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Thinking Beyond The Clinical:Creating An Optimal Commercial Reimbursement LandscapeNathan White, CPC • Executive Director,...
The journey to bring pharmaceutical products from                              molecule to market is complex and filled wi...
1. Background and Case Studies On                ReimbursementObjectives             2. Discover How Proactive REMS Can Of...
The pharmaceutical industry is embarking on a perilous journey,bracing itself for the perfect storm          What does the...
Increasing premiums and cost sharingMedicare and Medicaid expansion                                  Comparative Effective...
Patient Protection and Affordable Care Act                               Uncertainties with new Congress                  ...
The Value Equation:Safety + Efficacy + Comparative Cost/Clinical Effectiveness                                            ...
Today’s Afterthought.Tomorrow’s Storm. Label Restrictions Black Box Warnings Restrictive Coverage Policies Access Barr...
CASE STUDIES:What can we learn?
Case Study:                Company with no US commercialization experienceEU Diagnostic              created strategic par...
Case Study:               Company with some US commercialization experienceMid-size Biotech          launched a lyo-formul...
The End Goal:A clinical & regulatorystrategy that meetsregulatory approvaland ensures a labelthat in turn resonateswith pa...
Development & Commercialization. Not as simple as you think. Strategic Direction and Planning                             ...
inVentiv Health can mobilize our teams of                          experts to forge a clear path to your success. Strategi...
inVentiv Health. Thinking Forward.
Introduction To Panel
Steve BloomVice PresidentBusiness Development & OperationsSteve has more than 25 years of commercial experience in the pha...
Joff MasukawaVice PresidentGlobal Government Relations & Public PolicyJoff Masukawa established and leads global governmen...
Shefali Shah, MBASenior DirectorManaged MarketsMrs. Shah has extensive experience from assisting small start ups with new ...
Jeff Fetterman, MBAPresidentJeff Fetterman is President of ParagonRx, a company specializing in REMS (Risk Evaluation and ...
Connect. Engage. Simplify.with inVentiv Health
BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011
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BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011

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BIO Windhover Pharmaceutical Strategic Alliances Conference April 2011

