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Treatment with innovative drugs is a modern method of therapy. Does every patient have access to it? The answers to this question and many others are provided by Artur Fałek, a doctor and expert from the Rafał Piotr Janiszewski Advisory Office.
Anna Tłustochowicz: Doctor, do Poles have access to the most modern drugs and therapies today?
Artur Fałek:They have… 1/3 whistle, so I would describe it. Not in half, but 1/3. If we look at modern technologies, used, for example, in rare diseases that are registered in Europe, about 1/3 of them are reimbursed by us. And the European average is well above half! So, in general, there are modern drugs. They appear systematically in Poland and are reimbursed, but social expectations - measured, for example, by the positions of patient organizations - are certainly much higher.
This can be seen from the discussions that are also taking place in the media. Systematically, there is information that when it comes to access to, among others, oncological drugs, Poland is at the bottom end in Europe. Society is against this.
Yes, but I would not like us to reduce this conversation only to the issue of oncological drugs - whether it is cancer or another disease, we should not value it. If drugs are effective and are able to save a person from death or save his he alth, then they should be financed by the system.
Meanwhile, reality is lame. Why?
The answer is very simple, and the reality is brutal: drugs are available not in half, but in 1/3 of the whistle, because this is due to the we alth of our system. It all comes down to money. For a reimbursement budget, in which there is no guarantee that 17 percent. funds for he althcare services will be allocated to drugs. The demand expressed in the document "State Drug Policy" to stipulate rigidly what part of the expenditure on benefits is to be constituted by expenditure on drugs has still not been implemented. This is a fundamental mistake!
The financing of drugs in Poland is limping and is developing at a slower pace than the financing of other services.
Suffice it to say that if you were to change this little recipe andallocate 17 percent of all funds that we spend generally on he alth services, precisely on drugs, and these 17 percent. this is the average in OECD countries, we would have over PLN 4 billion more for drugs. PLN 4 billion! It is easy to imagine what this would mean in practice for patients: if we have over 100 drug programs today and they cost PLN 4.5 billion, then we could have twice as many drug programs.
What you are saying now strongly stimulates the imagination.
Because these are simple things! But unfortunately this is not the case, and admittedly, something is changing in drug policy, new drug programs appear, but these are all small steps. This is evolutionary development. However, we need a revolutionary leap! And here the change in financing is essential. Drugs cost money.Modern drugs are expensive, very expensive or terribly expensive.And there is no choice: if these drugs are to be available to Polish patients, we have to pay for them. We must have money for this. The cost of the therapy we are discussing now is so enormous for a single patient that he would not be able to bear them, even if his whole family had to pay for it. I am speaking brutally now, but the reality - as I mentioned - is ruthless and brutal. And most of all, that's not the point. It is not about the whole family throwing themselves off to treat a sick person or looking for fundraising money on the Internet. This is what the insurance system is for, to remove the economic barrier in accessing medicines.
The famous singer Kora Jackowska, who suffered from cancer, spoke publicly about the fact that she could not afford to buy a drug that could prolong her life. He was registered in Poland, he was available, but he was not reimbursed.
This is exactly the kind of situation I'm talking about. It was about Olaparib, a drug used in ovarian cancer. Today, this treatment is reimbursed. And many other drugs could be as well, but the he alth minister has to make reimbursement decisions responsibly. We know how much money we have and what we can afford.
You mentioned drug programs. What are they?
They are a specific form of drug reimbursement.
Drug programs concern technologies that are expensive or very expensive, and in Poland they are available to patients, but not to the general public.
They are intended and used by relatively small groups of people: for several dozen, one hundred, several thousand people. In some European systems, these drugs are simply available from prescription pharmacies. However, with us they are available as part of the drug program, incl. in order to be in control of how much it costs. Patientonly eligible for the program in specific indications. Of course, this is a form of rationing. We finance treatment when we believe (as assessed by the He alth Technology Assessment Agency) that the drugs will give the patient the greatest benefit.
Will they live longer?
Often yes. Sometimes they can even lead to recovery. Much of these therapies turn a fatal disease into a chronic disease. In some cases, these drugs must be used for life.
And you have already said that if you change the structure of spending money in the he alth care system and allocate 17 percent. of the total sum for drugs, we would have twice as many such drugs. Instead, we constantly hear that patients do not have access to drugs that are available "in the West."
It is very rarely a physical barrier to access to the drug! It is not that we do not have this drug, that its purchase is impossible.
Sure. It is possible, but the patient would have to buy it out of his own pocket.
