Special Report: The Pricing and Reimbursement Environment for Autoimmune Biologics
Decision Resources, Inc, August 2011
The combined diagnosed populations of patients with Crohn's disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus (SLE), and ulcerative colitis in seven leading pharmaceutical markets (United States, France, Germany, Italy, Spain, United Kingdom, and Japan) will grow from 19 million in 2010 to 20.7 million in 2020, an increase of 9% in ten years. Many of these patients will be candidates for biologic therapy, but the high cost of these drugs will prompt payers to tighten their already strict controls on the use of biologics.
- In the United States, almost half of all commercial insurance plans assign most immune biologics to tiers 2 or 3 of their formularies. Which leading drugs have the most and least favorable formulary placement? How do Medicare plans compare with commercial plans in their tier positioning of immune biologics? Which coverage restrictions are most commonly applied to immune biologics?
- A recent Decision Resources survey of 27 gastroenterologists, 26 rheumatologists, and 25 dermatologists in the United States found widespread concern about barriers to access to immune disease therapies. To what extent do out-of-pocket costs restrict patients' access to and compliance with immune disease therapies? What impact do coverage restrictions have on access to immune biologics? What changes in cost containment are likely in the next five years?
- The French healthcare system reimburses a substantial proportion of the cost of immune disease therapies. What is the standard reimbursement rate for drugs in this therapeutic area? For which immune disorders can patients qualify for exemption from out-of-pocket costs for medications? What restrictions are imposed on the distribution of immune biologics in France?
- As in other therapeutic areas, the National Institute for Health and Clinical Excellence (NICE) has had a major influence on the management of autoimmune disorders in England, Wales, and Northern Ireland. What guidance has NICE issued on the use of immune biologics? How has the agency used conditional reimbursement agreements to limit the cost of some immune disease therapies? What other methods has the U.K. government used to control spending on biologics?
Scope
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: Survey of 27 gastroenterologists, 26 rheumatologists, and 25 dermatologists in the United States.
Indication focus: Rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, ulcerative colitis, Crohn's disease, systemic lupus erythematosus.
Pricing: International comparison of the ex-manufacturer prices of leading immune biologics.
Reimbursement: Detailed Fingertip Formulary data on the formulary status and coverage restrictions of leading immune biologics in commercial and Medicare plans in the United States; reimbursement policies in France, Germany, Italy, Spain, United Kingdom, and Japan.
General market access environment: Concise overviews of health insurance coverage, pharmaceutical reimbursement, and cost containment trends that impact the market for immune biologics in each country under review.
Exhibits: 37 data-rich tables and figures.
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
International Price Comparisons for Immune Biologics
United States
General Environment
Healthcare Reform
Formulary Positioning
Cost-Containment Measures
Physician Survey
Physicians' Acceptance of Different Types of Health Insurance
Physicians' Prescribing Behavior
Distribution Restrictions Imposed by Health Plans
Affordability of Biologics
Increasing Cost-Containment Pressures
Prospects for Biosimilars
Reimbursement Prospects for New Immune Biologics
Suggested Industry Actions to Improve Access to Immune Biologics
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
France
General Environment
Health Insurance
Pharmaceutical Reimbursement
Cost Containment
Hospital Prescribing
National Guidelines for the Appropriate Use of Expensive and Innovative Drugs
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Germany
General Environment
Health Insurance and Pharmaceutical Reimbursement
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Italy
General Environment
Heath Insurance
Pharmaceutical Reimbursement
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Spain
General Environment
Health Insurance
Reimbursement
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
United Kingdom
General Environment
Health Insurance Coverage
Pharmaceutical Pricing and Reimbursement
Health Technology Assessment
Cost Containment
Hospital Prescribing
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Japan
General Environment
Health Insurance
Pharmaceutical Reimbursement
Cost Containment
Musculoskeletal Disorders
Gastrointestinal Disorders
Other Disorders
Outlook and Implications for the Pharmaceutical Industry
About the Author
- Abbott Laboratories
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- Sun Pharma
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- World Bank
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- Yong Yu
- Zhejiang Guojing Pharmaceutical
- Zhejiang Hisun Pharmaceuticals
- Zhejiang Medicine
- Zhejiang Tianyuan Bio-Pharmaceutical
- Zuellig Pharma China
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