Market access update
ICER 2020 value assessment framework: 7 updates that market access professionals need to understand
Written by Nicole Lodowski
In this market access report, Nicole Lodowski provides an overview of the ICER value assessment framework and explains the 7 key areas that have been updated in 2020.
The Institute for Clinical and Economic Review (ICER) is an independent healthcare research organization in the US. ICER evaluates the clinical and economic value of prescription drugs, diagnostic tests, and other innovations.
ICER primarily focuses on new pharmaceutical treatments and healthcare interventions that may:
- significantly improve patient outcomes
- have uncertain comparative effectiveness relative to other treatment options
- have a substantial financial impact on patients or the broader healthcare system.
Topics are identified through a process of “horizon scanning”. This involves research by ICER and other stakeholders to determine focus areas for ICER assessments and reports.
What is the ICER value assessment framework?
The ICER value assessment framework (VAF) is a conceptual framework and set of methodologies that underpin the evidence reports published by ICER.
The ICER VAF serves to:
- strengthen the foundation for evaluating the clinical and economic value of new health technologies
- create a transparent mechanism of reviewing evidence and translating it into policy decisions
- support and foster a more effective, efficient, and transparent healthcare system.
Guided by the VAF, ICER aims to assess the value of therapies from various perspectives, including short-term affordability and long-term value.
This video explains more or watch our free webinar on demand now.
Why did ICER update the value assessment framework?
To continue to enhance its approach to value assessments, ICER identified that updates were needed in key areas of the VAF.
Extensive benchmarking was completed with HTA agencies around the world, and through a 7 month period of public consultation with more than 100 organizations and individuals in the US healthcare system.
The updates specifically aim to:
- achieve stronger prominence on the use of real-world evidence (RWE)
- highlight a broader context of value, both to patients and the healthcare system
- launch a formal patient engagement program, with emphasis on feedback from patient groups throughout the entire assessment process.
What are the 7 key areas that have been updated?
The 7 key areas that ICER updated in its 2020 review are:
1. Enhancing commitment to the use of real-world evidence within product and therapeutic assessments
ICER has committed to continue leveraging existing RWE within assessments, while exploring collaborations and opportunities to generate additional RWE.
A challenge with accelerated approval processes is that new interventions may have limited evidence at the point of approval.
Recognizing this, ICER places increased focus on using RWE to support updated assessments on interventions that were approved by the FDA under accelerated approval pathways and that have been on the market for at least 24 months.
2. Amending the ICER voting structure to further capture other benefits and contextual considerations
As outcomes that often matter most to patients are poorly reflected within clinical trials, ICER has expanded the domains of “potential other benefits” and “contextual considerations” within the assessment process. At ICER public deliberation meetings, independent evidence appraisal committees will now vote on how these two domains should be integrated into the cost-effectiveness results when making decisions around pricing.
Within this process, a new three-item Likert-scale voting structure will be used to highlight the relative importance of these domains, from lower long-term value for money to higher long-term value for money.
These changes will help guide decision-makers in a broader overall assessment of value.
3. Further defining patient subpopulations where treatments may provide differential benefits
Within assessment reports, ICER has added a distinct section on heterogeneity and subgroups. This emphasizes subpopulations where a therapy might provide added or differential therapeutic benefit.
This may include effect modifiers or differences in baseline risk between different subpopulations.
Any of these known subgroup differences will be highlighted within the report and may also carry through to economic analyses or impact evidence ratings.
4. Standardizing cost-effectiveness thresholds
All ICER reports (including those for ultra-rare disorders) are reported from a US healthcare perspective and estimates of cost-effectiveness are reported as both cost ($) per quality-adjusted life-year (QALY) and per equal value of life-year gained (evLYG).
ICERs evidence reports assign drugs a cost-effectiveness result using set benchmarks of $50,000, $100,000, $150,000 and $200,000 per QALY and per evLYG. ICER recognizes that single cost-effectiveness thresholds should not be used as a blunt decision rule. Decision-makers may want to consider different thresholds given their own view of their opportunity costs and their interpretation of a treatment’s potential other benefits and contextual considerations.
The health-benefit price benchmark, previously called the “value-based price benchmark,” will continue to use the threshold ranges of $100,000–150,000 per QALY and per evLYG. These values are derived from several readily available estimates relating to willingness to pay thresholds and opportunity costs within the US healthcare system.
5. Promoting a modified societal perspective “co-base case” in some cost-effectiveness analyses
In certain disease areas where the societal costs of care are large in relation to direct healthcare costs, ICER will present a modified societal perspective as a co-base case within cost-effectiveness analyses.
This is likely to occur when the incremental cost-effectiveness ratio changes by more than 20%, more than $200,000 per QALY, and/or when the estimates are outside the boundaries of the health-benefit price benchmark ($100,000–150,000 per QALY).
6. Conducting 12 month final report check-ups
1 year after issuing a final evidence report within a therapeutic area, ICER will initiate a 3 month process to determine whether the initial recommendations remain relevant to the current US healthcare market.
ICER will assess any new evidence that might impact its recommendations and will share its decision via a public statement.
This may subsequently lead to a revision to the clinical evidence rating or estimates of incremental cost-effectiveness.
7. Implementing a more formal patient engagement program
To empower patient organizations to play a greater role in every phase of the value assessment process, ICER has developed a more formal patient engagement program.
Key components of the new patient engagement program include:
- Ongoing engagement with disease-specific patient groups.
For major therapeutic classes, ICER will engage with disease-specific patient groups through annual discussions around new treatments, priorities, and opportunities for patient outcome data generation. Other patient groups will also receive early notification about when ICER will be conducting an assessment of relevance.
- Providing input to economic models
ICER will work with patient groups to determine if it is helpful for them to empirically contribute to economic models.
- Supporting RWE generation.
ICER will work with patient groups to identify sources of RWE, provide inputs for contextual consideration around the disease/treatment, and potentially support development of patient-based surveys.
- Ongoing partnership.
Following assessment, ICER will continue to collaborate with patient groups to debrief on the process, as well as partnering on recommendations to the FDA around specific patient-relevant data within the drug development process.
If you are keen to explore some real-world examples of how the updated ICER VAF is being used by manufacturers to drive market access, our free webinar is available to watch now on demand.
It would be great to hear from you if have any questions or would like to discuss how these ICER updates could impact your brand or organization.
Please contact me, Nicole Lodowski, at email@example.com
2020–2023 ICER value assessment framework
Preparing for ICER assessments