Monitoring the effect of therapy

BULGARIA CONTINUES ON THE PATH OF EVIDENCE-BASED MEDICINE IN DRUG TREATMENT
The role of the National Council on Pricing and Reimbursement of Medicinal Products (NCPR)


Article in the journal "Science and Pharmacology" 2023/1 - TEN YEARS NATIONAL COUNCIL ON PRICES AND REIMBURSEMENT OF MEDICINAL PRODUCTS. STRUCTURE, MAIN OBJECTIVES, METHODOLOGY AND ACHIEVEMENTS 


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.


The monitoring the effect of therapy with medicinal products is carried out by medical facilities for hospital care and medical facilities under Art. 5, para. 1, Art. 10, item 3, 3a, 3b and 6 of the MEDICAL ESTABLISHMENTS ACT in which there are structures based on the profile of the disease. In the course of monitoring the effect of therapy, the medical facilities will collect the information for each specific medicinal product and provide it daily to the National Council through automatic transfer from the hospital information system.

The data provided to the National Council by the hospital information systems are relevant to the specified conditions and criteria for monitoring the effect of therapy with innovative medicinal products, and the information will be completely anonymized (data that does not contain personal information about the specific patient). The Council collects, stores and analyzes the information.


Reasons for monitoring the effect of drug therapy

What is the purpose of monitoring the effect of therapy?

In which cases is it prescribed to monitor the effect of drug therapy?

How is the treatment effect monitored?

For what period of time?

What is the result of monitoring the effect of drug therapy?