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## Complete Summary

#### GUIDELINE TITLE

Adalimumab for the treatment of adults with psoriasis.

#### BIBLIOGRAPHIC SOURCE(S)

National Institute for Health and Clinical Excellence (NICE). Adalimumab
for the treatment of adults with psoriasis. London (UK): National
Institute for Health and Clinical Excellence (NICE); 2008 Jun. 25
p. (Technology appraisal guidance; no. 146).

#### GUIDELINE STATUS

This is the current release of the guideline.

### COMPLETE SUMMARY CONTENT

 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 CONTRAINDICATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Psoriasis

#### GUIDELINE CATEGORY

Assessment of Therapeutic Effectiveness\
Treatment

#### CLINICAL SPECIALTY

Dermatology\
Family Practice

#### INTENDED USERS

Advanced Practice Nurses\
Nurses\
Physician Assistants\
Physicians

#### GUIDELINE OBJECTIVE(S)

To evaluate the clinical effectiveness and cost-effectiveness of
adalimumab for the treatment of psoriasis

#### TARGET POPULATION

Adult patients with plaque psoriasis

#### INTERVENTIONS AND PRACTICES CONSIDERED

Adalimumab treatment

#### MAJOR OUTCOMES CONSIDERED

-   Clinical Effectiveness

    -   Psoriasis area and severity index (PASI) 50, 75, 90, and 100

    -   Physician\'s global assessment (PGA)

    -   Quality of life: dermatology life quality index (DLQI), Euro
        quality of life questionnaire (EQ-5D), and short form (version)
        36 (SF-36)

    -   Adverse events

-   Cost-effectiveness

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Hand-searches of Published Literature (Primary Sources)\
Hand-searches of Published Literature (Secondary Sources)\
Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: The National
Institute for Health and Clinical Excellence (NICE) commissioned an
independent academic centre to perform a systematic literature review on
the technology considered in this appraisal and prepare an Evidence
Review Group (ERG) report. The ERG report for this technology appraisal
was prepared by Southampton Health Technology Assessment Centre,
University of Southampton (see the \"Availability of Companion
Documents\" field).

**Clinical-Effectiveness Searches**

The minimum database search criteria that are specified by NICE
(Medline, Embase, Medline in Progress \[MEIP\] and Cochrane) for
undertaking clinical-effectiveness searches have been fully adhered to
by the manufacturer. The manufacturer has exceeded the remit by
undertaking searches on additional databases. The three key dermatology
conference proceedings (American Academy of Dermatology \[AAD\],
European Academy of Dermatology and Venerology \[EADV\], British
Association of Dermatology \[BAD\]) are recorded as having been
searched. The manufacturer also records additional searching having been
undertaken on their in-house database (\"PRLIT\" -- product literature).

Clinical-effectiveness searches for the systematic review were
undertaken on the 8th August 2007. Databases were searched from 1996 to
the search date. The manufacturer\'s submission (MS) states that it was
not deemed necessary to search older databases as the clinical phase of
adalimumab began in 1997. No start date is given for searches of
conference abstracts but results are presented for AAD 2004-2007, for
EADV 2005-2007, and for BAD 2006-2007. No start date or end date is
given for the in house database search.

The search terms selected by the manufacturer include appropriate
descriptor and free text terms (the latter were adequately truncated)
for the disease area. The terms selected to identify clinical trials
represent an adequate filter for the search. The documented strategies
are appropriately run on the specified databases. All steps of the
search strategy have been carefully recorded and the numbers from each
search line have been recorded. The publication type (PT) has been
applied in Medline to randomised controlled trials (RCTs) and controlled
trials, which has good retrieval potential of relevant studies. The
search could possibly have been extended to include follow up, cross
over and meta analysis.

Cochrane was searched and a simple strategy is recorded in the MS. The
ERG re-ran the first two lines of the search strategy and obtained the
same number of results in Cochrane Central.

*Ongoing Trials*

The manufacturer has manually searched the conference abstracts for
three major dermatology meetings: AAD, EADV and BAD and records the
number of hits for each conference year searched. The manufacturer\'s
in-house data and database (PRLIT) were also searched, which should
comprehensively retrieve all ongoing trials that the manufacturer is
undertaking pertaining to adalimumab. Biosis is charted as having been
searched which contains conference and meeting abstracts which might
present interim data before the studies are fully published in journals.

