Market entry agreements (MEA) for pharmaceuticals have become extremely popular and widespread geographically. Emerging countries that have not yet begun to introduce MEAs are now actively engaged in doing so. This book examines the concept of MEAs, detailing how depreciation of some specific regenerative therapies through intangible asset amortization is unavoidable.
The authors provide a historical vision of the development of MEAs with experiences, failures, and successes that have shaped the evolution and place of MEAs in access to pharmaceuticals. They provide an extensive review of MEA typology and propose a new one that is pragmatic and actionable.
FEATURES
Discusses the affordability of future therapies and the possible challenges for health insurance systems
Addresses the practical and applied issue of market access and includes the most up-to-date developments, such as the Pelosi bill
Describes the potential paradigm change that will challenge all payers and may question the sustainability of our health care systems
Highlights the gradual move from repeated treatment administration to a single administration with the potential for a definite cure
Managed Entry Agreements and Funding for Expensive Therapies provides invaluable information to all stakeholders involved in market access and to students in the field.
Author(s): Mondher Toumi, Szymon Jarosławski
Series: Pharmaceuticals, Health Economics and Market Access
Publisher: CRC Press
Year: 2022
Language: English
Pages: 179
City: Boca Raton
Cover
Half Title
Series Page
Title Page
Copyright Page
Contents
Series Preface
Authors
List of Abbreviations
1. Introduction to Managed Entry Agreements
1.1. History
1.2. Definition and Concepts
1.3. Global Phenomenon
1.4. From MEA Managing Price to New Policies Managing Funding
1.5. Future Perspective of MEA
References
2. Definition and Classification of MEAs
2.1. Definition
2.2. Typology of Market Access Agreements and Their Impact on the Pharmaceutical Market
2.2.1. Finance-Based Agreements
2.2.2. Performance-Based Agreements
2.2.3. Service-Based Agreements
2.3. Conclusions
References
3. From Coverage with Evidence Development to Individual Performance-Based Agreements in Italy
3.1. CRONOS Project
3.2. The Emergence of IPBAs
3.3. Conclusions
References
4. Coverage with Evidence Development for Multiple Sclerosis Drugs in the UK: A “Costly Failure”?
4.1. Performance of the MS CED
4.2. HTA Recommendations for MS Drugs in Other Countries
4.3. Conclusion
References
5. Country Comparison of the Implementation of Managed Entry Agreements
5.1. France
5.1.1. CED/P4P for Actos® (Pioglitazone) and Avandia® (Rosiglitazone) in Type 2 Diabetes
5.1.2. P4P for Cimzia® (Certolizumab Pegol) in Rheumatoid Arthritis
5.1.3. P4P for Imnovid® (Pomalidomide) in Multiple Myeloma
5.1.4. CED/P4P/PVA for Pradaxa® (Dabigatran), Xarelto® (Rivaroxaban) in Cardio- and Cerebrovascular Events
5.1.5. CED/P4P for Risperdal Consta® (Risperidone) in Schizophrenia
5.1.6. CED for Kymriah® (Tisagenlecleucel) in B-Cell Acute Lymphoblastic Leukaemia (ALL) and Diffuse Large B-Cell Lymphoma (DLBCL)
5.2. Germany
5.2.1. P4P and Discount for Kymriah® (Tisagenlecleucel) in B-Cell ALL and DLBCL
5.2.2. P4P and Discount for Mavenclad® (Cladribine) in Multiple Sclerosis
5.3. Italy
5.3.1. CED/P4P for Adcetris® (Brentuximab Vedotin) in Lymphoma
5.3.2. P4P for Aricept® (Donepezil) in Alzheimer Disease
5.3.3. P4P and Indication-Specific Pricing for Avastin® (Bevacizumab) in Multiple Indications in Oncology
5.3.4. Portfolio Discount for a Combination of Herceptin® (Trastuzumab) and Perjeta® (Pertuzumab) in Breast Cancer
5.3.5. Portfolio Agreement for Olysio® (Simeprevir) and Incivo® (Telaprevir) in HCV
5.3.6. P4P for Strimvelis® (Autologous CD34+ Enriched Cell Fraction) in Severe Combined Immunodeficiency due to ADA
5.3.7. P4P for Esbriet® (Pirfenidone) in Idiopathic Pulmonary Fibrosis
5.3.8. P4P for Kymriah® (Tisagenlecleucel) in B-Cell ALL and DLBCL
5.4. Netherlands
5.4.1. P4P and Discount for Imnovid® (Pomalidomide) in Multiple Myeloma
5.4.2. P4P for Kadcyla® (Trastuzumab Emtansine) in Breast Cancer
5.4.3. CED for Myozyme® (Alglucosidase Alfa) in Pompe Disease
