MMV Tenth Anniversary: A Decade of Discovery

Thursday, 12 November 2009Red Cross Museum Geneva

Getting drugs to patients: The challenges of

access and delivery

George Jagoe, MMV Global Access

Is Access really the Final Frontier?

CONFIDENTIAL – MMV internal use only

What’s our greatestchallenge Captain?

It’s Access Mr. Spock – it’s as difficult and

expensive as R&D

Availability

Affordability

Acceptability

Quality

Delivery

Quality

Affordability

Availability

Acceptability

Quality

Quality?

MMV portfolio 3Q’09

Pivotal StudyPreclinicalResearch Translational Development

MK 4815(Merck)

Novartisminiportfolio

GSKminiportfolio

Other Projects13 Projects

DHODHUTSW/UW/Monash

PyridoneGSK

iv artesunateQuilin

ArtemisoneUHKST

GSK 932121GSK

Pyramax®Shin Poong/University

of Iowa

AminoindoleBroad/ Genzyme

PfizerWhole cell screen

OzonideMonash/UNMC/STI

KAE 609Novartis

Lead Opt Phase IIPhase ILead Gen

Whole Cell LeadNovartis

sanofi aventisOrthologue screen

Natural Products5 Projects

P218 DHFR(BIOTEC/Monash/

LSHTM)

TafenoquineGSK

OZ 439(Monash/UNMC/STI)

(+) MefloquineTreague

Coarsucam®sanofi aventis/DNDi

KinasesMonash

QuinolineMethanols

WRAIR

DHODHBroad/Genzyme

Whole Cell Hits St Jude/Rutgers

Broad/ Genzymeminiportfolio

Coartem®-DNovartis

Registration

Eurartesim™sigma-tau

Quality – We Get It

Quality – A universal acceptance?

Health Impact

Supporting adoption

Expanding reach Shaping R&D

Health Impact

ACCEPTANCE EXPANSIONMeasure /Evaluate /Feedback

MMV’s Strategic Columns of Access & Delivery

Affordability

Affordability?

Guarantee It….

• August 2009 -- Novartis announces third price reduction for public sector buyers of Coartem since 2006

• Coartem is now 50% lower in price than it was in 2006

• Guarantee of 100 million treatment annual mfg capacity

• Coartem Dispersible - Youngest patients – $0.36 / treatment

• A Promise, a Guarantee

CSR Matters – and so does economics

Coartem Price-Volume, 2004-2009

0

10

20

30

40

50

60

70

80

90

2004 2005 2006 2007 2008 2009 (?)

mill

ion

tx

-

0.20

0.40

0.60

0.80

1.00

1.20

1.40

1.60

1.80

usd

pric

e / t

x

treatmentsprice

?

Affordability?

Study It….

Product PriceACTs 3.00 - 9.00Artemisinin mono 3.00 - 24.00Amodiaquine 0.24 - 0.48Chloroquine 0.12 - 0.30SP 0.30 - 0.60Quinine 2.50

Affordability?

Hypothesize an Answer

Masindi

Nakasongola

Kasese

Hoima

Kibaale

Kiboga

Luwero

Apac

MukonoKAMPA

LA

Mubende

Kabarole

Nebbi

Arua

Gulu

Adjumani

Kabale

Mbarara

Rakai

Sembabule Mas

aka

Kalangala

Iganga

Busia

Mle

Tororo

Kapc

hor

wa

Pallisa

Kumi

Katakwi

Moroto

Kotido

Kitgum

Soroti

Lira

Mpigi

Bushenyi

Rukungiri

Kamuli

Ntungamo

Moyo

SUDAN

KENYA

TANZANIARWANDA

Kamwenge

Kyenjojo

Knga

Kanungu

Yumbe

Pader

Sironko

NakapiripiritKma

ido

BugiriMay

uge

DEMOCRATIC REPUBLIC

CONGO

Kisoro

Wakiso

Jinja

Fort Portal

Bukedea

Kiru

hur

aIban

da

Isingiro

Bud

aka

Butaleja

Nak

ase

ke Kaliro

= 6 Interventiondistricts**

= 2 Controldistricts***

Study areas: Total population 3 million

Affordability?

Document ItIs the solution suggested by the AMFmworkable and relevant? …Is this a good use of resources? … Where is the evidence?...

Evidence is available from two pilot studies in Tanzania and Uganda in 2007–08 and 2008–09, respectively. Both studies have informed the design of the AMFm.

Let us take the example of Uganda.

