Czech drug policy shifts toward patients with rare diseases

Czech Minister for Health Adam Vojtěch: "Patient organisations are represented at the Ministry of Health through the Patient Council, through which patients can take an active part in decision-making processes in the sector, including active involvement in legislative drafting." [EU Council]

The Czech government has launched a legislative initiative to improve access to most modern medications and rare disease drugs, Health Minister Adam Vojtěch told EURACTIV in an interview. He said patients are involved in the decision-making process at a very early stage, including in drafting the law.

“For medications treating rare diseases that cannot meet the cost-efficiency condition in the course of the decision-making process concerning reimbursement, we propose that soft criteria be also considered, such as the seriousness of the disease, improvement of the patient’s quality of life, and the realistically expected benefit of the treatment,” he said.

“It is in this part of the decision-making process that we want to involve representatives of patients afflicted by the disease concerned,” the Czech minister added.

Adam Vojtěch spoke to EURACTIV’s editor Sarantis Michalopoulos.

What is the structure of the new drug policy system and why did the government decide to change it?

Drug policy in our country has functioned very well for years and patients with common diagnoses are always helped quickly.  But we want more.  We want to focus on serving patients, on continuing to increase their comfort and the availability of services for them,  and we also to think about “irregular” patients, who suffer from rare diseases or who, for some reason, can only use one medication to treat their problem.  These patients have to apply for exceptional payments from public insurance, which are, however, governed by strict rules and processes.  That is why we are looking for ways to make the most modern medications available to patients.

The specific impulse for initiating a change in the system was the very slow admission of innovative drugs to the public health insurance system, which is primarily due to the administrative demands of the process and the enormous increase in the number of applications for reimbursements, pursuant to Section 16 of the amendment to the Act on Public Health Insurance, i.e., approval of exceptional reimbursement for medications that are otherwise not covered, if this is the only option for treating the patient.  The system has become too clumsy and inefficient.

Our objective in submitting the amendment to the Act on Public Health Insurance was to accelerate and simplify administrative proceedings conducted by the State Institute for Drug Control and to introduce new rules for judging the most modern and most expensive methods entering the market.

We focus primarily on expanding the possibilities for the inclusion of highly innovative medications, medicinal products for modern therapy, and medications for rare diseases, in the reimbursement system.  We want to allow a broader range of patients easier access to the most modern effective treatment that they require while guaranteeing sustainable financing.

In the sphere of standard reimbursements, the amendment act aims to encourage the seeking of regular reimbursement for a broader range of medications, without circumventing the model from the outset by applying pursuant to Section 16.  This means that the maximum of truly efficient, necessary effective medications would be reimbursed in a standard manner, through administrative proceedings conducted before the SIDC, and only in exceptional cases, when the system fails because a specific patient does not fit the definition of the average patient and his specific situation must be taken into account, would it be appropriate to go by way of an exceptional reimbursement pursuant to Section 16.

But we want to set clear rules for the process of exceptional reimbursements pursuant to Section 16, in order that patients have clearly defined procedural rights and that the process is fast and transparent, that there be the possibility to appeal, and that consistency is assured across the decision-making of all health insurance funds.

What is the role of patients in this and how will you practically involve them in the process?

Ever since I became minister of health at the end of 2017, I have insisted that I want to build a patient-oriented ministry, a ministry that benefits patients.  That is why patient organisations are represented at the ministry of health through the Patient Council, through which patients can take an active part in decision-making processes in the sector, including active involvement in legislative drafting.

In this particular case, patients have been involved since the very beginning and they took part in drafting the amendment.  For medications treating rare diseases that cannot meet the cost-efficiency condition in the course of the decision-making process concerning reimbursement, we propose that soft criteria be also considered, such as the seriousness of the disease, improvement of the patient’s quality of life, and the realistically expected benefit of the treatment.  It is in this part of the decision-making process that we want to involve representatives of a patient afflicted by the disease concerned.

What is the expected added value from this?

Clearly in that patients will have easier access to most modern medications, rare-disease drugs, and a transparent approval process for medications for exceptional reimbursements pursuant to Section 16. I also see significant added value in the involvement of patients in decision-making processes that I have mentioned earlier.  We also want to rely on the opinions of expert societies much more.

At what stage is the legislation process?

The draft amendment was carefully prepared on the platform of a broad working group in which all involved parties were represented, from health insurance funds, regulators and drug suppliers, specialised medical associations and professional chambers, to patient organisation representatives.  Representatives of all segments spent hundreds of hours identifying problems in existing regulation and searching for viable solutions.  This amendment is the result, which is, above all, a compromise supported in its basic point across all parties.  I believe that lawmakers will appreciate this careful work and that it will contribute to the legislative process being successful.

The draft is currently undergoing comment procedure.  If no unexpected delays occur during the legislative process, the amendment may take effect in the first quarter of 2020.

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