Autoimmune diseases

Arthritis

Manuscript and analysis on an anti-inflammatory treatment for arthritis
PRO literature review for two different anti-inflammatory drugs for the treatment of arthritis

Ankylosing spondylitis

Interactive cost-effectiveness model for a selective inhibitor treatment used for ankylosing spondylitis
Manuscript cost-effectiveness analysis of a treatment for ankylosing spondylitis in Norway
Workshop and FAQ development in immunology in ankylosing spondylitis
Development of a payer value deck in immunology in ankylosing spondylitis
Competitor review deck in ankylosing spondylitis
Total Brand FAQ deck and Total Brand Workshop in ankylosing spondylitis
Global value dossier and budget impact model for a biosimilar in ankylosing spondylitis
Competitor value story slide deck in ankylosing spondylitis
Core value dossier in ankylosing spondylitis
Global value dossier update for the latest HEOR evidence in ankylosing spondylitis
Development of launch materials in ankylosing spondylitis
HTA strategy in ankylosing spondylitis
GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

Axial spondyloarthritis

Payer slide kit in non-radiographic axial spondyloarthritis
Structured literature review and value dossier updates in a biosimilar for axial spondyloarthiritis
Payer value deck for a biosimilar in axial spondyloarthiritis

Juvenile idiopathic arthritis

Workshop and FAQ development in immunology in juvenile idiopathic arthritis
Development of a payer value deck in immunology in juvenile idiopathic arthritis
Frequently asked questions deck in juvenile idiopathic arthritis
Structured literature review and value dossier updates in a biosimilar for juvenile idiopathic arthritis
Payer value deck for a biosimilar in juvenile idiopathic arthritis

Osteoarthritis

Global value dossier and budget impact model for a biosimilar in osteoarthritis
Literature review of PROs and endpoints of pain in osteoarthritis
Literature review to support the use of COA measures in osteoarthritis
Competitive assessment and burden of illness study in osteoarthritis
Review of endpoints for clinical trials in osteoarthritis
Instrument review and assessment strategy in osteoarthritis
Mixed treatment comparison of two treatments for osteoarthritis of the knee
Mode of administration validation study for an electronic diary in back pain for osteoarthritis patients
Development and cognitive debriefing on a patient global response to a treatment measure in osteoarthritis pain
Translation and validation of the revised Hopkins Verbal Learning Test for osteoarthritis
Translation and validation of an osteoarthritis diary
Development of a measure of disease flare in osteoarthritis patients
Patient interviews to capture disease burden and unmet treatment needs in hand osteoarthritis
Mode of administration equivalency and usability testing of COA instruments in osteoarthritis
GI tolerability endpoint white paper including literature and instrument reviews on osteoarthritis
Consulting on PRO analysis and study design of trials in osteoarthritis
Top up literature review of PROs in osteoarthritis
Gap analysis and review of PRO measures in osteoarthritis
Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with osteoarthritis

Psoriatic arthritis

Payer dossier update in psoriatic arthritis
Support for a manuscript on a network meta-analysis in psoriatic arthritis
Systematic literature review and network analysis in psoriasis and psoriatic arthritis
Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
Workshop and FAQ development in immunology in psoriatic arthritis
Development of a payer value deck in immunology in psoriatic arthritis
Competitor review decks in psoriatic arthritis
Competitor value story slide deck in psoriatic arthritis
Structured literature review and value dossier updates in a biosimilar for psoriatic arthritis
Data checks and DEF amendments in psoriatic arthritis
HTA support regarding psoriatic arthritis submissions in Canada, Spain and the UK
Regulatory support on SMC questions on psoriatic arthritis work
Payer interviews and message testing in psoriatic arthritis
Payer value deck for a biosimilar in psoriatic arthritis
Core value dossier on psoriatic arthritis
Global value dossier update for the latest HEOR evidence in psoriatic arthritis
Development of launch materials in psoriatic arthritis
HTA strategy in psoriatic arthritis
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of psoriatic arthritis

