Outi-Maria Liedes asks why Kela lacks case-by-case consideration. According to the doctor’s assessment, the change in medication could prevent the cancer from spreading in the brain.
If a patient with cancer has time to receive one drug, it may be impossible to change it to an alternative that entered the market later.
Outi-Maria Liedes, 66, found out in the summer of 2018 that he was suffering from non-smoker’s lung cancer.
Liedes had been to the doctor several times due to feeling unwell. Various options for ill health were considered for two years. When the right side of his body suddenly became paralyzed, Hus underwent detailed examinations and a brain tumor was found. It was a metastasis of lung cancer. Lung cancer was found at a fairly early stage, but it still had time to spread.
Outi-Maria Liedes’ lung cancer is a type of non-small cell, disseminated lung cancer. There is no cure for widespread lung cancer, but current targeted drugs effectively slow down the progression of the cancer.
At that time, in the summer of 2018, Husi’s oncologist prescribed afatinib (Giotrif drug) as Liedes’ first-line treatment, which at the time was also the best drug available. It also worked and the treatment response was good, the tumors were removed.
“It causes strong side symptoms, and according to research, it does not prevent cancer from spreading to the brain. In January 2023, a new metastasis was found in my brain,” says Liedes.
In the beginning of the year In 2019, the new drug osimertinib (Tagrisso) was approved for basic reimbursement in the treatment of lung cancer, in 2021, and this year its reimbursement expanded. European Medicines Agency According to Ema’s summary, osimertinib is given to patients with changes in the gene for the EGFR protein. If the patient has previously received another drug, a T790 mutation is required to receive Tagrisso.
In Finland, reimbursement decisions for medicinal products are made by the Medicines Price Board (Hila), which is subordinate to the Ministry of Social Affairs and Health.
According to research, the newer drug, Tagrisso, prevents metastasis better than Giotrif. This is due to the fact that it penetrates the blood-brain barrier well, based on the doctors’ assessment and research work.
Outi-Maria Liede’s doctor in Hus prescribed her the newer osimertinib, or Tagrisso, because it causes fewer side symptoms and better prevents metastases from forming in the brain.
However, Kela will not grant compensation to Liede because the conditions required by the Health Insurance Act are not met.
Tagrisso can be given to patients for whom the drug would be a first-line treatment, i.e. one that is started as the first treatment after the diagnosis is confirmed. In addition, those who have a mutation in their lung cancer whose treatment requires the drug in question, according to the Medicines Price Board (Hila), can also receive the drug. According to Outi-Maria, he would have been entitled to Tagrisso treatment if he had received the same diagnosis six months later, when this medicine became reimbursed in Finland.
It’s about two key cornerstones of medical reimbursement: treatment of primacy and about which indication of use the pharmaceutical company has applied to the authorities for its drug.
A monthly dose of Tagrisso costs 5,700 euros at the pharmacy, and Giotrif approximately 2,000 euros.
In practice Kela grants reimbursement to Tagrisso if the patient has fallen ill in February 2019 or after.
According to Kela, first-line cancer treatment means the first treatment given to a patient and generally considered the best treatment for a certain disease. Second-line treatment is given if the first-line treatment does not work or stops working.
“The concept of first-line treatment for cancer is interpreted at Kela based on the indications for use according to the medicines’ marketing authorization and the criteria of the studies carried out to grant them. Solutions for drug reimbursements are always based on Hila’s currently valid decisions and the conditions for Kela’s reimbursement rights drawn up based on them. Patients in a similar situation are treated in the same way”, Kela’s specialist doctor Katariina Klintrup says.
This is how Kela justifies its decision
■ Even based on the information of the latest B doctor’s opinion, the conditions for reimbursement of osimertinib according to the valid Kela decision are not met, because it is not a first-line medical treatment, and no EGFR T790M mutation has been found in the tumor.
■ Because of this, your disease does not meet the conditions for replacement of osimertinib.
SOURCE: Kela
“I however, I am fit and I want to live. I cannot accept as an answer that there is such a problem here, but I want to know how to solve that problem”, says Outi-Maria Liedes.
