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The Pricing and Reimbursement Environment for Metabolic Disease Therapies

Decision Resources, Inc, March 2011, Pages: 70

Metabolic disorders are among the most common serious diseases in the world, and their prevalence is increasing rapidly in many countries. Governments and other healthcare sponsors have made the prevention and treatment of metabolic disorders a priority and generally offer generous coverage of drugs for these diseases. Spending in this therapeutic area is growing rapidly, prompting payers to review their cost-containment strategies. Drug manufacturers need to be aware of the barriers to access they will face in marketing metabolic disease therapies in major pharmaceutical markets.

Questions answered in this report:

- The United States has the highest overall prescription drug prices of any of the major pharmaceutical markets. How do the prices of metabolic disease therapies in Europe and Japan compare with U.S. prices? Which metabolic disease therapies have the highest international prices?

- In the United States, the majority of commercial health plans assign most metabolic disease therapies to tiers 2 or 3 of their formularies. Which leading drugs have the most and least favorable placement? How do Medicare plans compare with commercial plans in their positioning of metabolic disease therapies? Which coverage restrictions are most commonly applied to metabolic drugs?

- A recent Decision Resources survey of 50 endocrinologists and 50 primary care physicians in the United States found widespread concern about barriers to access to metabolic disease therapies. To what extent do out-of-pocket costs restrict patients’ access to, and compliance with, metabolic disease therapies? What impact do coverage restrictions have on access to medications? What changes in cost containment are likely in the next five years?

- The French healthcare system reimburses a substantial proportion of the cost of metabolic drugs. What is the standard reimbursement rate for drugs in this therapeutic area? For which metabolic disorders can patients qualify for exemption from out-of-pocket costs for medications?

- German physicians tend to rely very heavily on generics for the treatment of some of the most common metabolic disorders. What national targets have been set for the prescribing of generic antidiabetics, statins, and bisphosphonates? What pressures are exerted on German physicians to prescribe economically?

- The Italian healthcare system covers the full cost of most metabolic disease therapies but imposes strict controls on the prescription of many of these drugs. Which drugs are included in the Register of Antidiabetic Drugs Subject to Monitoring? How has the Agenzia Italiana del Farmaco (AIFA; Italian Medicines Agency) used restrictive notes to control the use of treatments for dyslipidemia, osteoporosis, and gout?

- The influence of the National Institute for Health and Clinical Excellence (NICE) on the healthcare system in England, Wales, and Northern Ireland can scarcely be overstated. What guidance has NICE issued on the management of metabolic disorders? What other methods has the U.K. government used to control spending on metabolic disease therapies?

Scope of the report:

- Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.

- Indication focus: Diabetes, dyslipidemia, osteoporosis, gout.

- Primary research: Survey of 50 endocrinologists and 50 primary care physicians in the United States.

- Pricing data: Prices of 20 best-selling metabolic drugs in seven major markets.

- Reimbursement: Detailed Fingertip Formulary data on the formulary status and coverage restrictions of 30 drugs in commercial and Medicare plans in the United States; reimbursement policies in France, Germany, Italy, Spain, the 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 metabolic disease in each country under review.

Executive Summary
- Strategic Considerations
- Stakeholder Implications
- Introduction

International Price Comparisons for Metabolic Disease Therapies

United States
- General Environment
- Healthcare Reform
- Formulary Positioning
- Cost-Containment Measures
- Physician Survey
- Impact of Out-of-Pocket Costs on Access to Therapy
- Impact of Out-of-Pocket Costs on Patient Compliance
- Impact of Coverage Restrictions on Access to Therapy
- Increasing Cost-Containment Pressures
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

France
- General Environment
- Health Insurance
- Pharmaceutical Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

Germany
- General Environment
- Health Insurance and Pharmaceutical Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout
- Sidebar: Impact of Reference Pricing on the German Statin Market

Italy
- General Environment
- Heath Insurance
- Pharmaceutical Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

Spain
- General Environment
- Health Insurance
- Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

United Kingdom
- General Environment
- Health Insurance Coverage
- Pharmaceutical Pricing and Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

Japan
- General Environment
- Health Insurance
- Pharmaceutical Reimbursement
- Cost Containment
- Diabetes
- Dyslipidemia
- Osteoporosis
- Gout

Outlook and Implications for the Pharmaceutical Industry

About the Author

Companies:

- Abiogen
- Amylin
- Astellas
- AstraZeneca
- Bayer
- Biovail
- Bouchari Recordati
- Bristol-Myers Squibb
- Daiichi Sankyo
- Dainippon Sumitomo
- DepoMed
- Eisai
- Eli Lilly
- Fournier Pharma
- GlaxoSmithKline
- Ipsen
- Kaken Seiyaku
- Kissei
- Kowa
- Menarini
- Merck & Co.
- Mochida
- Molteni Farmaceutici
- Novartis
- Novo Nordisk
- NPS
- Nycomed
- Ono
- Pfizer
- Prometheus Laboratories
- Roche
- Sanofi-Aventis
- Sanwa Kagaku
- Servier
- Seven Seas
- Shionogi
- Solvay
- Solvay
- SPA
- Takeda
- Temmler
- Tori Yakuhin
- UCB
- Uri Pharma
- Warner-Chilcott
- Watson

Drugs:

- Acarbose
- Alendronate
- Allopurinol
- Amfepramone
- Atorvastatin
- Atorvastatin/amlodipine
- Benzbromarone
- Bezafibrate
- Calcitonin (intranasal)
- Cholestyramine
- Colchicine
- Colesevelam
- Conjugated estrogen/MPA
- Estradiol
- Etidronate
- Exenatide
- Ezetimibe
- Ezetimibe/simvastatin
- Febuxostat
- Fenofibrate
- Fenofibric acid
- Fluvastatin
- Gemfibrozil
- Gliclazide
- Glimepiride
- Glipizide
- Glyburide/glibenclamide
- Ibandronate
- Insulin aspart
- Insulin detemir
- Insulin glargine
- Insulin glulisine
- Insulin lispro
- Insulin, neutral protamine Hagedorn
- Insulins, regular human
- Ipriflavone
- Liraglutide
- Lovastatin
- Mazindol
- Menatetrenone
- Metformin
- Metformin/glipizide
- Metformin/glyburide
- Miglitol
- Minodronate
- Mitiglinide
- Nateglinide
- Niacin (extended release)
- Niacin/laropiprant (extended release)
- Niacin/lovastatin (extended release)
- Niacin/simvastatin (extended release)
- Omega-3 acid ethyl esters
- Orlistat
- Phentermine
- Pioglitazone
- Pioglitazone/glimepiride
- Pioglitazone/metformin
- Pioglitazone/metformin (extended release)
- Pitavastatin
- Pramlintide
- Pravastatin
- Probenecid
- Raloxifene
- Repaglinide
- Risedronate
- Rosiglitazone
- Rosiglitazone/glimepiride
- Rosiglitazone/metformin
- Rosuvastatin
- Saxagliptin
- Sibutramine
- Simvastatin
- Sitagliptin
- Sitagliptin/metformin
- Strontium ranelate
- Teriparatide
- Tibolone
- Vildagliptin
- Vildagliptin/metformin
- Voglibose
- Zoledronate

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