**Cost-Effectiveness Searches**

The cost-effectiveness searches run by the manufacturer meet the minimum
database criteria set by NICE (Medline, Embase, MEIP, National Health
Service Economic Evaluations Database \[NHS EED\] and the Health
Economic Evaluations Database \[HEED\]). No additional searches were
made in the company database PRLIT. The searches are recorded as
undertaken on the 4th September 2007. The databases Medline (PubMed),
Medline (R) InProcess, and Embase were searched from 1996 to the search
date. No start date is given for the databases HEED and NHS EED and the
ERG assumes that these were searched from inception to the search date
of 4th September 2007.

The manufacturer clearly states that scoping searches revealed a paucity
of literature on cost studies for the drugs and hence it seems sensible
to extend this to the disease area of psoriasis. However the search
strategy contains only a few search terms: the free text terms \"cost\"
and \"effectiveness\" and \"Psoriasis\"; the search string \"cost adj
effectiveness\"; and finally cost or effectiveness appearing anywhere in
the indexing or abstract. Cost-effectiveness could have been truncated
to cost\$ effective\$. There are no free text synonyms used such as
price, pricing, economic\$ pharmacoeconomic\$ fee\$ charges, budget\$,
expenditure\$, resources, utility, utilities. For the sake of being
systematic a full cost filter could have been applied using the mix of
index and free text terms for the drugs and then for the disease area in
order to overtly spell out the absence or paucity of relevant results.
The full economic filters always produce a large amount of irrelevant
hits but the ERG feels the process should have been recorded. There is
no strategy recorded for HEED and NHS EED (N/A is recorded for these two
databases, however the number of retrieved items is recorded).

The ERG re-ran the manufacturer\'s search strategy on Medline and
obtained similar numbers of hits.

Refer to Section 3.1.2 of the ERG report (see the \"Availability of
Companion Documents\" field) for statement of the inclusion/exclusion
criteria used in the study selection and comment on whether they were
appropriate.

#### NUMBER OF SOURCE DOCUMENTS

**Clinical Effectiveness**

Seven randomized controlled trials (RCTs) were identified (the main
evidence was derived from 3 RCTs).

**Cost-Effectiveness**

Six studies were identified and a manufacturer\'s model was submitted.

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Expert Consensus

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

Not applicable

#### METHODS USED TO ANALYZE THE EVIDENCE

Systematic Review with Evidence Tables

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

**Note from the National Guideline Clearinghouse (NGC)**: The National
Institute for Health and Clinical Excellence (NICE) commissioned an
independent academic centre to perform a systematic literature review on
the technology considered in this appraisal and prepare an Evidence
Review Group (ERG) report. The ERG report for this technology appraisal
was prepared by the Southampton Health Technology Assessment Centre,
University of Southampton (see the \"Availability of Companion
Documents\" field).

**Clinical Effectiveness**

**Manufacturer\'s Approach to Validity Assessment**

The manufacturer\'s submission (MS) provides a formal appraisal of the
validity of the included trials using the quality assessment criteria
developed by NICE. The process of applying quality criteria was not
reported in the MS so the ERG requested further information from the
manufacturer about the process used. The manufacturer responded stating
that the quality of trials was assessed by one researcher. The ERG
assessment of the four trials can be found in the ERG report (see
\"Availability of Companion Documents\" field) and differs from the MS
for some of the trials but is generally in agreement.

**Description and Critique of the Statistical Approach Used**

The MS presents results from each trial independently, little narrative
summary or tabulation of the overall effect of treatment from the trials
is reported. In general the data presented in the MS reflects the data
reported in the trial publications. In the MS the achievement of
psoriasis area and severity index (PASI) 50, 75 and 90 are reported as
proportions of patients (numbers and proportion in REVEAL) with p-values
reported for comparisons between groups in most cases (in some, p-values
were only presented in the confidential clinical study reports
\[CSRs\]). Quality of life outcomes (dermatology life quality index
\[DLQI\], Euro quality of life questionnaire \[EQ-5D\], short form
version 36 \[SF-36\]) were presented as change from baseline scores. For
the CHAMPION trial the p-values alone for quality of life outcomes were
presented in the MS. The variance around point estimates was not
presented in many cases (see Tables 3 to 9 in the ERG report \[see the
\"Availability of Companion Documents\" field\]). There is no discussion
in the MS of whether or not it was necessary or appropriate to make
adjustments to the level of statistical significance in order to correct
for multiple comparisons in the analyses, but this was not discussed in
the trial publications either.

