The National Council has provided for the third consecutive year (2021, 2022, 2023) an Analysis of the collected and processed statistical information (cumulative) for the period from April 1, 2018, to December 31, 2022, for Annex 1 of the Positive Drug List (PDL) regarding pharmaceutical products reimbursed for home treatment, and for the period from July 1, 2018, to December 31, 2022, for Annex 2 of the PDL concerning pharmaceutical products applicable to the treatment of malignant diseases reimbursed in hospital care outside the value of provided medical services. The analyses are provided in fulfillment of the regulatory obligation based on Article 31b, paragraph 6 of the Regulation, upon which the Ministry of Health and the National Health Insurance Fund can make proposals for the purposes of the efficient allocation of public funds. For the first time, a new data analysis method has been introduced in the Report provided in 2023, resulting from the accumulated database since the beginning of the activity. An additional alignment of the characteristics of the real population to those from the clinical study has been performed using the Iterative Proportional Fitting (IPF) algorithm. This method has been applied to pharmaceutical products with a sufficiently large patient cohort in real-world data.
On June 5, 2019, the implemented software for monitoring the effect of the therapy of medicinal products with a new International Non-proprietary Name (INN), included in the Positive Drug List, was officially launched.
The pilot launch of the software platform is implemented in "St. Ivan Rilski" hospital in Sofia by the Chairman and members of the National Council on Prices and Reimbursement of Medicinal Products, together with Dr. Boyko Penkov - Deputy Minister of Health and Management the medical establishment.
The monitoring of the effect of the therapy with the medicinal products shall be performed by medical establishments for hospital care and medical establishments under Art. 5, para. 1, art. 10, items 3, 3a, 3b and 6 of the Law for the medical establishments, in which there are structures according to the profile of the disease.
In the course of monitoring the effect of the therapy, the medical establishments will collect the information for each specific medicinal product and will provide it to the National Council on a daily basis through an automatic transfer from the hospital information system.
The data provided to the National Council by the hospital information systems are relevant to the defined conditions and criteria for monitoring the effect of therapy with innovative medicinal products, and the information will be completely anonymized (data that do not contain personal information about the patient).