Rheumatoid arthritis

Literature search, data extraction and report on rheumatoid arthritis
Cost-consequences manuscript on rheumatoid arthritis
Generating evidence to support the unmet need in rheumatoid arthritis
Measuring indirect and societal costs of morning stiffness in patients with rheumatoid arthritis
Manuscript on a treatment in rheumatoid arthritis
Review of an economic model to assess utility requirements for a treatment in rheumatoid arthritis
Utility study and economic model in rheumatoid arthritis
Review of European HTA requirements for treatment in rheumatoid arthritis
Adaptation of an economic model on treatment of rheumatoid arthritis for the USA
Value message testing for a biosimilar in rheumatoid arthritis
Objection handler in rheumatoid arthritis
Economic model on a treatment for rheumatoid arthritis
Budget impact model for a biosimilar in rheumatoid arthritis
Competitor review in rheumatoid arthritis
Competitor review of two JAK inhibitors in rheumatoid arthritis
Payer focused value communication on rheumatoid arthritis
Payer value proposition in rheumatoid arthritis
Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
Literature review of unmet need in rheumatoid arthritis
Literature review and recommendations for rheumatoid arthritis
Utility study in rheumatoid arthritis
Competitor value story in rheumatoid arthritis
Competitor value stories for two treatments of rheumatoid arthritis
Manuscript on a budget impact model for a cross-indication biosimilar in conditions including rheumatoid arthritis
Core value dossier, value deck and objection handler in rheumatoid arthritis
Update to an AMCP dossier for a rheumatoid arthritis biosimilar
Global value dossier and budget impact model for a biosimilar in rheumatoid arthritis
Workshop and FAQ development in immunology in rheumatoid arthritis
Development of a payer value deck in immunology in rheumatoid arthritis
Total Brand FAQ deck and Total Brand Workshop in rheumatoid arthritis
Structured literature review and value dossier updates in a biosimilar for rheumatoid arthritis
Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of rheumatoid arthritis
Generation of evidence to support the unmet need in rheumatoid arthritis
Modified Delphi Panel to gain consensus in rheumatology (rheumatoid arthritis)
Update to payer materials in rheumatoid arthritis
Payer value deck for a biosimilar in rheumatoid arthritis
Development of a PRO strategy in rheumatoid arthritis
Qualitative research in rheumatoid arthritis
Poster and manuscript on an indirect comparison of biologic treatments for TNF-IR rheumatoid arthritis patients
Systematic review to explore minimal important differences in PROs for rheumatoid arthritis
Meta-analysis of joint structural deterioration over time in minimally treated rheumatoid arthritis patients with inadequate response to disease-modifying anti-rheumatic drugs (DMARD-IR)
Mixed treatment comparison of efficacy and safety of an immunosuppressant drug versus a TNF inhibitor drug in rheumatoid arthritis patients with DMARD-IR
Mixed treatment comparison of an oral drug used in the treatment of rheumatoid arthritis
Characterising and predicting treatment response to rheumatoid arthritis biologic therapy
Literature review of unmet need in rheumatoid arthritis
Mixed treatment comparison of a treatment for rheumatoid arthritis populations – DMARD-IR and MTX-naive patients
Q&A and mixed treatment comparison on a treatment for rheumatoid arthritis
Indirect comparison of a monotherapy treatment for rheumatoid arthritis patients with DMARD-IR
Face and content validity testing of a tiredness item in a sample of rheumatoid arthritis patients
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis
Psychometric evaluation of a PRO in rheumatoid arthritis
Evaluation of fatigue in rheumatoid arthritis using a PRO instrument
Patient interviews on rheumatoid arthritis
Patient interviews to capture disease burden and unmet treatment needs in rheumatoid arthritis
Support in development and analyses of a patient support programme in indications including rheumatoid arthritis
GI tolerability endpoint white paper including literature and instrument reviews on rheumatoid arthritis
Top up literature review of PROs in rheumatoid arthritis
Development and Drug Development Tools (DDT) qualification of a PRO measure to assess the symptoms of rheumatoid arthritis

Crohn’s disease

Early global value dossiers for a new monoclonal antibody in Crohn’s disease
Literature review and recommendations for Crohn’s disease
Payer objection/question responses in Crohn’s disease
Structured literature review and value dossier updates in a biosimilar for Crohn’s disease
Payer value deck for a biosimilar in Crohn’s disease and paediatric Crohn’s disease
White paper on PROs in Crohn’s disease
FDA briefing document on Crohn’s disease
Advisory board on a treatment for Crohn’s disease
Development and implementation of a plan to deliver economic and outcomes evidence to support commercialisation of a treatment for Crohn’s disease in key markets
US database analysis to support a pharmacoeconomic model in Crohn’s disease in the US
PRO review in Crohn’s disease
PRO gap analysis and initial PRO dossier development in Crohn’s disease
Support in development and analyses of a patient support programme in Crohn’s disease