He says that a young patient with the same lung cancer died last fall. The background was insufficient diagnosis and incorrect first-line treatment. The doctor therefore tried to change the medicine to Tagrisso. The patient finally bought the medicine with his own money when he couldn’t get it reimbursed.
“But too late,” says Liedes.
From the point of view of the compensation system, in the case of Outi-Maria Liedes, determining the type of cancer mutation is a decisive problem. Because in order to get the drug, it would have to be verified that the cancer mutation is exactly type T790M.
“According to neurologists, it is too high a risk to take a sample from a tumor that is in the brain. In a fluid sample from elsewhere in the body, the mutation is not visible, and that is often the case,” says Liedes.
“It seems that Kela does not use the discretion it has under the law at all when handling patients’ compensation applications,” he adds.
Liedes calculates that with his current cancer treatment, he is causing health care costs all the time. Due to the metastasis found in the brain at the beginning of the year, numerous MRI and CT images were taken. He often goes to the doctor because of the side symptoms.
According to Kela, first-line cancer treatment means the first treatment given to a patient and generally considered the best treatment for a certain disease. Second-line treatment is given if the first-line treatment does not work or stops working.
“The concept of first-line treatment for cancer is interpreted at Kela based on the indications for use according to the drug’s marketing authorization and the criteria of the studies conducted to grant them. When evaluating drug reimbursement rights, the solutions are always based on Hila’s currently valid decisions and the conditions for Kela’s reimbursement rights drawn up based on them. Patients in a similar situation are treated in the same way”, Kela’s specialist doctor Katariina Klintrup says.
Medicines the price board (Hila) processes reimbursement applications for medicinal products where the applicant is a pharmaceutical company. When the price board makes a decision on whether or not the medicine is to be reimbursed, the National Pension Institute decides for the patient whether the medicine is to be reimbursed in his case or not. For some medicines, Hila has limited the reimbursability of the medicine to a certain group of patients, for example the first line of treatment.
Chief physician of the Medicines Price Board (Hila). Jyrki Vanakoski does not take a position on patient-specific cases.
However, he opens up the grounds related to the reimbursability of medicines. For each new drug, Hila weighs the effectiveness, safety and cost-effectiveness of the drug. The costs of a new drug are evaluated more broadly in relation to other drugs already in use using several health economics metrics.
“The policy on the substitutability of osimertinib is based on research evidence of mutation. It has been noticed that lung cancers treated with older drugs develop resistance to other drugs,” he says.
The T790M mutation is therefore, in the case of lung cancer, a sign that older drugs are not working.
“If treatment for advanced cancer has been started with previous drugs, this can be a back-pocket drug that can then be used to slow down the progression of the disease,” says Vanakoski.
Vanakoski reminds that compensability decisions are regulated by the Health Insurance Act, according to which the compensability of any medicine can only be granted for an approved indication.
“Our must comply with the legislation. You must be able to justify the fact that all patients will be treated equally. Of course, I know and understand that cancer treatment in many cancers has progressed towards individualized treatment, and indications for use do not necessarily always follow,” says Jyrki Vanakoski.
More and more often, with cancer drugs, there are situations where a pharmaceutical company does not apply to the authorities for an indication for a small group of patients.
The Health Insurance Act entered into force in 1964 and has since been updated piecemeal.
Outi-Maria Liedes is of the opinion that the laws related to drug reimbursement should be updated so that patients can get the treatment they need in accordance with the doctors’ orders without unnecessary bureaucratic obstacles.
“I am going to continue my fight against the system’s disadvantages. There was no way I wanted to become a patient activist, but in the end it was necessary,” he says.
HS has seen Liedes’ medical reimbursement applications to Kela, the negative answers to them and his appeals to the social security appeals board and two appeals to the parliamentary ombudsman. The latter, made this year, is still being processed by the parliamentary ombudsman.
#Medicines #OutiMaria #Liedes #sick #wrong #time #medicine