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Intrepid Health Solutions Ematuzumab Launch. November 15, 2013 TEAM 1 David Waintraub Jason Bloom Manasa Parakala Michael Kwatkoski. Executive Summary. WHO?. HER2/ neu Breast Cancer Patients. WHAT?. Ematuzumab -Disruptive Monoclonal Antibody. WHERE?. Launch in the United States.
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Intrepid Health SolutionsEmatuzumab Launch November 15, 2013 TEAM 1 David Waintraub Jason Bloom Manasa Parakala Michael Kwatkoski
Executive Summary WHO? HER2/neu Breast Cancer Patients WHAT? Ematuzumab-Disruptive Monoclonal Antibody WHERE? Launch in the United States WHEN? FDA Approval by 2015 • Risk Sharing Pricing Model • High Overall Survival WHY? • High Complete Response Rate • No Cardiac Risk
What is HER2/neu? • Biomarker: promotes cancer cell growth • Causes aggressive cancer • 38,400 diagnosed each year • Standard of Care: Genetech’s Herceptin • New Paradigm: Perjeta enhances Herceptin’s effectiveness
Breast Cancer Continuum Before Surgery After Surgery Before/After Surgery Neo-Adjuvant Adjuvant Metastatic HER2/neu : 38,400 patients/year
Perjeta Landscape Before Surgery After Surgery Before/After Surgery Neo-Adjuvant Adjuvant Metastatic P P P P P P E E E E E E
Metastatic 1st Line: Ema vs. Perjeta Comparative Effectiveness Research
Breast Cancer Continuum Before Surgery After Surgery Before/After Surgery Neo-Adjuvant Adjuvant Metastatic HER2/neu : 38,400 patients/year
Neoadjuvant: Ema vs. Perjeta Comparative Effectiveness Research
Breast Cancer Continuum Before Surgery After Surgery Before/After Surgery Neo-Adjuvant Adjuvant Metastatic HER2/neu : 38,400 patients/year
Pricing Argument • Ematuzumab: $6500/month Perjeta: $5900/month • Comparative Effectiveness Research • Risk sharing model • Lower overall health care costs
Comparative Effectiveness Research • Stronger Complete Response • Stronger Overall Survival • No Cardiac Risk
Lower Overall Healthcare Costs • Value Based Purchasing • Shifting story from price of drug to overall cost of care • High Complete Response • No Cardiac Risk • Accountable Care Organizations • Pay for total continuum of patient • Look at drug’s efficacy • Overall cost
Better Drug, Better Plan • Have better results for less costs • Head to head studies • Risk sharing model • Uniform message to medical community • Payors, physicians, and patients
Pre-Launch Plan • Timeline of Phase III Data • San Antonio Breast Cancer Symposium: December 2013 • Metastatic 1st Line Phase III Data • American Society of Clinical Oncology: June 2014 • Neo-Adjuvant Phase III Data
Ema SWOT Analysis • STRENGTHS • Higher Complete Response • Higher Overall Survival • No Cardiac Risk • Innovative Pricing Model • WEAKNESSES • 2nd to Market • Genentech franchise • 1st time in oncology • Progression Free Survival • Longer drug administration • OPPORTUNITIES • Adjuvant • 2nd line metastatic • Potential to expand in oncology • THREATS • Phase III results weaker than projected • New product launches in the breast cancer space