Download New Anti-Cancer Drugs Cancer Drugs

Speaker
Invited Issue Panel Session
New AntiAnti-Cancer Drugs
Reimbursement Issues in Cancer Drugs:
Do We Have To Pay For All Cancer Drugs?
Are they as Valuable as we Think?
Are they a Special Case?
Kenneth R. Paterson MBChB,
MBChB, FRCP, FFPM
Prof Ken Paterson
ISPOR - Prague
Chair, Scottish Medicines Consortium
Consultant Physician, Glasgow Royal Infirmary
Glasgow, UK
New AntiAnti-Cancer Medicines
► Considerable
pent
pent--up demand
 Patients
 Clinicians
► Much
media interest
 “miracle drugs”, “life
“life--saving treatment”
► Often
political interest
 …especially if threat not to make drug available
► Legitimate
interest from pharma
Does some ‘Hype’ Matter?
► May
raise false hopes
► Often fails to represent the downside of
treatment
► May
M distort
di t t priority
i it setting
tti in
i healthhealth
h lth-care
 Use of ineffective therapy
 Failure to adopt new, effective therapy
► Subverts
true evidenceevidence-based practice
 Keen to sell drug and boost share price/profile
► How
good are new antianti-cancer drugs?
Scottish Medicines Consortium
► Rapid
health technology assessment of all
new drugs – established 2002
 Unique position in world newnew-drug HTA
► Manufacturer
makes the case for use –
 Clinical effectiveness
 Cost
Cost--effectiveness
► Cost
Cost--utility
analysis (cost per QALY) the
preferred approach
► Analysis of QALYs only (not cost)
Why QALYs?
► Can
(should) capture all the benefits and
adverse effects of the medicine in question





Survival gain (or loss)
Improvement
p
in quality
q
y of life from treatment
Reduction in quality of life from adverse events
Impact on quality of life of treatment protocol
Appropriate modelling very sensitiven to change
► Allows
comparison across (and within)
disease areas
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SMC and AntiAnti-Cancer Medicines
► 87
cancer medicines reviewed
 38 for advanced/metastatic cancer
 49 for earlier/adjuvant treatment
► Median
M di
QALY gain
i (over
(
currentt treatment)
t t
t)
 0.26 for advanced cancer
 0.37 for earlier/adjuvant treatment
► Mean
QALY gain (over current treatment)
 0.51 for both groups
What does this Mean?
► Median
► Mean
of the greatest healthhealth-gains are with
really innovative drugs –
 Trastuzumab – 2.4 QALYs
 Nilotinib – 2.1
2 1 QALYs
 Lenalidomide – 1.8 QALYs
► Even
if these are expensive, they offer good
‘value-for
‘valuefor--money’
► Only
► 22
8 drugs (9%) offered ≥1 QALY
drugs (25%) offered ≤0.2 QALY
 = 3 months at 70% of normal QoL
 Note NICE ‘end
‘end--ofof-life’ decision
decision--making
Is There No Good News – 2?
► Anti
Anti--cancer





offer no health gain (=me too!)
28% offer >0 – 0.1 QALY
25% offer >0
>0.1
1 – 0.5
0 5 QALY
13% offer >0.5 – 1.0 QALY
12% offer >1 QALY
Median health gain (n = c. 300) = 0.1 QALY!!
drugs are much like other drugs
Musculoskeletal (11) – 0.66 QALY
Infections (33) – 0.11 QALY
Endocrine (24) – 0.07
0 07 QALY
Cardiovascular (33) – 0.05 QALY
CNS and pain (55) – 0.04 QALY
► New
drugs in general are not as valuable as
many would like to think!
How Good are New Drugs?
► 22%
health gain
 8-9 months
th with
ith QoL
Q L 70%
Is There No Good NewsNews- 1?
► Some
health gain
 6 months with quality of life 70% of normal
Caveats and Criticisms
► Health
gain is as presented by pharma
 May overover-estimate true gain by a factor of 2!!
 SMC did not always accept the QALY given
► QALY
may nott adequately
d
t l capture
t
b
benefits
fit
 Responder v nonnon-responder
 Problems with QoL assessment
► Clinical
trial ≠ clinical practice
 ?possible to maximise benefit & minimise S/E
2
Special Cancer Issues - 1
► Often
scanty phase 3 clinical data
regimens with polypoly-pharmacy
make comparators hard to define
► Complex
 RCTs
RCT often
ft use comparators
t
diff
differentt ffrom
current Scottish practice
 May require indirect comparison
► Survival
benefits often unclear
 Overall v ‘progression‘progression-free’ survival
 Extrapolation not clearclear-cut
Conclusions
medicines are rarely as valuable as
they might like to appear
► Health
Health--gain from many new cancer
medicines is modest
Special Cancer Issues - 2
► Quality
of life assessment difficult
 Impact of adverse events a problem
 ? revaluation of QoL near life’s end
 ? special benefit with low expectancy
► Increased
niching by indication
 …more (ultra(ultra-)orphan drugs
►…with
► Rule
expectations of “special case”
of Rescue - a rule??
Scottish Medicines Consortium
► New
www.scottishmedicines.org.uk
 …and often overover-stated in media etc
► Some
innovative new drugs are breaking
the mould
► Cancer medicines have only limited grounds
to be a ‘special case’
QUESTIONS
• Is there something ‘special’ about cancer that implies that
it should be taken outside normal prioritization decisions
and funded separately?
• Should payers establish a minimum clinical hurdle for
new cancer drugs to be seen as an advance to
subsequently command a price premium - otherwise only
similar acquisition costs to current standards?
• Should payers automatically reject new risk sharing
schemes unless fully transparent and all administrative
costs considered?
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