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Patients are hearing more and more about biological treatment. It is one of the most modern pharmacotherapy methods used in the world! It is extremely effective, among others in rheumatology, dermatology and oncology. It is a pity that it is used so rarely in Poland.
Modern biological drugs have been developed through genetic engineering using live plant, animal, bacterial, virus or yeast cells. They usually contain proteins obtained through genetic recombination and thus they differ from traditional drugs that are produced by chemical synthesis or obtained from natural sources, e.g. from plants. Human insulin is considered to be the first biological medicine in the world. live vaccines. These genetically modified proteins have the ability to stimulate the body’s immune response. They may also aim to regulate and modify the inflammatory process in the body. Therefore, they are the hope of modern oncology – thanks to their action, tumor growth is inhibited, and they also prevent the formation of metastases. And this is without the toxicity accompanying the traditional chemistry, because they only affect the cells affected by the disease (which is why the term targeted therapies is often used). Interestingly, the patient can see and feel their action almost immediately after administering the drug. Doctors and scientists have high hopes especially for monoclonal antibodies and fusion proteins. Currently, laboratories around the world are working on about 10 new drugs of this type.
Biological drugs are used, for example, in the treatment of myeloma, leukemia, melanoma. But also in the treatment of diabetes, psoriasis and rheumatoid diseases: rheumatoid arthritis (RA), ankylosing spondylitis (AS). Also in chronic inflammatory bowel disease (colitis ulcerosa, Crohn’s disease).
Hope for a rheumatism
– Most biological drugs are used in rheumatology, and the field in which they are used most widely in our country was entered on the reimbursement lists only 2-3 years ago – says prof. Piotr Wiland, head of the Department and Clinic of Rheumatology and Internal Diseases at the Medical University of Wrocław, president of the Polish Society of Rheumatology.
These drugs have been used around the world for 15 years. Polish patients have limited access to them. Although (according to various sources) about 9 million Poles suffer from various rheumatic diseases, including at least 200-300 thousand. on RA. Meanwhile, biological drugs are used only in about 1 percent. sick. For comparison, in most European countries the percentage of patients treated with this method reaches up to 20 percent. – If we want to equal Western countries, we should biologically treat about 38 thousand. patients. We treat less than 5 – adds prof. Wiland. – It shows the gulf between us.
Only patients with high disease activity and failure of classical methods of treatment can rely on biological treatment. That is the criteria. Therefore, Poland is the only country in Europe where, prior to biological treatment, classic treatment should be used for a year … despite its ineffectiveness. We are also the only country where, for administrative reasons, six months after achieving remission or low disease activity, the therapy has to be discontinued because it is no longer reimbursed. There are no such recommendations in any of the European countries! They mean that after the patient’s health improves, treatment should be discontinued awaiting a further exacerbation of the disease.
– In other words, biological treatment is given to patients in the last stage – those who cannot leave their home due to illness, have left their jobs long ago. As if it has not been known for years that without effective treatment, patients will face a progressive disability, inevitably leading to disability, and that they start each day with unbearable pain, which often lasts for several hours – says Monika Zientek from the association “Let’s get together”, which brings together people suffering from rheumatic diseases. – The system was created to qualify for the program and monitor the course of treatment, but it works to the detriment of patients! And when the results improve, the patient is removed from the program. This means that most patients are afraid to feel better!
According to the survey conducted by the association, most patients see positive effects of biological therapy. As much as 65 percent claims that he feels a marked improvement as a result of the recommended treatment (for comparison, only 35% of respondents see improvement in the group of people treated traditionally). In many of them, the improvement is so great that it allows them to return to their daily and professional activities and activities.
Absolute sieve
We have two news, good and bad. The bad news is that in 2014, the criteria for admission to biological treatment programs were even more stringent. This is the effect of changes in the so-called the Reimbursement Act, in which there was a provision that the Coordination Team qualifies patients “on the basis of the criteria for inclusion in a given program”.
– This probably eliminates the possibility of qualifying beyond the program description, i.e. custom requests. This will limit patients’ access to treatment, explains Marcin Stajszczyk, MD, PhD, head of the XNUMXnd Rheumatology Department of the Silesian Rheumatology and Rehabilitation Hospital in Ustroń.
It should also be added that a patient with AS or PsA cannot use the second biological drug if the first one is ineffective – he is simply removed from the drug program. Another example of absurd notations and interpretations is the regulator’s sequential therapy in the RA program, which limits the number of usable drugs from six (which are available) to three, and a completely incomprehensible interpretation of which drugs can be used one after the other and which are not.