Fibromyalgia

Literature review of PROs and endpoints of pain in fibromyalgia
Competitive assessment and burden of illness in fibromyalgia
Assessment of the feasibility of achieving claims for cognitive functioning in fibromyalgia
Gap analysis and endpoint review in fibromyalgia
Validation of the fatigue Visual Analogue Scale (VAS) and Jenkins Sleep Scale for fibromyalgia
Development of a manuscript on fatigue and sleep triangulation results in fibromyalgia
Development of a manuscript on the use of the Jenkins Sleep Scale on patients with fibromyalgia
Focus groups to determine the best questionnaire to assess fibromyalgia and recommendations for clinical trials
Assessment of PROs in fibromyalgia
Development of a manuscript in fibromyalgia (reporting results from focus groups and Delphi panel phases)
Endpoint review of fatigue and functioning in fibromyalgia
Development of a conceptual framework for the measurement of fatigue in patients with fibromyalgia
Pilot testing interviews on fibromyalgia fatigue
Consultancy relating to the psychometric validation of the daily diary of fatigue symptoms in fibromyalgia (DFS-Fibro)
Manuscript reporting the results from the validation of the DFS-Fibro
PRO assessment in fibromyalgia and diabetic peripheral neuropathy
Development of a dossier on the Daily Diary of Fatigue Symptoms – Fibromyalgia (DFS-Fibro) and regulatory consultancy for fibromyalgia
Consultancy for fibromyalgia fatigue study
Post-hoc Rasch analysis of existing data from the DFS-Fibro
Validation study of the modified version of the Brief Pain Inventory – Short Form (mBPI-SF), MOS-S and 3 single item questions in fibromyalgia and diabetic peripheral neuropathy
Report of sleep problems in fibromyalgia
Burden, economics, epidemiology and treatment patterns in fibromyalgia

Hidradenitis suppurativa

Core value dossier to support new treatment in hidradenitis suppurativa
Update to a value proposition deck with adolescent data in hidradentis suppurativa
Core value dossier, payer value proposition and objection handler update in hidradenitis suppurativa
Structured literature review and value dossier updates in a biosimilar for hidradenitis suppurativa
Payer value deck for a biosimilar in hidradenitis suppurativa
Development and validation of a PRO tool in hidradenitis suppurativa
Measurement of pain in hidradenitis suppurativa
Development of a PRO in hidradenitis suppurativa
Development of an investigator training manual in hidradenitis suppurativa
Development of FDA response on phase II hidradenitis suppurativa study protocol
Poster for a PRO in hidradenitis suppurativa
Mechanism of Action (MOA) Equivalency Testing in hidradenitis suppurativa
Clinical endpoint guidance and observational study in hidradenitis suppurativa
ClinRO inter-rater reliability study in hidradenitis suppurtiva
Design, placement and placement of outcomes in registry for hidradenitis suppurativa
HEOR strategic consulting in hidradenitis suppurativa
Pre- and post-surgery research study in hidradenitis suppurativa
Development of three measurement dossiers in hidradenitis suppurativa to support regulatory submissions
Psychometric testing of the Hidradenitis Suppurativa Impact Assessment (HSIA) and Hidradenitis Suppurativa Symptom Assessment (HSSA)
Summary report and publications for hidradenitis suppurativa pain and relevant tools
Evaluating the clinical meaning of defining treatment response based on the Hidradenitis Suppurativa Clinical Response (HiSCR)
Statistical analyses of registry data (UNITE) in hidradenitis suppurativa
Literature review on hidradenitis suppurativa

Immune thrombocytopenic purpura

Analysis and reporting on immune thrombocytopenic purpura
Caregiver interviews to support content validity of an ObsRO in a paediatric population with chronic immune thrombocytopenic purpura
Palatability and acceptability of a treatment in paediatric populations with chronic immune thrombocytopenic purpura
Development of a scoring algorithm for an acceptability and palatability questionnaire in chronic immune thrombocytopenic purpura
Literature review and qualitative research to support the content validation of the immune thrombocytopenia quality of life index

