1. Thinking Beyond The Clinical:
Creating An Optimal Commercial Reimbursement Landscape
Nathan White, CPC • Executive Director, Access and Reimbursement
BIO Windhover PSO • New York, NY • March 31, 2011
Connect. Engage. Simplify.

2. The journey to bring pharmaceutical products from
molecule to market is complex and filled with
The 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. 1. Background and Case Studies On
Reimbursement
Objectives
2. Discover How Proactive REMS Can Offset
Commercial Risk
3. Panel Discussion

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. Increasing premiums and cost sharing
Medicare and Medicaid expansion Comparative Effectiveness Research
Access to affordable coverage Safety Doughnut hole rebates
Outcomes
Quality
Premium subsidies Insurance exchanges

6. Patient Protection and Affordable Care Act
Uncertainties with new Congress
Future legislative changes
Expansion of coverage
Cost Containment
Quality and outcomes

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. Today’s Afterthought.
Tomorrow’s Storm.
 Label Restrictions
 Black Box Warnings
 Restrictive Coverage Policies
 Access Barriers
 Reduced Reimbursement Rates

9. CASE STUDIES:
What can we learn?

10. Case Study: Company with no US commercialization experience
EU 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 rates
Co. A invested in a product that had no commercial value in the US due to
reimbursement issues and scrapped the project.
“Look Before You Leap” - Consider the commercial reimbursement
landscape before investing!
Results & Lessons Learned

11. Case Study: Company with some US commercialization experience
Mid-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 with
patient education and altered the label pre-approval.
“Consider The Label” – nuances in the label can have drastic repercussions
on the future reimbursement scenario!
Results & Lessons Learned

12. The End Goal:
A clinical & regulatory
strategy that meets
regulatory approval
and ensures a label
that in turn resonates
with payers and
reduces patient and
provider access
barriers.

14. 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 Execution
Account Management Field Sales and MSL
3PL Operations Patient Services
Operations Operations
Programs and Tools Development
Physician Materials and Patient Materials and Payer Materials and
Programs Programs Programs
Monitoring and Reporting
Safety Database/
Pharmacovigiliance REMs
Program

15. 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 Development
Physician Materials and Patient Materials and Payer Materials and
Programs Programs Programs
Monitoring and Reporting
Safety Database/
Pharmacovigiliance REMs
Program

16. inVentiv Health. Thinking Forward.

17. Introduction To Panel

18. Steve Bloom
Vice President
Business Development & Operations
Steve has more than 25 years of commercial experience in the pharmaceutical, biotechnology and
outcomes/reimbursement industries. Steven is currently responsible for a full array of business
development activities (identification & evaluation of opportunities, structuring and negotiating
transactions, out-licensing and alliance management). In addition, Mr Bloom is responsible for the
commercial 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 Development
at PHARMetrics (aquired by IMS in 2005) where he manged the business development team and the
early integration of the company into the IMS organization. Prior to joining PHARMetrics, Mr. Bloom
was Vice President of Business Operations at Inflexxion where he built the marketing, business
development and sales organization as the company expanded from 35 - 55 employees. Mr. Bloom
spent 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.

19. Joff Masukawa
Vice President
Global Government Relations & Public Policy
Joff Masukawa established and leads global government relations and public policy for Shire, one of
the world’s leading biopharmaceutical companies. Shire markets products for attention deficit and
hyperactivity disorder, gastrointestinal and renal diseases, and rare genetic disorders, with a robust
pipeline 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 Genzyme
before joining Shire.

20. Shefali Shah, MBA
Senior Director
Managed Markets
Mrs. Shah has extensive experience from assisting small start ups with new product launch planning to
top biotech companies with environmental assessments, product launch strategies, patient services
strategies and product life cycle management. She has developed pricing and reimbursement
strategies for pre-launch ultra-orphan and specialty/biotech products based on extensive market
research for the US and EU markets.
She has worked extensively in Rare Diseases, Neurology and Oncology developing launch strategies
for the US and EU.
Prior to joining inVentiv, Shefali worked as a consultant in the Pharmaceutical and Biotech Industry at
top companies like Andersen Consulting and PricewaterhouseCoopers and as an employee of Wyeth.

21. Jeff Fetterman, MBA
President
Jeff 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.

22. Connect. Engage. Simplify.
with inVentiv Health