The collection of data from real-world data (RWD) is of great importance for making a decision on the inclusion of innovative personalized technologies - cell, gene therapy, complex genomic profiling (NGS-diagnostics) - in the system of state funding, noted Nuria Musina, Advisor to the Head of the Federal State Budgetary Institution "CECCMP" of the Ministry of Health Russia at the Russian Cancer Congress.

The extremely high cost of treatment, the limited evidence base for efficacy, especially in the long term, lead to a high degree of uncertainty in the clinical and economic assessment required for making a decision on the financing of such technologies.

In foreign countries, innovative models of drug provision (IMLO) - risk-sharing agreements - are widely used to include personalized technologies in the public funding system, which are based on data from real-world data.

Existing IMLO models are classified as financial and outcome-based. Financial schemes are most often used due to the ease of administration. These include:

1. Limiting the upper limit of budget spending - the agreement fixes a certain level of prescription of the drug, if this level is exceeded, the company provides it free of charge
2. Confidential discounts are the most commonly used form, but such agreements do not appear in the external reference pricing system
3. Price-volume - price regulation depending on the purchase volume - the larger the purchase volume, the lower the cost of the drug

The use of outcome-based IMLO regimens requires administration costs, but these costs are justified in the case of extremely high cost of the drug and high uncertainty about the effect. Most often, such regimens are used for orphan drugs, gene and cell therapy, as they can increase cost efficiency and pay for the result.

Nuria Musina, Advisor to the Head of the Federal State Budgetary Institution "CEKKMP" of the Ministry of Health of Russia:

“The development of drugs towards ever greater personalization, the arrival of innovative personalized technologies raise the question of the availability of such technologies for patients. Their inclusion in the public funding system requires new approaches. The future of healthcare is the transition to value-based models of drug reimbursement and pricing (pay-per-result). "

Source: https://rosmedex.ru/imlo/