Special Report: The Pricing and Reimbursement Environment for Autoimmune Biologics

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
- Alkem Laboratories
- Anhui Huayuan Pharmaceutical
- Aspen Pharmacare
- AstraZeneca
- Aurobindo Pharma
- Bank of China Group
- Bayer
- Bayer HealthCare (BHC)
- Bayer Zydus Pharma
- Beijing Aixin Weiye Medicine
- Beijing Pharmaceutical
- Beijing Skywing Technology
- Biocon
- Bioton
- Bristol-Myers Squibb
- Buchang Pharmaceutical
- Cachet Daheng Pharmaceutical
- Cachet Pharmaceutical
- Cardinal Health
- Changchun Xiangtong Pharmaceutical
- Changzhou Pharmaceutical
- Chennai Patent Office
- China Health Systems (CHS)
- China State Institute of Pharmaceutical Industry (CIPI)
- China YCT International
- Chinese State Food and Drug Administration (SFDA)
- Chiva Pharmaceuticals
- Chongqing Pharmaceutical
- Chongqing Tongjunge
- Cipla
- Citic Pharmaceutical
- Claris Lifesciences
- ClinicalTrials.gov
- Credit Suisse
- Daheng Beisheng Pharmaceutical
- De Xin Pharmacy
- Delhi High Court
- Dr. Reddy's Laboratories
- Dupromise Holdings
- Elder Pharmaceutical
- Eli Lilly & Company
- First China Pharmaceutical
- Frontage Laboratories
- GlaxoSmithKline
- GlaxoSmithKline Pharmaceuticals
- Guangdong Qinqfa Pharmaceutical
- Guangzhou Pharmaceutical
- Guilin Dahua Pharmaceutical
- Guoco Group of Malaysia
- Hainan Kaihua Pharmaceutical
- Hainan Litzman Pharmaceutical
- Harbin Pharmaceutical
- Harbor BioSciences
- Hebei Huamin Pharmaceutical
- Hindu Business Line
- Hong Kong Stock Exchange
- Hutchison MediPharma
- India's Pharmaceutical Exports Promotion Council (Pharmexcil)
- Indian Patent Office
- Infinity Group
- Intas Pharmaceuticals
- Intellectual Property Appellate Board (IPAB)
- International Monetary Fund (IMF)
- Interpharm Consultancy
- Jiangsu Chia Tai Fenghai Pharmaceutical
- Jointown Pharmaceutical
- Kelun Bio-Tech Pharmaceutical
- Kun Ming Xin Yuan Tang Pharmacies (XYT)
- L.Y. (HK) Biotech
- Le Ren Tang Pharmaceutical Chain
- Ligand Pharmaceuticals
- Lupin
- Madras High Court
- Mankind Pharma
- Matrix Laboratories
- MediciNova
- Medisan Pharmaceutical
- Merck KGaA
- Merck Millipore Process
- Merck Serono
- Merck, Sharp, and Dohme
- Nanjing MeiRui Pharmaceuticals
- Nanjing Pharmaceutical
- Natco Pharma
- North China Pharmaceutical
- Novartis
- Novo Nordisk
- Onco Laboratories
- Onco Therapies
- Pfizer
- PharmaStrategy Consulting
- Piramal Healthcare Solutions business
- Ranbaxy Laboratories
- Roche
- Roche Pharma China
- Sanofi
- Schering (now part of Merck & Co.)
- Shandong Run Kang Pharmaceutical
- Shanghai Pharmaceuticals
- Shenzhen Ming He Tang Pharmaceutical
- Shenzhen Stock Exchange.
- Shijiazhuang Pharmaceutical
- Shijiazhuang Xingbai Pharmaceutical
- Sichuan Kelun Pharmaceutical
- Sichuan Pharmaceutical
- Sihuan Pharmaceutical
- Sino Biopharmaceutical
- Sinopharm
- Sinopharm Le Ren Tang
- Strides Arcolab
- Sun Pharma
- Sun Pharmaceutical Industries
- Supreme Court of India
- Takeda Pharmaceutical (China)
- Temasek Holdings
- Tianjin Lisheng Pharmaceutical
- Tianjin Pharmaceutical
- Tianjin Takeda Pharmaceuticals
- Tianyin Pharmaceutical
- Torrent Pharmaceuticals
- United Laboratories International
- United Nations Population Fund
- Vinise Pharmaceutical
- World Bank
- World Economic Forum (WEF)
- World Health Organization (WHO)
- World Intellectual Property Organization (WIPO)
- World Trade Organization (WTO)
- Wuxi PharmaTech
- Wyeth Pharmaceuticals
- Xiuzheng Pharmaceutical
- Yabao Pharmaceuticals
- Yancheng Suhai Pharmaceutical
- Yangtze River Pharmaceutical
- Yong Yu
- Zhejiang Guojing Pharmaceutical
- Zhejiang Hisun Pharmaceuticals
- Zhejiang Medicine
- Zhejiang Tianyuan Bio-Pharmaceutical
- Zuellig Pharma China
- Zydus Cadila

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