New treatments for cancer through immunotherapy are a revolution in the treatment of certain types of this disease. This is the case of CAR-T therapies, which modify the cells of the patient’s immune system to detect and destroy the cancer-causing cells. However, the price with which some of them have come onto the market is creating -and will create- a barrier of access and availability for all the people who may need them.
Therefore, to discuss this issue, last Monday we organized in Madrid the ‘Workshop on access to treatments for cancer in Europe: CAR-T and transparency’, together with representatives of the international organizations Knowledge Ecology International (KEI) and Just Treatment UK, among others.
We take the opportunity to speak with James Love, director of KEI and one of the largest international experts on cancer and access to medicines.
What the arrival of CAR-T to the market could mean for the patients?
CAR-T therapies are a new class of treatments which has a lot of promises for patients. What people are looking at right now is the ability of CAR-T to treat very serious types of cancer and give some patients an effective cure for a types of cancer that otherwise would be untreatable.
And will these treatments be available for other types of cancer?
Initially, CAR-T has been developed for a small number of blood cancers. But there has already been research to extend it to solid tumors, such as chest and lung cancer. Scientists believe that it is a matter of time to find out how to do it.
Nowadays, cancer drugs are very specific in terms of the types of cancers they treat. Some have better results than others. I think that the progress with CAR-T will be similar and that over time more and more problems will be solved.
Kymriah from Novartis and Yescarta from Gilead, the two most advanced treatments available for now, have been developed with a lot of public money, right?
Absolutely. In general, there is a huge footprint of public research, particularly in the initial phases. For example: the US Health System (NHS) supported Dr. Carl June’s CAR-T work at the University of Pennsylvania for many years and the patents were directly licensed to Kite, a small biotech, which was subsequently acquired by Gilead for 12,000 million dollars.
And how is it possible that companies are imposing prices of around 400,000 euros for these treatments?
Well, I think that companies are experimenting to see how much they can charge to the health systems of the countries. There are other treatments for other diseases which also have very high prices. This is the case of Rydapt, for certain types of blood cancer, which costs around $380,000. My wife takes a drug for breast cancer that costs about $150,000. And it doesn’t cure you. The companies are being very aggressive. They do not care about what they have really invested in the research and development (R&D) phases or in the purchase of the technology if they have to buy a company. What they really are trying to figuring out is how high the price can they charge.
And do you think they are being particularly aggressive with cancer?
The truth is that they would do it with any disease for which they found a way to treat it, such as diabetes or asthma. It is true that if you are treating a disease such as cancer, which is so frightening because it can kill you, they feel that they can be much more aggressive on prices. And even more if you are treating a child, for example. They can charge a higher price because it’s harder for the insurances companies or the governments to say no.
It is an unfortunate situation because they are putting at risk the sustainability of health systems, which are beginning to suffer great financial stress. Because if this were so for a few patients it would not be noticed too much, but if you have a large number of patients, which some people are predicting, the impact on health budgets will be enormous.
And do not these prices of the first CAR-T imply a dangerous precedent?
Definitely. And there is no guarantee that the next treatments will not come with even higher prices.
So, what alternative models could change the current one?
We are very keen with the idea that we must separate the price of the drug from the expectation that companies have about the profits they are going to obtain with it, which we call delinkage. However, there must be good incentives for research and innovation, of course.
A model that is interesting is the creation of rewards for those people who discover successful treatments, something that, by the way, has a lot of support, even from Andrew Witty, general manager of a large pharmaceutical company like GSK.
CAR-T therapies could be a good test case to test this model because right now is going to be considerable restriction of access to these treatments because of the high price. It would be much cheaper for governments to finance R&D incentives than to pay for the price of treatments and favor the monopoly. It is better for governments and for patients. Governments should take the first step and conduct feasibility studies of the incentives to delink prices.
However, the companies say that it costs a lot of money to develop a treatment, although they do not show their accounts. Should not there be more transparency?
Of course. Governments should not allow a company like Novartis to come and say ‘hey, we’ve spent a billion dollars on Kymriah’. It’s a lie. It is impossible that they have spent that money. In addition, as we have said, a large part of this work has been developed with public money. The NHS spent, over a long period of time, around $200,000 on CAR-T, buy they develop tons of different candidates in many different institutions. And now comes Novartis and claims that in just one year he has spent a billion dollars? Nobody can believe this is true. But, until governments demand transparency, you don’t really know. If you want to have a rational conversation about prices or how big the incentives should be, you should require for more audited data about how much money companies spend on R&D.
From different sectors it is proposed to put conditions to pharmaceutical companies to sell their products if there is public money invested in the initial phases of the development. What do you propose?
Until reaching a delinkage system, it is necessary that when governments license the technology to some pharmaceutical company, they put conditions on price, affordability and transparency. In fact, from KEI we propose a set of conditions.
The first is that the price should not be higher than what an independent health technology assessment would say. The second is that the price of medicines or treatments is not so high that it can cause restrictions in access to patients due to high copayments. The third is that being a high income or similar country does not involve discrimination in order to impose higher prices.
And the fourth condition is that, once you have reached a certain number of dollars in sales for a therapy, you should start reducing the years of monopoly, by one year for every 500,000 million dollars. That means that, if you have a technology that generates $4 billion in revenues, something that is not unreasonable in the field of cancer and in particular with the Kymriah of Novartis, the exclusivity could be reduced in up to 6 years.