Moscow, October 8, 2019



Ministry of Health of the Russian Federation,

Federation Council Committee on Social Policy,

Center for Healthcare Quality Assessment and Control of the Ministry of Health of the
Russian Federation,

Autonomous Non-Profit Organization "National Center for Health Technology Assessment",

International Society for Pharmacoeconomics and Outcomes Research (ISPOR),

Health Technology Assessment Association.

Moscow, October 8, 2019

Renaissance Moscow Monarch Centre Hotel


The conference is being held on the initiative of the Center for Healthcare Quality and Control of the Ministry of Health of the Russian Federation with the support of the Ministry of Health of the Russian Federation, Federation Council Committee on Social Policy, Federal Compulsory Medical Insurance Fund, Health Technology Assessment Association and Autonomous Non-Profit Organization “National Center for Health Technology Assessment”.

This conference is held in accordance with the plan of scientific and practical events of the Ministry of Health of the Russian Federation for 2019, p. 75 (Order of the Ministry of Health of Russia dated February 28, 2019, No. 99).

Nowadays, numerous steps are taken to implement innovative health technologies including medicines and medical devices which significantly improve treatment outcomes, quality of life of patients as well as it leads to inevitable increase of costs of health care system. Over the last years personalized medicine has become one of the key ways for development of pharmaceutical industry and health care in general which allows to adapt treatment methods to genetic features of particular patients thereby increasing therapy efficiency and reducing side effects.

This conference is devoted to personalized medicine implementation in the Russian health care system in particular gene and cell therapy, companion diagnostics as well as comprehensive assessment and financing.

Gene therapy is associated with the progress in treating numerous incurable diseases since gene therapy, unlike traditional, is aimed at cause of the disease (gene disorders) and most promising from this point of view are orphan and oncological diseases. However, first gene medicines are very expensive, long-term effects remain unexplored and scaling their production is a formidable task which also contributes to high cost of treatment.

Cell therapy is a promising innovative way of treating numerous diseases including rare forms of blood cancer and lymphomas. In foreign countries chimeric antigen receptor has been registered and is being used, which implies injection of patient’s own T-cells with joint chimeric receptor in order to recognize tumor cells. CAR-T in foreign countries demonstrates positive results: 50-90% of patients with some oncological diseases in terminal phase turn to stable remission. In Russia cell medications are regulated by the Federal Law No. 180-FZ on Biomedical cell products, however, to ensure cell therapy implementation in practice and availability of innovative treatment methods this law requires further development.

Implementation of personalized medicine is impossible without development of companion diagnostics, which means combination of methods and medical devices that help clinicians decide whether this particular medicine is appropriate for a patient and what dosage should be used. Nowadays, our country uses target medications to treat oncological diseases, the purpose of which is ineffective without first conducting molecular-genetic or histochemical research. In future number of such medications will increase and clinical and economic efficiency of its use will be directly related to efficiency and cost of the companion molecular-genetic test. In many foreign countries, when deciding on reimbursement, joint procedure of health technology assessment for a medication and a companion test is provided. Unfortunately, in our country, in accordance with our legislation, only medication is subjected to comprehensive assessment since comprehensive assessment of medical devices, which includes molecular-genetic test, is not provided. This restriction does not allow to evaluate in full clinical and economic consequences from implementation of new target medications in health care system.

Advantages of personalized medicine for patients are undeniable. In the coming years, new innovative technology of gene and cell therapy is expected to appear on market and also wider use of a full genome sequencing in the diagnostics and treatment process. However, to ensure its availability for patients is a complicated task since gene and cell technologies are expensive and have limited data on effectiveness. Due to this, the government as a payer should develop appropriate approaches for comprehensive assessment and financing using innovative models of medical provision (risk sharing agreement).

Considering the aforesaid, this conference is planned with the aim to study approaches of ensuring availability and increasing efficiency of public expenditures on innovative health technologies.

Heads of departments, committees and divisions of federal executive authorities, representatives of the Federal and Territorial Compulsory Medical Insurance Fund, representatives of scientific and expert society, employees of Medical Universities, Skolkovo, representatives of the European Federation of Pharmaceutical Industries and Associations (EFPIA), National Institute for Health and Care Excellence (NICE), and other representatives of foreign HTA institutes and leading international HTA experts are welcome to participate in the conference.

Issues to be discussed:

-   Review of principal ways and development of cell and gene therapy;

-   Problems and prospects of cell technology implementation in RF;

-   Availability of cell and gene therapy technologies;

-   Innovative models of medical provision (risk sharing agreement);

-   Financing of companion diagnostics abroad;

-   Current condition and prospects of molecular-genetic and histochemical studies of cancer patients in RF;

-   Possible ways to implement companion diagnostics in public financing system;

As a result of the Conference, it is planned to prepare proposals on gene and cell therapy technologies implementation in the health care system and further development of HTA system in the Russian Federation.




Registration period has passed