Critique on lower NICE threshold research

Hi everyone,

sitting here on my desk with a typical December cold, I came across this critique from the OHE of something that gives me even more headaches when reading it. I can't resist giving my 5 cents to it. Seems like Claxton and colleagues have proposed a new NICE threshold of £12,936 ... wooooow and how accurate! I am amazed how politely and scientific the OHE responded to that. My critique is much simpler and less kind: total rubbish!
With all respect for the academic credentials and experience of this group, but this tells me that someone has not understood the bigger things in life that are far more complex than putting forward such a silly paper (and number). I recommend reading a bit of Friedrich August von Hayek's key papers: "The pretence of knowledge" and "The theory of complex phenomena" before engaging in another round of "scientific" threshold analysis: Medicine is not physics, decision making about factors that affect health, physical well being and perceived quality of life etc. do not fit, and should not be decided based on, a foolish formula, full stop.

A good evening to everyone


UK VBP - paddling back big time ?

Dear All,

it took some time for the UK government to come out with something on the VBP debate. Now the first details of the new "deal" emerged. What is now on the table looks quite different from what was set out as an objective, but not at all from what has been done so far. Of course we are not surprised knowing all along how difficult it is to implement something that sounds easy in theory. Pretty much everything stays the same, the threshold, NICE doesn't have a role in price setting apart from some wider  benefits to the society are now supposed to be included in the assessment of new drugs.

Below a bit of reading on the topic.




Survival and spending on cancer care in the EU

Dear All,

a new study has been presented at ESMO in Amsterdam. Researchers presented data on cancer spending in relation to overall mortality across the European Region. Not surprisingly confirming the relation between poor investments in cancer care and overall outcomes.



"No hour" week...

Hi All,

today a post a little off our topic here but most important. Patti from healtheconomics.com posted this link, which I find very interesting. Its about flexibility in your daily working considering our times of modern technology and connectivity. It just hit it right on the head, I remember working in big corporate headquarters occasionally sitting around in endless meetings where some of them appeared to be dictated to beating time or because they were in some sort of agenda or somebodies annual objectives... there is only so much to say in endless weekly market access meetings when your product is still 3 years away, is there..?

So this article was refreshing, indeed within pharma we need a mindset like that, treat people like adults and work on the important stuff with focus, passion and dedication and cut out the dead wood. Go for a round of mountain bike to start the day and do something right later in the office rather than pester people around the globe with the x update of the update at 7 a clock in the morning.

The other topic is remote working, motivated and dedicated workers will perform well weather they sit an office or on their terrace at home - at this level childish control is counterproductive. Yet I was surprised to hear when Yahoo's new CEO decided to ban remote working. Most ridiculous, at least in my view, was the argument that best ideas and solution come from the talks in the floor around the coffee machine. A phrase that is totally overused and as I believe also fundamentally wrong. What people do at such encounters is engage in latest company gossip.. Best ideas come from motivated, happy, engaged and well rewarded employees that can identify themselves with their company and products and are treated in a way that allow them to flourish professionally, shift their work around their style, e.g. no use to force a night owl at 7am in the office etc..

I like and already live that concept and, yes, it does work very well but so far mostly in smaller companies although a very few of the bigger ones are already further ahead as well.

Have a nice day


VBP event September 24-26 London

Dear All,

VBP in the UK is around the corner and Hanson Wade (see post below) have invited Olivier and myself to run a pre-conference workshop on VBP. Looking forward to seeing many of you!

Best wishes

At Value Based Pricing (24 - 26 September, London) authors of The Future of Health Economics, Ulf Staginnus and Olivier Ethgen will be leading an introductory workshop to get you up to speed on the considerations and implications surrounding value-based pricing. This interactive session will enable you to practically implement value-based strategies into your drug development programmes and ensure you meet the growing demands of payers around Europe.

Attend their interactive half-day workshop to:
  • Explore what a VBP structure will mean for the UK - get to grips with the changing pricing structure and understand how it relates to other EU countries
  • Evaluate the practicalities of incorporating VBP into your strategies and realise what is achievable for your portfolios
  • Understand how value can be defined and whether it should be consistent across disease indications and patient populations
  • Discuss international reference pricing in relation to value-based pricing

Download the brochure to see the full Value Based Pricing agenda and information on the other 2 workshops. 

Following on from the workshop day, Value Based Pricing will feature companies working across Germany, France, Switzerland, The Netherlands, Belgium and the UK openly sharing their experiences of developing value-based pricing strategies, preparing you for the impending pricing changes in the UK. 

This meeting represents your greatest chance to be as prepared as possible for a value based pricing system in the UK and across Europe. Join your peers at Bayer, Vifor Pharma, Novartis, Ipsen Pharma, InterMune, GSK, Merck Serono, Takeda, Bristol-Myers Squibb, Pfizer and Amgen among others.

