Southern EU states present unified front in drug talks

Folks an article on the intensified pricing collaboration activities among European countries. This has been a long debate for years but it seems more concrete steps are undertaken. Its a pity that countries still don't realize that engaging with the industry on different and novel payment models is more promising than the ever increasing eagerness on pure cost mindset "collaboration". Affordability is an important criterium and can be adressed differently, all these joint purchasing efforts however will only create more inefficiencies and bureaucracy and most likely increase time to access for patients, especially those with rare diseases. It ignores the fundamental economic principle of price differntiation in accordance withbthe exonomic situation and circumstances in every country. Lets hope they can prove me wrong on this one.

The Future of Health Economics - new book availabe soon

Dear All,

Olivier, the "work horse" ;) finally managed to get all the chapters back from the various authors and the book goes into print. Book should be available at Routledge in a couple of month.

Regards
Ulf

IQWIG not bullish on EMAs adaptive pathways pilot

Hi All,

just saw an interesting post (https://www.iqwig.de/en/press/press-releases/press-releases/adaptive-pathways-ema-still-leaves-open-questions-unanswered.7492.html) from IQWIG, that speaks to the difficulties to get even a clinical effectiveness assessment under one roof as always proposed by various stakeholders. Clearly the RWE bit is still an open book in many ways but a topic to be tackled on various fronts in order to make true value based pricing a reality.

Cheers
Ulf

Drug prices: Tweaking the formula

Financial Times

By Andrew Ward

April 25, 2016

 

What is the value of a human life? It is one of the most fraught questions in public policy as governments around the world struggle with rising healthcare costs from ageing populations.

The answer matters not only to patients, taxpayers and insurers, but also to the pharmaceuticals companies seeking rewards for the medical advances that have helped double global life expectancy in the past century.

Nowhere is the debate more intense than in the UK, where budget pressure on the National Health Service has capped growth of the annual £12bn drugs bill and created tensions with the often competing interests of the pharma sector.

 “We can’t continue as we have in the past,” George Freeman, UK life sciences minister, told a conference in London last week, urging a “new deal” between government and drugmakers.

 Mr Freeman’s vision will be set out in an official report later this year which is expected to propose mechanisms for getting the most promising new therapies to patients faster and affordably. Meanwhile, an overhaul of the way cancer drugs are evaluated for the NHS is due to come in to force in July.

Together, these developments promise to make the UK a test of whether austerity-hit western societies can keep up with the quickening pace of medical innovation. A surge in drug approvals over the past two years has revived faith in the pharma industry’s productivity after a long fallow spell and a further wave of products are nearing market, many involving transformativetechniques targeting faulty genes or modifying cells. Yet the cost of these advances threatens to increase strain on the NHS as it chases savings of £22bn by 2020.

It is a dilemma echoed in public health systems across Europe but also, increasingly, across the Atlantic as the US seeks to keep a lid on the $3tn it spends each year on healthcare.

 

At the forefront of pharma

The UK’s importance as a test bed goes beyond its 3 per cent share of global pharma sales. As home of GlaxoSmithKline and AstraZeneca, two of Europe’s largest drugmakers, and half the world’s top 10 medical research universities, according to Times Higher Education, the country punches above its weight in life sciences. Many of the world’s best-selling drugs belong to a category called monoclonal antibodies pioneered by UK scientists in the 1970s and 1980s.

Yet British patients have not always benefited from homegrown innovation; the country has among the slowest uptake of new drugs in western Europe. This reflects the tough hurdles created by the National Institute for Health and Care Excellence, which acts as gatekeeper for companies seeking access to the NHS for their medicines. The agency, known as Nice, weighs the price of a treatment versus the benefit to patients measured by a formula called “quality-adjusted life years added” or qualy. It will not normally recommend a drug costing more than £30,000 per qualy.

This dispassionate approach to life and death decisions has given Nice global influence as a model of evidence-based policymaking. Yet the UK system has many critics, especially among drug companies and patient groups who see its methodology as too rigid and its £30,000 spending cap as too low. “Only a very small number of countries operate with such a fixed threshold,” says Richard Erwin, UK general manager for Roche, the Swiss pharma group.

