Pharmaceutical Pricing and Reimbursement: Global Markets

Publisher Name :
Date: 09-Jul-2020
No. of pages: 164

Report Scope:

This new report on pricing and reimbursement in a global market provides a brief overview on the pharmaceutical markets, healthcare reforms and regulations across the globe over the last decade and how this has impacted mergers and acquisitions and venture capitalist investment in the sector. It reviews pricing and reimbursement policies and processes in the U.S. and Europe and the ways in which pharmaceutical investment in generics, biosimilars, over the counter (OTC), small molecule and biological agents; and the shift toward more innovative medicines such as cell and gene therapies may change future treatment paradigms and future pricing and reimbursement policies.

Report Includes:

- An overview of the global markets for pharmaceuticals, specifically healthcare legislation and regulation, pricing mechanisms, and reimbursement procedures

- Analyses of the global market trends, with data corresponding to market size for 2014-2019, and projections of compound annual growth rates (CAGRs) through 2024

- Information on the current price and reimbursement landscape, benchmarking statics, and future development opportunities in the pharma industry

- Case studies of different price and reimbursement strategies for prescription drugs, orphan drugs, generics, over-the-counter products, and value-based pricing

- Discussion on the impact of COVID-19 on pharmaceutical sales in Q1 2020 and overall healthcare marketplace

- Insight into the greater adoption of value-based pricing schemes, with emphasis on the innovative payment models, increased investment in cell and gene therapies, and long-term response to COVID-19

Summary:

Global healthcare spending is projected to rise to around REDACTED in 2020, with spending as a percentage of gross domestic product (GDP) flat at around REDACTED, due to the hostile economic environment and the implementation of cost constraining measures, including a re-evaluation of the "clinical value" that products bring to the healthcare ecosystems.

In 2019, global pharmaceutical sales were estimated to be worth REDACTED and rise by REDACTED in 2020, as new innovative, expensive cell and gene therapies and biologics reach the market and the number of originator products at risk of patent expirations decline. During the first quarter of 2020, most pharmaceutical companies, such as Bristol-Myers Squibb, GlaxoSmithKline, Eli Lilly, Johnson & Johnson, and Novartis, witnessed a short-term boost in sales as wholesalers stockpiled products due to supply chain concerns. Some areas such as physician or hospital administered medications and travel vaccines saw a decline in sales, for obvious reasons.

Mergers and acquisitions (M&A) activity in the pharmaceutical sector keeps ticking along, with 2019 being one of the most active years in the last decade, attracting around REDACTED in investment; many transactions involved the acquisition of cell and gene therapies and immune-oncology assets or to diversify risks through the adoption of digital technologies and artificial intelligence (AI).

To contain healthcare costs, governments across the globe have introduced healthcare reforms and initiated new legislation and pharmaceutical regulations that look more closely at the performance and cost-effectiveness of care. The pharmaceutical regulatory landscape is highly fragmented and divergent, and the following section summarizes the regulatory processes adopted by the latest top five European countries and the U.S. However, as regulatory oversight increases there is a growing need for regulatory harmonization.

Since the first reports of COVID-19 in Wuhan, China in December 2019, there have been 5,165,481 confirmed cases and over 336,430 confirmed deaths in 216 countries worldwide, as of May 24, 2020. Relatively few countries remain unscathed by the pandemic and scientists across the globe have worked together to advise local, regional and national healthcare organizations to contain the spread of the disease and develop prophylactic vaccinations and new therapies to treat the symptoms of the viral infection. Each country has adopted its own healthcare strategies and mobilized resources based on their individual circumstances, but only by working together will the world be able to combat this lethal

disease.

More than $830 million in funding has been pledged to support R&D efforts in COVID-19, and health tech and pharmaceutical companies are working together in public-private collaborations, while numerous diagnostics, vaccines and treatments are already under development and research.