Register before Friday 28th June to save up to £300 off standard rates. To secure your place, visit: www.valuebased-pricing.com/register 

Best wishes,

Emma Hosgood
Programme Director
Hanson Wade


Oncologists critizise cancer drug pricing in the US

Dear All,

a recent paper in Blood sharply criticizes the pharmaceutical industry for the prices of cancer (CML) drugs. I am a little surprised that they have started to hinge the debate so much on Gleevec maker Novartis Oncology. Among all the newer cancer drugs that is certainly not at all an example of over pricing, considering the tremendous benefits that this drug has brought to CML patients. Its pricing, especially compared to other cancer drugs nowadays was actually rather modest. In addition, in Europe (already in some markets) and the US it is available off patent soon. (Net) Price increases have certainly not happened in Europe and the cited US increase surprises me as well as we know net pricing is a different story. Anyhow, they do have a point however on other occasions and it is therefore important to move away from the price per pill concept and discuss and establish innovative pricing models that meet the interest of all stakeholders involved, especially those that are linking the financials closer to the actual benefits delivered over time.



The UK NHS struggles to implement VBP

Dear All,

an interesting article from the Financial Times elaborating on the issues around VBP. It doesn't surprise me at all that they find it difficult to implement such a system. Indeed the danger is that VBP becomes a buzzword if things are left unclear and do not progress well. Interesting to see the German system is being eyed on, it does make more sense to move towards some sort of "negotiation based approach" relying on multiple criteria after a clinical appraisal rather than trying to square the circle with some sort of modified QALY threshold system. About two years ago I brought some of the top academics together to think about what a VBP could look like and I remember how difficult it was to get a bunch of real experts on pricing matters to agree on something that can be made operational. In the end of the day it maybe not so different with some form of price/profit control a la the PPRS plus some sort of system that expands on the cost/QALY threshold a little. Interesting for sure how this will unfold further.



Spanish Ministry warns of excessive pricing of cancer drugs

Dear All,

in a recent newsletter BCN health outlined that the Spanish Ministry is getting increasingly wary of too high prices on cancer drugs. They have stated that if the products fail to demonstrate cost-effectiveness they will not be funded by the NHS. Various drugs are stuck in the Spanish Ministries' pricing commission.
Indeed I also saw a lot of articles recently on the new pricing system to be implemented. Some lawyers talk about the need of an "entire new house" for the system of drug price setting in Spain. Clearly the involvement of more economic analysis in terms of cost effectiveness and budget impact will be part of it. I believe reference pricing will also play an import role coupled with more risk sharing that we see emerging in certain communities. The bigger pricing threads comes from those who like to introduce more centralized tender purchasing.

There are no signs of recovery of the Spanish economy hence serious pricing pressures will continue throughout 2013 and beyond.



Recordings eyeforpharma AMNOG webinar

Dear All,

just got the word from eyeforpharma that the webinar on how to overcome the AMNOG hurdles to achieve access in Germany’s market was a great success last week. They’ve just finished putting together the recordings for you. 

Over 400 people listened to the payer panel as Dr. Mathias Flume, Physicians Association, Westphalia-Lippe, Dr Detlev Parow, Statutory Health Insurance, DAK Deutsche Angestellten Krankenkasse and Andreas Guhl, Founder, ValueMAxes shared exclusive insights with the audience.

You can check out the recordings here



HEOR Consultant Basel, Switzerland

Dear All,
this is a current search, please contact Theo (below) if interested.


As the Health Economics and Outcomes Research market continues to grow, this global consultancy is seeking an organised and experienced individual to lead teams and work within a stimulating environment as a HEOR Consultant. Based in Switzerland, you will possess a profound knowledge of HEOR and will have experience of working within the pharma and healthcare industry. 

Being part of a fast-growing and highly successful division, you will focus upon delivering tangible business results to clients and business managers across the international pharmaceutical and healthcare industries. You will also be heavily involved in outcomes research, economic analysis and the natural history of a disease, HEOR consultants will work with a diverse mix of clients, typically including the global top 20 pharmaceutical companies. 


- Reviews and analyses client requirements in order to help develop proposals for cost-effective solutions 
- Organises and conducts high quality research for clients with input and review by colleagues 
- Has a thorough knowledge of consulting methodologies and the health care sector 
- Contributes to the development of value dossiers and support material for clients 
- Engagement based responsibilities are assigned and managed by senior consultants, engagement managers or principals 
- Performs outcomes research, health economic analyses or environment analyses to assist in the identification of client issues and the development of client specific solutions 
- Supports systematic review and meta analysis projects 


- BA/BSc in science or economics or related discipline essential 
- MSc/MPhil/PhD in economics/health economics health services research or a relevant related area 


- Post-graduate work experience in a related area (such as economics, health economics, statistics, psychology or science) 
- Experience in undertaking economic analysis (in either Pharmaceutical or other Healthcare Industry, Academic Organisation, HTA Group, or Health Services Research). 