The fiercest disputes have involved cancer drugs. These tend to be very expensive — especially those for advanced or rare forms of the disease — because companies need to make a return on investment from relatively small numbers of patients during short periods of treatment. In recognition of these issues Nice has a higher £50,000-per-qualy threshold for “end of life” treatments. Even this is often not high enough for modern cancer drugs. Since 2011, the agency has rejected more than half the treatments it has evaluated.

 

Funding pressure

 For admirers of the UK system, Nice should be applauded for its scepticism towards drugs that often provide just a few extra months of life, at best, for large sums of money that could be used more productively elsewhere in the NHS. “The price we can afford to pay is the point at which the benefits [of a drug] match the benefits we are going to give up as a consequence of those net costs,” says Karl Claxton, a health economist at the University of York.

This argument might seem incontestableto academics but David Cameron, UK prime minister, knew that cancer patients and their families would not accept it. Alarmed by data showing the UK falling behind other western European countries in cancer survival rates, he set up a special scheme in 2010 to provide extra funds for cancer drugs deemed too expensive by Nice.

Since then, 80,000 people have received treatments through the Cancer Drugs Fund. Without Nice’s scrutiny, there was no pressure on companies to moderate prices or doctors to moderate use. This resulted in the cost of the fund soaring from £38m in 2010-11 to £416m in 2014-15 — 50 per cent over that year’s budget. “The Cancer Drugs Fund shows once and for all that there is no blank cheque big enough to solve this problem,” says Prof Claxton.

In an attempt to restore fiscal discipline, NHS England in February confirmed plans to restore Nice’s power of veto. From July, it will evaluate all new cancer drugs within 90 days of regulatory approval — faster than in the past — and issue a “yes, no, or maybe”. The “maybes” — medicines that show promise but require more evidence — will be financed for up to two years by a revamped Cancer Drugs Fund. Only if they prove their worth during that probation period will they be recommended for use.

NHS England say the changes will put cancer care back on a sustainable footing and ensure money is directed at the most effective treatments. However, there have been protests from pharma companies and their allies which fear that without change to Nice’s methodology, most of their products will be blocked. One charity said cancer care in the NHS risked being “set back by a generation”. Erik Nordkamp, UK managing director for Pfizer, said even crisis-hit Greece had wider access to the latest treatments.

Sir Andrew Dillon, Nice chief executive, says there is a simple remedy: companies should drop their prices. “Unless there is a change in price or in the quantum of benefits these drugs bring to patients, then the Nice methodology will result in broadly the same outcomes as before. Ultimately, it is up to the companies to decide.”

Drugmakers question why they should be expected to offer further discounts to the UK when it already has among the lowest prices in the developed world. The industry has paid more than £1bn in rebates to the Department of Health since a 2013 deal that capped annual growth in the NHS drugs bill at a below-inflation rate for five years — with companies collectively reimbursing any spending above the agreed limit.

The fear is that any further squeeze in the UK would have a knock-on effect on pricing across Europe. This, in turn, would risk increasing US political scrutiny of the transatlantic divide in drug costs that can see Americans pay double the price for medicines — due in large part to the absence of UK-style controls on spending.

There is little immediate prospect of the US setting up a federal rationing body. However, there are signs that some people are learning lessons from Nice. New York’s Memorial Sloan Kettering Cancer Center, one of the leading US cancer hospitals, last year launched an online tool called DrugAbacus to help healthcare providers assess the value of cancer drugs.

Drug companies are responding by experimenting with pay-for-performance models tied to how well a medicine works rather than the volume sold. But Alexander Moscho, UK head of Bayer, the German drugmaker, says the qualy system is not flexible enough for the new world of personalised medicines. “It needs a new approach which is not one-size-fits-all.”

Sir Andrew, who has been in charge of Nice since its launch in 1999, denies that the system is broken. “I would not argue that Nice’s methodology is perfect but I don’t think there is anything fundamentally wrong with it either. In terms of being able to do a rigorous evaluation of what a product offers, I think we do that really well.”