*Meta-Analysis*

There was no meta-analysis undertaken on the data from the included
trials for any of the outcomes.

*Indirect Comparison/Mixed Treatment Comparison*

Evidence was collected for a mixed treatment comparison from the results
of a different systematic literature search to the one which informed
the systematic literature review (ERG report section 3.1.1.1 \[see the
\"Availability of Companion Documents\" field\]). Although a publication
is referenced in which a mixed treatment comparison is described, full
methodological details were not supplied in the MS. It was not clear
what the processes were for determining which studies would be included
and for performing the data extractions so the ERG requested
clarification from the manufacturer. The manufacturer responded by
providing some additional information about how data abstraction and
quality assessment were carried out (refer to Appendix 1, section A6 of
the ERG report \[see the \"Availability of Companion Documents\"
field\]).

Refer to Sections 3.1.3 to 3.1.5 of the ERG report (see the
\"Availability of Companion Documents\" field) for more information.

**Cost-Effectiveness**

**Cost-Effectiveness Analysis Methods**

The model assumes individuals have a short period of therapy during
which their response to treatment is assessed, this is referred to in
the report as the trial period. Individuals will continue treatment if
they have a sufficiently good response at the end of this trial period.
Those who respond adequately progress to treatment for a maximum of ten
years. The expected length of time that individuals would spend
receiving treatment after the trial period was stated as having been
estimated through a Markov type process using a discount rate of 3.5%.
Treatment effectiveness is defined in terms of the number of individuals
who achieve defined responses from baseline PASI score. These changes
were combined with estimates of the quality of life improvements
associated with a reduction in PASI score. The direct costs associated
with each therapy and also costs associated with being a non-responder
to treatment are included in the model. The analysis is based closely
upon the York Model.

**Sensitivity Analyses**

A series of one-way sensitivity analyses were carried out and these are
presented in the MS. Also presented in the MS are the results of a
probabilistic sensitivity analysis and an expected value of perfect
information analysis.

**Model Validation**

The model was validated by comparison to the York model. In addition,
models were developed using two computer packages and results were
compared.

Refer to Section 4.2 of the ERG report (see the \"Availability of
Companion Documents\" field) for more information.

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

**Considerations**

Technology appraisal recommendations are based on a review of clinical
and economic evidence.

**Technology Appraisal Process**

The National Institute for Health and Clinical Excellence (NICE) invites
\'consultee\' and \'commentator\' organisations to take part in the
appraisal process. Consultee organisations include national groups
representing patients and carers, the bodies representing health
professionals, and the manufacturers of the technology under review.
Consultees are invited to submit evidence during the appraisal and to
comment on the appraisal documents.

Commentator organisations include manufacturers of the products with
which the technology is being compared, the National Health Service
(NHS) Quality Improvement Scotland and research groups working in the
area. They can comment on the evidence and other documents but are not
asked to submit evidence themselves.

NICE then commissions an independent academic centre to review published
evidence on the technology and prepare an \'assessment report\'.
Consultees and commentators are invited to comment on the report. The
assessment report and the comments on it are then drawn together in a
document called the evaluation report.

An independent Appraisal Committee then considers the evaluation report.
It holds a meeting where it hears direct, spoken evidence from nominated
clinical experts, patients and carers. The Committee uses all the
evidence to make its first recommendations, in a document called the
\'appraisal consultation document\' (ACD). NICE sends all the consultees
and commentators a copy of this document and posts it on the NICE
website. Further comments are invited from everyone taking part.

When the Committee meets again it considers any comments submitted on
the ACD; then it prepares its final recommendations in a document called
the \'final appraisal determination\' (FAD). This is submitted to NICE
for approval.

Consultees have a chance to appeal against the final recommendations in
the FAD. If there are no appeals, the final recommendations become the
basis of the guidance that NICE issues.

**Who is on the Appraisal Committee?**

NICE technology appraisal recommendations are prepared by an independent
committee. This includes health professionals working in the NHS and
people who are familiar with the issues affecting patients and carers.
Although the Appraisal Committee seeks the views of organisations
representing health professionals, patients, carers, manufacturers and
government, its advice is independent of any vested interests.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

Not applicable

#### COST ANALYSIS

The manufacturer based its cost-effectiveness analysis on the York model
used in \'Etanercept and efalizumab for the treatment of adults with
psoriasis\' (NICE technology appraisal guidance 103 \[TA 103\]).

