| Preface |
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ix | |
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Chapter 1 Biopharmaceutical Distribution: Early Structural Developments and the Changes Ahead |
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1 | (22) |
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1 | (3) |
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Structural Evolution of Biopharmaceutical Distribution |
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4 | (3) |
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The Move Away from Distribution |
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5 | (2) |
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The Biopharmaceutical Supply Chain (BPS) |
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7 | (14) |
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Branded and Generic Manufacturers |
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7 | (4) |
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11 | (2) |
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13 | (3) |
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Hospitals and Group Purchasing Organizations |
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16 | (2) |
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Health Maintenance Organizations and Pharmacy Benefits Managers |
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18 | (3) |
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Bringing the Supply Chain Together |
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21 | (2) |
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Chapter 2 Key Forces and Myths of Distribution in the BPS Supply Chain |
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23 | (32) |
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23 | (1) |
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Myths of Biopharmaceutical Distribution |
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24 | (24) |
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24 | (4) |
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Structure of Fee-for-Service Inventory Impacts |
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28 | (3) |
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Perception of Manufacturers to FFS |
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31 | (1) |
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Manufacturers---Stable Group |
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31 | (1) |
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Manufacturers---Explorer Group |
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32 | (1) |
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Manufacturers---Malcontent Group |
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33 | (1) |
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Manufacturers---Oblivious Group |
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33 | (1) |
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34 | (5) |
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Group Purchasing Organizations |
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39 | (2) |
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41 | (7) |
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48 | (7) |
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48 | (1) |
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49 | (1) |
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50 | (1) |
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Product Proliferation and Customer Segmentation |
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51 | (4) |
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Chapter 3 Regulatory Trends |
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55 | (38) |
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55 | (1) |
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A Complex Regulatory Distribution Environment |
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56 | (2) |
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Regulatory Environment for Wholesalers |
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58 | (11) |
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Prescription Drug Marketing Act (PDMA) of 1988 |
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58 | (2) |
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Hatch-Waxman Act: The Entry of Biosimilars and Generics |
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60 | (1) |
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Medicare Modernization Act of 2003 |
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60 | (1) |
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61 | (2) |
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63 | (1) |
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Medicare B: Impact on Oncology |
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64 | (1) |
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65 | (1) |
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Possible Robinson--Patman Liability for Price Discrimination |
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66 | (2) |
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Other Important Drug Distribution Laws |
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68 | (1) |
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Legislation That Ended the Forward-Selling Model for Wholesalers and Manufacturers |
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69 | (3) |
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The Obama Healthcare Reform Act |
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72 | (4) |
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74 | (1) |
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75 | (1) |
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Challenges to Enforcement---Counterfeit Drugs |
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76 | (2) |
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Subsequent Legislation in Anticounterfeiting and Pedigree: A Case Study |
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78 | (3) |
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Rebate, Pricing, and Payment Structures for Medicaid: A Significant Threat on the Horizon for Wholesalers |
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81 | (4) |
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Impact of Material Handling Legislation on Pharmaceutical and Biotech Distribution |
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85 | (5) |
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85 | (2) |
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The Rise of Biologics versus Pharmaceuticals |
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87 | (3) |
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Pay-for-Performance Mandates |
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90 | (1) |
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91 | (2) |
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Chapter 4 The Last Mile: Changes in the Hospital Environment That Impact the Life Sciences |
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93 | (34) |
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The Healthcare Imperative |
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93 | (2) |
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Patient Safety and Total Cost of Patient Care |
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95 | (1) |
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The Root Cause: Multiple Handoffs |
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96 | (5) |
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Life before Automated Pharmaceutical Dispensing |
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98 | (1) |
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Automated Dispensing Market Penetration |
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98 | (2) |
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Limitations to Automated Dispensing |
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100 | (1) |
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101 | (2) |
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101 | (1) |
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102 | (1) |
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The Journey toward Automated Pharmaceutical Distribution |
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103 | (8) |
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103 | (2) |
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Phase 1 Implementation of Auto-replenishment |
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105 | (2) |
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Phase 2 Early Integration |
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107 | (2) |
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Phase 3 Auto-replenishment Integration |
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109 | (2) |
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111 | (5) |
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Challenges on the Horizon for Biologics and Pharmaceuticals in the Hospital Provider Environment |
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116 | (8) |
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Personalized Medicine and Pay-for-Performance |
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118 | (1) |
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118 | (1) |
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Pay-for-Performance (PFP) |
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118 | (1) |
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119 | (1) |
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120 | (1) |
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120 | (1) |
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Accountable Care Organizations |
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120 | (2) |
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New Developments in Comparative Effectiveness |
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122 | (2) |
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124 | (3) |