Drug makers have been at loggerheads with Nice since its first ruling 17 years ago prompted a veiled threat by Glaxo to quit the UK, saying the decision called “into question the suitability of the UK as a base for multinational pharmaceuticals operations”. AstraZeneca, which is building a £330m R&D base in Cambridge, issued a similar rebuke last year when Nice resisted olaparib, its homegrown ovarian cancer drug. “How can a government say they want this country to be an innovation centre … yet when we discover new innovation it doesn’t find a market?” asked Pascal Soriot, chief executive.

For advocates of Nice, these confrontations are proof that the model has succeeded in creating a neutral arbiter. Pharma leaders, however, feel there should be more support for an industry that accounts for a quarter of the UK’s private sector research and development spending.

 “If new medicines are not being used in the UK, global companies will not invest here,” says Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry.

 

Open access

It is this stand-off that led Mr Freeman to launch the accelerated access review last year, led by Sir Hugh Taylor, formerly a senior civil servant at the health department. His report has been delayed, like much else in Whitehall, until after the referendum on UK membership of the EU in June. 

It is expected to propose that new medicines showing the greatest promise should be given early conditional access to NHS patients. Usage would be gradually expanded as “real world” data are accumulated on safety and efficacy. In theory, this should lower drug development costs by reducing time to market and lead to more consensual pricing discussions based on a clearer picture of the value offered.

“Everyone benefits: companies get a quicker return on a lower investment and patients get access to medicines faster,” says Stuart Dollow, an adviser to Sir Hugh’s review. “It is about getting away from the current adversarial model where industry goes in with a high price knowing it is going to get negotiated down.”

Pharma companies say they can be part of the solution to the NHS budget crisis by providing treatments that reduce long-term costs. Novartis, the Swiss drugmaker, last week reported strong demand in Europe for a new drug that has shown the potential to cut hospitalisation rates from heart failure by a fifth.

“We need to stop looking at medicines as a cost and look at the value they can create for UK plc,” says Mr Thompson. He admits, though, that the industry will have to be realistic about pricing. “There is a clear message from government: There is no more money.”

Patient Access positions with Baxalta

Dear Readers,

I am currently building my access team in EMEA and have a few positions open. I am looking for a patient access lead oncology Switzerland/Austria. See job posting: https://lnkd.in/d3MyQgQ 

Equally I am looking for patient access heads for Italy and the UK. Oncology experience plus experience with local P&R submissions and negotiations is required.

If you are interested please get in touch: ulf.staginnus@baxalta.com

Cheers
Ulf

England NHS cancer drug fund to be handed over to NICE?

Dear All,

Some interesting developments on the Cancer Drug Fund have been announced today.

Cheers
Ulf

Market Access in Germany and AMNOG reform needs

Dear All,

hope you are getting ready for the summer.. just came across an interesting post on the GKV Spitzenverband website. A latest study from the Technical University of Berlin demonstrates the fastest (even after AMNOG) and broadest access to medicines occurs in Germany as compared to other EU countries (well, it´s nothing really new). This comes at a "cost" with highest pharmaceutical prices being paid in Germany (we also knew that). The study has a lot of good sources such as the times to access after EMA approval (many of you in the industry get this question all the time from management), approaches to pricing in the different EU countries as well as the reference baskets etc...

The interesting part comes further down in the GKV press release. Prof Busse (check out his slides) suggests that pricing is related to the benefit provided in each subgroup. Something economists welcome as it it would allow for differential and indication specific pricing better linking value achieved to pricing potential. The pessimists would obviously say that it further increases pressure but in my view that would be the right direction and for really innovative and beak through therapies provides opportunity.

Reform needs are seen with AMNOG, measures such as retrospective rebates are suggested in the presentation from v. Stackelberg (GKV SV) from month 7 onwards of the benefit assessment process. He makes a fair statement in saying with "retrospective price setting premium pricing is still possible for top products, but no excessive pricing for drugs without additional benefit".