In the manufacturer\'s base-case analysis, the incremental cost per
quality-adjusted life year (QALY) gained for adalimumab compared with
supportive care was 30,500 pounds sterling. Etanercept given
continuously was dominated by adalimumab (that is, adalimumab had
greater effectiveness and lower costs than etanercept), and etanercept
given intermittently (assumed to be 88% of the cost of continuous
etanercept) and efalizumab were ruled out on the grounds of extended
domination (that is, the incremental costs per QALY gained were higher
than for adalimumab even though either the cost or effectiveness was
more favourable).

The manufacturer\'s base-case analysis included only people whose
psoriasis had a substantial effect on their quality of life, as
indicated by a baseline dermatology life quality index (DLQI) score
greater than 10. The manufacturer conducted a sensitivity analysis for
people with milder forms of psoriasis (baseline DLQI less than or equal
to 10) and this increased the incremental cost per QALY gained for
adalimumab compared with supportive care from 30,500 pounds sterling
(baseline DLQI greater than 10) to 80,100 pounds sterling (baseline DLQI
less than or equal to 10).

The manufacturer carried out further sensitivity analyses to test key
assumptions in the model. Changing the number of hospital inpatient days
assumed to be avoided by using a biological therapy instead of
supportive care had a large impact on the results. Changing the
assumption used in the base-case analysis (21 hospital inpatient days
avoided per year) to 0 days and 39 days was associated with incremental
costs per QALY gained of 60,600 pounds sterling and 4800 pounds
sterling, respectively, compared with supportive care.

Changing the assumption regarding the cost of intermittent etanercept
from 88% of the cost of continuous etanercept to 74% (the figure used in
the York model) reduced the incremental cost per QALY gained for
intermittent etanercept compared with supportive care from 37,300 pounds
sterling to 27,600 pounds sterling.

The Evidence Review Group (ERG) ran the manufacturer\'s model, changing
the assumption for the cost of intermittent etanercept to the value used
in the York model (74% of the continuous etanercept cost); this resulted
in 27,300 pounds sterling per QALY gained for intermittent etanercept
compared with supportive care and 36,700 pounds sterling per QALY gained
for adalimumab compared with intermittent etanercept. Changing the
assumption for the cost of intermittent etanercept did not alter the
cost effectiveness results for adalimumab compared with continuous
etanercept; adalimumab continued to have greater effectiveness and lower
costs than etanercept.

The ERG performed a probabilistic sensitivity analysis, re-running the
manufacturer\'s model using different assumptions for treatment with
intermittent etanercept (74% of the continuous etanercept dose used to
calculate costs rather than 88%) and infliximab (three infusions in the
trial period rather than four). The ERG found that adalimumab had a 16%
probability of being cost effective at a threshold of 30,000 pounds
sterling per QALY, compared with 46% estimated by the manufacturer.

The Committee noted that in the manufacturer\'s base-case analysis using
indirect comparisons, etanercept given continuously was dominated by
adalimumab (that is, adalimumab had greater effectiveness and lower
costs) and etanercept given intermittently (assumed to be 88% of the
cost of continuous etanercept) was ruled out on the grounds of extended
domination (that is, the incremental cost per QALY gained was higher
even though either the cost or effectiveness was more favourable).

The Committee noted that the manufacturer\'s base-case analysis included
an estimate of utility for the use of intermittent etanercept that
assumed a disutility related to the associated \'gaps\' in therapy. The
Committee was concerned, however, that the dose of intermittent therapy
used to calculate costs (88% of the continuous etanercept dose) was
estimated from US data and was inconsistent with the dose assumed in
TA103 (74%).The Committee noted that assumptions regarding the yearly
dose for etanercept based on an intermittent dosing schedule had a large
impact on the results, and it agreed that the assumptions used should be
consistent with those applied in TA103. It also noted the
manufacturer\'s sensitivity analysis, where the assumption regarding the
cost of intermittent etanercept was changed to 74% of the cost of
continuous etanercept (as in TA103); the resulting incremental cost per
QALY gained for intermittent etanercept compared with supportive care
(27,600 pounds sterling) was consistent with the value calculated by the
ERG (27,300 pounds sterling) in its re-analysis of the manufacturer\'s
model. In addition, the Committee noted that the ERG had also estimated
the incremental cost per QALY gained for adalimumab compared with
intermittent etanercept, which was 36,700 pounds sterling.

