Supply Chain Management of Second Line Drugs: Russian Example Dr Vadim V. Testov Central TB Research Institute, Moscow, the Russian Federation

LOGO Total population in 2015 – The Russian Federation

LOGO TB incidence and TB mortality rates ЗаболеваемостьСмертность 2015 TB incidence TB mortality

Registration of TB cases in the Russian Federation 2013New cases and relapses including MDR-TB New cases and relapses Including MDR-TB

Implementation of M/XDR-TB Programmatic Management in the Russian Federation Implementation of DOTS-Plus regional projects in 3 Russian Subjects with support of WHO and international humanitarian organizations - total number of treated MDR-TB patients about 1.000; October 2007 – May 2010 treatment of MDR-TB patients implementation of GLC approved projects in 23 Russian Subjects within GF TB Control project, Round 4 - total number of treated MDR-TB patients ; Since June 2010 all Russian Subjects (Regions) provide treatment of MDR-TB patients with national resources

Principles of TB Control in the Russian Federation Federal legislation and regulations for TB Control; Federal surveillance and monitoring of TB; TB care for citizens of the Russian Federation is free of charge; Subjects (Regions) of the State is fully responsible for the organization of TB treatment in local (regional) health facilities with their own budgets.

DR survey in Subjects Anti-TB Drugs H (%) R (%) S (%) E (%) Z (%) HR (%) Ofx (%) Km (%) Penza Ulyanovsk Astrakhan % IC

Registration of Drugs for MDR-TB treatment in the Russian Federation Drugs for MDR-TB treatment National registration kanamycinyes amikacinyes capreomycinyes levofloxacinyes moxifloxacinyes gatifloxacinyes ofloxacinyes ethionamideyes prothionamideyes cycloserineyes terizidoneyes p-aminosalicylic acidyes

Registration of Drugs for MDR-TB treatment in the Russian Federation Drugs for MDR-TB treatment National registration bedaquilinyes linezolidyes amoxicillin/clavulanateyes thioacetazoneyes clarithromycinyes imipenemyes

Russian market of Second Line Drugs More than 30 traders regularly participate in tenders; 17 Russian manufactures of Second Line Drugs; More than 10 offers for each international Nonproprietary Name of anti-TB drugs; Competition of prices

Quality of Second Line Drugs National legislation and regulations on drugs quality control; Correspondence to the national regulation and national registration; GMP is not obligatory for participation in the bidding

Established in 1997 Leader of Russian anti-TB drugs market (42% market share) Full cycle manufacturing according to cGMP (GMP /15; ISO 9001:2008; GOST ISO ) PHARMASYNTEZ OVERVIEW API manufacturing (2017) Cycloserine Terizidone Single ingredient (full cycle) Cycloserine Capreomycin PAS Kanamycin Linezolid Protionamide Terizidone Future directions: WHO prequalification currently underway Export to foreign markets

Financing of Second Line Drugs Supply Federal Budget (70%) Budget of the Subject (Region) (30%) Consolidated Budget for Second Line Drugs Supply in the Subject (Region) (100%)

Drug management cycle

Russian Second Line Drugs Management Cycle SLD Drug Management Cycle 5 steps Ministry of Health of the Russian Federation Health Administration in the Subject local TB team in the Subject federal TB expert responsible team

Set of recommendations and tools Timelines for Second Line Procurement; Recommendation on Second Line Drugs Calculation; Federal legislation on public biddings; Standard Agreement between Russian Ministry of Health and Local Health Administration in the Subject for the federal transfer

Second Line management Cycle. Russian example The First Step (January- February) Assessment of Second Line needs and preparation request for drug supply by local TB team; The federal TB expert team is responsible for: technical support for Subjects, supervision of needs assessment and confirmation that both financial sources (Federal and Subject’s budgets) cover SLD needs of the Subject;

Second Line management Cycle. Russian example The Second Step (March) Approval of the request for drug supply by federal TB Head specialist; Transfer of the federal money for Second Line Purchase to the Subject

Second Line management Cycle. Russian example The Third Step (April –August) The authorities of the Subjects provide purchase of SLD through local markets according to the state regulations and procedures

Second Line management Cycle. Russian example The Forth Step (September- November) Supply SLD to the Subject Central Drug Stock (or to two- three sub-regional drug stocks for large Subjects)

Second Line management Cycle. Russian example The Fifth Step (during the next year) Distribution of Second Line Drugs to local health facilities and treatment of MDR-TB patients

Costs of anti-TB drugs for MDR-TB treatment Costs of anti-TB drugs for one 24-months MDR-TB treatment course with bedaquilin and linezolid comprised in 2015 – USD 9.200; Costs of anti-TB drugs for the first 12 month of the treatment –USD 6.324; Costs of anti-TB drugs for the second 12 month of the treatment –USD 2.876

Results In 2014: MDR-TB patients started treatment and totally MDR-TB patients received treatment; In 2015: MDR-TB patients started treatment and totally MDR-TB patients received treatment

How to improve national system of Second Line Drugs Management? Implementation of national (all Russian) electronic TB register with incorporated tools for Drug Management: programme for Drug calculation and monitoring of drug consumption; Centralization of Second Line Drugs bidding on federal level with long-time contracts for decreasing of prices

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