The availability of a drug for Estonian patients depends largely on whether it is in the reimbursement list and at least partly reimbursed by the health insurance. Thus, the objectives, transparency and duration of the process of adding pharmaceuticals to the reimbursement has a great impact on the actual availability of the drug.
The study aims to analyse whether the process of adding new pharmaceuticals to the reimbursement list is in accordance with the goals, and meets the needs of different stakeholders. So an overview of pharmaceutical policy stakeholders, their needs and relationships is compiled, and the current process of making reimbursement decisions is analysed, based on stakeholder interviews.
The process analysis includes the description of regulations and practice of different stages in the process, and the assessments made by the interviewees. In addition, a brief overview of the international experience and future trends is given.
A key finding is that the transparency, stakeholder involvement and fluency can be improved in the current process of making reimbursement decisions. What is more, the distribution of pharmaceutical reimbursement between the positive list and the list of health care services is not clear. Straightforward objectives in the national drug policy and addressing the specific technical and procedural aspects of the process are needed to improve the process.
The conclusions of the study are:
- the process of reimbursing pharmaceuticals does not have a clear goal on the policy level;
- the applications of adding pharmaceuticals to the reimbursement list vary in quality and there is no possibility for an official consultation before presenting the application;
- the capacity of the Agency of Medicines and the Estonian Health Insurance Fund when compiling the pharmacoeconomical assessment is dependent on the establishments’ current financial and time-related possibilities, and there is no uniform set of rules to include experts in this stage of the process;
- the member organisations have no definite sets of rules or procedures to prepare for the Pharmaceutical Committee’s meeting and the thoroughness of preparing for the meeting is varied;
- the current setup of the process of including the Pharmaceutical Committee may create a situation where the pharmaceuticals’ suitability for the reimbursement list cannot be considered with enough thoroughness;
- there are many standards for deciding the reimbursement of pharmaceuticals, but they do not approach the subject of health and pharmaceutical policy in a wider manner;
- the Pharmaceutical Committee considers the opinions of different committee members, but the thoroughly prepared opinions are at an advantage;
- the process of reimbursing pharmaceuticals as a whole does not enable to consider the opinion of professionals with enough thoroughness;
- the process of adding pharmaceuticals to the reimbursement list and the process of amending the list of healthcare services are separate, although both lists include pharmaceuticals;
- the earlier research in the field of pharmaceutical policy has touched upon different parts of the pharmaceutical field, but there are only a few studies which look at the pharmaceutical policy as a whole and are in accordance with the general pharmaceutical policy;
- Different future trends make the pharmaceutical reimbursement decisions more difficult in time.
Improving the process requires, on the one hand, for the state to set clear aims for the pharmaceutical policy, and on the other hand, dealing with the development of the technical and procedural aspects of a specific process.