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2018 ; 36
(8
): 917-927
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gab.com Text
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Ixekizumab for Treating Moderate-to-Severe Plaque Psoriasis: An Evidence Review
Group Perspective of a NICE Single Technology Appraisal
#MMPMID29480455
Ramaekers BLT
; Wolff RF
; Pouwels X
; Oosterhoff M
; Van Giessen A
; Worthy G
; Noake C
; Armstrong N
; Kleijnen J
; Joore MA
Pharmacoeconomics
2018[Aug]; 36
(8
): 917-927
PMID29480455
show ga
The National Institute for Health and Care Excellence invited Eli Lilly and
Company Ltd, the company manufacturing ixekizumab (tradename Taltz(®)), to submit
evidence for the clinical and cost effectiveness of ixekizumab. Ixekizumab was
compared with tumour necrosis factor-? inhibitors (etanercept, infliximab,
adalimumab), ustekinumab, secukinumab, best supportive care and, if
non-biological treatment or phototherapy is suitable, also compared with systemic
non-biological therapies and phototherapy with ultraviolet B radiation for adults
with moderate-to-severe plaque psoriasis. Kleijnen Systematic Reviews Ltd, in
collaboration with Maastricht University Medical Center, was commissioned as the
independent Evidence Review Group. This article presents a summary of the company
submission, the Evidence Review Group report and the development of the National
Institute for Health and Care Excellence guidance for the use of this drug in
England and Wales by the Appraisal Committee. The Evidence Review Group produced
a critical review of the clinical and cost effectiveness of ixekizumab based on
the company submission. The company submission presented three randomised
controlled trials identified in a systematic review. All randomised controlled
trials were phase III, multicentre placebo-controlled trials including 3866
participants with moderate-to-severe psoriasis. Two trials also included an
active comparator (etanercept). All randomised controlled trials showed
statistically significant increases in two primary outcomes, static Physician
Global Assessment (0,1) and improvement of 75% from baseline in the Psoriasis
Area and Severity Index. Ixekizumab was generally well tolerated in the
randomised controlled trials, with similar discontinuation rates because of
adverse events as placebo or etanercept. The most frequent adverse events of
special interest were infections and injection-site reactions. The company
submission also included a network meta-analysis of relevant comparators. The
Evidence Review Group highlighted some issues regarding the systematic review
process and an issue with the generalisability of the findings in that the trials
failed to include patients with moderate psoriasis according to a widely used
definition. This issue was considered by the Appraisal Committee and the
population was deemed generalisable to patients in England and Wales. Based on
the network meta-analysis, the Appraisal Committee concluded that ixekizumab was
more clinically effective than adalimumab and ustekinumab, and agreed it was
likely that ixekizumab was similarly effective compared with secukinumab and
infliximab while tolerability was similar to other biological treatments approved
for treating psoriasis. The Evidence Review Group's critical assessment of the
company's economic evaluation highlighted a number of concerns, including (1) the
use of relative outcomes such as Psoriasis Area and Severity Index response to
model the cost effectiveness; (2) the exclusion of the consequences of adverse
events; (3) the assumption of no utility gain in the induction phase; (4) equal
annual discontinuation rates for all treatments; (5) the selection of treatment
sequences for consideration in the analyses and; (6) the transparency of the
Visual Basic for Applications code used to develop the model. Although some of
these issues were adjusted in the Evidence Review Group base case, the Evidence
Review Group could not estimate the impact of all of these issues, and thus
acknowledges that there are still uncertainties concerning the cost-effectiveness
evidence. In the Evidence Review Group base-case incremental analysis, the
treatment sequence incorporating ixekizumab in the second line has an incremental
cost-effectiveness ratio of £25,532 per quality-adjusted life-year gained vs. the
etanercept sequence. Ixekizumab in the first-line sequence has an incremental
cost-effectiveness ratio of £39,129 per quality-adjusted life-year gained
compared with the treatment sequence incorporating ixekizumab in the second line.
Consistent with its conclusion regarding clinical effectiveness, the Appraisal
Committee concluded that the cost effectiveness of ixekizumab for treating
moderate-to-severe plaque psoriasis was similar to that of other biological
treatments, already recommended in previous National Institute for Health and
Care Excellence guidance. The committee concluded that the incremental
cost-effectiveness ratio was within the range that could be considered a
cost-effective use of National Health Service resources.
|Adalimumab/economics/therapeutic use
[MESH]
|Adult
[MESH]
|Anti-Inflammatory Agents, Non-Steroidal/economics/therapeutic use
[MESH]
|Antibodies, Monoclonal, Humanized/*economics/therapeutic use
[MESH]
|Antibodies, Monoclonal/economics/therapeutic use
[MESH]
|Cost-Benefit Analysis/*statistics & numerical data
[MESH]
|England
[MESH]
|Etanercept/economics/therapeutic use
[MESH]
|Humans
[MESH]
|Infliximab/economics/therapeutic use
[MESH]
|Phototherapy/economics
[MESH]
|Psoriasis/drug therapy/*economics
[MESH]
|Quality-Adjusted Life Years
[MESH]
|Technology Assessment, Biomedical/*statistics & numerical data
[MESH]
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