Tag Archives: drugs

“The purse is closed!” – this is no way to run a hospital

Rosa Giuliani, medical oncologist, S. Camillo-Forlanini Hospital, Rome, Italy

Rosa Giuliani, medical oncologist, S. Camillo-Forlanini Hospital, Rome, Italy

 

As a medical oncologist my primary interest is in helping patients to live longer and better. The best part of my job is the integration of clinical and molecular views: see the problem in the clinic, look for answers in the lab, bring back the solution to patients. I wish it could be as simple as that.

Research & development have a price, which is often difficult to understand. Why new drugs and devices cost that much, and not a penny less, is a complicated conundrum for many of us. The EU regulatory and reimbursement systems, the lack of a universal health policy through Europe and the profound economic crisis are regularly debated.

While I was at ECCO participating in debates on the need to promote equity and defeat disparities in access to precision medicine in Europe, hospital managers where I work notified the oncology department that the budget allocated to cancer drugs expenditure was over:no “expensive” drugs could be purchased until the budget for the new year will be discussed in January. The purse was closed. Meetings followed, some very unpleasant; poor use of resources by medical staff was implied, not even too subtly. Of course, this prompted self-examination: am I a good oncologist? Am I following guidelines? Am I spending money for my pleasure to give drugs?

After this last question, I realized that I was losing my mind and luckily, I returned to my senses. I respect rules, I need rules, I love rules. I appreciate fair rules. Budget negotiations at local hospitals are as obscure as the procedure of setting prices at EU or national level. A rule, which lacks of transparency, is not fair. The fact that the rules are set and dealt by people who are not prepared to manage the process, is terribly wrong. The overwhelming gap between cancer politics at EU Headquarters, where precision medicine is being promoted, and cancer politics at local level, where the only interest is that 2+2 should be equal to 3, because 4 is already too expensive, is frightening.

Money is an important part of the equation: resources are not infinite and their rational employment is of utmost importance. The process of drug development is not cost-effective, and many managers are not, because they have not been adequately prepared to deal with a different type of economy. Cancer medicine cannot be dealt as if providing water or electricity.

The global curriculum for being a good medical oncologist has dramatically changed in the past 10 years. Medical oncologists in 2015 cannot neglect molecular biology, health policies, precision medicine and so on. The same change should happen with managers who allocate resources for health politics, especially at hospital level. Being a good accountant does not suffice anymore, just as being exclusively a good clinician is not enough. Another level of knowledge and preparation is needed. And honestly, sometimes, a little bit of emotional intelligence would not do any harm.

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The price isn’t right, but neither is the effect

Marc Beishon

Marc Beishon

 

Concern about the high prices of cancer drugs is nothing new but there are signs now that the issue may be coming to a head. There is a flood of new agents coming onto the market and, if anything, the prices charged are still going up, with more agents reaching eye-watering levels above $100,000 a year. Global annual spending on cancer drugs has now hit $100 billion for the first time.

At the upcoming European Cancer Congress, a study by a UK pharmacologist on how much it costs to make cancer drugs such as imatinib (Glivec) will reveal that Americans in particular are paying hugely more than the manufacturing cost, but Western European prices are also high.

Just a few weeks ago, a group of more than 100 senior oncologists, mostly in the US, launched a ‘grassroots’ petition calling on the powers that be in America to address the harm that high drug prices cause patients. Writing in Mayo Clinical Proceedings, the oncologists says the average price of new cancer drugs in the US increased 5- to 10-fold over 15 years, to more than $100,000 a year in 2012 and the cost of drugs for each additional year lived (after adjusting for inflation) has increased from $54,000 in 1995 to $207,000 in 2013.

Of course, the US has particular conditions that determine drug prices – its Medicare system for older people is not allowed to negotiate prices, and the lack of a universal healthcare system means many patients are faced with huge ‘co-pays’ on drugs through their private insurers. As the Mayo article says: “For a patient with cancer who needs one cancer drug that costs $120,000 per year, the out-of-pocket expenses could be as high as $25,000 to $30,000.” In calling for people to sign the petition, the oncologists say: “The individuals most harmed and least engaged in these discussions are cancer patients because they are exhausting their energy, resources, and time fighting for their lives,” and note that advocacy proved successful in stimulating treatments for those affected by the AIDS epidemic.

