Table of Contents
CHAPTER 1. INTRODUCTION: THE ASCENDANCY OF THE PRIMARY CARE MODEL
Definition of a Specialty Pharmaceutical
- 1.1. Background: Evolution of the Industry' s Focus on Primary Care Markets
- 1.2. The Impact of the Blockbuster Model on the Current Structure and
Economics of the Pharmaceutical Industry
- 1.3. The Uninsurable Risk of High-Volume Drugs
- 1.4. The Stirrings of a Shift
- Increased Spending on Specialty Drugs
- A Surge in New Product Development of Biologicals
CHAPTER 2. THE EMERGING PORTFOLIO BALANCE
- 2.1. Drivers behind Big Pharma' s Interest in Specialty Markets
- Cost Reduction
- Clinical Development
- Comparative Approval Rates: Large vs. Small Molecules
- Sales and Marketing
- Pharmacovigilance
- Incremental Revenue
- Risk Management
- R&D
- Post Market
- Public Image
- 2.2. Hoffman-La Roche Case Study: The Big Pharma Specialist
- Background
- Evolution of Roche' s Specialty Care Strategy
- Roche' s Financial Performance
- 2.3. Other Examples from Industry
- Pfizer: Buy It and Sell It
- Bayer: Hunker Down and License
- Eli Lilly: Build It Up from Scratch
CHAPTER 3. THE WORLD OF THE SPECIALIST
- 3.1. The Specialist Emerges as a Key Player in the Health Care Economy
- 3.2. Specialist Practice Economics
- Changes in Reimbursement and Utilization Management Impacting Specialists
- Medicare CAP and "Buy and Bill"
- Special Feature: The Medicare Competitive Acquisition Program (CAP)
- Movement of Injectables to the Pharmacy Benefit
- Practice Structure and the Service Component
- Conditions Requiring "High-Touch" Service
- Referral Generation
- PCPs
- "Suspect and Refer" Physicians
- Patient Self Referrals
- Impact of Medicare Part D on Referrals
- Specialists and Clinical Research
- Upside for Physicians
- Upside for Sponsoring Company
- 3.3. Detailing to Specialists
- The Specialist vs. the PCP
- Ease of Access
- PCPs and Primary Care Reps
- Specialists and Specialty Care Reps
- Opportunities for Providing Value-Added Support Services to Specialist
Practices
- The Specialist Rep
- 3.4. The Specialist-Focused Strategy
- Relationship Equity with KOLs
- The Cycle of Mutual Support
- KOLs and Clinical Research
CHAPTER 4. THE WORLD OF THE PATIENT
- 4.1. Profile of the Specialty Care Patient
- An Engaged and Proactive Mindset
- Patient Activism
- Specialist Marketers Discover the Patient
- 4.2. Reaching the Specialty Care Patient
- The Channels
- The Specialist
- Specialty Pharmacies
- Patient Advocacy Groups
- DTC Advertising of Specialty Drugs
- 4.3. A 3-Step Method for Reaching New Patients: A Case Study of Pegasys
for Hepatitis C
- Know Your Patient Population
- Know the Disease
- Know Your Physician Population
CHAPTER 5. REGULATORY AND REIMBURSEMENT ISSUES
- 5.1. FDA Regulatory Pathways for Specialty Care Products
- The Orphan Drug Act
- The Accelerated Approval Program
- 5.2. Managed Care and Specialty Drugs
- Specialty Products Move from the Medical Benefit to the Pharmacy Benefit
- A Bewildering Variety of Benefit Plans and Copay Structures
- Specialty Injectables and the Formulary
- Tactics for Gaining Formulary Placement
- Clinical Data will be the Cornerstone of Negotiations
- How Managed Care is Controlling Utilization of High-Cost Specialty
Products
- Prior Authorization
- Managed Injectable Programs
- Cost Shifting
- 5.3. Biogen Idec' s Amevive: A Case Study in Positioning a Specialty
Product for Managed Care
CHAPTER 6. ANALYSIS OF TWO SPECIALTY DISEASE MARKETS: PULMONARY ARTERIAL HYPERTENSION AND SCLERODERMA
- 6.1 Pulmonary Arterial Hypertension
- Pathophysiology, Taxonomy, and Symptoms
- Pathophysiology
- Taxonomy and Symptoms
- Epidemiology
- Diagnosis
- Treatments
- Calcium Channel Blockers
- Prostanoids
- Endothelin Receptor Antagonists (ETRAs)
- Phosphodiesterase 5 (PDE-5) Inhibitors
- Market Dynamics
- 6.2. Scleroderma
- Pathophysiology, Taxonomy, and Symptoms
- Pathophysiology
- Taxonomy and Symptoms
- Epidemiology
- Diagnosis
- Treatments
- Fibrosis Inhibitors: CTFG Antagonists and TGF-beta
- Immune Inflammation: CCR2 Antagonists, Cyclophosphamide, Interferon, and
Leukocyte Elastase Inhibitors
- Vascular: Prostacyclin and Alpha-2-Adrenoreceptor Agonists
- Market Dynamics
CHAPTER 7. CONCLUSIONS: IMPLICATIONS AND CONSIDERATIONS
- 7.1. Factors Impacting the Future Commercial Vitality of Specialty Disease
Markets
- Price and Utilization Controls
- High-Cost Specialty Drugs Come under Fire
- The Industry Reconsiders the Rationale for High Drug Prices
- What does It Mean for Specialty Products?
- Biogenerics
- R&D Considerations
- A Finite Number of Targets for Protein Drugs?
- The Oral Deliverability of Biologicals
- Q&A with Manuel Vega, PhD, of Nautilus Biotech
- Small Molecules that Target Protein-protein Interactions
- 7.2. Some Strategic Implications of Big Pharma' s Embrace of Specialty
Products
- The Organization
- GSK' s Biopharmaceutical CEDD
- The Rise of the Specialist
- The Ongoing Morphing of Disease States
- Conclusion
EXPERTS INTERVIEWED FOR THIS REPORT
Thomas Bumol, PhD (Vice President of Biotechnology Discovery Research
at Eli Lilly)
David Caponera (former Vice President of Strategic Initiatives at
TheraCom, a division of Caremark)
Dan Hawkins (founding Partner of Clarion Healthcare Consulting)
Kenneth Kaitin, PhD (Director of the Tufts Center for the Study of Drug
Development)
Sandy Lauterbach (Senior Director of Global Marketing at Genzyme)
Jesus Leal (Vice President North America Infectious Diseases,
Transplantation & Immunology at Novartis; former Vice President of Interferons
at Roche)
Paul C. Nagel (Partner at Biomedical Insights)
James F. Resch, PhD (Director of Strategic Intelligence at AstraZeneca)
Ramana Sonty, PhD (Senior Director of Project Management and Medical
Operations at Pfizer)
Debra Stern (Vice President of RxPerts)
Manuel Vega, PhD (CEO of Nautilus Biotech)
Eugene Williams (CEO of Cambridge Healthtech Associates; former Senior
Vice President of Immune-Mediated Diseases at Genzyme)
References
Glossary
Company Index with web sites
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