The COVID-19 pandemic has already dramatically changed healthcare delivery, and the economic impact of COVID-19 pandemic on healthcare spending is unknown. It will depend on many factors including: level and severity of infection, availability of diagnostics prophylactic treatments and vaccines, and whether the health system can manage supply constraints and defer non-essential healthcare services.

Pharmaceutical Pricing and Reimbursement: Global Markets

Table of Contents
Chapter 1 Introduction
Study Goals and Objectives
Reasons for Doing This Study
Scope of Report
Information Sources
Methodology
Geographic Breakdown
Analyst's Credentials
BCC Custom Research
Related BCC Research Reports
Chapter 2 Summary and Highlights
Chapter 3 Global Healthcare Expenditures, Legislation and Pricing Mechanisms
Global Healthcare Costs
Forecasts Pre-COVID
Forecasts Post-COVID
Acute Healthcare Response to COVID-19
Expansion of Low-Cost Digital Services
Funding for COVID-19 Research and Development
Drug Expenditures
North America
Europe
Japan
BRIC Economies
Impact of COVID-19 on Pharmaceutical Sales in Q1 2020
Mergers and Acquisitions (M&A)
M&A Activity Pre-2019
M&A Activity in 2019
M&A Activity in Q1 2020
Healthcare Reforms
France
Germany
Italy
Spain
United Kingdom
United States
Pharmaceutical Regulation
France
Germany
Italy
Spain
United Kingdom
United States
Acute Impact of COVID-19 on Healthcare
France
Germany
Italy
Spain
United Kingdom
United States
Chapter 4 Pricing Strategies
Introduction
Primary Reasons for the Rise in the Cost of Pharmaceuticals
Replacement of Older, Lower-Cost Drugs by Newer, Higher Priced Drugs
Increased Use of Drugs
New Drugs for Diseases for Which No Treatment Was Previously Available
Increases in the Prices of Existing Medicines
Pharmaceutical Pricing Strategies
External Price Referencing
Internal Referencing Pricing
Prescription Drug Pricing
United Kingdom
United States
Over-the-Counter (OTC) Drug Pricing
Europe
United Kingdom
United States
Generic Drug Pricing
United Kingdom
United States
Orphan Drug Pricing
Value-Based Pricing
Open Tender Invitations and Procurement
Framework Agreements
Chapter 5 Reimbursement Strategies
Pharmaceutical Reimbursement
Admission to Reimbursement
Reimbursement Procedure
Europe
United Kingdom
United States
Hospital Reimbursement
Europe
United Kingdom
United States
Patient Access Schemes
Financially Based Schemes
Outcome-Based Schemes
Early Access to Medicines Schemes
Europe
United Kingdom
United States
Formulary Lists
Europe
United Kingdom
United States
Health Technology Assessments (HTA)
Europe
United Kingdom
United States
The Value of Health Economics and Outcome Research (HEOR)
Top 10 HEOR Trends
Chapter 6 The Future
Greater Adoption of Value-Based Pricing Schemes
Increased Investment in Cell and Gene Therapies
Innovative Payment Models
Greater Clarity on Brexit
Political Wrangling Over Drug Prices
Long-term Response to COVID-19 Undefined
Chapter 7 References

List of Tables
Table 1 : Major Market Drivers of Global Healthcare Expenditures
Table 2 : Total Healthcare Expenditure in G20 Economies, 2018
Table 3 : Inpatient Care Average Length of Stay in All Hospitals, 2014
Table 4 : Steps Implemented to Access Diagnostics and Treatment Following the COVID-19 Pandemic
Table 5 : Steps Implemented to Boost and Optimize Healthcare Capacity
Table 6 : COVID-19 Vaccines under Development
Table 7 : COVID-19 Treatments under Development
Table 8 : Major Mergers and Acquisitions in the Global Pharmaceutical Market, 2019
Table 9 : Major M&A Deals in the Global Pharmaceutical Market, Q1 2020
Table 10 : Allowed Growth Rates, 2014-2018
Table 11 : Net Revenues Retained in the U.S. Pharmaceutical Market, by Type of Prescription Drug Participant, 2016
Table 12 : Pricing of Medicines in Europe
Table 13 : Using Market Forces to Price Generics in the U.K.
Table 14 : Pricing Policies for Biosimilars in Europe, as of April 2017
Table 15 : National Authorities in Charge of Market Authorization, Pricing and Reimbursement in the EU5 Countries
Table 16 : Federally Funded Health Insurance Programs in the U.S.
Table 17 : An Overview of Early Access Schemes
Table 18 : Example of a Five-Tier Formulary System in the U.S.
Table 19 : Acronyms Used in the Global Pharmaceutical Pricing and Reimbursement Market

