Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis

Introduction

Introduction

Public healthcare costs are rising. Governments need to get them under control. In Europe, that means the systematic use of health technology assessments (HTA) and reference pricing. The US, on the other hand, focuses on comparative effectiveness research (CER) to identify drugs that maximise clinical efficacy, minimise clinical harm and are more in tune with individual needs. Vastly different solutions—but are they working?

Scope

Report Overview

In Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis, FirstWord Dossier lays bare the US model by defining comparative effectiveness research and exploring its limitations with regards to drug trials. The report expertly examines direct versus indirect cost effectiveness analysis, the role of key government institutions and managed care organisations and the impact such research is having on blockbuster drugs. Based on au courant research, expert interviews and several compelling case studies, the report takes a critical look at US policy decisions and trends and offers a clear, uncluttered view of the US drug reimbursement system.

Highlights

Key Report Features

Puchase Reasons

Key Benefits

Key Questions Asked

Who Would Benefit From This Report?

Key quotes

“Where is the risk/benefit quantitative standardised analysis that goes hand-in-hand with the CER analysis? It should never just be about avoiding a safety event in the absence of having a discussion of what is the married benefit. What's the right ratio we're looking for, not just the lack of a serious adverse event or the production of a clinically beneficial event? I think it's both.”

–John Doyle, Senior Vice-President and Practice Lead, Managed Markets at Quintiles

“There’s a paradox of lots of CER data collected, but the companies don't know what to do with it. But they are getting better at finding the right data sources and understanding how to analyse it. There is going to be a tipping point, I believe, when the very purpose of comparative effectiveness will become clear.”

–Samuel Wagner, head of Health Economics, Oncology, for Bristol-Myers Squibb

“There are more similarities than differences, in terms of the US and Europe, regarding most of the key issues. Accordingly, it is time for cooperation between the industry, HTAs and payers. The adversarial tones that we can read about currently, do not lead to a good place - for anyone.”

–Alicia Granados, Senior Director Global HTA Strategy at Genzyme

Expert Views

Table of Contents
for Pricing and Reimbursement Trends in the US: Impact of Comparative Effectiveness Research and Cost-Effectiveness Analysis

• 1.Executive Summary

  2.Introduction

  3.US share of global branded pharmaceuticals sales

  3.1. Diminishing impact of US: Revenue for branded biologics

  3.2. Tumour Necrosis Factor-Alpha (TNF-a) Inhibitors

  4.Use of CER in the US

  4.1. Medicare

  4.2. Medicaid

  4.3. The Food and Drug Administration (FDA)

  4.4. The FDA’s response to GSK’s Avandia in type 2 diabetes

  4.5. New criteria for the approval of biosimilars

  4.6. Managed care tools to restrain utilization and costs

  4.7. The Managed Care Formulary

  4.8. Prior Authorization

  4.9. Open-label naturalistic studies: Focus on Medco’s study of Plavix and Effient

  4.10. Impact of the managed care tools

  4.11. Disease indications that mitigate the impact of managed care

  4.12. Oncology drugs

  4.13. Amgen’s Xgeva

  4.14. Roche’s Avastin

  4.15. Orphan drugs and the lack of alternative treatments

  4.16. Atypical antipsychotic agents via the Medicaid connection

  4.17. Governmental agencies practicing CEA indirectly: Case studies

  4.18. Age-related macular degeneration: Avastin versus Lucentis

  4.19. Erbitux in advanced/metastatic colorectal cancer

  4.20. FDA delays “me-too” with a Novel Mechanism of Action

  4.21. Pros and cons of conducting head-to-head clinical trials

  4.22. The combination therapy compromise

  4.23. Implications of combination therapy on branded drug costs

  4.24. Fixed-combination drugs

  4.25. Future considerations

  4.26. Contentious CER proposals

  4.27. Cooperative CER Proposals

  4.28. Potential renaissance in drug development

  4.29. Implications of the renaissance in drug development

  5.References

  6.Acknowledgements

  7.Appendix 1

  7.1. Use of CER by international governmental agencies

  7.2. Health Technology Assessment: The UK’s NICE

  7.3. Reference pricing

  7.4. Risk-sharing strategies

  7.5. Risk sharing in the US

Additional Details

Publisher

FirstWord Pharma

Publisher Information

Reference

3 |

Number of Pages

85

Report Format

PDF

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