Download The American Society of Clinical Oncology (ASCO) Net Health

The American Society of Clinical Oncology (ASCO) Net
Health Benefit (NHB) Assessment Tool: Which Implications
for Value Assessment of Cancer Therapies?
Rémuzat
1
C,
Chouaid
2
C,
Auquier
3
P,
Borget
4
I,
Kornfeld
1
M,
Toumi
3
M
1Creativ-Ceutical,
Paris, France; 2Centre Hospitalier Intercommunal, DHU-ATVB, Créteil, France; INSERM U955 and Université Paris
Est (UPEC), UMR U955, Faculté de médecine, Créteil, France3Faculté de Médecine, Laboratoire de Santé Publique, Aix-Marseille
Université, Université de la Méditerranée, Marseille, France; 4Institut Gustave Roussy, Villejuif, France
BACKGROUND
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Financial toxicity concept was recently introduced in the United States
related to financial distress resulting from out-of-pocket payments of
costly cancer medicines [1].
In this context, the American Society of Clinical Oncology (ASCO)
developed in 2015 a framework (updated in 2016) to support
physicians and patients in assessing value of new cancer therapies and
to facilitate dialogue between physicians and patients [2,3].
OBJECTIVES
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This research aimed to review the ASCO value framework and to
identify its contributions and limits for fair decisions toward cancer
medicines options.
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Drug acquisition costs and patient out-of-pocket payment are also
considered but not included in the NHB.
 Since ASCO value framework allows to weight cost with clinical benefits
and side effects, it has been considered as a potential valuable tool for
oncologists and may have a potential to impact a clinical practice [5,9].
However, several limitations of the framework were reported by the
authors themselves and by other stakeholders, which could limit it
usefulness in providing physicians and patients with properly informed
basis for making treatment decisions [Figure 2].
Figure 2. Factors potentially limiting adoption of ASCO framework to the practice
Lack of patient-centeredness
• Despite the incorporation of QoL into the framework it awards only 10 points for QoL improvement
and does not include other factors significant for patients such as work productivity, unmet need, and
burden of disease [5,6,7].
METHODS
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 This issue is related to the lack of relevant data in clinical trials, and the authors of the framework
hope that such endpoints will be included in a larger number of clinical trials in the future [2].
ASCO value framework (initial version and update [2,3]) was reviewed
and analysed to identify:
 Dimensions taken into account to assess the value of cancer drugs,
 Its contribution for patients and physicians’ shared-decision making in
Inability to perform cross-trial comparisons
• If two alternative therapies were not compared within a single trial it is not possible to compare them
using the framework. It is due to the methodological differences between clinical trials, especially in
terms of patient population and comparator used [3,7], since different outcomes can be observed
when:
treatment options.
 A drug is compared to placebo or to active treatment,
 A drug is used in patient populations with different prognosis.
A comprehensive literature review was also performed to identify
discussions on the practical usability of the framework.
Difficult interpretation of outcomes for patients
RESULTS
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• The interpretation of the value score could be challenging, in particular for patients, mainly because of
two reasons:
ASCO value framework is built to compare new cancer therapies
versus standard of care using data from prospective randomised trials
 The use of hazard ratio (HR) might be misinterpreted by patients while a favourable HR does not
necessarily represent a large absolute gain in OS or PFS (and this should be well explained by the physicians) [3].
 The NHB scale length, reaching from -20 to 130 points, suggests that the score in the middle of the
scale is not a high score. However it has been shown that mid-range scores should be interpreted as
excellent rating and that the entirety of the scale is rarely applied [8].
(single-arm trial data might be accepted if sole available data; response rate should
be used in this case).
The framework includes 2 sub-frameworks:
 For advanced cancers,
 For potentially curative treatments (adjuvant or neoadjuvant therapy).
Both of these sub-frameworks include 2 main dimensions computed in
net health benefit (NHB):
 Clinical benefit including overall survival (OS), progression-free survival
(PFS), response rate (RR), disease-free survival (DFS) depending on
available data,
 Toxicity.
