Pricing and Reimbursement Issues for Immune Disease Therapies
Decision Resources, Inc, October 2007, Pages: 32
Introduction
Within major international pharmaceutical markets, drug therapies for immune disorders span an enormous price range—from a few cents per day to tens of thousands of dollars per year. Not surprisingly, payers impose restrictions on the use of the most expensive agents, especially the tumor necrosis factor alpha (TNF-a) inhibitors used in the treatment of immune disorders such as rheumatoid arthritis, psoriasis, psoriatic arthritis, ankylosing spondylitis, and Crohn’s disease. Reimbursement policies for all immune disease therapies in the United States, Europe, and Japan can be influenced not only by the overall pricing and reimbursement environment in the respective country, but also by specific policies and various, restrictive cost-containment measures governing immune disease drugs.
Questions Answered
- In the United States, Medicare Part D plans use a variety of cost-containment measures to reimburse for immune disease therapies. What are these measures, and how do they vary across specifi c Medicare Part D plans for specific immune disease drugs?
- In the United Kingdom, TNF-a inhibitors are prescribed in hospitals, and physicians must apply to local PCT directorates to prescribe these drugs to new patients. However, 46% of rheumatologists have been unable to prescribe these inhibitors to all patients identified as candidates for such treatment. What is the main barrier to use of this therapy?
- Because of its relatively high price in major international markets, Genentech’s Xolair often has tighter reimbursement controls in these markets than do other immune disease therapies. What cost-containment measures are placed on Xolair in the various major international pharmaceutical markets?
- Immune disease therapies in France generally qualify for 65% reimbursement. However, patients with chronic disorders receive full reimbursement for the cost of drugs purchased to treat the chronic disorder itself. Which immune disorders qualify for full reimbursement in France?
- In some cases in France, the government limits reimbursement of some immune disease therapies to specific populations or indications. For which class of immune disease drugs does the French government strictly limit reimbursement?
- Reference pricing, introduced in Germany in 1989, has been that nation’s most enduring costcontainment measure. Although no patent-protected immune disease therapies are currently subjected to reference pricing, beclomethasone, budesonide, methotrexate, salbutamol, sulfasalazine, and theophylline have reference prices. How do the retail prices for these drugs compare with their reference prices in Germany?
Scope:
- International price comparisons: prices of TNF-a inhibitors, antirheumatic drugs, asthma therapies, prescription antihistamines in Europe and Japan in comparison with U.S. prices.
- General pricing and reimbursement environment: major policies governing overall pharmaceutical pricing and reimbursement decisions in the United States, France, Germany, Italy, Spain, the United Kingdom, and Japan.
- United States: Medicare Part D formulary guidelines for immune suppressants, TNF-a inhibitors, and asthma therapies; coverage of select antirheumatic drugs in formularies of leading insurers and PBMs.
- France: SMR ratings and ASMR scores for reimbursement of immune disease therapies; controls on TNF-a inhibitors; reimbursement policies for asthma and COPD.
- Germany: reference pricing in relation to immune disease therapies; restrictions regarding TNF-a inhibitors and patients enrolled in disease management programs for asthma and COPD.
- Italy: restrictions for TNF-a inhibitors; asthma drugs qualifying for full reimbursement; reservations concerning delivery systems for asthma drugs.
- Spain: “hospital use” of TNF-a inhibitors; reduced copayments for asthma treatments; controls for Xolair.
- United Kingdom: permissions to prescribe TNF-a inhibitors; effect of generics on GP prescriptions for inhaled asthma drugs; Xolair guidelines.
- Japan: reduced copayments for some immune diseases; limited approval for TNF-a inhibitors; generous reimbursements for asthma therapies.
- Outlook: worries about costly biologics; increased use of cost-containment measures; the possibility of postmarketing research; upcoming requirements in Germany; intensifi ed efforts to use generics.