Let's see what is cooking out in Germany. Happy Summer Holidays ;)
Cheers
Ulf

The value discussion

Dear All,

first of all apologies for the quite time lately, been busy with various projects. Seeing the article from Ed it reminded me of the ever ongoing discussion about the value topic and if agreement can be found between payers and industry. Certain attempts, thinking here of VBP in the UK have failed and others have not taken off. Ed does a good job in listing the issues and especially pointing out the ways the industry could change things internally. This is definitely true and also a very old story. I have a bit of my own theory why things are so slow to catch on internally. Everyone is talking the market access talk and adds resources and re-invents departments etc. What I see happening though is that the wrong people with the wrong skill set are often doing this. Just because it seems to be hip to talk about payers and access and engagement doesn't necessarily mean the skills are there. Too many of certain "talkers" who are used to making colorful slides are digging around the access area, which however doesn't make them an expert just as yet. Health economics and especially pricing and skills around data creation and epidemiology are typically missing. Also lack of experience with the various health care and reimbursement systems and how things are working often leads to the wrong expectations. I couldn't agree more with Ed's comments that functional organizations, usually the experts from health economics/pricing and access, get the issues quickly but often have limited influence to the top and on R&D decision making as there still too often the old fashioned "slide makers" and "talkers" are sitting. The 'species' of real good access people often doesn't bother to engage on this "less scientific" level of discussions hence nothing ever changes. The only way to change that would be if jobs are re-defined and key roles are being filled with people who have exactly that payer perspective and experience - and they don't need to have been in sales to do a fine job there. That is a relict from a time that doesn't exist and wont come back anymore.

Cheers
Ulf

Potential "Pay if you clear" access scheme in Scotland

Dear All,

just saw this on BBC

Now if that scheme materializes it truly deserves to be called an innovative one ..

Cheers
Ulf

Jobs and interviewing in Market Access, Health Economics and Pricing

Dear All,

a little post from the beach, I trust most of the readers enjoying their well deserved summer vacation. By popular demand in the past when I conducted and published my salary review, and actually due to a lot of personal experience, I am finally getting around on writing a little about the topic of interviews and job search. Most positions in our field are recruited by headhunters or company talent scouts but also network and other ads, e.g. on pages like healtheconomics.com and healtheconomics.org are important information for job seekers. Networking through linkedin.com has also proven very valuable for many of my colleagues and fiends. But nothing beats a personal recommendation or contact that puts you in touch with a potential employer. Therefore in identifying positions you should not find it too difficult as this market is rather transparent and demand for health economists, market access and pricing as well as health policy people seems to be still steadily increasing.

What is interesting is how different companies conduct their interviews. I must say I came across the whole spectrum from very professionally conducted and fast processes to total odd behavior. One day for example I went to an interview for a position of EU market access head with a specialty pharma company and flew about 8 hours in one day taking 4 flights, and changed an important family event travel in order to get to a city in Eastern Europe where they were at a conference. Finding the meeting room the head of Europe of this firm shows up, and with very little introduction and barely a 'hello' and combined with a rather odd and impatient behavior asked me about an old story that he had encountered years back in one EU country where a drug was supposed to be introduced into the market and they had some package insert issue of a cardiovascular agent that the agency apparently had been misplaced etc. etc... now wanting to know what I would have done... I was a bit puzzled about the wired case and answered that this was a regulatory matter usually not in my shop but as in any interaction with authorities would have gone back to them with another copy of the package insert and asking them politely to reconsider and approving  bla bla bla.. that was apparently not a very satisfying answer and even more impatient now the guy rambled on about how this would have delayed his launch in the country as the agency would have found another excuses and bla bla bla.. now me getting tired I simply said (so smartass I thought to myself) what did you finally do? ..well he said he put the updated package insert and launched without approval of the regulatory agency and than creating some political pressure and bla bla bla.. as you can guess by now we are talking about a Southern European country here with lovely pasta tough... anyhow, I just responded dry, coming from a couple of companies that take compliance as a serious value, that is an answer he couldn't have expected to receive from me... anyway the talk didn't get better, we went through a few more odd cases alike and the second guy that showed up thereafter, equally arrogant, didn't really improve my day.

