QUALITY OF EVIDENCE ON THE COST-EFFECTIVENESS OF DRUGS PROPOSED FOR THE INCLUSION IN THE RUSSIAN VITAL AND ESSENTIAL DRUGS LIST IN 2014-2017

Author(s)

Bezdenezhnykh T1, Omelyanovskiy V2, Avxentyeva M2, Sura M2
1Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation, Moscow, MOW, Russia, 2Center for Healthcare Quality Assessment and Control of the Ministry of Health of the Russian Federation, Moscow, Russian Federation

OBJECTIVES: To appraise the evidence on the cost-effectiveness submitted for the inclusion of pharmaceuticals in the vital and essential drugs list (VEDL) in the Russian Federation between 2014 and 2017. METHODS: All submissions for the inclusion in the VEDL made in 2014-2016 were reviewed and grouped according to the year and the decision made (approval or rejection). The record for every submission included authors, date, diagnosis, patient population, comparators, type of economic evaluation, type of outcomes, time horizon, costs, CER or ICER if calculated. The ICERs of approved and rejected drugs were compared. RESULTS: A total of 374 submissions over a four-year period were reviewed, most of which presented economic evaluation: a cost-effectiveness analysis (19-39% of all submissions depending on the year), a cost-utility analysis (6-26%), a cost-minimisation analysis (11-28%). Some dossiers included only budget impact analysis (6-13%), while others contained only burden of disease and cost of illness studies (2-13%) or no studies for the Russian healthcare setting at all (4-28%). A few studies included ICER (15-23%), although about 5% of studies where better outcomes had been achieved at higher costs failed to calculate it. An analysis of methods for ICER calculation revealed a lack of consistency in methodology, frequent use of surrogate endpoints throughout all disease groups, inappropriate time horizons, incorrect choice of comparators and costs included. We could not reveal any correlation between the results of economic evaluations and the final decisions made on the inclusion in VEDL. CONCLUSIONS: In spite of the fact that economic evaluation is required for the drugs proposed for the inclusion in the VEDL in Russia, the methodology of the pharmacoeconomic studies lacks consistency and needs substantial improvement. Unified requirements for pharmacoeconomic studies should be established and followed.

Conference/Value in Health Info

2018-11, ISPOR Europe 2018, Barcelona, Spain

Value in Health, Vol. 21, S3 (October 2018)

Code

PHP236

Topic

Health Policy & Regulatory, Health Technology Assessment

Topic Subcategory

Decision & Deliberative Processes, Reimbursement & Access Policy

Disease

Multiple Diseases

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