Executive Summary
Strategic Considerations
Stakeholder Implications
Introduction
International Price Comparisons for Immune Disease Therapies
Overview
Tumor Necrosis Factor-Alpha Inhibitors
Conventional Disease-Modifying Antirheumatic Drugs
Asthma Therapies
Antihistamines
Reimbursement Environment
United States
General Environment
Private Insurance
Medicare
Medicaid
Antirheumatic Drugs
Asthma Therapies
France
General Environment
Antirheumatic Drugs
Asthma Therapies
Germany
General Environment
Antirheumatic Drugs
Asthma Therapies
Italy
General Environment
Antirheumatic Drugs
Asthma Therapies
Spain
General Environment
Antirheumatic Drugs
Asthma Therapies
United Kingdom
General Environment
Antirheumatic Drugs
Asthma Therapies
Japan
General Environment
Antirheumatic Drugs
Asthma Therapies
Outlook and Implications for the Pharmaceutical Industry
Pharmacoeconomics, Pricing, and Reimbursement 13-3
Tables and Figures
Tables
1. Brand Names and Marketing Companies of Select Immune Disease Therapies
2. Ex-Manufacturer Prices of Select Immune Disease Therapies in Europe and Japan As a Percentage of U.S. Prices, 2006
3. Health Insurance Coverage of the U.S. Population, 2002-2006
4. Formulary Tiers for Select Immune Disease Therapies Covered by Leading U.S. Private Insurers and Pharmacy Benefi t Management Companies
5. Percentage of Medicare Part D Plans That Apply Cost-Containment Measures to Select Immune Disease Therapies, September 2006
6. Status of Select Immune Disease Therapies in Five States’ Medicaid Preferred DrugList
7. Assessment of Select Immune Disease Therapies by France’s Medicines Evaluation Commission
8. Reference and Retail Prices of Select Doses and Pack Sizes of Immune Disease Therapies Subject to Reference Pricing in Germany, September 2007
Figures
1. Average Ex-Manufacturer Prices of Tumor Necrosis Factor-Alpha Inhibitors As a Percentage of U.S. Prices, 2006
2. Average Ex-Manufacturer Prices of Select Disease-Modifying Antirheumatic Drugs As a Percentage of U.S. Prices, 2006
3. Average Ex-Manufacturer Prices of Select Asthma Therapies As a Percentage of U.S. Prices, 2006
4. Average Ex-Manufacturer Prices of Select Antihistamines As a Percentage of U.S. Prices, 2006
5. Projected Expenditures in the U.S. Prescription Drug Market, 2000-2016
6. Main Sources of Funding in the U.S. Prescription Drug Market, 2000-2016 (Projected)
7. Coverage of Select Immune Disease Therapies by Medicare Part D Plans, September 2006
8. Sources of Health Care Funding for U.S. Residents Below Age 65, by Immune Disease Being Treate,)2006
9. Sources of Health Care Funding for U.S. Residents Aged 65 and Older, by Immune Disease Being Treated, 2006
10. Sources of Health Care Funding for All U.S. Residents, by Immune Disease Being Treated, 2006
11. Mean Retail Prices for Immune Disease Therapies As a Percentage of Reference Prices in Germany, August 2007
Companies
- Abbott Laboratories
- Aetna
- Amgen
- AstraZeneca
- Boehringer
- Ingelheim
- Caremark
- Cigna
- Express Scripts
- Genentech
- GlaxoSmithKline
- Humana
- Johnson & Johnson
- Medco
- Merck & Co.
- Novartis
- Pfi zer
- Sanofi -Aventis
- Schering-Plough
- UCB
- United Healthcare
- WellPoint
Drugs
- Adalimumab
- Advair
- Allegra
- Arava
- Beclomethasone
- Budesonide
- Cetirizine
- Clarinex
- Claritin
- Desloratadine
- Enbrel
- Etanercept
- Fexofenadine
- Flunisolide
- Fluticasone
- Foradil
- Formoterol
- Humira
- Infl iximab
- Lefl unomide
- Loratadine
- Methotrexate
- Montelukast
- Omalizumab
- Pulmicort
- Reactine
- Remicade
- Rheumatrex
- Salbutamol
- Salmeterol
- Seretide
- Serevent
- Singulair
- Spiriva
- Sulfasalazine
- Telfast
- Theophylline
- Tiotropium
- Xolair
- Zyrtec/Zirtek
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