drug into the first-line setting (it is approved for second-line and maintenance use in the overall population).
In the initial studies of Tarceva in the front-line setting there was no benefit on top of chemo. "And if you think about the history of drug development in any field, particularly in oncology, once a molecule would fail in a certain disease … the idea that you would actually repeat the study and not only go head to head with a chemotherapy but actually be superior to that was essentially unheard of," Barron said. "But by selecting out … these EGFR mutations, the biology was telling us this could be a viable study." The data now show a 63% reduction in risk of death or progression.
Tarceva and MetMAb also exemplify another of Roche/Genentech's oncology tenets: the impact of synergistic combinations. Based on research showing that amplification of cMET played a role in resistance, and preclinical evidence of synergy, the company ran a Phase II trial of erlotinib +/- MetMAb. The combination was well-tolerated and had a marked improvement in progression-free survival and overall survival; a Phase III study in MET-positive patients is slated to start later this year.
The company is also hoping a biomarker can support Avastin's continued marketing in metastatic breast cancer. In response to CDER's determination that the indication should be withdrawn, Genentech has offered to run another confirmatory trial using plasma VEGF-A levels as a predictor of efficacy ("Genentech Banking On Biomarker Data To Save Avastin In Breast Cancer," "The Pink Sheet," June 6, 2011).
Multiple sessions at ASCO, however, addressed the difficulty of identifying a biomarker for VEGF inhibitors.
By Mary Jo Laffler

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