– We are afraid that this will further limit the availability of treatment, and even so in Poland it is very difficult to access – says Dr. Ewa Stanisławska-Biernat from the Clinic and Polyclinic of Rheumatology of the Institute of Rheumatology in Warsaw. – This is best seen in the number of sick leaves and pensions granted due to rheumatic diseases: in the world since 2006, when biological treatment was widely used, their number has been systematically decreasing. Unfortunately, it is growing here.
The second, good news is that since January 2014, new drugs, much cheaper biosimilars of infliximab, have been reimbursed for rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis. Abatacept and tocilizumab – medicines used in children suffering from juvenile idiopathic arthritis and RA are also waiting for reimbursement.
Expensive therapy
When you don’t know what’s going on, it’s usually about … – as the popular saying goes. So how much does treatment cost? The cost of traditional therapy in rheumatology is PLN 4000 per year.
The cost of biological drug therapy – an average of PLN 31 per year. Disease remission with traditional methods may take 000 years. In biological treatment, it is 2 years. In our country, older and worse treatment methods have been chosen mainly because they are cheaper. It did not take into account that perhaps it would be cheaper, even expensive, to heal people – than to pay sickness benefits and then pensions to infirm and sick patients for years.
Freedom from psoriasis
Although this disease affects about 800 thousand in Poland. people, of whom about 150 struggle with its severe form, it is still an unknown disease. Patients cannot find a job, are not allowed in the swimming pool, etc. Psoriasis also has a negative impact on their social relationships, relationships with loved ones and sexual activity. – Who has not heard about this disease, seeing changes on my skin thinks that it is some leprosy that can be infected – says 30-year-old Mateusz, who has been suffering from psoriasis for 10 years. – After moving to Warsaw, I had huge problems with finding a hairdresser who, at the mere sight of my skin, would not want me to leave the salon.
– Psoriasis is really called “leprosy of the 10st century” – says prof. Andrzej Kaszuba, head of the Department of Dermatology, Pediatric Dermatology and Oncology of the Medical University of Lodz, national consultant in the field of dermatology and venereology. – However, it is not only about skin changes, because it is a disease that affects the entire body. It attacks the joints (psoriatic arthritis), causes obesity, weakens the heart, can lead to a heart attack or other cardiological complications, affects the development of diabetes, etc. The research results are absolute: patients with psoriasis live 15-XNUMX years shorter than their peers. Not to mention the psychological aspects. They are often diagnosed with depression, feel rejected, and have a much poorer quality of life.
Biological drugs for patients with severe psoriasis are their only hope. However, the fight for their reimbursement in Poland lasted as long as 5 years! In the end, it worked, but as in the case of rheumatics, the qualification criteria for the therapy are so strict that instead of 1000 patients, only about 60 people use them. – In other European countries, such as Belgium or France, one criterion is taken into account: the patient’s quality of life. Often, large changes in the nails, causing soreness, are enough for the patient to be granted the right to biological treatment, which is the most effective – says prof. Kashuba.
And the treatment results are spectacular! A sick person, who often stayed home and lived on a pension, returns to normal life, work and activity after administering biological drugs.
– For years I used greasy ointments at night. My big dream was to go to bed with clean, fragrant sheets… And it happened. After starting the therapy, the symptoms of psoriasis disappeared – says Mateusz. – I stopped having problems at work, I returned to playing sports. And finally I’m dating!
How do I get biological treatment?
It is decided by the doctor who has to fill in the appropriate application – usually on-line. Then it goes to the coordination team (composed of medical authorities in a given field, representatives of the Ministry of Health and the National Health Fund), where they are verified. The tasks of the team also include the analysis of the legitimacy of the submitted applications, the needs in terms of the number of biological therapies, the amount and distribution of individual types of therapy, and considering appeals against decisions already made. The team also informs the National Health Fund about the possible occurrence of adverse drug reactions. The team established in rheumatology is considered to be the best organized team. Unfortunately, the bad news for patients is that the team’s deliberations are secret, and in the event of refusal, there is no appeal against this decision. Only the attending physician may appeal.
method
Biological drugs must always be administered in a hospital setting, after the doctor’s approval and in his presence, because they are most often administered intravenously, subcutaneously or intramuscularly. Each formulation has a specific treatment regimen, for example entanercept (Enbrel) is given as weekly injections under the skin, and infliximab (Remicade) has a more complex infusion cycle – the first every 2 and four weeks, then every 8 weeks.
Contraindications
Biological treatment is not a miracle cure for everyone. Biological preparations must not be used in the case of hypersensitivity (allergy) to a given drug or its ingredients. They cannot be used in pregnant or breastfeeding women, therefore young patients must use effective contraceptives during biological treatment. Other contraindications are: active or latent viral, bacterial, fungal and protozoal infections, severe circulatory failure, and the simultaneous use of other treatments that suppress the body’s immunity.
Tekst: Agnieszka Katrynicz