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Chapter 5 The Blurring of Boundaries in Biopharmaceutical Supply Chains: The Case of Oncology Medicine |
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127 | (32) |
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127 | (4) |
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128 | (2) |
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Growth of Cancer Treatments |
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130 | (1) |
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The Oncology Supply Chain |
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131 | (2) |
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The GPO--Distributor--Physician Relationship in Oncology |
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133 | (3) |
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Services Provided by Specialty Wholesalers and Distributors |
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135 | (1) |
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135 | (1) |
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Profitability in the Oncology Market |
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136 | (1) |
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Class-of-Trade (COT) Pricing |
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137 | (2) |
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Emerging Relationships in the Oncology Supply Chain |
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139 | (2) |
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Competitive Acquisition Program (CAP) |
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141 | (1) |
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142 | (3) |
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J-Code Specificity Challenge |
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143 | (1) |
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143 | (1) |
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144 | (1) |
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Payer and Reimbursement Systems |
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145 | (3) |
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147 | (1) |
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Misaligned Incentives in the Oncology Supply Chain |
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148 | (7) |
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148 | (1) |
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149 | (2) |
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151 | (1) |
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152 | (1) |
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152 | (1) |
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153 | (2) |
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155 | (1) |
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155 | (2) |
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157 | (2) |
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Chapter 6 The Changing Landscape of the Life Sciences Supply Chain: Recommendations for Players in the Industry |
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159 | (84) |
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Introduction: An Industry in Flux |
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159 | (1) |
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A Multi-agent Simulation View |
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160 | (3) |
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Massive Disruptions in Biopharma Value Chains |
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163 | (6) |
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Growing Adoption of Price Restrictions by Regulators and Governments |
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163 | (1) |
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Declining R&D Productivity |
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164 | (1) |
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Emphasis on Pay-for-Performance |
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165 | (1) |
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Increasing Emphasis on Personalized Medicine |
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165 | (1) |
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Fragmentation of Mass Markets |
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166 | (1) |
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Emergence of Biotech and Biologics |
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167 | (1) |
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More Restrictive Regulations |
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167 | (1) |
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Increasing Use of Pervasive Monitoring |
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168 | (1) |
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Changing Roles of Primary and Secondary Care |
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168 | (1) |
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169 | (2) |
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Global Market Channel Development and Alternative Reimbursement Models |
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171 | (12) |
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172 | (1) |
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Opportunity: Emerging Markets |
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173 | (1) |
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174 | (4) |
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178 | (2) |
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180 | (1) |
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180 | (1) |
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181 | (1) |
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181 | (1) |
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181 | (1) |
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Partnering with Governments as Part of the Solution |
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182 | (1) |
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Opportunity: Personalized Medicine and Customized Therapeutic Distribution |
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183 | (10) |
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184 | (6) |
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190 | (2) |
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Aligning Capabilities to Drive Solutions |
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192 | (1) |
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E-Pedigree and Serialization: The War on Counterfeit Drugs and Black Market Sales |
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193 | (1) |
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Counterfeit Drug Challenges |
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193 | (30) |
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The Rise of E-Pedigree Regulation |
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195 | (3) |
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The Early Promise of RFID Technology |
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198 | (4) |
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Counterfeiting and Pedigree Technology Solutions |
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202 | (2) |
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GS1 and the Serialization Alphabet Soup |
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204 | (5) |
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Distinguishing Attributes |
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209 | (2) |
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Key Issues Surrounding Traceability |
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211 | (1) |
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The Global Serialization Landscape |
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211 | (5) |
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Pfizer: Setting Priorities and Learning from Experience |
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216 | (1) |
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Merck: Learning to Manage the Process |
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217 | (2) |
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What Does It Take to Be Able to Implement Serialization? |
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219 | (2) |
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Critical Requirements for Successful Collaboration |
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221 | (1) |
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Rx-360: Industry Collaboration Initiative for Global Track-and-Trace |
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221 | (2) |
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Opportunity: Specialized Distribution Channels |
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223 | (14) |
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Direct-to-Consumer Customized Distribution for Oncology and Injected Biotherapies |
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225 | (1) |
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Temperature-Controlled Specialized Distribution |
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226 | (1) |
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Why Is Cold Chain a Current Issue? |
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227 | (1) |
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227 | (1) |
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228 | (1) |
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228 | (1) |
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229 | (3) |
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Looking Forward: What's Next? |
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232 | (5) |
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237 | (6) |
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240 | (3) |
| Index |
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243 | |