As part of the VIII St. Petersburg International Oncology Forum "White Nights 2022", the 13th Symposium "Pharmacoeconomics in Oncology" was held on the topic: "RWD/RWE - new horizons for development in Russia".

Moderators: Pavlysh Andrey Vladislavovich, Head of the Department of Pharmacology and Pharmacy, N.N. I.I. Mechnikov, Federal State Budgetary Institution National Medical Research Center of Oncology named after N.N. N.N. Petrov, Chief Freelance Clinical Pharmacologist of the Committee for Health Care of the Government of St. Petersburg Aleksey Sergeevich Kolbin, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, P. I.P. Pavlova"

Speakers: Aleksey S. Kolbin, Head of the Department of Clinical Pharmacology and Evidence-Based Medicine, FSBEI HE “P.S. I.P. Pavlov"; Ivanov Alexander Viktorovich, head of the consulting department of Aston Health; Kurylev Aleksey Alexandrovich I.P. Pavlov, Federal State Budgetary Institution "N.N. N.N. Petrov"; Musina Nuria Zagitovna, Advisor to the Head of the Federal State Budgetary Institution "CEKKMP" of the Ministry of Health of Russia; Zyryanov Sergey Kensarinovich, Head of the Department of General and Clinical Pharmacology, RUDN University; Pavlysh Andrey Vladislavovich, Head of the Department of Pharmacology and Pharmacy, North-Western State Medical University. I.I. Mechnikov"

The main trends in the development and definition of research data and evidence of real clinical practice (RWD/RWE) in Russia and abroad are presented. The current situation with the legislative consolidation of the main provisions of the RCP within the framework of the EAEU is described. A detailed description of the current situation and prospects for the use of clinical registries in oncology as a source of RCP data as part of the development of the OncoMonitoring integrative system is presented. The features of RCT data collection in the treatment of patients with malignant neoplasms are considered, practical examples of the use of RCT approaches in oncological practice are given. The current situation with the prospects for using RCP data for assessing healthcare technologies is considered on the example of the development of personalized therapy in the field of oncology. The role of RCP data and evidence in assessing the safety profile of drugs, analyzing information on adverse events, and improving the functioning of the pharmacovigilance system was discussed. Examples of using the results of RCP studies in making regulatory and clinical decisions are shown. The experience of evaluating available data from randomized clinical trials and RPC studies based on the results of indirect comparisons of the use of CDK 4/6 inhibitors in combination therapy for mBC is presented.

According to the results of the symposium “Pharmacoeconomics in oncology. RWD/RWE – new horizons for development in Russia” the final resolution was adopted:

1. The main trends in the development of RWD/RWE research in Russia and abroad are the active use of RWD/RWE in the field of decision-making in the field of healthcare. In March 2022, within the framework of the Eurasian Economic Union, the definitions of RWD/RWE were given and legally fixed. A legislative initiative is being considered to consolidate the main terms and provisions in the Concept for the Development of Approaches to the Collection, Analysis and Use of RWD.
2. The need for a unified monitoring and resource management system in oncology can be satisfied by integrating RWD from the OncoMonitoring system into the existing information systems of the EGISZ, VIMIS, FFOMS, patient registers, etc.
3. The collection, processing and storage of RWD obtained in the treatment of cancer patients is not systematized, data integration is difficult due to the lack of a single depersonalized patient identifier. The development of the EGISZ and VIMIS information systems can contribute to the development of the RWD/RWE concept.
4. The collection and use of RWD is necessary for making decisions in the context of a limited evidence base, for example, on registration and financing of personalized medicine technologies. Efficient financing of personalized therapy requires the introduction of a system of innovative drug supply models (risk-sharing) and the transition to value-based drug reimbursement and pricing models (personalized reimbursement and pay-for-performance), which are also based on RWD/RWE.
5. RWD/RWE is certainly a valuable source of information for making regulatory and clinical decisions in the field of drug safety control, developing the design of RWD studies, and making changes to the dossiers of used drugs.
6. Comparison of data from pre-registration RCTs (randomized clinical trials) and RWD/RWE studies on the example of evaluating studies on the use of CDK4/6 inhibitors allows us to obtain a more objective picture for making an informed decision on the choice of specific tactics for the treatment of HR+ HER2- mBC.

The text of the resolution was agreed with the leadership of the Association of Specialists in the field Health Technology Assessment Institute, Association of Clinical Pharmacologists, St. Petersburg Branch of the International Society for Pharmacoeconomic Research and Scientific Outcome Analysis (St.Petersburg branch of ISPOR)

LINK: https://forum-onco.ru/media/farmakoekonomika-v-onkologii-rezolyutsiya-13-go-simpoziuma-sostoyavshegosya-v-ramkakh-foruma-belye-n/