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Review of Influence: The Institute for Clinical and Economic Review (ICER)

Review of Influence: The Institute for Clinical and Economic Review (ICER)

As the Institute for Clinical and Economic Review's (ICER) influence on payer behaviour and health policy grows, how should pharma respond?

The ICER's novel and inclusive work on the value of drugs, using its own value framework and assessing the affordability, and even going so far as setting the value-based price benchmark of new drugs, has given payers powerful negotiating tools. The impact on pricing is being felt while drug affordability and access in the US's overheated drug sector is touching a wider stakeholder community. But not everyone is convinced. Pharma questions the emphasis on drug costs as the main determinant of value in the health care system, use of list prices (which can differ from actual prices paid in the US system), and use of Quality Adjusted Life Year (QALY) as a measure of cost-effectiveness.

The fact is the ICER is well supported and here to stay. As all new drugs in the US will be subject to ICER scrutiny, companies would be wise to fully engage in order to respond to ICER's negative results on their drugs, and benefit from positive ICER findings. That is why in Review of Influence: The Institute for Clinical and Economic Review (ICER) we interviewed leading experts in market access and Health Technology Assessment to help you understand where—and how—ICER will impact pharma and the steps industry can take to engage with ICER, and benefit from or challenge findings.

Experts explore the role and impact of ICER

How does ICER stand out from the other US organizations conducting value assessments of drugs?
What influence do ICER affordability assessments and price benchmarks have on a new drug's coverage and/or price?
Will future changes in ICER's value framework increase or decrease the organization's influence?
What has been the impact of ICER's work on pricing negotiations?
What could ICER change about its work in the face of industry/patient pushback?
What difference will it make to ICER for manufacturers to have access to ICER's executable economic models on their drugs?

What our experts say…

"My understanding is that there isn't the possibility that, as the drug maker, you can ask for an ICER report, or an update. I would like to see ICER allowing drug makers to request an assessment, if there is new evidence. It would be a positive thing if this can be done, say on the basis of new evidence such as change in the long term or medium term data."Rito Bergemann

"ICER can share their data around cost-effectiveness with payers and then it is easier for payers to take decisions to put expensive drugs down the formulary tiers. Basically tiering decisions are going to be driven by ICER's analysis. Examples like CVS allowing clients to exclude drugs that don't meet ICER benchmarks, we will see more of these happening."Shruti Desai

"ICER invites industry to weigh in during the assessment process but the relationship remains like a bull in a china shop because historically, industry has driven discussions about value—not a third party. While ICER, manufacturers, and payers have a shared interest in ensuring that the right patient gets the right drug at the right time, there's inevitable tension in that process." Prof Laura Pizzi

What to expect

A detailed report examining the role, activities and ambitions of ICER and how their work is impacting payer decision making and pharma pricing policies.
An examination of 18 key issues that pharma needs to understand and respond to
20 targeted questions put to experts
Their perceptive responses that yielded 50 insights supported by 65 directly quoted expert comments

Expert contributors

The report harnesses critical insights and opinions from front-line industry experts who completely understand the potential for ICER's reports to be used by payers and the key areas where pharma can benefit.
Rito Bergemann, Global Head of Health Economics and Outcomes Research (HEOR) and Vice President, Evaluserve Life Sciences Health Care. Rito has worked with a company that has reviewed an ICER report on their product.
Shruti Desai, Manager at Decision Resources Group (DRG). Shruti has been monitoring the growing influence of ICER as part of her role as a Pharmacy Benefit Market Expert at DRG. Her work can be found in DRG's PBM Profile Series.
Chris Henshall, Independent consultant and Visiting Fellow, Office of Health Economics, founding President of HTAi, founder and former chair of HTAi Global Policy Forum and Asia Policy Forum, and previously Pro Vice Chancellor, University of York and Deputy Director of R&D at the Department of Health in England. Chris has been working with ICER for the last five years, facilitating and co-authoring reports of the ICER Policy Summits.
Prof Laura T Pizzi, Director, Health Outcomes, Policy, and Economics (HOPE) Program and Professor, Rutgers University and Deputy Editor, American Health and Drug Benefits Editorial Board Member, PharmacoEconomics Chair, Student Chapter Faculty Advisor Council, International Society for Pharmacoeconomics and Outcomes Research (ISPOR).

