Global Health Outcomes &

Strategic Pricing

(GHOSP)

Carole Dembek

November 10-11, 2008Confidential

Global Health Outcomes

Establish and communicate the economic value of Mozobil to global markets

Support value-based pricing & market adoption through outcomes research studies, economic models and value dossiers

Collaborate with US and global colleagues to adapt economic models to specific markets or customers to support product adoption

November 10-11, 2008Confidential

Identifying Value Drivers

Reduced cost of remobilization

More patients reach 2m cells -

fewer failed mobilizers

Patients mobilize more

cells for transplant

More cells transplanted associated with less resource use & cost

Fewer apheresis

proceduresLower apheresis

costs

Mozobil is well -tolerated with

few side effects

Eliminates cost of treating side effects of mobilizing with

chemotherapy

Clinical Data* Economic Value

* Data from Phase III trials 3101 & 3102

November 10-11, 2008Confidential

Value Pre- and Post- Transplant

Pre-transplant Period (Mobilization & Apheresis)

Post-transplant Period

Economic Value:Cost savings from fewer side effects of chemomobilizationCost savings from fewer apheresis proceduresPotential for less use of G-CSF compared to chemomobilizationFewer failed mobilizers will result in less remobilization costMore predictability in scheduling apheresis

Economic Value:More CD34+ cells may result in less supportive care, hospital days and lower costMore CD34+ cells may be associated with better survival

Transplant

November 10-11, 2008Confidential

Economic Value Messages

Compared to mobilization with G-CSF alone: Mozobil may reduce cost by reducing apheresis days Mozobil may reduce the cost of post-transplant care by

enabling patients to be transplanted with more cells Mozobil may reduce cost by reducing the number of patients

who require remobilization

Compared to mobilization with G-CSF + chemo Mozobil may reduce cost by eliminating side effects of

chemomobilization and reducing the amount of G-CSF required for mobilization

Mozobil may improve the predictability of scheduling apheresis & provide greater efficiency in the apheresis unit

November 10-11, 2008Confidential

Evidence to Support Value Messages

Mozobil clinical data Good data comparing Mozobil to G-CSF mobilization No data comparing Mozobil to G-CSF + chemotherapy

No economic data collected in Mozobil trials Published literature – not specific to Mozobil

20+ publications Cost data – cost of apheresis day avoided Limitations – old data, small sample sizes, not MM or NHL

Outcomes studies Partner with physicians to generate new economic data

November 10-11, 2008Confidential

Supporting EvidenceMore CD34+ cells = Less resource use

Author Journal Year CountryKlaus Eur J of Haematology 2007 GermanyScheid BM Transplantation 1999 GermanyLimat Eur J of Cancer 2000 FranceKetterer Blood 1998 FranceOlivieri Haematologica 1998 ItalySchulman J of Clinical Oncol 1999 USASola Hematology 1999 Spain

November 10-11, 2008Confidential

Supporting EvidenceSide effects of Chemomobilization

Author Journal Year CountryCorso Haematologica 2002 ItalyJantunen BM Transplantation 2003 FinlandFitoussi BM Transplantation 2001 FranceDesikan J of Clinical Oncology 1998 USAPetrucci Acta Haematologica 2003 ItalyAlegre BM Transplantation 1997 SpainMilone Leuk & Lymphoma 2007 ItalyGojo BM Transplantation 2004 USA

November 10-11, 2008Confidential

Outcomes Research Studies

Pr. Michallet – France200 MM pts

Comparison of resource use and cost of patients transplanted with >4m vs. <4m CD34+ cellsStatus – Preliminary data expected Q4

Pr. Einsele – Germany200 MM & NHL pts

Resource use and CD34+ cell dose Treatment of chemomobilization side effects Status – Data collection underway for cell dose study

Pr. Apperley – UK150 MM & NHL

Outcomes of mobilizing with chemotherapy - % febrile neutropenia, cost, failure rateStatus – Preliminary data received; ASH abstract accepted

Dr. Gertz – US (Mayo)

500-700 MM & lymphoma pts

Comparison of resource use in patients mobilized with G-CSF alone vs. G-CSF + 3g Cytoxan (no cost data)Status – Preliminary data expected Q4

November 10-11, 2008Confidential

Pharmetrics Private Payer Data

Study #1 – Cost of ASCT

Objectives Determine total cost of ASCT Determine proportion of cost

associated with mobilization & apheresis

Findings Total cost = $150,000 Mobilization/apheresis = 26%

Abstract accepted for poster presentation at ASH

Study #2 – Cost comparison of chemo + G vs. G alone

Objectives Determine cost of mobilization

with chemo vs. G-CSF alone Findings

Cost of mobilization with chemo was 27% higher than G-CSF

More inpatient hospital days & drug use in chemo pts

Excluding Rituxan & G-CSF, cost difference in drugs was $1,600 per patient

Abstract submitted for Tandem

November 10-11, 2008Confidential

Tools to Support Economic Value

Cost-effectiveness Model

Model will support global health technology appraisals & reimbursement submissions Preliminary model for frontline use completed Rescue model under

development Validating with KOLs Models to be finalized in Q4 GHOSP will work with

affiliates to adapt models for specific country needs

Budget Impact Model

Model will demonstrate the budgetary impact of adopting Mozobil Can be used for hospitals, payers, HTA organizations, local, regional and national health systems Model to be completed in Q4 Adapt to specific

hospitals, payers or countries

Value Dossier will be used to communicate the clinical & economic value story to global decision makers

Dossier to be completed end of 2008

Dossier will be updated as new data become available through clinical trials, outcomes studies

and published literature

Value Dossier

November 10-11, 2008Confidential

Next Steps

Complete economic models & value dossier by end of 2008 Collaborate with country affiliates to adapt for local

reimbursement submissions & HTA reviews Adapt models to support formulary adoption by

transplant centers

Complete outcomes studies, present & publish data ASH Tandem EBMT

Training on economic messages, models, value dossier