The Committee concluded that adalimumab should be recommended as a
treatment option only for people with severe plaque psoriasis when
standard systemic therapies have failed.

Refer to Sections 3 and 4 of the original guideline document for details
of the economic analyses provided by the manufacturer, the ERG comments,
and the Appraisal Committee considerations.

#### METHOD OF GUIDELINE VALIDATION

External Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

Consultee organizations from the following groups were invited to
comment on the draft scope, Assessment Report and the Appraisal
Consultation Document (ACD) and were provided with the opportunity to
appeal against the Final Appraisal Determination.

-   Manufacturer/sponsors

-   Professional/specialist and patient/carer groups

-   Commentator organisations (without the right of appeal)

In addition, individuals selected from clinical expert and patient
advocate nominations from the professional/specialist and patient/carer
groups were also invited to comment on the ACD.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

Adalimumab is recommended as a treatment option for adults with plaque
psoriasis for whom anti-tumour necrosis factor (TNF) treatment is being
considered and when the following criteria are both met.

-   The disease is severe as defined by a total Psoriasis Area Severity
    Index (PASI) of 10 or more **and** a Dermatology Life Quality Index
    (DLQI) of more than 10.

-   The psoriasis has not responded to standard systemic therapies
    including ciclosporin, methotrexate **and** PUVA (psoralen and
    long-wave ultraviolet radiation); **or** the person is intolerant
    of, **or** has a contraindication to, these treatments.

Adalimumab should be discontinued in people whose psoriasis has not
responded adequately at 16 weeks. An adequate response is defined as
either:

-   A 75% reduction in the PASI score (PASI 75) from when treatment
    started, **or**

-   A 50% reduction in the PASI score (PASI 50) and a five-point
    reduction in DLQI from start of treatment.

When using the DLQI, healthcare professionals should ensure that when
reaching conclusions on the severity of plaque psoriasis they take into
account a person\'s disabilities (such as physical impairments) and
linguistic or other communication difficulties. In such cases,
healthcare professionals should ensure that their use of the DLQI
continues to be a sufficiently accurate measure. The same approach
should apply in the context of a decision about whether to continue the
use of adalimumab in accordance with the above section.

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The recommendations are supported primarily by randomized controlled
trials, supplemented by extension and open-label studies, as well as an
economic model for cost-effectiveness.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

Appropriate use of adalimumab for the treatment of psoriasis in adults

#### POTENTIAL HARMS

Common adverse events associated with adalimumab, as reported in the
summary of product characteristics (SPC), include injection-site
reactions, infections, dizziness, headache, diarrhoea, abdominal pain,
stomatitis and mouth ulceration, nausea, increased hepatic enzymes,
musculoskeletal pain and fatigue.

For full details of side effects and contraindications, see the SPC.

### CONTRAINDICATIONS

#### CONTRAINDICATIONS

Contraindications listed in the summary of product characteristics (SPC)
include active tuberculosis or other severe infections such as sepsis,
opportunistic infections and moderate to severe heart failure.

For full details of side effects and contraindications, see the SPC.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

-   This guidance represents the view of the Institute, which was
    arrived at after careful consideration of the evidence available.
    Healthcare professionals are expected to take it fully into account
    when exercising their clinical judgement. The guidance does not,
    however, override the individual responsibility of healthcare
    professionals to make decisions appropriate to the circumstances of
    the individual patient, in consultation with the patient and/or
    guardian or carer.

-   Implementation of this guidance is the responsibility of local
    commissioners and/or providers. Commissioners and providers are
    reminded that it is their responsibility to implement the guidance,
    in their local context, in light of their duties to avoid unlawful
    discrimination and to have regard to promoting equality of
    opportunity. Nothing in this guidance should be interpreted in a way
    which would be inconsistent with compliance with those duties.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

-   The Healthcare Commission assesses the performance of National
    Health Service (NHS) organizations in meeting core and developmental
    standards set by the Department of Health in \"Standards for better
    health\" issued in July 2004. The Secretary of State has directed
    that the NHS provides funding and resources for medicines and
    treatments that have been recommended by the National Institute for
    Health and Clinical Excellence (NICE) technology appraisals normally
    within 3 months from the date that NICE publishes the guidance. Core
    standard C5 states that healthcare organisations should ensure they
    conform to NICE technology appraisals.

