Clerical error or deliberate action? The draft of the new ordinance of the National Health Fund takes away from patients and doctors what the Minister of Health gave them: the possibility of choosing the optimal therapy for hepatitis C
Patients living with HCV may again be concerned about their health and life. The joy of introducing all the most modern therapies used in the treatment of hepatitis C to the list of reimbursed drugs by the Ministry of Health did not last long. All because of the draft ordinance of the President of the National Health Fund, which introduces the principle that hospitals implementing the hepatitis C therapy program are to use drugs purchased under the central tender. Currently, they individually tailor therapies to specific patients. What does the planned change mean in practice? Unfortunately, the draft is illegible, and some records appear to be inconsistent, but it implies that doctors will not be able to choose a drug based on medical criteria. Such a move would be unfavorable for 10 Polish patients currently awaiting treatment. And yet we are talking about a dangerous disease (improperly treated or not treated hepatitis C leads to liver cirrhosis, cancer and, consequently, the patient’s death).
In the opinion of the Polish Group of HCV Experts, made up of people with the highest authority in the treatment of hepatitis C in our country, optimal HCV therapy includes four different schemes (source http://www.pteilchz.org.pl/data/standardy/rekomendacje_2016.pdf) ). In accordance with the binding decision of the Minister of Health, published in a relevant announcement, patients with hepatitis C acquired the right to receive them as guaranteed benefits under health care financed from public funds in Poland. The attending physician should decide on the choice of the appropriate treatment regimen, in line with the recommendations of experts and the shape of the drug program of the Ministry of Health, based on the patient’s clinical situation. Before starting HCV therapy, it is especially necessary to check potential interactions with other medications taken by the patient and possible medical contraindications, which may affect not only the effectiveness and dosage, but most importantly – the safety of the treatment.
If the ordinance of the National Health Fund enters into force, doctors will be able to treat only with the drug that will be purchased under a centralized tender, and for some patients this may turn out to be far from optimal. The draft ordinance does leave the door open to the purchase of another drug, but only for 5 percent of patients. It is a mystery where this value comes from. The solution proposed by the National Health Fund may also mean that people infected with the virus of genotypes 2 to 6, with decompensated cirrhosis or after organ transplants will remain without optimal treatment. In total, this could be as much as 40 percent of patients awaiting treatment today.
– For now, we only have concerns, because the draft ordinance is formulated vaguely, but the intentions of the National Health Fund seem obvious. Fund officials, most likely taking into account only economic considerations, want to force doctors to use the cheapest treatment. The substantive premises, which clearly guided the Minister of Health when making decisions on financing the treatment of hepatitis C in Poland, are relegated to the background. This approach is unacceptable because these are not the same therapies. We are talking about completely different substances, mechanisms of action, indications and therapeutic contraindications, or drug interactions, a different target population, a different duration of therapy. In addition, such an order means a difficult and certainly time-consuming tender. Who will guarantee that the losers will not protest, indefinitely prolonging the procedure in force? What will doctors then treat patients with hepatitis C? What about treatments already started, will they be interrupted? And what if in the next central tender a different drug than the one used so far is purchased, because the supplier offers better prices? In this case, will treatment initiated with drug A be continued with drug B? ” – rhetorically asks Barbara Pepke, president of the Star of Hope Foundation supporting HCV patients. And he adds: “We have already dealt with similar legislative errors in the past. And it ended badly.
In December 2009, the President of the National Health Fund issued the famous Regulation No. 65/2009 / DGL, as a result of which patients were to be treated under non-standard chemotherapy only in those hospitals where a national or provincial consultant worked. Many patients were discontinued as a result. The then President of the National Health Fund, Jacek Paszkiewicz, had to withdraw from the order, but in many patients their health deteriorated as a result of this step. I hope that this time the National Health Fund will withdraw even before the patients suffer. Just in case, we are already intervening in this matter with the Minister of Health, who, with his decisions to date, has saved the lives of many patients with hepatitis C in Poland. There is still time to think about this step ».