List of Figures
Figure 1 : Projected Annual Growth in Global Healthcare Spending, 2020
Figure 2 : Global GDP Growth Forecast Comparison, February 2020 vs. May 2020
Figure 3 : Overview of Coronavirus Impact Index, by Industry
Figure 4 : Potential Initial Impact of Partial or Complete Shutdowns on Activity in the G7 Economies
Figure 5 : Schematic Diagram of Global Healthcare Spend to Increase, 2020
Figure 6 : Trends in Global Pharmaceuticals Sales, by Market Segment, 2018-2024
Figure 7 : Projected Annual Growth Forecast in Global Pharmaceutical Market, by Region Group, 2018-2022
Figure 8 : Market Shares of Generic Medicine Sales in Selected European Countries, as of 2016
Figure 9 : Cumulative Pharmaceutical M&A Spending Comparison, 2019 vs. 2018
Figure 10 : Healthcare Reforms in Germany
Figure 11 : Worldwide Confirmed Cases and Number of Fatalities from COVID-19, as Reported by WHO, as of May 24, 2020
Figure 12 : Regional Confirmed Cases and Number of Fatalities from COVID-19, as Reported by WHO, as of May 24, 2020
Figure 13 : European Countries Where External Reference Pricing is Used
Figure 14 : Overview of Countries that Refer to the U.K.
Figure 15 : European Countries Where Internal Reference Pricing is Used
Figure 16 : NHS Spending on Prescription Pharmaceuticals, 2010-2018
Figure 17 : Pharmaceutical Pricing Process in the U.S.
Figure 18 : Countries Using Generic Prices in Europe
Figure 19 : Share of Generic Drug Sales (by Value and Volume) Across the OECD Nations, 2014
Figure 20 : Comparing Prices of Biosimilars and Branded Products
Figure 21 : U.S., EU and Japan Orphan Designations per Year and Cumulative, 1983-2016
Figure 22 : Top 100 Orphan Drug Costs per Patient per Year in the U.S., 2012-2016
Figure 23 : Value-Based Pricing Process in the U.K.
Figure 24 : Overview of Pharmaceutical Tendering Process
Figure 25 : Overview of the Application of Reimbursement Schemes in Europe
Figure 26 : Organization of the U.S. Healthcare System
Figure 27 : U.S. Healthcare Expenditures as a Share of GDP, by Source of Funds, 1987-2018
Figure 28 : Organization of the Healthcare System in England
Figure 29 : Evolution of PAS England, 2007-2015
Figure 30 : PAS Approval Process (Simplified Version)
Figure 31 : Pathways for Accessing an Orphan Therapy in the EU
Figure 32 : Three-Stage EAMS Process in the U.K.
Figure 33 : Types of Reimbursement Lists Used in the Outpatient Sector Europe
Figure 34 : Process of Identifying if an Item Can be Prescribed on the NHS
Figure 35 : Two Simplified Examples of HTA Utilization in Europe
Figure 36 : Tools and Disciplines Involved HEOR Analysis
Figure 37 : Elements of Value-Based Pricing
Figure 38 : Global Cell and Gene Therapy Market, 2018 vs. 2024
Figure 39 : Innovative Payment Models for Cell and Gene Therapies
Figure 40 : Four Waves of COVID-19 on Healthcare
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