Report Description:

Global Data “Pharma Sphere: North American Market Access Strategy” report provides a strategic analysis of the pharmaceutical market landscape in this geographic region, and the impact of the current and emerging market access strategies that the pharmaceutical industry is using for its for new and existing drugs. It discusses the regulatory requirements for pharmaceutical products in North American, key health insurance trends, recent government healthcare reforms, and general industry trends.

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It also describes the macroeconomic factors that impact the commercialization of new pharmaceutical products. Furthermore, it includes a geographic segmentation of the various markets in North America, including the US, Canada, and Mexico, providing an in-depth analysis of these markets regulatory frameworks, healthcare systems, health insurance markets, key domestic players, and strategic outlook.


Key Questions Answered

  • What are the main factors influencing market access in North America?
  • How do demographic trends impact market access in Canada and Mexico?
  • What are the important elements of the healthcare systems in the US, Canada, and Mexico?
  • How important is health technology assessment (HTA)? What are the key processes leading up to a successful HTA in North America?
  • What are the different pricing and reimbursement procedures adopted by regulators in North America?
  • How has recent healthcare reform legislation changed market access considerations from the perspective of regulators and pharmaceutical companies?
  • How have cost-containment pressures impacted the commercialization of new pharmaceutical products?

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1 Table of Contents

1 Table of Contents 4

1.1 List of Tables 7

1.2 List of Figures 7

2 Introduction 8

2.1 Report Scope 8

2.2 Companies Mentioned 9

2.3 Upcoming Reports 9

2.4 Related Reports 10

3 Market Access Policy Evolution 11

3.1 Key Concepts in Market Access 11

3.1.1 Reference Pricing System 13

3.2 Health Technology Assessments 14

3.2.1 Use of Pharmacoeconomics 14

4 United States 16

4.1 Pharmaceutical Market 16

4.1.1 Market Size and Forecast 16

4.1.2 Market Segments and Disease Areas 19

4.2 Health Insurance Market 25

4.2.1 Managed Care 26

4.2.2 US Government-Sponsored Health Insurance Plans 29

4.2.3 Children’s Health Insurance Program 34

4.3 Regulatory Landscape 35

4.3.1 Implementation of the ACA 35

4.3.2 Health Insurance Marketplace 39

4.4 Drug Pricing 39

4.4.1 Pricing Policies 39

4.4.2 Types of Funding 42

4.5 Reimbursement 43

4.5.1 Academy of Managed Care Pharmacy Guidance Format 43

4.5.2 Medicare Coverage Policies 45

5 Canada 46

5.1 Pharmaceutical Market 46

5.1.1 Market Size and Forecasts 46

5.1.2 Market Segments and Disease Areas 47

5.2 Health Insurance Market 51

5.2.1 Public Insurance 51

5.2.2 Private Insurance 52

5.3 Regulatory Landscape 54

5.3.1 Canada Health Act 54

5.3.2 National Pharmaceuticals Strategy 55

5.4 Pricing 56

5.4.1 Pricing Policies 56

5.4.2 Patented Drug Price Trends 57

5.5 Reimbursement 59

5.5.1 Reimbursement Policies 59

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