-   \"Healthcare Standards for Wales\" was issued by the Welsh Assembly
    Government in May 2005 and provides a framework both for
    self-assessment by healthcare organisations and for external review
    and investigation by Healthcare Inspectorate Wales. Standard 12a
    requires healthcare organisations to ensure that patients and
    service users are provided with effective treatment and care that
    conforms to NICE technology appraisal guidance. The Assembly
    Minister for Health and Social Services issued a Direction in
    October 2003 which requires Local Health Boards and NHS Trusts to
    make funding available to enable the implementation of NICE
    technology appraisal guidance, normally within 3 months.

-   NICE has developed tools to help organisations implement this
    guidance (listed below). These are available on the NICE website
    ([www.nice.org.uk//TA146](http://www.nice.org.uk/TA146) \[see also
    the \"Availability of Companion Documents\" field\]).

    -   Costing report and costing template to estimate the savings and
        costs associated with implementation

    -   Audit support for monitoring local practice

#### IMPLEMENTATION TOOLS

Audit Criteria/Indicators\
Patient Resources\
Quick Reference Guides/Physician Guides

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Getting Better\
Living with Illness

#### IOM DOMAIN

Effectiveness\
Patient-centeredness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

National Institute for Health and Clinical Excellence (NICE). Adalimumab
for the treatment of adults with psoriasis. London (UK): National
Institute for Health and Clinical Excellence (NICE); 2008 Jun. 25
p. (Technology appraisal guidance; no. 146).

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

2008 Jun

#### GUIDELINE DEVELOPER(S)

National Institute for Health and Clinical Excellence (NICE) - National
Government Agency \[Non-U.S.\]

#### SOURCE(S) OF FUNDING

National Institute for Health and Clinical Excellence (NICE)

#### GUIDELINE COMMITTEE

Appraisal Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee Members*: Professor Keith Abrams, Professor of Medical
Statistics, University of Leicester; Dr Ray Armstrong, Consultant
Rheumatologist, Southampton General Hospital; Dr Jeff Aronson, Reader in
Clinical Pharmacology, University Department of Primary Health Care,
University of Oxford; Dr Darren Ashcroft, Reader in Medicines Usage and
Safety, School of Pharmacy and Pharmaceutical Sciences, University of
Manchester; Professor David Barnett (*Chair*) Professor of Clinical
Pharmacology, University of Leicester; Professor Stirling Bryan, Head,
Department of Health Economics, University of Birmingham; Professor John
Cairns, Professor of Health Economics, Department of Public Health and
Policy, London School of Hygiene and Tropical Medicine; Dr Mark
Charkravarty, Director, External Relations, Procter and Gamble Health
Care, Europe; Professor Jack Dowie, Health Economist, London School of
Hygiene and Tropical Medicine; Ms Lynn Field, Nurse Director, Pan
Birmingham Cancer Network; Professor Christopher Fowler, Professor of
Surgical Education, Barts and The London School of Medicine and
Dentistry, Queen Mary, University of London; Dr Fergus Gleeson,
Consultant Radiologist, Churchill Hospital, Oxford; Ms Sally Gooch,
Independent Nursing and Healthcare Consultant; Mrs Barbara Greggains,
Lay member; Mr Sanjay Gupta, Former Service Manager in Stroke,
Gastroenterology, Diabetes and Endocrinology, Basildon and Thurrock
University Hospitals Foundation NHS Trust; Mr Terence Lewis, Lay member;
Professor Gary McVeigh, Professor of Cardiovascular Medicine, Queens
University, Belfast; Dr Ruairidh Milne, Senior Lecturer in Public
Health, National Coordinating Centre for Health Technology, University
of Southampton; Dr Neil Milner, General Medical Practitioner, Tramways
Medical Centre, Sheffield; Dr Rubin Minhas, General Practitioner,
Coronary Heart Disease Clinical Lead, Medway PCT; Dr John Pounsford,
Consultant Physician, Frenchay Hospital, Bristol; Dr Rosalind Ramsay,
Consultant Psychiatrist, Adult Mental Health Services, Maudsley
Hospital, London; Dr Stephen Saltissi, Consultant Cardiologist, Royal
Liverpool University Hospital; Dr Lindsay Smith, General Practitioner,
East Somerset Research Consortium; Mr Roderick Smith, Finance Director,
West Kent PCT; Mr Cliff Snelling, Lay member; Professor Ken Stein,
Professor of Public Health, Peninsula College of Medicine and Dentistry,
University of Exeter; Professor Andrew Stevens, Professor of Public
Health, Department of Public Health and Epidemiology, University of
Birmingham; Dr Rod Taylor, Associate Professor in Health Services
Research, Peninsula Medical School, Universities of Exeter and Plymouth

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members are asked to declare any interests in the technology
to be appraised. If it is considered there is a conflict of interest,
the member is excluded from participating further in that appraisal.