A few days later they (I had advanced already another process with a biotech that professionally quick conducted two interviews in one day, plus a few on Skype the day thereafter) wasted more time by having had the headhunter call one of my references etc.. just to tell me two weeks later, via the recruiter, they were still deliberating and thinking and needed to ask more references about my strategic abilities... probably due to my answers on the package insert discussion beforehand ;)

That's when I decided I had enough of this BS and emailed the headhunter to call it a day with this process, which I should have probably done right after the second round 8 hour trip... after all in my career I had launched more than 4 major products in Europe each of them largely exceeding their one or two product portfolio and therefore concluded to myself that I had no desire no need for additional nonsense from this company. I was wondering anyway what they really wanted here.. it seemed like they were selling a glorified "head" as sort of an assistant to the two guys probably wanting to get rid of stuff they didn't wanted to do anymore... outside voices later on confirmed my sensation about a wired climate there...

But why am I telling you all this, what's the morale of the story here. Well, know your worth and live it! Don't sell yourself too cheap or too fast nor let yourself in strange situation be diverted from what your true experience but moreover your values are. Don't settle for any compromise that doesn't feel right even if you may get impatient with your job search. And remembering Steve job's famous words from a Stanford graduation, don't let your inner voice be drowned by other peoples opinion, don't settle if it doesn't feel right, keep looking, stay hungry, stay foolish ;) !!! and listen to your gut feeling...

And here my personal checklist:

- do your background research very well, ask around, this is a small world, you quickly would find out why a role is vacant too often or takes too long too fill.. there might be personality issues at this company
- ask about the real responsibilities, who decides what, what can you do, are you going to be part of negotiations/authority contacts etc? Who decides your travel, can you attend certain professional meetings/conferences? What budget does the role have, reporting lines etc as titles often are inflated or mean little. From a certain level onwards you don't want to sit around in the headquarter talking about the payer needs but actually never seeing the payer
- be wary of two many rounds and hick hack, the best jobs and match in my experience are those where the process is closed from first call to signature in 4-6 weeks max. Imagine if the process is a major pain, what will the work environment be like ???
- don't become a quotation filler, in other words feel when you are being put forward just to fill the candidate pipeline, don't waste your time with silly presentations unless you need interview practice
- be open and transparent about your situation, financials and expectations but also request the same
- people who don't hold their word... will call you back by Friday, and don't.. drop them, no worth considering, they will continue like this
- you get an offer with the one you like, they have been quick, honest, with professional style and ethics - take it quickly and don't be too fussy about unimportant things, negotiate the big items important to you, if the salary is great and you get stock  .. don't patronize about canteen vouchers for example ;) .. you are laughing, I have seen it...
- and I repeat it, trust your gut, if something doesn't feel right it will be most likely not be good in the end
- remember for skilled people with experience this is a buyers market, far more demand than qualified people, get the right job for you and wait if the first one that comes along casts any doubts


Cheers to all readers, happy summer holidays!
Ulf

Guidelines for payment by results in Catalunya

Dear All,

CatSalut has published a first version of guidelines for the implementation of payment by results schemes for pharmaceuticals.

http://www20.gencat.cat/docs/salut/Minisite/catsalut/Proveidors_professionals/medicaments_farmacia/Acords_Risc_Compartit/Guia_EPR_castellano_1.0.pdf

Regards
Ulf

No linear association between drug prices and perceived benefit criticises US cancer expert...

Dear all,

pricing of cancer drugs and now also hepatitis C has steered another debate among US payers and physicians about drug prices. See a recent article in business week.

Cheers
Ulf

Germany becoming the "wild card" in drug pricing

Dear Readers,

just saw this in the news (see link below). Germany is thinking of issuing a new law that the so far confidential price discounts be made public. That would be an entire new ballgame for the industry in Europe with potentially significant price erosions and spillover effects elsewhere.

Will keep an eye on that.

Cheers
Ulf

http://www.reuters.com/article/2014/02/18/us-germany-drugs-analysis-idUSBREA1H09E20140218

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
Regards
Ulf

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.

Cheers
Ulf

http://blogs.nature.com/news/2013/11/uk-backs-away-from-value-based-pricing-for-drugs.html
http://www.pharmexec.com/pharmexec/Noteworthy/What-Does-the-UKs-New-PPRS-Mean-for-Value-Based-Pr/ArticleStandard/Article/detail/828958?contextCategoryId=48158