The procedure of selecting a biological drug for people with rheumatic diseases is illegal and makes access to treatment difficult, patients say. The Ministry of Health defends itself that thanks to it, the costs of treatment are reduced and that more patients can benefit from it.
Members of the Polish Federation of Rheumatism Associations REF presented on Tuesday at a press conference in Warsaw their objections to the procedure of selecting the so-called Initiating therapy for patients with rheumatoid arthritis and juvenile idiopathic arthritis and ankylosing spondylitis who are qualified for a therapeutic program in which biological drugs are administered. They included their comments in an open letter to Minister Ewa Kopacz.
As the president of the federation, Jakub Górecki recalled, biological drugs are used in patients with inflammatory joint diseases of an aggressive course who have not been helped by traditional drugs modifying the course of the disease. They are very expensive, but reimbursing them for patients in need pays off. Thanks to them, the sick are fit, they can live a normal life – start families, work, and pay taxes. In Poland, access to these drugs is to be provided by a therapeutic program.
Currently – in accordance with the regulation of the Minister of Health – once every 6 months, it indicates one biological drug (initiation therapy), which should be the starting point for the treatment of all arthritis patients qualified for the program. It is selected from among four drugs with an equivalent mechanism of action (the so-called TNF inhibitors) after price negotiations with pharmaceutical companies.
The spokesman for the Ministry of Health, Piotr Olechno, told PAP that indicating the initiating therapy allows the payer to reduce the costs of treating patients, thanks to which more patients can benefit from biological medicines. According to federation representatives, this procedure does not bring the savings announced by the ministry and significantly reduces the number of biologically treated patients.
We found out unofficially that a given company gets the so-called initiation therapy, because it offers free doses of the drug, the so-called charitable. Meanwhile, we have signals from hospitals that these doses do not reach them or that they are delayed. In addition, hospitals often do not want to admit them, because they do not know how to settle them with the National Health Fund, whether they have to pay tax for them, etc. – said attorney Bartłomiej Kuchta, president of the Association of People with ZZSK and Their People, who suffers from ankylosing arthritis. Supporters. As a result, too few patients are still taking biological drugs or starting to take them late.
Meanwhile, in a letter sent to PAP, the spokesman for the Ministry of Health assured that he had not known any problems with the settlement of charity therapies, discounts and bonuses so far.
According to an expert on the medical market, Piotr Rykowski, the procedure for selecting the initiating therapy is not very transparent and has no basis in Polish legislation. The ordinance of the ministry does not specify the method of submitting offers, the price criterion, the procedure for submitting appeals, it is not even known whether the ministry concludes contracts with pharmaceutical companies. Besides, in Poland there are no legal tools that would regulate the settlement of charitable donations – he stressed.
In his opinion, a good solution would be to introduce a price cap for the entire group of biological drugs used in rheumatic diseases or to introduce an official price. Such solutions function in therapeutic programs for other diseases.
According to the president of the Association of Rheumatics and Their Sympathizers, Jolanta Grygielska, it is doctors, not officials, who could decide which drug to administer. She recalled that TNF-alpha inhibitors differ in the method of administration. Some of them are administered as an intravenous infusion in a hospital, and some – subcutaneously, at home or on an outpatient basis, which is convenient for fit, professionally active patients (PAP).