access without excess: bedaquiline · 12/16/2016  · 2016/12/16 1 2016/12/16 1 access without...

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Access without Excess: Bedaquiline Global Health Policy Forum: “Access to New Medicines”

Myriam Theeuwes, Compound Development Team Leader December 12, 2016

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Overview

• Adult, pediatric drug

sensitive and drug resistant regimens

• WHO prequalified drugs and innovative drugs

• User-friendly diagnostic kits

• Sales to more than 133 countries

• Technical assistance to improve drug management systems

• Pioneered a standard 4-language package global package

Early Access Programs:

Russia & Lithuania

N=57

ATU France

N= 194

Compassionate Use

Global

N=554 N = 760

>800 patients

in 47 countries

Access: When Most Needed

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Access: Where Most Needed

> 80% of the world’s MDR-TB burden has regulatory access to bedaquiline at the end of 2016.

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Access: Janssen Approach

Established markets High burden countries Low to moderate burden countries

< 500 cases / year

500-5,000 cases / year

> 50,000 cases / year

5,000-15,000 cases / year

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Access: Global Drug Facility

• Adult, pediatric drug

sensitive and drug resistant regimens

• WHO prequalified drugs and innovative drugs

• User-friendly diagnostic kits

A UN Operations organization within the STOP TB Department, the GDF is the largest global supplier of quality-assured anti-TB treatments

Administration and oversight of a regulatory waiver process has contributed to an significant advances in patient access to treatments

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Janssen Contributions: Beyond the Pill

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Janssen & South Africa: A New Paradigm in Collaboration

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Questions? Thank you!