Modern drugs, especially drugs for rare diseases and drugs used in oncology, are centrally registered in Europe. They are authorized by the European Commission based on the opinion of the European Medicines Agency. We now have an example of COVID-19 vaccines, right? They are not admitted consecutively in all countries, separately, but centrally. It is the same with other innovative drugs. So it's not that modern drugs are "in the West", but we don't have them. They are also available from us, you can buy them, but they are not always refunded. Please also note that where they are reimbursed in Europe, they are also not always financed by all insurers! It happens that one insurer reimburses the most modern medicine, and another - does not.
In Poland, we have the principle of equal access to he alth services and it is a constitutional principle, so either all patients who meet the same he alth conditions have access to the drug or not.
Well, we all have equal numbers: "1/3 whistle".
Yes. We have less modern technologies reimbursed in Poland than on average in Europe, and the time from the moment of their admission to trading until they are covered by a refund - is usually longer than that of our neighbors. Ma'am, what we are talking about today is not a complicated matter. She is - I repeat - very simple! We have less access to drugs because we have less money. We must honestly tell ourselves that Poles pay relatively low he alth insurance contributions. This is the cause of this state of affairs! We like to compare each other to the "West", to Germanyexample, right? Well, let's have a look: Germany pays 15 percent. for he alth insurance, and we are 9 percent. And the wages in Germany are roughly four times higher than in Poland. So it turns out - this is a simple calculation - that the Germans have almost 8 times more money in the system than the Poles. Germany spends more money on drugs than we do on our entire he althcare system, of course taking into account the size of the population. There is no need to break down an open door here! A decision has to be made to increase the funding of drugs in the system. Unfortunately, nothing in this world - apart from parental love - is for free.
If our system remains less affluent, and we are still satisfied that we pay a lower premium, do not expect miracles that someone will give us anything.
Of course, drug price negotiations are important! And it is happening. The Economic Commission, which negotiates the prices of drugs, does a good job and they are usually lower in Poland than in other European countries. Well, these prices are lower by 5.10 or even 30 percent. But not eight times!
And doesn't the Polish Governance guarantee more money for he alth protection?
The Polish Order increases funds for financing the entire he alth protection. We are to aim for 7 percent. GDP for he alth in 2027. But here we are talking about the entire system, and I repeat like a mantra that it is absolutely necessary to guarantee that 17 percent. of the total funds spent on he alth care will be allocated to drugs. Without this guarantee, spending on drugs is pushed back by other needs of the system, and, for example, wage regulation limits the ability to increase drug spending. These are connected vessels. Only the fixation of the parity of the distribution of funds allocated to drugs secures this financing and guarantees a proportional increase in expenditure for this purpose along with the increase in the system's we alth. Otherwise, the firefighting mode will always have more politically important things than funding new drugs.
If you are talking about fire fighting, please tell me what Emergency Access to Drug Technologies is all about. What is it anyway? Which patients can benefit from it?
Here we are talking about drugs that are not regularly funded by public funds. They are, of course, registered and admitted to trading and present on the market in Poland, but they can only be used under the RDTL if it is an emergency therapy, i.e. that it saves the patient's life and he alth and all other treatment options have been used. These are statutory conditions.
Really very difficult to access?
A year ago, the presidential law on the Medical Fund changedthe principle of starting this therapy. Previously, an application was submitted to the minister of he alth, which gave consent, which actually took a long time. Now the path is simpler and shortened. The statutory conditions I mentioned still have to be met, but the centers have a pool of funds that they can spend on RDTL. And they do not have to obtain the approval of the minister of he alth, but only obtain a positive opinion of a consultant in a given field.
In 2022, we spent about PLN 62 million on RDTL, this year we could theoretically spend slightly over PLN 160 million - this is the limit for the entire country, and so far about PLN 49.5 million has been spent.
The amounts you talk about make you dizzy. There is probably no greater fear than the fact that a loved one becomes seriously ill and suddenly it turns out that the drug is not reimbursed and you would have to pay for it yourself. And man will not be able to afford it.
As a rule, it will not be, because Poles do not have such huge savings that they could afford to finance a therapy costing several dozen or several hundred thousand. PLN per month.
Expert
Dr. Artur Fałek, doctor
He is an expert of the Rafał Piotr Janiszewski Consulting Office in the field of the organization and operation of the he alth care system, the operation of state administration, legislation in the field of he alth care, and an expert in the field of reimbursement and drug management. He worked in the Ministry of He alth as the Director of the Department of Drug Policy and Pharmacy (2007-2015), previously as the Deputy Director (2007), in the National He alth Fund Headquarters as the Director of the Drug Management Department.
From 2005 he was a member and from November 2007 the Chairman of the Drug Management Team. He is the author, co-author of many organizational solutions and legislation in the field of pharmacy and drugs, he was a Deputy Member of the Management Board at the European Medicines Agency; Senior Project Officer in the "Transparency of the National He alth System Drug Reimbursement Decisions" project (2007-2008); was a representative of Poland in the work of working groups at the European level.
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