Contents:

Pharmaceutical pricing strategies Executive Summary The importance of price optimization Pricing and reimbursement in North America Pricing and reimbursement in Europe Pricing and reimbursement in Japan and the rest of the world Pricing strategies for new drugs Pricing strategies for established drugs Chapter 1 The importance of price optimization Summary Introduction Maximizing return on investment R&D productivity shortfall Key patent expiries Healthcare cost containment Cost-containment initiatives Cost containment in pharmaceutical expenditure Key issues Price optimization Reimbursement regulations Reference pricing Pharmacoeconomic evaluations Parallel imports Generic substitution Hot topics US reimportation Medicare Drug Benefit EU enlargement Price harmonization Pricing and reimbursement hurdles Chapter 2 Pricing and reimbursement in North America Summary Introduction US pricing regulations Medicare Medicaid Private healthcare Recent developments in the US The 2003 Medicare Prescription Drug Act Expanded access… Improved drug compliance… Higher utilization… Price comparison tool… Medicare drug benefit formularies… Medicaid budget crisis Price controls in Maine? Florida's Medicaid drug rebates Pharmacoeconomics in the US Pharmacoeconomics in public healthcare provision Pharmacoeconomics in private healthcare provision Managed care pharmacoeconomic submissions Future use of pharmacoeconomics in the US Parallel imports in the US Developments in cross-border trade Reimportation task force report… State-level action… Generic substitution in the US The Waxman-Hatch Act Pediatric exclusivity provisions Anti-competition agreements Delaying tactics and 180-day exclusivity Biogenerics Trends in generic usage 'March-in' law… Future pricing scenarios in the US Best case pricing scenario Worst case pricing scenario Most likely pricing scenario Canadian pricing regulations Federal measures Provincial measures Driving down prices Reimportation Chapter 3 Pricing and reimbursement in Europe Summary Introduction European pricing regulations France Recent developments… Germany Recent developments… Italy Recent developments… Spain Recent developments… The UK Recent developments… Pharmacoeconomics in Europe France Germany Italy Spain UK Parallel importing in Europe Penetration of parallel imports Price differentials… Initiatives to encourage use of parallel imports… Ability to obtain a license to import products… Regulations and key legal decisions Merck versus Stephar… Bayer (Adalat)… Bristol-Myers Squibb versus Paranova… The Silhouette case… The Maglite case… The Davidoff case… Recent developments GSK's supply restriction in Greece… Lack of regulatory framework in France… Novo Nordisk's supply of Actrapid Novolet in Spain… Pfizer's direct distribution to pharmacies in Spain… Generic substitution in Europe The mutual recognition procedure Future changes in European generics legislation Government initiatives encouraging generic uptake EU accession Drug pricing policies and reimbursement post-accession Parallel trade post-accession Generics post-accession Future pricing scenarios in Europe Best case pricing scenario Worst case pricing scenario Most likely pricing scenario Chapter 4 Pricing and reimbursement in Japan and the rest of the world Summary Introduction Japanese pricing regulations Recent developments Pharmacoeconomics in Japan Parallel importing in Japan Generic substitution in Japan Future pricing scenarios in Japan Best case pricing scenario Worst case pricing scenario Most likely pricing scenario Australian pricing regulations Benchmark pricing Cost plus method Average monthly treatment cost Prices for new items Chinese pricing regulations Chapter 5 Pricing strategies for new drugs Summary Introduction Pricing strategies in early-stage development Therapy area analysis Epidemiology analysis Treatment delivery analysis Market needs analysis Pricing analysis Cost analysis Economic analysis Decision-maker analysis Market research Initial assessment of drug candidates Pricing strategies in mid stage development Evaluating opportunities Case study: Aventis appeal against NICE… Improving product value Case study: Johnson & Johnson's Concerta… Pricing strategies in late stage development Sub-population analysis Choosing outcomes Case study: Merck's Zocor (simvastatin)… Patient reported outcomes Case study: Pfizer's Viagra… Head-to-head trials Phase III pharmacoeconomic studies Phase IV studies Pricing strategies for new product approvals Submission dossiers Identifying key decision makers Failure to secure reimbursement Working with decision makers… Case study – Eli Lilly's Xigris… Applying pressure through lobbying… Case study – Amgen's Aranesp… Brokering deals… Case study – Celebrex in France… External support EU launch order First choice countries… Second choice countries… Third choice countries… Fourth choice countries… Global price optimization Chapter 6 Pricing strategies for established drugs Summary Introduction Strategic pricing of reformulations Benchmarking relative pricing Patient expansion strategies Patient switching and generic defence strategies Generic defence reformulations Strategic pricing at patent expiry US patent expiry European patent expiry Chapter 7 Appendix Glossary Sources y