5.4.4. CED for Replagal® (Agalsidase Alpha) in Fabry Disease
5.4.5. P4P for Xolair® (Omalizumab) in Asthma and Chronic Urticaria
5.4.6. CED for Spinraza® (Nusinersen) in Spinal Muscular Atrophy (SMA)
5.5. Spain
5.5.1. P4P for Iressa® (Gefitinib) in Non-Small Cell Lung Cancer
5.5.2. P4P and Budget Cap for ChondroCelect® (Autologous Cartilage Cells) in Symptomatic Cartilage Defects of the Knee
5.5.3. P4P for Cimzia® (Certolizumab) in Rheumatoid Arthritis
5.5.4. Class Agreement and Budget and Utilisation Caps for Hepatitis C Drugs
5.5.5. P4P and Budget Cap for Sovaldi® (Sofosbuvir) in Hepatitis C
5.5.6. CED and Discount for Spinraza® (Nusinersen) in Spinal Muscular Atrophy (SMA)
5.5.7. CED for Dupixent® (Dupilumab) in Severe Atopic Dermatitis
5.6. Sweden
5.6.1. CED for Duodopa® (Levodopa/Carbidopa) for Advanced Parkinson’s Disease
5.6.2. Financial-Based MEA and Data Collection for Entresto® (Sacubitril/Valsartan) in Heart Failure
5.6.3. Financial-Based MEA and Data Collection for Raxone® (Idebenone) in Leber’s Hereditary Optic Neuropathy
5.6.4. Therapeutic Class Agreement for Hepatitis C Drugs (Direct-Acting Antivirals)
5.6.5. Portfolio Agreement for Orkambi® (Lumacaftor/Ivacaftor) in Cystic Fibrosis
5.6.6. P4P/Financial-Based Agreement for Zytiga® (Abiraterone) in Prostate Cancer
5.7. UK
5.7.1. CED for Kymriah® (Tisagenlecleucel) in B-Cell ALL and DLBCL
5.7.2. CED and Cap on the Patient Number for Benlysta® (Belimumab) in Systemic Lupus Erythematosus
5.7.3. Indication-Specific Pricing for Humira® (Adalimumab) in Hidradenitis Suppurativa
5.7.4. P4P and Discount for Mavenclad® (Cladribine) in Multiple Sclerosis
5.7.5. P4P for Olysio® (Simeprevir) in Hepatitis C
5.7.6. P4P for Maviret® (Glecaprevir/Pibrentasvir) and Sovaldi® (Sofosbuvir) in Hepatitis C
5.7.7. CED for Spinraza® (Nusinersen) in Spinal Muscular Atrophy (SMA)
5.8. USA
5.8.1. P4P for Kymriah® (Tisagenlecleucel) in B-cell ALL
5.8.2. P4P for Entresto® (Sacubitril/Valsartan) in Heart Failure
5.8.3. P4P for Repatha® (Evolocumab) in Cardiac Arrest Prevention
5.8.4. Population-Based P4P for Trulicity® (Dulaglutide) in Type 2 Diabetes
5.8.5. P4P for Iressa® (Gefitinib) in Non-Small Cell Lung Cancer
5.8.6. P4P for Enbrel® (Etanercept) in Rheumatoid Arthritis
5.8.7. Preferential Formulary Status for Orbactiv® (Oritavancin) in Bacterial Skin Infections
5.8.8. PVA Linked to Patient’s Adherence to Aristada® (Aripiprazole Lauroxil) in Schizophrenia
5.9. Canada
5.9.1. CED for Fabrazyme® and Replagal® (Agalsidase α and β) in Fabry Disease
5.9.2. Therapeutic Class Discounts for Hepatitis C Drugs
5.9.3. P4P for Revestive® (Teduglutide) in Short Bowel Syndrome
5.10. Conclusions
5.10.1. Key Success Factors for Innovative MEAs
5.10.2. Key Hurdles for Innovative MEAs
References
6. Novel Funding Models for Expensive Therapies
6.1. Amortisation
6.2. Bundle Payment and Episode of Care
6.3. Annuity/Instalment Payments
6.4. Healthcoin
6.5. Outcome-Based Arrangements
6.6. Patient Loan from Private or Government Organisations
6.7. Payer Loan from Private or Government Organisations
6.8. Special Dedicated Governmental Fund
6.9. Insurance Pool
6.10. Reinsurance
6.11. Intellectual-Property Buy-Out
6.12. Discussion
References
7. Managed Entry Agreement for Cell and Gene Therapies
7.1. Evolving Drug Development and Challenges in Clinical Trials
7.2. Limitations in the Clinical Evidence for Cell and Gene Therapies
7.3. The High Price of Cell and Gene Therapies
7.4. The Implementation of Managed Entry Agreements
7.4.1. Yescarta® (Axicabtagene Ciloleucel)
7.4.1.1. UK
7.4.1.2. France
7.4.1.3. Germany
7.4.1.4. Italy
7.4.1.5. Spain
7.4.2. Kymriah® (Tisagenlecleucel)
7.4.2.1. UK
7.4.2.2. France
7.4.2.3. Germany
7.4.2.4. Italy
7.4.2.5. Spain
7.4.3. Zynteglo® (Betibeglogene Autotemcel)
7.4.3.1. France
7.4.3.2. Germany
7.4.4. Zolgensma® (Onasemnogene Abeparvovec)
7.4.4.1. UK
7.4.4.2. France
7.4.4.3. Germany
7.4.4.4. Italy
7.4.5. Tecartus® (Brexucabtagene Autoleucel)
7.4.5.1. UK
7.4.5.2. France
7.4.5.3. Germany
7.4.6. Libmeldy® (Autologous CD34+Cells Encoding ARSA Gene)
7.4.6.1. France
7.4.6.2. Germany
7.5. Challenges and Recommendations in the Implementation of MEA
7.6. Conclusion
References
Index
