improving access to innovator drugs

7/25/2019 Improving Access to Innovator Drugs

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Improving Access to InnovatDrugsHepatitis C and lessons from HIV

January 26 - Bangkok


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All people in need should have access

to Gilead medicines, regardless of

where they live or their economicstatus


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Our Model of Treatment Expansion

Tiered Pricing

Branded drugs available

at deeply discounted prices

Generic Licensing

Partnerships with generic manufacturers

to produce high-quality, low-cost medicines

Drug Registration

Working with networkof business partners

to submit regulatory

dossiers on a country

by country basis

Relevant Data

Broad clinical trials acrossbroad patient populations;

local clinical trials where

appropriate; key

demonstration projects

Partnerships &

Health Systems StrengtheningAgreements with non-profit

service providers and on the

ground medical education and

training

Product D

Targeted donattreatment initia

underserved

A dedicated business unit working to improve treatment access in 130 count


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Guiding Principles

PartnershipCollaborate with public

sector and other

companies

AdaptabilityHeed lessons learned;

continually innovate

SustainabilityDesign access efforts for

the long term

ResponsibilityFocus where needs

are greatest


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More Than a Decade of Progress

2006 2011 20132003 201

Gilead H

medicine

million pthe devel

world

Gilead expands HIV

Access Program

through licensing

agreements withIndian generic

manufacturers

Gilead launches its

HIV Access Program

Gilead becomes the first HIV

manufacturer to sign a licensing

agreement with the Medicines

Patent Pool

2014

Gileads first hepatitis C medicine

becomes available in Egypt, the

highest-burden country in the world,less than a year after its U.S. approval

Gilead expands its hepatitis C licensing

agreements to include more companies,

more countries and more products

Gilead licenses its

hepatitis C medicines to

India-based generic

manufacturers

Gilead is ranked #1 by the

Access to Medicine Index for

patents/licensing and

equitable pricing

2012


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Generic Competition Has Reduced Prices

Driven by competition among licensed generic manufacturers, the

cost of Gilead HIV medicines has fallen by 80%

30 133413

703

1,400

2,400 2,900

5,400

7,3008,000

$17.00

$12.42$12.42

$8.25

$6.50

$5.50

$4.49 $ 4. 00 $ 4. 00$3.60

2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

LowestPrice(PerPatient/M

onth)

PatientsReached(Thousa

nds)

Year


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Patient Access to ARVs

More than half of patients on antiretroviral therapy in the developi

world are now receiving Gilead medicines

Generic drug

manufacturers account

for 98% of Gilead HIVmedicines prescribed in

developing countries

Includes patients receiving Vireadfor hepatitis B. Viread is approved for both HIV

and chronic hepatitis B virus infection


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Hepatitis C Treatment Expansion Approach

Significantbrandedmedicinediscounts

Supportingcountry &

NGOprograms

Businesspartnerships

Investment inresearch

Policydevelopment

Genericmanufacturing

For 101 resource poor countries

that represent >50% of the

global hepatitis C burdenTo strengthen hepatitis C

and care, and to reach hi

populations

Partners register medicin

regulatory authorities, co

distribution, manage sup

and conduct safety repor

Including local clinical trials and

demonstration projects

Investing in initiatives to foster

global support for greater

action against hepatitis C

Flat pricing in all low-income and nearly alllower-middle-income countries; tiered pricing (b

per capita) for all other middle-income countries

negotiated on an individual country basis

STRATEGIES


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Hepatitis C Generic Licensing Partners

Eleven International Partners

Produce generic hepatitis C medicines for

101 resource poor countries

Three In-Country Partners

Produce generic hepatitis C medicines fo

their home countries


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Egypt has the highest HCV prevalence in the world

nearly 15%, by some estimates.

The partnership:

Ministry of Health implementing ambitious national HCV

treatment program, providing care through government

clinics and hospitals

Gilead provides branded Sovaldi to Egyptian Ministry of

Health at a significantly reduced price

Gilead supports MoH-led HCV medical education and

prevention efforts

As of December 2015, more than 150,000 patients have

initiated treatment with Sovaldi

Will also begin providing Harvoni in January 2016

Access in Action: Egypt

Launch of Egypts nationa

hepatitis C treatment initiati

October 2014


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Egypt has the highest HCV prevalence in the

world

nearly 15%, by some estimates.

Access in Action: Georgia

Approximately 7% of Georgians are infected with HCV

the third-highest prevalence in the world.

The partnership:

Ministry of Health, the U.S. Centers for Disease Control and

Prevention and Gilead collaborating to eliminate hepatitis C in

Georgia

Goal is to demonstrate the impact of widespread HCV

screening and universal treatment on a national scale

Ministry of Health to lead and implement the program

U.S. CDC to provide technical support and guidance

Gilead to provide branded Sovaldi and Harvoni at no cost to

program with aims to initially treat 5,000 patients in its first year

with the eventual goal of treating up to 20,000 patients eachyear

A patient participating in the pro

May 2015


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