Inflammatory bowel disease

Pre-budget impact analysis in personalised medicine (biomarkers) for inflammatory bowel diseases

Lupus and systemic lupus erythematosus

Manuscript on the understanding of payers and pricing in lupus nephritis
PRO consulting in lupus for labelling claims
Assessing utility for flares in systemic lupus erythematosus in the UK, France, Spain, Australia and Canada, including training and managing local interviewing agencies and providing support to local teams
Key opinion leader contracting and additional interviews for assessing utility in various severities of flares in systemic lupus erythematosus
Study on the treatment of systemic lupus erythematosus in Japan
Update of a literature search in systemic lupus erythematosus and lupus nephritis
Strategic literature review and gap analysis in systemic lupus erythematosus and lupus nephritis
Communication of a literature review on systemic lupus erythematosus and lupus nephritis
Indirect treatment comparison, network meta-analysis and feasibility assessment of therapies for lupus nephritis
Literature review and network meta-analysis feasibility assessment in lupus
Manuscript on the health-related quality of life benefits of a treatment for systemic lupus erythematosus
A study of the value of simple disease activity tools to rheumatologists who treat systemic lupus erythematosus
Target product profile development in systemic lupus erythematosus
Analysis of a PRO and resource utilisation in systemic lupus erythematosus
Development of posters on the analysis of a PRO and resource utilisation in systemic lupus erythematosus
Critical review of PRO instruments in systemic lupus erythematosus and fatigue and pain in rheumatic disease

Multiple sclerosis

Global value dossier update in multiple sclerosis (MS)
Multiple technology appraisal in MS for NICE
Research into UK data sources for MS
Delphi study (with KOL and payer interviews) to inform market access strategy in MS
Utility elicitation study on patients with MS
Validation of three cost-effectiveness and budget impact models in MS
Negotiation of a licensing agreement for the Multiple Sclerosis Impact Scale (MSIS-29)
Review and formatting of patient reported resource use, work productivity and caregiver burden in MS
Qualitative research to validate a screening tool for secondary progressive MS
PRO endpoint review in MS
Briefing document, advisory board and labelling strategy for the FDA on a treatment for MS
Cognitive debriefing UK study on walking impairment in MS
Psychometric testing of walking impairment in MS
Manuscript for the development and psychometric assessment of the Early Mobility Impairment Questionnaire (EMIQ) in MS
Rasch analysis of the cognitive debriefing survey data collected in a qualitative phase for MS
Rasch analysis and report of DSP data collected on the Full Scale Intelligence Quotient (FSIQ) measure in MS
PRO instrument reviews in relapsing MS and spinal cord injury
PRO review on MS
PRO statistical analysis plan for a clarity trial in MS
Selection of a PRO for depression in MS
Endpoint review of a treatment for MS
Concept confirmation and cognitive debriefing of spasticity PRO measures in MS patients, and development of spasticity screener
Development and validation of a clinical screening tool for overactive bladder in MS
Advisory board for a clinical screening tool for overactive bladder in MS
Development of a predictive calculator for a clinician-completed screening tool in secondary progressive multiple sclerosis (SPMS)
Psychometric validation of a clinician completed screening tool in SPMS
Exploratory analysis of phase II clinical trial data for acute optic neuritis

Relapsed-remitting multiple sclerosis

Development, content confirmation and validation of a fatigue measure in relapsing-remitting multiple sclerosis (RRMS)
Work on the equivalency of an e-PRO on the FSIQ in RRMS
Qualitative work in subgroups with RRMS
Development of a PRO measurement strategy in relapsing MS
Mode of administration equivalency and usability testing of the MSIS-29 in patients with relapsing MS
Development of a PRO dossier for the MSIS-29 in RRMS
Psychometric validation of a newly developed PRO for patients with RRMS
Poster development on the Fatigue Symptom and Impact Questionnaire for Relapsing Multiple Sclerosis (FSIQ-RMS)