Cancer drug prices are of great concern elsewhere, of course. In European hospitals and healthcare systems the pressure on budgets for new drugs is great. In the UK, for instance, there are endless arguments over reimbursement for new treatments. In 2011 the government resorted to setting up a special cancer drugs fund for England to pay for treatments that the National Health Service would not otherwise fund.

At European Union level, there are a string of initiatives, such as the new European Commission expert group on Safe and Timely Access to Medicines for Patients (STAMP), which in turn is hearing updates on various projects such as the European network for Health Technology Assessment, and the network of Competent Authorities on Pricing and Reimbursement. But joint negotiation of pricing among countries, which could lower cost, is not in the Commission’s remit, although there is a joint procurement agreement for vaccines and other “medical countermeasures”. There is though a move by Belgium and the Netherlands to engage in joint drug price negotiation, initially for orphan drugs, where small patient numbers can mean high prices, and which will also involve cooperation on registries and evaluation.

The US oncologists propose a number of actions that could help, including price negotiation, allowing drug imports, faster access to generics, a reform of the patent system, and perhaps most importantly, taking steps to include both the cost and efficacy of drugs in assessments of treatment value and in guidelines. In fact, England already has what many countries, notably the US, lack – a body that recommends reimbursement only for treatments that meets value for money criteria, namely the National Institute for Health and Care Excellence (NICE), which uses QALYs (quality adjusted life years). But the hasty establishment of the cancer drugs fund shows that the pressure to access treatments beyond NICE’s recommendations (and the NHS budget) is great, as stories about patients denied drugs flood the media.

The high price of cancer drugs would of course be less of a problem if they were more effective, but breakthroughs have been the exception not the rule. As Fatima Cardoso, co-chair of the Advanced Breast Cancer conference, has recently commented in Cancer World: “In early breast cancer the standards of care haven’t changed in more than two decades; in advanced disease median overall survival is still a dismal two to three years.”

Certainly, more can be done to add to measures of drug effectiveness. This year, the European Society of Medical Oncology introduced the first version of the Magnitude of Clinical Benefit Scale (MCBS), which grades therapies with both curative intent and palliative intent, and which its developers say is a validated tool that can be used to prioritise drugs for assessment and develop clinical guidelines founded on magnitude of benefit rather than just level of evidence. A quick check on several grade 4 (out of 5) palliative drugs in the MCBS shows they are also recommended by NICE, so there may be some duplication here, initially, although at least one with a grade 5 score, the breast cancer drug Kadcyla, was turned down by NICE owing to its very high price and is now one of several drugs cut from the NHS cancer drugs fund.

Meanwhile in the US, the American Society of Clinical Oncology (ASCO) has just launched a framework for assessing the value of new cancer therapies “based on treatment benefits, toxicities and costs”. Developed by ASCO’s Value in Cancer Care Task Force, this aims to be a “user friendly” tool that oncologists can use with patients to discuss the value of new treatments compared with standard ones, and has been out for consultation. A paper in JAMA Oncology has also looked at how applying a value-based cost can work in a drug used in metastatic lung cancer, but political forces in the US are hard to influence along these lines.

Along with efforts to pin down cost-effectiveness and to carry out more meaningful clinical trials, Cardoso says a priority is to ensure that each patient is treated according to current knowledge and guidelines, which is often not the case. And in England, Karl Claxton, an economics professor specialising in health technology, has published research that calls into question the cost-effectiveness threshold that NICE uses – saying that it is in fact too high. His study made the news, as the implication is that some money spent on cancer drugs, and particularly the drugs funded by the special fund, would be more effectively deployed across the health system, both on standard cancer care and other health conditions.

The UK’s NHS has had long battles with drug companies over price but drugs are also rejected because of lack of effect. Were the US to take similar steps to agree on what constitutes an effective new therapy then there could be a move towards more meaningful drug development as well as lower prices for patients. As the authors of the ESMO MCBS paper also say: “A key challenge for the future will be to establish whether there can be harmonisation between the different approaches to value in Europe and the US.”

 

 

 

Why should older patients pay the price of failures of holistic care and HTA?

roger WilsonA debate between two medical oncologists over whether younger patients should get priority when it comes to access to very expensive drugs with the potential to prolong life was recently published online by Cancer World. In this guest post, Roger Wilson, a patient advocate and Honorary President of Sarcoma Patients Euronet, argues that giving patients a voice in these discussion is the only way to move on from these “simplistic, inward looking  solutions”.

