ICER and Value Assessment Frameworks: 5 key insights for biopharma

In this market access update, we describe the growing need, use, and impact of independent, unbiased Value Assessment Frameworks (VAFs) in the US. 

Five key insights for biopharma manufacturers are explored:

1. Market access professionals wanting to drive access and protect margins need to acknowledge, study, and understand the methodologies and potential downstream impact on payer coverage implicit in VAFs.
   
   
2. Some biopharma manufacturers are looking the other way and imagining ICER doesn’t exist; it’s an unhealthy approach, particularly as the media have been critical of drug pricing.
   
   
3. Some VAFs are more influential than others. ICER is one to track and its assessments focus on drug cost-effectiveness.
   
   
4. There is evidence that payers are using ICER assessments as a negotiation tool with manufacturers.
   
   
5. In 2020, ICER updated its VAF and other changes are expected to follow. In due course, we expect ICER to become the go-to source of information and the importance of VAFs in the US to increase further.

Given the potential impact of VAFs, we recommend that biopharma manufacturers acknowledge the growing use of VAFs and move now to develop their own playbooks to provide guidance to global and regional market access and HEOR teams.

In this way, biopharma will be better prepared for appraisals by external stakeholders. As part of this readiness, we also suggest preparation for an unfavorable assessment outcome.

The emergence of the VAF

ISPOR recently noted that “healthcare systems have been moving towards more value-driven approaches that focus on evaluating therapeutic options based on health outcomes, value to the patient and effectiveness compared with other treatment options.”¹ More familiar in Europe, through health technology assessment (HTA) agencies such as NICE and HAS, VAFs have now arrived in the US – and how.

Without an established centralized government agency in the US undertaking value-for-money assessments, a range of organizations have emerged to create proprietary frameworks. Each one has a different audience in mind and employs a different approach, but any of them could impact biopharma businesses.

Why payers need VAFs

Payers have decided they need to use VAFs as a tool – a source of unbiased, transparent, third-party information on drugs, providing information that goes beyond journal studies, reviews, and the usual manufacturer perspectives.

Payer budgets continue to be restricted in the US and treatments have become more costly, so payers are taking a longer, harder look at what they are paying for. They’re pivoting towards value for money (cost-effectiveness) rather than their previous laser-like focus on the clinical benefits, safety, and efficacy of a drug. When we add into this mix the fact that the US public are increasingly concerned about spiraling healthcare costs, we expect payers to be more likely to use VAFs to target ever-larger price discounts and rebates from manufacturers.

The cost-effectiveness focus is interesting because it was not a metric for assessment by most private payers in the US. However, this has shifted over the last couple of years as payers can’t afford every drug that is granted marketing authorization. Some payers are doing their own reviews, while the smaller ones rely more on third-party VAFs.

Examples of VAFs

Major US-based VAFs

• ACC and AHA
• ASCO (US oncology, solid tumors)
• Avalere and FasterCures Patient Perspective Value Framework
• BCBS Evidence Street
• Drug Abacus MSKCC
• ICER Value Assessment Framework 
• NCCN Evidence Blocks

Other global frameworks

• ASCO-ESMO Joint Framework
• ESMO-MCBS (European oncology, solid tumors)
• NICE Guide to the Processes of Technology Appraisal

Treatment guidelines are being informed by VAFs

VAFs are being used to develop treatment guidelines for a growing number of conditions through an assessment of the performance of different therapies.

For example, the NCCN has trademarked an Evidence Block framework to arrive at judgements (scored 1–5) around five different categories assessed as relevant to patients, payers, and clinicians.

The NCCN Guidelines are “a statement of evidence and consensus of the authors regarding their views of currently accepted approaches to treatment”.² The framework has already been applied to more than 50 different cancer types. Although the Evidence Blocks themselves are visual and accessible to patients, the accompanying assessment is heavyweight material, suitable for professional use only. 

Interestingly, “any clinician seeking to apply or consult the NCCN Guidelines is expected to use independent medical judgment in the context of individual clinical circumstances to determine any patient’s care or treatment”.² So, the guidelines are just that – guidelines.  

Nonetheless, they carry some weight, particularly as they may be used as a decision tool to facilitate discussion about the best value and the best course of treatment between prescribers and patients, who may be paying a large share of the treatment costs. 

The growing influence of ICER 

Among the many organizations in the US offering VAFs, ICER is fast becoming the most influential. Its set-up is similar to government-supported HTA agencies such as NICE in the UK. 

ICER’s framework is public, fairly transparent, and focused on cost-effectiveness. 

However, unlike NICE, which reviews most new treatments, ICER doesn’t yet review every newly authorized drug in the US. Decisions about which drug to review are influenced by a range of factors, including its annual budget. ICER’s outputs, unlike those of NICE, are complex and not suitable for use by patients, even with physician support. All of this may change in the future, however. 

Recommendations for preparing for an ICER assessment 

We are advising biopharma manufacturers to prepare for an ICER assessment of any asset, particularly in therapeutic categories previously reviewed by ICER or in a high cost vertical. This includes developing and implementing a robust cost-effectiveness model upfront. 

Preparation for engagement with ICER is important as there’s increasing evidence that payers are using ICER assessments as a tool for negotiating discounts and rebates from manufacturers. This is particularly true in rare diseases and oncology and where there are multiple treatment options. 

As the ICER VAF evolves, the developments present new challenges for biopharma manufacturers. Understanding the ICER assessment process in advance and preparing for engagement is the best way forward. 

In due course, we expect ICER to become the go-to source of public and payer information and the importance of VAFs in the US to increase. It’s time to get ready. 

Don’t miss out! It’s important to stay informed about developments in VAFs and ICER assessments 

Keeping up-to-date with, and understanding the implications of, the methodologies implicit in VAFs will help market access professionals to accelerate access and protect margins. It’s important to stay informed about the ICER process, both to improve the potential for positive assessment outcomes, and to help you prepare for addressing cost-effectiveness concerns and discussions. 

We’ll continue to share developments and explore the implications for market access in future articles, so please subscribe to receive the updates. 

Further reading

1. Value Assessment Frameworks: ISPOR’s Initiative on US Value Assessment Frameworks.  

2. NCCN Clinical Practice Guidelines in Oncology for Merkel Cell Carcinoma.