The Estonian Health Insurance Fund processes the applications for new and generic medicinal products submitted by the manufacturers of medicinal products. The EHIF with Ministry of Social Affairs ensures that all the necessary medicinal products are put on the list of medicinal products distributed at a discount in timely manner on quarterly basis.
Medicinal products distributed at a discount
The establishment of a discount to a medicinal product is based on the following criteria:
- the need for a medicinal product, including the financial accessibility of a medicinal product distributed without a discount or with a lower discount rate;
- proven efficacy and safety of a medicinal product;
- the cost-effectiveness of a medicinal product (price and efficiency ratio, justification of price level);
- the existence of alternative medicinal products or treatments;
- possibilities for misuse and overuse of the medicine and their consequences;
- possibilities for providing the rational use of a medicinal product and a reliable prognosis of its retail sale volume;
- compliance with the financial means of health insurance, including the principle that the expenses incurred to provide medicinal benefits must not exceed 20 per cent of the expenses prescribed for health care benefits in the annual health insurance budget.
Amendment of the list of medicinal products distributed at a discount
The list of medicinal products distributed at a discount will be amended regularly, once per quarter (on 1 January, 1 April, 1 July and 1 October), simultaneously with the adjustment of reference prices.
Application for a new active substance to be added to the list of medicinal products distributed at a discount will be made by manufacturers of medicinal products who plan to launch a new product on the market and who have the most information about the efficiency, safety, and intended price level of the new medicinal products. Price negotiations will be held with them. Any interested party, including manufacturers of medicinal products and associations of specialised medical care specialists, can make applications with respect to the prescription of medicinal products that have already been entered to the list of medicinal products distributed at a discount.
The submission and processing of applications is described in the regulation of the Minister of Social Affairs: Procedure for drafting and amendment of a list of medicinal products of the Estonian Health Insurance Fund and the content of criteria establishing the list and evaluators of compliance with the criteria
In cases where the amendment of the list of medicinal products distributed at a discount might bring along important changes in the use of medicinal products and the financial obligations of the Estonian Health Insurance Fund, the Committee for Medicinal Products is included in the processing of applications.
The Committee for Medicinal Products has eight members – the representatives of the Estonian Medical Association, the Family Physicians Association of Estonia, the Estonian Chamber of Disabled People, the Estonian Patients Union, the State Agency of Medicines, the Estonian Health Insurance Fund, the Institute of Family Medicine and Public Health of the University of Tartu, and the Ministry of Social Affairs. The committee is an advisory body to the EHIF and the minutes of the discussions of the committee are public. The meetings of the committee are held at an average of every two months.