The push to use age as a determining factor in drug funding permissions is blatantly discriminatory. There are better methods and measures for discerning eligibility, if only someone researched them properly.

The pharma industry is not interested in this research. Its business model (which determines its approach to pricing) is encouraged by the current inadequacy of HTA and political decisions such as England’s Cancer Drugs Fund. Indeed the latter encourages higher prices.

When the current UK government came to power in 2010 they vowed that by 2014 we would have a value-based approach to funding decisions. Its nearly 2015 and there is no sign of it but as there was no research into how value could be defined let alone measured, its no wonder we are back to simplistic thinking about age.

The core issues here are about the holistic treatment of a patient. Just looking at the disease (albeit hosted by a person) does not take into account the needs of the whole person. This debate should be about integrating supportive care into oncology practice, about losing the barriers between palliative care and oncology, about educating patients on the balance between cure and end-of-life care so that when disease is truly incurable patients make rational decisions themselves.

Another cycle of chemo given to a dying patient is immoral. Living and dying have to become palatable points for discussion. This will deliver benefits for individuals and society and could well cut drug costs. While politicians, healthcare administrators, academics and doctors are the main voices on this issue simplistic inward-looking solutions will result.

Get patients involved, introduce some earthy common sense.

An essential cancer medicines list for Europe

piccart1

Martine Piccart

Patients are still waiting to feel real benefit from the rapid advances in knowledge and technologyseen over the past decade. This October, 50 experts from across the globe involved in researching, developing, evaluating and delivering new therapies will meet to develop consensus recommendation on who needs to do what tospeed the development of effective treatments. The meeting is one of a series of World Oncology Forum summits organised by ESO in collaboration with the Lancet.


How can we improve access to important new cancer therapies? Martine Piccart – president of ECCO and past-president of ESMO, argues the case for a WHO-style essential drugs list for Europe.

WHEN I BECAME PRESIDENT OF ESMO (European Society for Medical Oncology) in 2012, I had on my agenda to visit countries of eastern Europe, because I was shocked by statistics indicating that even inside Europe there are significant differences in cancer outcomes between the western and eastern parts.

Of course there are huge discrepancies between Europe and Africa, for instance, but that this exists inside Europe came as a shock, so I decided to travel to the countries and talk to the oncologists there.

I will be talking at WOF about what I learned from them about their efforts to improve access to new therapies, and how that prompted ESMO to develop a rating scale to evaluate the magnitude of benefit of new anti-cancer drugs for solid tumours.

Which would I choose?

The idea is to help oncologists focus their lobbying efforts on the most important therapies, and also to strengthen their bargaining position, because they can show that the therapies they are asking for are considered to be very important by the wider medical oncology community.

It’s taken us more than a year to come up with something that we are beginning to be happy with. And we’re now awaiting input from patient organisations about rating impact on their quality of life.

It’s a first attempt at getting a community of oncologists to look at all the very expensive drugs that we have seen in development in the last 10 years and really asking the question: if I have to choose only a few, which ones am I going to choose.

Potential dangers

As I will explain, this was an interesting exercise. When you start something like that you think it is going to be easy, but then you discover that it is actually incredibly complicated and there are potential dangers. For instance, we don’t want it to be used by governments in an aggressive way, to decide that they are only going to pay for one or two top-scoring drugs and never for the others.

What I hope to present at WOF is the reasoning behind the development of the scale, and how we went about it, and why we think it will be important. And I’m looking forward to the discussion.

Convincing governments

More generally, I hope that WOF won’t just look at what needs to be done, but also how to convince governments and politicians to take the necessary action.

We need to be able to show them how outcomes for citizens in their country compare with what is being achieved in other parts of Europe, to bring home the consequences of lack of access to the right treatments – and this is not just about new drugs but also the basics of high-quality surgery and radiotherapy. I think this kind of language is more powerful for politicians than simply going to them and saying we need money and we need new innovative treatments

These sorts of comparisons require high-quality cancer registries with homogenous cancer data – something I was shocked to find out still doesn’t exist in many European countries. So I think more support for high quality registries must be one of the messages from this WOF.

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