Pharmaceutical market access in developed markets

Cover......Page 1
Colophon......Page 3
Preface......Page 10
 1.1Origin of the Market Access Term......Page 12
 1.2Healthcare Market Access Definition......Page 13
 1.3Market Access Key Concepts......Page 14
 1.5Market Access from Payers’ Perspective......Page 17
 1.6Market Access Agreements......Page 21
 1.7Market Access for Orphan Drugs......Page 22
 1.8Early Advice......Page 25
 1.9Early Access Programs......Page 26
 1.10To Know More......Page 27
 2.1General Outlook of Healthcare System and Health Policies......Page 30
 2.2Pathways of Market Access (Regulation, Pricing, and Reimbursement)......Page 33
 2.3Mapping and Structure of Decision Makers (Reimbursement/HTA)......Page 41
 2.5Challenges and Catalyzers for Market Access......Page 42
 2.6Key Success Factors for Market Access in Germany......Page 46
 2.8Acknowledgements......Page 47
 2.9References......Page 48
 3.2General Outlook of Healthcare System and Health Policies......Page 50
 3.3Pathways of Market Access......Page 51
 3.4Mapping and Structure of Decision Makers......Page 53
 3.5Challenges and Catalyzers for Market Access......Page 55
 3.6Advances in the Near Future......Page 56
 3.7Bibliography......Page 57
 4.1General Outlook of Healthcare System......Page 60
 4.2Pathways of Market Access (Regulation, Pricing and Reimbursement)......Page 61
 4.3Mapping and Structure of Decision Makers......Page 63
 4.6References......Page 65
 5.1General Outlook of National Health Service and Health Policies......Page 68
 5.2Pathways of Market Access......Page 69
 5.3Mapping and Structure of Decision Makers......Page 79
 5.4Challenges and Catalyzers for Market Access......Page 81
 5.5References......Page 82
 6.1General Outlook of Healthcare System and Health Policies......Page 86
 6.2Pricing and Reimbursement......Page 91
 6.3Mapping and Structure of Decision Makers (Reimbursement/HTA)......Page 95
 6.4Challenges and Catalyzers for Market Access......Page 99
 6.5Innovative Mechanisms for Funding, Purchasing and Paying for Drugs......Page 100
 6.6Look-out for Near Future......Page 105
 6.7Bibliography......Page 106
 7.1Introduction......Page 108
 7.2Healthcare System and Subsystems in Portugal......Page 111
 7.3Pathways to Market Access......Page 112
 7.4Mapping of Stakeholders......Page 125
 7.5Major hurdles......Page 127
 7.6References......Page 128
 8.1Denmark......Page 130
 8.2Sweden......Page 133
 8.3The Netherlands......Page 136
 8.4References......Page 138
 9.1Market Background......Page 142
 9.2General Outlook of Healthcare System and Health Policies......Page 143
 9.3Structure of Decision Making and Pathways of Market Access......Page 148
 9.4Challenges......Page 160
 9.5Look-out for Near Future......Page 164
 9.6Bibliography......Page 165
 10.1Background......Page 168
 10.2The Healthcare System......Page 169
 10.4Pathways of Market Access (Regulation, Pricing, and Reimbursement)......Page 173
 10.5Mapping and Structure of Decision Makers......Page 178
 10.6Challenges and Catalyzers for Market Access......Page 181
 10.8Look-out for Near Future......Page 183
 10.9Bibliography......Page 184
 11.1Background......Page 188
 11.2The Healthcare System......Page 190
 11.3Pathways of Market Access (Regulation, Pricing, and Reimbursement......Page 192
 11.4Mapping and Structure of Decision Makers......Page 196
 11.5Challenges and Catalyzers for Market Access......Page 199
 11.7Bibliography......Page 201
 12.2History and Development of the Pharmaceutical Industry Market in the U. S.......Page 204
 12.3Pharmaceutical Market Structure......Page 206
 12.4Accessing the American Pharmaceutical Market......Page 209
 12.5In Summary......Page 213
 12.6References......Page 214
 13.2Canadian Healthcare System......Page 216
 13.4Drug Approval Process......Page 217
 13.6Prescription Drug Promotion......Page 218
 13.8References......Page 219
 14.1Introduction......Page 222
 14.2Regional Access Hurdles......Page 226
 14.4In summary......Page 229
 14.5Bibliography......Page 230
 15.1Introduction......Page 232
 15.2History of HTA......Page 233
 15.3HTA and Market Access......Page 234
 15.4HTA, Regulation, Pricing and Reimbursement of Pharmaceuticals......Page 235
 15.5How HTA Differs from One Setting to Another......Page 237
 15.6Ongoing Developments Impacting on the Role of HTA to Improve the Managed Entry of New Medicines......Page 243
 15.7References......Page 253
 16.3Use of the IRP in Different Countries......Page 264
 16.4Impact of the IRP on the Pharmaceutical Industry......Page 265
 16.6References......Page 267
 17.2Need for VPB in the Pharmaceutical Industry......Page 270
 17.3Stakeholders......Page 271
 17.5Challenges to VBP implementation......Page 272
 17.6Factors Responsible for a Successful VBP Implementation......Page 273
 17.8References......Page 274
 18.1Patients are Active Partners......Page 276
 18.3Is Industry Prepared for the Change?......Page 277
 18.4Industry Should be Interested: Improved Commercial Attractiveness Through Patient‑centric Product Development......Page 279
 18.5What do Patients Expect from the Engagement Activities?......Page 280
 18.6Who is the Patient?......Page 281
 18.7Guidance on Involvement in Industry Research, Regulatory Processes, or HTA......Page 282
 18.8Activities for Gaining Patient Insights and for Patient Involvement......Page 284
 18.9Up for Discussion......Page 290
 18.10Appendix: Organizations vested in Patient Involvement......Page 291
 18.11References......Page 293
 19.1Introduction......Page 298
 19.2Recent Developments in Advanced Therapies......Page 299
 19.3Cost-Effectiveness Analysis......Page 302
 19.4Market Access......Page 304
 19.5Pricing and Reimbursement Policies......Page 305
 19.7Acknowledgements......Page 308
 19.8References......Page 309
List of Main Abbreviations......Page 312
Authors......Page 318