#### GUIDELINE STATUS

This is the current release of the guideline.

#### GUIDELINE AVAILABILITY

Electronic copies: Available in Portable Document Format (PDF) format
from the [National Institute for Health and Clinical Excellence (NICE)
Web site](http://www.nice.org.uk/Guidance/TA146).

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Adalimumab for the treatment of adults with psoriasis. Quick
    reference guide. London (UK): National Institute for Health and
    Clinical Excellence (NICE); 2008 Jun. 2 p. (Technology appraisal
    146). Available in Portable Document Format (PDF) from the [National
    Institute for Health and Clinical Excellence (NICE) Web
    site](http://www.nice.org.uk/Guidance/TA146/QuickRefGuide/pdf/English).

-   Adalimumab for the treatment of adults with psoriasis. Costing
    template and report. London (UK): National Institute for Health and
    Clinical Excellence (NICE); 2008 Jun. Various p. (Technology
    appraisal 146). Available in Portable Document Format (PDF) from the
    [NICE Web
    site](http://www.nice.org.uk/Guidance/TA146/CostTemplate/xls/English).

-   Adalimumab for the treatment of adults with psoriasis. Audit
    support. London (UK): National Institute for Health and Clinical
    Excellence (NICE); 2008. 6 p. (Technology appraisal 146). Available
    in Portable Document Format (PDF) from the [NICE Web
    site](http://www.nice.org.uk/Guidance/TA146/AuditCriteria/doc/English).

-   Adalimumab for the treatment of psoriasis. Evidence review group
    report. London (UK): National Institute for Health and Clinical
    Excellence (NICE); 2007 Nov. 102 p. (Technology appraisal 146).
    Available in Portable Document Format (PDF) from the [NICE Web
    site](http://www.nice.org.uk/nicemedia/pdf/PsoriasisAdalimumabACDERGreport.pdf).

Print copies: Available from the National Health Service (NHS) Response
Line 0870 1555 455. ref: N1610. 11 Strand, London, WC2N 5HR.

#### PATIENT RESOURCES

The following is available:

-   Adalimumab for psoriasis. Understanding NICE guidance - Information
    for people who use NHS services. London (UK): National Institute for
    Health and Clinical Excellence (NICE); 2008 Jun. 4 p. (Technology
    appraisal 146).

Electronic copies: Available in Portable Document Format (PDF) from the
[National Institute for Health and Clinical Excellence (NICE) Web
site](http://www.nice.org.uk/Guidance/TA146/PublicInfo/pdf/English).

Print copies: Available from the NHS Response Line 0870 1555 455. ref:
N1611. 11 Strand, London, WC2N 5HR.

Please note: This patient information is intended to provide health
professionals with information to share with their patients to help them
better understand their health and their diagnosed disorders. By
providing access to this patient information, it is not the intention of
NGC to provide specific medical advice for particular patients. Rather
we urge patients and their representatives to review this material and
then to consult with a licensed health professional for evaluation of
treatment options suitable for them as well as for diagnosis and answers
to their personal medical questions. This patient information has been
derived and prepared from a guideline for health care professionals
included on NGC by the authors or publishers of that original guideline.
The patient information is not reviewed by NGC to establish whether or
not it accurately reflects the original guideline\'s content.

#### NGC STATUS

This NGC summary was completed by ECRI Institute on September 16, 2008.

The National Institute for Health and Clinical Excellence (NICE) has
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summaries of their Technology Appraisal guidance with the intention of
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this regard. All NICE technology appraisal guidance is prepared in
relation to the National Health Service in England and Wales. NICE has
not been involved in the development or adaptation of NICE guidance for
use in any other country. The full versions of all NICE guidance can be
found at [www.nice.org.uk](http://www.nice.org.uk/).

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
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### DISCLAIMER

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Date Modified: 11/10/2008