• Nov 10 2009 – Global Fund Board approves funding forPhase One AMFm country proposals

• A major public health experiment• Intensive country consultation from Nov 08 to Jul 09• 11 Countries submitted proposals.

MMV:

• Co-developed Uganda & Senegal proposals.

• Supported CHAI and AMFm secretariat in devisinginformation and comms outreach

• Advised GF in M&E design and final RFP reviews

• Extensive contributions to HWG

Affordability? We Hope We Get It

Don’t be afraid to try for BHAGs* (but be smart too)

* Big Hairy Audacious Goals – JCollins and JPorras in Built to Last

Availability

Availability in General?

Who got the drugs there, what incentivizes them?

In Public Sector….Availability?

In Public Sector….Availability? And…Correct Use / Good Case Management?

CQ pilots

ACT pilots

RDT pilots

Inclusion in ICCM

Evolution of HBMF Programs and Research Focus

• Goal:• Evaluate the process by

which HBMF can be effectively implemented in rural settings

• Goal:• Determine whether ACTs

can be appropriately distributed and used within existing HBMF structures

• Goal: • Assess RDT quality• Determine whether CHWs

can effectively utilize RDTs to distinguish cases requiring ACT treatment

• Challenges identified:• Lack of compelling product• Community acceptance

(esp. in absence of treatments for negative test results)

• Potential for many false positives in endemic areas

• Goal: • Integrate CHW-delivered

community health activities• Provide range of treatments

for all major childhood diseases

• Challenges identified:• Lack of plan for expanding

CHW training and managing drug supply

• Should CHWs be trusted to manage multiple resistance-prone therapies (including antibiotics)?

1998 - 2003Beginning in mid-2000’s

Beginning in 2007-2008

Gaining focus in 2009-2010

CQ = chloroquine; ACT = artemisinin-based combination therapy; RDT = rapid diagnostic test; ICCM = integrated community case management

• Challenges identified:• Need for community buy-in• Importance of prepacking• CHW incentive structures and

attrition rates• Need for simple training materials

and re-training on ACTs

Best-known: Burkina Faso, Ghana, Nigeria, Uganda E.g., Sudan, Zambia 17 countries (PSI/TDR, others)

Availability….Innovation to last mile?

As of 2009, most countries have included HBMF in their national malaria control strategic plans

Some HBMF efforts discussed or planned*

HBMF using ACTs – pilot stages

HMM using ACTs + RDTs – scaling up

Malawi

Some HBMF implementation

HBMF using ACTs – scaling up

Status of HBMF Program ImplementationNiger

Ghana

Ethiopia

KenyaUganda

Tanzania

ZambiaAngola

Namibia

South Africa

Mali

BurkinaFaso

Moz

ambi

que

Senegal

Zimbabwe

Botswana

DR Congo

Somalia

SudanChad

CAR

GabonCongo

Cameroon

Nigeria

BeninGuinea

SierraLeone

Liberia

Coted’Ivoire

TogoM

adag

asca

r

Zanzibar

Gambia

Rwanda

Mauritania

South Sudan

Eq. Guinea

Guinea Bissau

No known HBMF efforts or plans to date

* E.g., mention in NMCP plan, request for funds in recent round of Global Fund or PMI (but details of implementation not known)

Burundi

AL is current 1st line treatment in national guidelines

Comoros

HBMF using ACTs + RDTs – pilot stages

DjiboutiEritrea

Mauritius

Swaziland

Lesotho

Note: Refer to file “HBMF Countries database_Sept09.xls” for details and full citations.

However, the status of existing and planned HBMF initiatives is highly variable across countries, with few having achieved significant scale to date

Acceptability

Acceptability? Do we make it easy to understand…. For moms?

Acceptability? Do we make it easy to understand…. For health workers?

Acceptability? Do we listen to…

• The Voice of the Policy Makers globally and nationally?• Malariologists, Reseachers and other KOLs?• National Logisticians and Central Medical Stores?• Funding Partners?• Patients

Acceptability? And when they say…

• We Need Simpler Dosing?• Longer-lasting protection?• Specially suited for pregnant moms?• Severe malaria?• New tools for IPTx?

Access… the Final Frontier…? Tell Me What You See….

The Mission / Vision helps clear the fog

MMV A&D’s VisionA world where free or easily affordable quality medicines that MMV has helped develop are always available to treat and when appropriate prevent malaria, wherever it occurs.

MMV A&D’s MissionTo ensure that medicines which MMV has helped develop are available in key malaria-endemic countries to a sufficient extent that they deliver a major health impact.

And in the end… a picture is worth one thousandwords. Voilà – the simple access ambition