According to the WAIT 2022 international study, in Lithuania it takes an average of 536 days to add a new drug to the reimbursement lists. For comparison, in Germany – 47.
One of the main reasons why our country’s patients are innovative medicines available much later – insufficiently efficient STV processes. Organizations uniting patients hope that joint evaluation of drugs starting next year will improve the current situation.
“For some cancer patients, the possibility of treatment with innovative drugs is critically important, because the latest scientific achievements in the race against cancer make it possible to gain time. Therefore, it is necessary to ensure that when making decisions on the reimbursement of new drugs, the STV process works properly, without preventing patients from receiving the most appropriate treatment in time and reducing diseases burden”, says Neringa Čiakienė, director of the Oncology Patient Support Association (POLA).
She also notes that due to the inefficiency of the STV processes, the planning of funds necessary for the reimbursement of targeted drugs has also suffered. One example of this is the situation of breast cancer patients. According to the director of POLA, the availability of medicines needed to treat this oncological disease in Lithuania is only 35%. Meanwhile, in Poland, this indicator is 62%, in Bulgaria – 83%.
Observations of foreign experts in the round table discussion
In order to Lithuanian to present the pending changes to the participants of the health system in more detail and to review, how other countries are preparing for them, at the beginning of March the Innovative Pharmaceutical Industry Association (IFPA) and the Association of Physicians’ Clinical Pharmacologists (GKFA) organized a round table discussion.
It was attended not only by representatives of Lithuanian state institutions, non-governmental organizations and pharmaceutical companies, but also by foreign experts. One of them – Professor Wim Goettsch of Utrecht University in the Netherlands – has accumulated long-term experience both in the development of the European joint assessment model and in preparing for its implementation.
“According to the current procedure, the European Medicines Agency assesses whether the medicine can enter the European market. When it registers medicines, the responsible institutions of each country conduct a national level assessment and decide on their inclusion in the compensable lists”, observes prof. W. Goettsch.
According to him, such a model creates great disparities between EU countries, as the pace of mandatory national-level processes is fundamentally different in the countries.
“Evaluating the data, we see that the duration of the processes sometimes differs in different EU countries, and this primarily affects patients who do not receive the latest treatment on time. By introducing a unified clinical evaluation system, the aim is to reduce the administrative burden on applicants and application evaluators and to ensure smoother and more efficient processes in all members of the community”, says Prof. W. Goettsch.
The expert also emphasizes that a common application evaluation model will ensure the exchange of good practices between different countries. According to him, by applying common methodologies, EU states will be able to pool human resources, share accumulated experience and data.
In order to achieve a breakthrough, dialogue is needed
According to IFPA director Jūra Smilgaitė, the preparatory phase of regulation of STV at the EU level is taking place already from 2022. According to her, in order to ensure smooth processes, during this period the Lithuanian pharmaceutical industry actively entered into a dialogue with other participants of the health system.
“The Lithuanian health system is awaiting a big change that can create a breakthrough. However, in order for the best practices to be adopted and implemented in the country as much as possible, it is necessary to prepare in advance for the upcoming joint assessment, and an integral part of this is an intensive dialogue between applicants and application assessors”, says J. Smilgaitė.
The transition to the joint evaluation model is expected to be implemented in several stages. Starting with oncology drugs and advanced therapy drugs next year, it is planned that from 2030 The EU will jointly assess all new medicines.
