Assessing Prescription Drug
Value in the US: A
Hypothetical Example
Comparing ASCO and ICER
Framework Outcomes
Duygu Bozkaya, MSc, MBA (Presenter)
Kristen Migliaccio-Walle, BS
Ken O’Day, PhD, MPA
Xcenda, Palm Harbor, Florida
May 23, 2016 (Session 1)
ISPOR 21st Annual International Meeting; May 21–25; Washington, DC
Background
 Increasing drug prices have led to several value-based framework initiatives
in the US
American College of
Cardiology/American
Heart Association
Memorial Sloan Kettering
Cancer Center
National Comprehensive
Cancer Network®
American Society of
Clinical
Oncology (ASCO)
2
5/26/2016
Institute for Clinical and
Economic Review (ICER)
Objective
 To understand the key determinants impacting decision making and to
compare and contrast the ASCO and ICER frameworks in terms of perceived
value, a hypothetical oncology treatment was evaluated
Benefits/
Costs
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ASCO framework
ICER framework
Value for $?
Value for $?
Value determination: ASCO vs ICER frameworks
ICER2
ASCO1 (adjuvant setting)
Value
determination
means
NHB + drug cost
Clinical value
NHB assessed vs standard care
• Max of 80 points (OS) or max
of 60 points (DFS);
• And a max of 20 points
based on the number of
grade 3–5 toxicities
• Reported costs include drug
acquisition and patient
payment
Comparative effectiveness,
cost-effectiveness, and budget impact*
•
•
•
•
•
•
Value
determination
•
•
NHB 0–100 points
Costs
•
•
Comparative clinical effectiveness
incorporated into economic models
Events other than death and progression
can be included
Toxicities can be included along with
consequences
QALYs as an outcome
Drug, administration, monitoring, and
event-related costs (as appropriate)
High (<$100,000/QALY), intermediate
($100K–150K/QALY), or low value
(>$150,000/QALY)*
Annual budget impact < $904 million
(drugs)
Public comments/voting
Key: DFS – disease-free survival; NHB – net health benefit; OS – overall survival; QALY – quality-adjusted life-years.
1. Schnipper LE, et al. J Clin Oncol. 2015 Aug 10;33(23):2563-2577.
2 http://icer-review.org/wp-content/uploads/2016/02/Slides-on-value-framework-for-website-v4-13-16.pdf . Accessed May 18, 2016.
* Other benefits/disadvantages, contextual considerations also considered in the context of “Care Value.”
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Methods - Overview
ASCO framework was used to calculate NHB
and assess drug cost
ICER was used to assess
cost-effectiveness and
budget impact
-
-
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Incremental cost/qualityadjusted life-year (QALY)
was determined using a
partitioned survival model
Budget impact was
estimated separately
using drug,
administration, and
adverse event costs
Various scenarios were
utilized to compare and
contrast outcomes of
the frameworks
-
Survival
Toxicity
Quality of life
Others
Methods - Treatments
 A hypothetical oncology treatment was compared to a hypothetical
commonly used antineoplastic regimen (standard regimen)
Hypothetical treatment
compared to standard regimen
OS
Moderate improvement (5%)
DFS
Moderate improvement (10%)
Drug cost
Ongoing, higher costs (20%)
Administration cost
Oral vs infusion
Adverse event rate
Lower event rates (75% reduction)
Adverse event cost
Lower event cost (75% reduction)
Key: PFS – disease-free survival; OS – overall survival.
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Other assessment parameters
Cost-effectiveness assessment
Budget impact assessment
 Progression cost
 Annual US disease prevalence:
4,000
 Health utilities (progression and
no progression)
 Disutility due to adverse events
 Discounting
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 Uptake <10%
 Lower drug costs, and higher
administration and adverse event
costs in treatment mix
(comparator treatments)
Results: Base-case
ASCO framework
ICER framework
$11 million
$318,274
6-month drug cost: $60K
 ASCO net health benefit (NHB) 40–58/100,
with a monthly drug cost of $10K
 ICER cost/QALY: low value (>$150,000/QALY
threshold)
 ICER annual budget impact estimate:
<$904 million threshold for drugs
 Likely overall ICER value determination is
low or Intermediate
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$60K
66%
reduction
$20K
Results: Overall Survival (OS) scenarios
ASCO framework
6-month drug cost: $60K
 OS affected both NHB and cost-effectiveness
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ICER framework
Results: Disease-free Survival (DFS) Scenarios
ASCO framework
ICER framework
6-month drug cost: $60K
 DFS had a considerable impact on NHB (eg, 5% improvement in DFS≈38%
change in NHB score)
 Cost-effectiveness was similar across different DFS estimates
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Results: Toxicity Scenarios
ASCO framework
ICER framework
6-month drug cost: $60K
 Toxicity had a considerable impact on NHB
 Cost-effectiveness and budget impact (not shown) were similar
with different toxicity scenarios
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Results: Best (Clinical) Case
ASCO framework
ICER framework
6-month drug cost: $60K
 Cost-effectiveness improved
significantly with the best clinical
scenario (NHB=100 ASCO points);
however, a 51% reduction in drug
price was required to meet the
$150K threshold
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$60K
51%
reduction
$29K
Results: Progression Cost Scenarios
ASCO framework
ICER framework
Not affected
 ASCO framework does not consider progression-related costs
 ICER cost-effectiveness may be substantially affected by these costs
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Results: Health Utility Scenarios
ASCO framework
ICER framework
Not affected
 ASCO framework (adjuvant setting) does not consider health-related
quality of life
 Changes in health utilities had a moderate effect on the ICER
cost-effectiveness
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Results: Budget impact scenarios
ASCO framework
ICER framework
$23
million
Not evaluated
$11
million
$6
million
 Budget impact remained well below ICER’s threshold ($904 million) due to
low disease prevalence
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Summary and Conclusion
Although not generalizable to all
economic assessments, the
following observations were made:
•
•
•
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Changes in survival affected
assessed drug value within both
frameworks
Toxicity had a considerable impact
on NHB; the effect on the ICER
framework outcomes was minor
Other parameters not evaluated
within the ASCO framework (eg,
quality of life, progression costs) may
affect cost-effectiveness and/or
budget impact
5/26/2016
Overall budget impact is considered in
the ICER framework, but is unlikely to
impact decision making for lowprevalence diseases
Substantial drug price reductions may be
necessary in order to meet ICER
thresholds, even when maximum NHBs
are present, as assessed within the
ASCO framework
The ASCO and ICER value frameworks
may favor different types of drugs
depending upon their clinical and
economic profile
Duygu Bozkaya, MSc, MBA
Thank you
Associate Director, Global Health
Economics
4114 Woodlands Parkway, Suite 500
Palm Harbor, Florida 34685, USA
Phone: 727.771.4100 ext. 203.4046
www.xcenda.com