NHB calculation includes clinical benefit score, toxicity score and
bonus points (Figure 1):
 Maximum scoring for clinical benefit is 100 (more important weight on
OS versus PFS or RR), while being 20 for toxicity.
 Bonus points are awarded for tail of the survival curve (20 points);
advance disease framework also includes palliation of symptoms (10
points) and/or treatment-free interval (20 points) and/or quality of life
(QoL) (10 points).
• The need to explain the framework outcomes to a patient during a time-limited visit could discourage
physicians from using the framework within their clinical practice [7].
Consideration of drug cost only
• The framework does not allow to include other costs than costs of drugs. This is important to consider
since [9]:
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Initially, QoL was deliberately not included in the framework, reflecting the lack of
QoL data in many clinical trials.
Figure 1. Outcomes included in the Net Health Benefit calculation
Advanced disease
Median OS
HR for death
HR for disease progression
Median OS
Median PFS
HR for DFS
RR
Median DFS
OR
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OR
OR
OR
OR
OR
NHB
Toxicity
Zafar SY et al. Oncologist. 2013;18(4):381-90.
Schnipper LE et al. J Clin Oncol. 2015 Aug 10;33(23):2563-77.
Schnipper LE et al. J Clin Oncol. 2016 Aug 20;34(24):2925-34.
Lederman L. Value Tools at ASCO 2016: Building a Framework fro
Prime Time. ZS Associates 2016.
(http://www.zsassociates.com/publications/articles/value-tools-atasco-2016-building-a-framework-for-prime-time.aspx)
5. Westrich K. Current Landscape: Value Assessment Frameworks.
National Pharmaceutical Council. Mar 2016.
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Tail of the curve
REFERENCES
1.
2.
3.
4.
readily available in clinical trials [2,3],
 A software application is currently being developed which will facilitate
fast access to relevant information and adjustment of selected parameters
to fit patient preferences [2,3,6].
Despite being still a conceptual tool, the ASCO value framework is the
one most commonly used among other value frameworks, as showed
in a survey conducted with 93 oncologists during the ASCO 2016
Annual Meeting [4].
CONCLUSIONS
OR
Tail of the curve
Palliation
QoL
Treatment-free interval
The limitations above should not be treated as permanent barriers for
the framework uptake because:
 The authors foresee an improvement in the future when more data will be
Adjuvant setting
HR for death
Toxicity
 The cost of a drug is usually only 20-25% of the total cancer care cost,
 New drugs may generate savings in cost components such as hospitalisation.
The authors argue that incorporation of additional cost data into the framework would be problematic
because such information is not readily available, nor easily quantifiable [3].
6.
7.
8.
9.
(http://www.npcnow.org/publication/current-landscape-valueassessment-frameworks)
Bankhead C. MedPage Today. Feb 2016.
(http://www.medpagetoday.com/publichealthpolicy/healthpolicy/582
73)
Pratt-Chapman M et al. Value in Oncology. Oct 2015, Vol 6, No 9.
Subramanian R, Schorr K. How valuable is a cancer therapy? It
depends on who you ask. Simon-Kuchner. Dec 2015.
(http://www.simonkucher.com/sites/default/files/how_valuable_is_cancer_therapy.pdf)
Okon T. VBCC Perspectives. Jul 2015, Vol 6, No 6.
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ISPOR 19th Annual European Congress, Vienna, Austria, OCT 29 – NOV 02, 2016. PRM15.
ASCO value framework represents clear improvement in supporting
physicians’ and patient’s decisions for cancer therapies but the use of the
tool might be complex in daily clinical practice unless all products are
already scored for relevant conditions.
In general, it reflects more physicians’ perspective:
• Clinical
benefits are overrated versus toxicity and only 10 bonus points awarded for QoL,
which may have more importance for patients
• Moreover, as the cost is just a background information not influencing the NHB, the usefulness
of the framework for payers is rather marginal.
However, this tool is continuously evolving through feedback of various
stakeholders with strong willingness to improve patient’s empowerment.