Successful candidates will be fluent in English and possess strong business/scientific written. Having strong written and verbal communication skills, they will have the ability to build strong consultative business relationships. Being able to deliver high quality work with strong attention to detail is crucial. An established net work of referrals and contacts is advantageous 

To apply, or for further information, please contact Theo Rowley on +44 (0) 207 440 0679 / t.rowley@proclinical.co.ukAlternatively, contact him via LinkedIn. 


Researchers claim NHS drug decisions 'are flawed'

NICE decides which drugs are cost effective on the NHS

Related Stories

The formula used by the NHS to recommend which drugs should be funded is "flawed" and should be scrapped, researchers say.
The European Commission-funded study tested the assumptions of the system used by NICE (the National Institute for Health and Clinical Excellence).
Researchers concluded the watchdog's system failed
to reflect variations in views on illness and disability.
NICE called the study "limited" and said the measure it used was the best.
NICE uses a method called quality-adjusted life years (QALY) for assessing the value of new drug treatments in England and Wales. A similar system is used by the Scottish Medicines Consortium (SMC).
The formula looks at the cost of using a drug for a year and weighs it against how much someone's life can be extended and improved. Generally if a treatment costs more than £20,000-30,000 per QALY, it would not be recommended as cost-effective by NICE.

Start Quote

"This isn't a scientific way to classify and prioritise the drugs - mathematically, it's totally flawed.”
Ariel BeresniakResearch leader
The European Consortium in Healthcare Outcomes (ECHOUTCOME) researchers will present their findings at a conference in Brussels on Friday.
Their work has already prompted a backlash by UK-based experts, who defended the current system for making decisions.
The researchers analysed a detailed questionnaire with more than 1,300 respondents - including 301 in the UK.
Their findings criticised the QALY system for grading different states of health. The researchers said people varied in their views about the impact of different levels of illness or disability, and in their approach to risk.
They also found that people's willingness to sacrifice remaining years of life in order to have better health varied enormously over different periods of time.
The researchers said 71% of the respondents would prefer to live 15 years in a wheelchair than die after 10 or five years in a wheelchair - but the remaining 29% said they would prefer to die earlier rather than spend 15 years in a wheelchair.
The project leader, Ariel Beresniak, a French doctor and economist who used to work in the drug industry, said: "Important decisions are being made on the basis of QALY, but it produces the wrong results.
"This isn't a scientific way to classify and prioritise the drugs - mathematically, it's flawed.
"We think it is time to open this debate, particularly as some of the newer European countries are trying to organise their health assessment systems and might be considering QALY.
"NICE has made negative recommendations about many major innovative drugs, based only on arbitrary incremental cost per QALY.
"Agencies such as NICE should abandon QALY in favour of other approaches."
Cost-benefit approach
A similar method is used by Canada and Australia for assessing new treatments.
The researchers suggest instead using a cost-benefit approach - such as how many cases of remission a drug can provide, or how many relapses it might prevent.
A NICE representative said: "We need to use a measure that can be applied fairly across all diseases and conditions. The QALY is the best measure anyone has yet devised to enable us to do this.
"It's developing and improving all the time and the criticisms in this rather limited study haven't shaken our confidence in its value to NICE in helping make decisions on the best way to use new and sometimes very expensive drugs and other health technologies."
John Cairns, professor of health economics at the London School of Hygiene and Tropical Medicine and a member of the NICE's appraisal committee for 10 years, said: "QALYs are certainly not perfect and we should be looking for better ways of informing decision making.
"But getting rid of an imperfect system without replacing it with a better one is not the way forward."
Dr Andrew Walker, an economist at the University of Glasgow, with 10 years' experience of reviewing new medicines at the SMC, said: "I am amazed it has taken these authors three years and one million euros to establish what we already know, that QALYs are not perfect.
"Anyone who makes decisions using QALYs and who cannot think of at least three issues with them is not thinking hard enough.
"As an alternative they propose cost per remission in arthritis, but I ask them to tell me how they define remission, how long remission lasts and how much we are willing to pay for one remission.
"If we want to spend more on cancer medicines, it has to come from somewhere. The researchers speak as though there were no budget limits."


Two years of AMNOG experiences in Germany - webinar

Hi everyone,
eyeforpharma have put together an interesting and free webinar with some experts talking about the past two years under the AMNOG process. 

I am posting the registration link for you to join.