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The Ministry of Health launched a liver cancer treatment program with a modern and expensive drug. However, the criteria for enrolling patients in the program are so formulated that half of them will never qualify for treatment. Prof. Krzysztof Krzemieniecki is a consultant in the field of oncology in the Małopolskie Voivodeship.
After all, patients with liver cancer have a therapeutic program within which they can be treated with modern medicine. Do they have anything to be happy about?
– It is good that the program was created, but it must be clearly stated that it is a compromise between the payer’s financial capacity and what we know about the treatment of this disease. The eligibility criteria for the program are formulated in such a way that almost 50% of patients for whom the drug has been registered will not be included in the program.
Which of the program inclusion criteria are too restrictive?
– The necessity to perform a biopsy stipulated in the criteria contradicts what is taught by oncology adepts. It happens that the location of neoplastic lesions makes it impossible to collect material for examination. Moreover, if the patient has cirrhosis of the liver, it is difficult to isolate neoplastic cells in the collected material. Therefore, the diagnosis of this cancer is based on changes visible in imaging tests and an increased marker index that indicates liver cancer or testicular cancer. If a testicular tumor is eliminated, a diagnosis can be made without a biopsy.
The criteria formulated in this way are also harmful, because the disregard of the results of research on this marker specific for liver cancer by the program’s creators may result in doctors not checking it. Meanwhile, this test allows for the early detection of liver cancer, and thus the initiation of the most effective surgical treatment. Oncologists, together with specialists in infectious diseases, implement a preventive program aimed at increasing the number of tests checking this marker, especially among patients with cirrhosis of the liver. But the National Health Fund and the minister of health discredit this research instrument unnecessarily, forgetting that treatment of liver cancer diagnosed too late is more expensive and less effective.
It should also be remembered that taking a biopsy for the patient means waiting for a visit to the surgeon and then for the result. Sometimes it turns out to be unreliable and the biopsy has to be repeated, and time passes. And when the biopsy finally shows that you have cancer, it may be too late for treatment.
The criteria also exclude patients with metastases, does the drug not work in such patients?
– The clinical trials, which are the basis for the registration of the drug, have proven that it extends the survival time also in patients with metastases. Meanwhile, such formulated criteria eliminate these patients from the program.
The therapeutic program also excludes patients who have abnormal coagulation values. However, it should be remembered that many patients with liver cancer have cirrhosis, which disrupts the functioning of this system. Therefore, I believe that these criteria should be modified.
It is believed that mainly alcoholics suffer from liver cancer. Is it true?
– In the world, more than 75% of cases are related to infection with hepatitis B or C viruses, while in developed countries, infection with the hepatitis C virus and alcoholic cirrhosis are of primary importance.
I know of a boy who was infected with the Type C virus during an appendectomy. His mother had long been striving to get him treated for this disease as part of a therapeutic program. The criteria assumed treatment of patients over 18 years of age, and her son was underage. When he finally qualified for the program, he developed liver cancer. Unfortunately, he cannot be treated under the new program because he has a lymph node involved, so he does not meet the criteria. This is so dramatic that he was infected by the health service and now she refuses to treat him.
How many people get liver cancer?
– Every year, approximately 630 people worldwide develop primary liver cancer, which accounts for 5,7% of all cancer cases. About 600 people die from this cancer every year. It is the third leading cause of death from cancer in the world. However, in most European countries, primary liver cancer is a relatively rare disease. In Poland, in 2007, 1343 people fell ill with primary liver cancer, and 1949 died. These are not large numbers, so the creation of artificial restrictions on qualifications for the program is even more surprising.
What is the prognosis for this disease?
– The 5-year survival rate in Europe is only 9%. The main criteria are cancer advancement and liver efficiency. Surgery is the only way to achieve recovery. The most effective action is to perform a liver transplant, which allows to achieve 5-year survival in approximately 70% of patients. However, radical local treatment is only possible in about 20% of patients.
When qualifying a drug to the therapeutic program, the Ministry of Health takes into account the average survival time of patients treated with these drugs. However, does calculating the ratio of costs to the effects of therapy allow for an equitable distribution of insufficient funds?
– The dilemmas of officials do not convince the sick or their families. Each day of their lives is priceless for them. Moreover, they believe that since the Constitution of the Republic of Poland guarantees everyone equal access to medical services, they should receive treatment – even if it only prolongs their life.
Does the creation of rigid criteria for qualifying for therapy mean that the National Health Fund no longer needs doctors, because the program decides which patients will be treated? Or maybe such criteria create an ideal patient model that is not reflected in reality?
– The program does not see the problems encountered by the doctor during therapy. Only 60% of patients fall within these criteria. The remaining 40% requires an individual doctor’s decision. This one, however, cannot take it, because his hands are tied by regulations, which of course has nothing to do with the Hippocratic oath, which we all take. Thus, the National Health Fund questions the qualifications of specialists and creates regulations to protect its budget. Meanwhile, we should not wonder how to account for the procedure, but how to cure the patient.
In non-regulatory situations, the decision must rest with the doctor.
– There are no provisions that would allow for the omission of the consent of the National Health Fund in such exceptional situations, and would allow a quick decision to be made by a provincial consultant or a specially appointed therapeutic committee. Currently, the consultant only issues an opinion that is in no way binding for the National Health Fund.
Oncologists say they will be able to save more than two-thirds of cancer patients in 2020, but this progress will be very costly. Will Polish medicine afford it?
– Each country is struggling with the problem of the lack of money for more and more modern medical technologies. Oncology is a huge financial challenge for everyone, because it is the place where the most innovation is. However, this is not a waste of money. It must be remembered that the pharmaceutical industry that sells innovative drugs returns some money to the bloodstream of science and medicine in the form of research into new drugs. In no country is modern oncological treatment financed from a single source, because no system could withstand it, especially the Polish National Health Fund. The problem is that it has to be honestly said. Additional health insurance is necessary. For now, I think that our health insurance system should allow patients to purchase drug therapies from their own resources, not financed by the National Health Fund. It is hypocritical to talk about inequality in access to medical services. After all, today some Poles have wonderful mansions, and there are also those who live in tin containers. If “Kowalski” pays for the drugs himself, other NFZ insured people will have more money to share. Already today, many patients who can afford it do diagnostics privately, skipping the queue, and this results not only in earlier diagnosis of their disease, but also shortening the queue for those who cannot afford private examinations.
Text: Halina Pilonis