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1. Research methodology and objectives
2. Key insights summary
3. Issues and insights
3. 1. What is ICER?
3. 1. 1. Issue summary
3. 1. 2. Questions
3. 1. 3. Key insights
3. 1. 4. Supporting quotes
3. 1. 5. Sources
3. 2. ICER and drugs
3. 2. 1. Issue summary
3. 2. 2. Questions
3. 2. 3. Key insights
3. 2. 4. Supporting quotes
3. 2. 5. Sources
3. 3. ICER’s value framework
3. 3. Issue summary
3. 3. 1. Questions
3. 3. 2. Key insights
3. 3. 3. Supporting quotes
3. 3. 4. Intelligence exhibits
3. 3. 5. Sources
3. 4. ICER considers budget impact and affordability
3. 4. 1. Issue summary
3. 4. 2. Questions
3. 4. 3. Key insights
3. 4. 4. Supporting quotes
3. 4. 5. Intelligence exhibits
3. 4. 6. Sources
3. 5. ICER value-based price benchmarks
3. 5. 1. Issue summary
3. 5. 2. Questions
3. 5. 3. Key insights
3. 5. 4. Supporting quotes
3. 5. 5. Intelligence exhibits
3. 5. 6. Sources
3. 6. ICER is engaging with the public
3. 6. 1. Issue summary
3. 6. 2. Questions
3. 6. 3. Key insights
3. 6. 4. Supporting quotes
3. 6. 5. Sources
3. 7. ICER produces timely reports
3. 7. 1. Issue summary
3. 7. 2. Questions
3. 7. 3. Key insights
3. 7. 4. Supporting quotes
3. 7. 5. Intelligence exhibits
3. 7. 6. Sources
3. 8. ICER seeking to influence policy
3. 8. 1. Issue summary
3. 8. 2. Questions
3. 8. 3. Key insights
3. 8. 4. Supporting quotes
3. 8. 5. Sources
3. 9. Payers use ICER’s work to inform coverage decisions
3. 9. 1. Issue summary
3. 9. 2. Questions
3. 9. 3. Key insights
3. 9. 4. Supporting quotes
3. 9. 5. Intelligence exhibits
3. 9. 6. Sources
3. 10. Payers use ICER’s work to inform price negotiations
3. 10. 1. Issue summary
3. 10. 2. Questions
3. 10. 3. Key insights
3. 10. 4. Supporting quotes
3. 10. 5. Sources
3. 11. ICER’s work can convince payers a drug is worth more
3. 11. 1. Issue summary
3. 11. 2. Questions
3. 11. 3. Key insights
3. 11. 4. Supporting quotes
3. 11. 5. Sources
3. 12. Drug manufacturers have used ICER’s work in price setting
3. 12. 1. Issue summary
3. 12. 2. Questions
3. 12. 3. Key insights
3. 12. 4. Supporting quotes
3. 12. 5. Sources
3. 13. Pushback to ICER from industry
3. 13. 1. Issue summary
3. 13. 2. Questions
3. 13. 3. Key insights
3. 13. 4. Supporting quotes
3. 13. 5. Sources
3. 14. Pushback to ICER from patient organisations
3. 14. 1. Issue summary
3. 14. 2. Questions
3. 14. 3. Key insights
3. 14. 4. Supporting quotes
3. 14. 5. Sources
3. 15. Pushback to ICER from academics and others
3. 15. 1. Issue summary
3. 15. 2. Questions
3. 15. 3. Key insights
3. 15. 4. Supporting quotes
3. 15. 5. Sources
3. 16. ICER’s response to criticism
3. 16. 1. Issue summary
3. 16. 2. Questions
3. 16. 3. Key insights
3. 16. 4. Supporting quotes
3. 16. 5. Sources
3. 17. International impact of ICER
3. 17. 1. Issue summary
3. 17. 2. Questions
3. 17. 3. Key insights
3. 17. 4. Supporting quotes
3. 17. 5. Sources
3. 18. Rising influence of ICER over time
3. 18. 1. Issue summary
3. 18. 2. Questions
3. 18. 3. Key insights
3. 18. 4. Supporting quotes
3. 18. 5. Sources

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