What’s new in the 2023 ICER Value Assessment Framework?

On September 25, ICER released its 2023 value assessment framework. What is new? What stays the same? Here are a few key points you need to know.

Special cases for ultra-rare and single or
short-term therapies (SST): These did not change from previous.Use of real-world data. While ICER says it is committed to using
real-world data, the two use cases it provides are pretty standard: “analyses of insurance claims data to
better understand health states, resource utilization, and costs, or the
analysis of new data from patient surveys to provide more direct information on
health utilities.”Use of data in confidence. This has been updated as of 2023. “academic-in-confidence data will be
redacted from all external and public ICER documents until the earlier of: (a)
publication or presentation of such data by the data owner or study
investigators; (b) 12 months following the date of the public ICER meeting; or
(c) for reports that are not subject to a public meeting, 12 months following
report publication. Following any of these dates, ICER will unmask all redacted
information from reports, presentations, and other public documents.” Thus, in confidence information should
largely be seen as evidence soon to be published at a conference or in a peer-reviewed
journal but has not yet been published rather than proprietary, confidential
data that stakeholders may wish never to become public. Broader value elements ignored again. ICER mentioned broader value elements such as
the value of hope, preferences
for health gains among those with more severe illness, and scientific spillovers. However, these will remain unquantified in
their approach. “After ongoing consideration of the potential to perform
quantitative analyses of these types of additional elements of value, we
believe that there are still many methodological uncertainties and concerns
that suggest it is more appropriate to consider these elements through
deliberation focused on a broad cost-effectiveness threshold range. There are
concerns related to potential double counting between these potential
additional domains and the health gains captured by the evLYG/QALY.But ICER says it will consider if/how to implement
GRACE in the future. ICER signals that it will “begin a special focus in coming months on considering
novel ways to quantify preferences related to severity, methods that often are framed
as abandoning an assumption of a linear relationship between health gain value
and replacing it with a formula that can capture risk aversion, severity, and
the value of insurance. We will focus on exploring the Generalized
Risk-Adjusted Cost-Effectiveness framework26,27 and
methods adopted by several international HTA programs that now weight health
gains in relation to severity”Health disparities quantified using HIDI, not
DCEA. ICER uses Health Improvement Distribution Index
(HIDI) index it created to quantify if a treatment might disproportionately
benefit (or not) disadvantaged groups. The HIDI method is explained in their
White Paper here,
but basically a HIDI value > 1.0 suggests that “more health may be gained on
the relative scale in the subpopulation of interest when compared to the
population as a whole.” Also, ICER uses a
Participant to Disease Prevalent Ratio (PDPR)
based on age, sex and race to quantify the representativeness of clinical
trials. However, distributional cost
effectiveness analysis (DCEA) is not used. ICER continues to use health care system (i.e.,
payer) as its base case. It
justifies this by saying the primary consumers of its reports (i.e., payers)
prefer this output.Modified societal as co-base case. ICER does sometimes include a modified
societal that includes productivity impacts, caregiver burden and potentially
some other factors. ICER says that when the difference between health care
system and societal perspectives is large, then modified societal will be a
co-base case. Estimating productivity and caregiver impacts
without direct evidence. In most previous applications, if there was not
direct productivity impact data at launch, ICER would assume no productivity
impact. In the latest value assessment
framework, ICER will also consider indirect methods whereby productivity
impacts may be available by health state and treatments ability to slow disease
progression will be captured based on differential time in health state. Also, if no caregiver data is available, ICER
will assume that “assume that
caregiver time spent is proportional to 75% of patient formal labor time.”Discount rate remains at 3%. No change
from previous. Dynamic pricing not considered…yet ICER says it will not estimates the impact of future price changes across
treatments due to loss of exclusivity…except they say they will consider generic
competition if a substantial price decrease is likely to occur within 12-24
months. However, it then says, due to
IRA cost growth is likely to be capped at inflation and the price of treatments
are likely to fall by 75% at 9 (small-molecule) or 13 (biologic) years after
launch. ICER does not commit to institute this estimate but rather will convene
expert to weigh in on how to discuss. Cost per QALY and cost per evLYG. Thresholds
based on willingness to pay of $50k, $100k, $150k and $200k, but price
benchmarks based on $100k/QALY and $150k/QALY thresholds. They cite a preferred threshold of $104,000 per QALY (see Vanness 2021), but still
the $100k/QALY and $150k/QALY are used.Revised methods for single and short-term
therapies (SST). These include: A 50/50 shared
savings model: In this case, ICER
assumes that 50% of the lifetime health system cost offsets from a new
treatment are “assigned” to the health system instead of being assigned
entirely to the new treatment; and Cost offset
maximum. Cost offsets generated by a new treatment are
capped at $150,000 per year, but are otherwise assigned entirely to the new
treatment. Benefits beyond health. Ones ICER mentions include unmet need, treatment
complexity; impact on caregiver quality of life, productivity, and family life;
health equity; and public health impact.Budget impact threshold. This will be “…calculated as double the average
net budget impact for new drugs that would contribute to overall health care
cost growth beyond the anticipated growth in national GDP plus an additional
1%.”