  1. 1. Thinking Beyond The Clinical:Creating An Optimal Commercial Reimbursement LandscapeNathan White, CPC • Executive Director, Access and ReimbursementBIO Windhover PSO • New York, NY • March 31, 2011 Connect. Engage. Simplify.
  2. 2. The journey to bring pharmaceutical products from molecule to market is complex and filled withThe Journey unforeseen challenges. inVentiv Health brings clarity to the intricate issues facing the biotech and pharmaceutical industries and provides the tools and talent necessary to succeed.CONSULTING · CLINICAL · COMMERCIAL
  3. 3. 1. Background and Case Studies On ReimbursementObjectives 2. Discover How Proactive REMS Can Offset Commercial Risk 3. Panel Discussion
  4. 4. The pharmaceutical industry is embarking on a perilous journey,bracing itself for the perfect storm What does the perfect storm look like? UNCERTAINTIES OF HEALTHCARE REFORM COMPLEXITY OF PROVING VALUE TO PAYERS CHANGING REGULATORY LANDSCAPE
  5. 5. Increasing premiums and cost sharingMedicare and Medicaid expansion Comparative Effectiveness ResearchAccess to affordable coverage Safety Doughnut hole rebates Outcomes Quality Premium subsidies Insurance exchanges
  6. 6. Patient Protection and Affordable Care Act Uncertainties with new Congress Future legislative changes Expansion of coverage Cost Containment Quality and outcomes
  7. 7. The Value Equation:Safety + Efficacy + Comparative Cost/Clinical Effectiveness Industry AHRQ NIH PCORI Payers Patients and providers (CMS & Private) Who’s Responsibility Is It?
  8. 8. Today’s Afterthought.Tomorrow’s Storm. Label Restrictions Black Box Warnings Restrictive Coverage Policies Access Barriers Reduced Reimbursement Rates
  9. 9. CASE STUDIES:What can we learn?
  10. 10. Case Study: Company with no US commercialization experienceEU Diagnostic created strategic partnerships to manufacturer,Company (Co. A) distribute and market a lab-based diagnostic. • Co. A wanted to target usage by PCP’s without approaching the AMA to alter UTI diagnostic guidelines • Co. A wanted higher reimbursement than CMS would clearly pay • Co. A’s product was not clinically differentiated from UTI diagnostics and would not receive approval for a new HCPCS code or higher reimbursement ratesCo. A invested in a product that had no commercial value in the US due toreimbursement issues and scrapped the project.“Look Before You Leap” - Consider the commercial reimbursementlandscape before investing! Results & Lessons Learned
  11. 11. Case Study: Company with some US commercialization experienceMid-size Biotech launched a lyo-formulated SQ injectable biologic for a(Co. B) chronic disease into a very crowded market. • Co. B had label restricting administration by a HCP in a market where most competitors were self-administered • This caused payers to cover the product under the medical benefit in most cases. • Prescriber adoption was poor due to the hassles with reimbursement when alternatives were easily accessible with fewer access hurdles.Co. B could have considered a pro-active REMS to negate concern withpatient education and altered the label pre-approval.“Consider The Label” – nuances in the label can have drastic repercussionson the future reimbursement scenario! Results & Lessons Learned
  12. 12. The End Goal:A clinical & regulatorystrategy that meetsregulatory approvaland ensures a labelthat in turn resonateswith payers andreduces patient andprovider accessbarriers.
  13. 13. Development & Commercialization. Not as simple as you think. Strategic Direction and Planning Access and Product Positioning Distribution Strategy Recall Strategy Pricing and Contracting Contingency Planning Reimbursement Strategy Implementation and ExecutionAccount Management Field Sales and MSL 3PL Operations Patient Services Operations Operations Programs and Tools DevelopmentPhysician Materials and Patient Materials and Payer Materials and Programs Programs Programs Monitoring and Reporting Safety Database/ Pharmacovigiliance REMs Program
  14. 14. inVentiv Health can mobilize our teams of experts to forge a clear path to your success. Strategic Direction and Planning Access and Product Positioning Distribution Strategy Recall Strategy Pricing and Contracting Contingency Planning Reimbursement Strategy Implementation and Execution (Outsourced Ops)Account Management MSL Operations Patient Services 3PL Operations Operations Programs and Tools DevelopmentPhysician Materials and Patient Materials and Payer Materials and Programs Programs Programs Monitoring and Reporting Safety Database/ Pharmacovigiliance REMs Program
  15. 15. inVentiv Health. Thinking Forward.
  16. 16. Introduction To Panel
  17. 17. Steve BloomVice PresidentBusiness Development & OperationsSteve has more than 25 years of commercial experience in the pharmaceutical, biotechnology andoutcomes/reimbursement industries. Steven is currently responsible for a full array of businessdevelopment activities (identification & evaluation of opportunities, structuring and negotiatingtransactions, out-licensing and alliance management). In addition, Mr Bloom is responsible for thecommercial assessment and planning for the late stage clinical pipeline of the company.Prior to joining ZIOPHARM Oncology, Mr. Bloom served as Vice President of Business Developmentat PHARMetrics (aquired by IMS in 2005) where he manged the business development team and theearly integration of the company into the IMS organization. Prior to joining PHARMetrics, Mr. Bloomwas Vice President of Business Operations at Inflexxion where he built the marketing, businessdevelopment and sales organization as the company expanded from 35 - 55 employees. Mr. Bloomspent the early part of his career at Eli Lilly and Company, with management positions in marketing(US Brand Leader PROZAC), corporate affairs, sales leadership and managed care.
  18. 18. Joff MasukawaVice PresidentGlobal Government Relations & Public PolicyJoff Masukawa established and leads global government relations and public policy for Shire, one ofthe world’s leading biopharmaceutical companies. Shire markets products for attention deficit andhyperactivity disorder, gastrointestinal and renal diseases, and rare genetic disorders, with a robustpipeline of products under development.Joff’s experience includes advocacy, communications, diagnostics, international government relations,health policy, industry and trade association management, investor relations, lobbying, market access,marketing, media, national accounts, orphan drugs, patient assistance programs, pricing, public affairs,reimbursement, sales and sales management, specialty pharmaceuticals and strategic planning.Joff began his career at Merck and subsequently worked for Gentiva, Visible Genetics and Genzymebefore joining Shire.
  19. 19. Shefali Shah, MBASenior DirectorManaged MarketsMrs. Shah has extensive experience from assisting small start ups with new product launch planning totop biotech companies with environmental assessments, product launch strategies, patient servicesstrategies and product life cycle management. She has developed pricing and reimbursementstrategies for pre-launch ultra-orphan and specialty/biotech products based on extensive marketresearch for the US and EU markets.She has worked extensively in Rare Diseases, Neurology and Oncology developing launch strategiesfor the US and EU.Prior to joining inVentiv, Shefali worked as a consultant in the Pharmaceutical and Biotech Industry attop companies like Andersen Consulting and PricewaterhouseCoopers and as an employee of Wyeth.
  20. 20. Jeff Fetterman, MBAPresidentJeff Fetterman is President of ParagonRx, a company specializing in REMS (Risk Evaluation and Mitigation Strategies) and benefit-risk management for pharmaceutical, biotech and medical device industries. As co-author of two pharmaceutical risk management books and consultant for numerous risk management programs, he is helping to pioneer this field in our industry. Having led the pre-startup safety assessment of the only nuclear reactor to be renovated following deactivation, Jeff is familiar with the cross-industry implications of risk management techniques.In previous work, he co-founded Empower Health, a business that integrated tools and services to improve clinical health outcomes of people with chronic illness. Jeff has extensive pharmaceutical industry experience, having led marketing, medical education, strategic planning, and business development organizations at DuPont Pharmaceuticals and DuPont Consumer Health.
  21. 21. Connect. Engage. Simplify.with inVentiv Health

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