Psoriasis

Development of a payer value proposition and materials in psoriasis
NICE submissions for a new biologic for the treatment of moderate to severe psoriasis in the UK
Systematic literature review of quality of life in psoriasis
Manuscript on a literature review of quality of life in psoriasis
Literature review and stakeholder interviews on payer decision drivers in psoriasis
Update a to core value dossier in psoriasis
UK value story for a new treatment in psoriasis vulgaris
Competitor review deck and objection handler in psoriasis
Mini competitor review for a value proposition in psoriasis
Budget impact model for a new treatment in psoriasis vulgaris
Systematic literature review and network meta-analysis update in psoriasis
Indirect treatment comparison for a 2nd round response to PBAC for a psoriasis treatment
Supplementary analyses and reporting for the psoriasis network meta-analysis
Payer evidence dossier for a new psoriasis treatment
Payer dossier on psoriasis
Payer dossier for paediatric psoriasis
Mini value dossier on paediatric psoriasis
Repurposing a slide deck for a payer value proposition in paediatric psoriasis
Core value dossier/payer value deck updates and competitor value differentiation slide sets on psoriasis
Core value dossier, payer value proposition and objection handler in psoriasis
Update to a value proposition slide deck for a treatment in psoriasis
Core value dossier update in psoriasis
Systematic literature review and network analysis in psoriasis
Early global value dossiers for a new monoclonal antibody in psoriasis
Total Brand FAQ deck and Total Brand Workshop in psoriasis
Global value dossiers and budget impact models for biosimilars in psoriasis
Systematic literature review in psoriasis – update for Poland
Targeted literature review in psoriatic arthritis patients with concomitant moderate to severe psoriasis
Country adaptation of a European payer dossier in psoriasis to Latin America and Spain
Core value dossier, value deck, literature review and objection handler in psoriasis
Global value dossier update in paediatric psoriasis
Structured literature review and value dossier updates in a biosimilar for psoriasis and paediatric plaque psoriasis
Budget impact model on the costs of treating psoriasis
Payer value deck for a biosimilar in psoriasis and paediatric plaque psoriasis
Psychometric testing of self-assessment of a psoriasis symptoms questionnaire
Psychometric validation of a psoriasis tool
Analysis and Abstract Development on a cumulative life course impairment (CLCI) in psoriasis
CLCI marketing and clinical data analysis of a psoriasis tool
Development of a PRO to assess sexual dysfunction in psoriasis
Development of a poster to describe the development of a PRO to assess the impacts of psoriasis
Scientific communications on the development of a PRO to assess sexual dysfunction in psoriasis
Development of psoriasis symptoms and treatment satisfaction measures
Patient preference study in plaque psoriasis
Strategic PRO review in psoriasis
Interviews with patient focus groups in psoriasis
Database analysis and publications in psoriasis treatment
Review of PROs and preparation and writing of a PRO briefing document for the FDA on the treatment of psoriasis
Review of a briefing document prepared for submission to the FDA in support of labelling claims in psoriasis
Briefing book support and psychometric evaluation of the Self-Assessment for Psoriasis Symptoms (SAPS)
International economic evaluation of a treatment for moderate to severe chronic plaque psoriasis
Measurement strategy in chronic plaque psoriasis
Support in development and analyses of a patient support programme in plaque psoriasis
Manuscript on Self-Assessment for Psoriasis Symptoms (SAPS) psychometric publications

Restless leg syndrome

Development of a value slide set in restless leg syndrome (RLS)
Global value dossier and e-v@luate platform development in RLS
PRO and Health Economics (HE) consulting on global health outcomes in RLS
Development of a sleep measure for a labelling claim in RLS
Linguistic validation management of the Restless Leg Syndrome Next Day Impact (RLS-NDI)
Synopsis of conclusions for diagnosis of paediatric RLS
Regulatory consulting to support development of a structured diagnostic interview and severity scale in paediatric RLS, along with development of two manuscripts to document the development and validation process
Abstracts and presentations on the results from an independent study of RLS
Psychometric validation of a two-factor solution for RLS
Analysis of RLS sub-scales
Manuscript on RLS, sleep and cognition
Consultation on the development of questionnaires for RLS
Expert meeting on paediatric RLS
Development and validation of a diagnostic interview and severity scale for paediatric RLS
Validation of the Medical Outcomes Study (MOS) sleep questionnaire using pooled trial data from RLS trials
Validation of the Restless Leg Syndrome Rating Scale (RLS-RS) and Restless Leg Syndrome Quality of Life (RLS QoL) questionnaire

Sjögren’s syndrome

Literature review and consultancy on symptom questionnaires for use as a primary endpoint and consultancy on inclusion of a PRO questionnaire as a secondary endpoint in Sjögren’s syndrome
Measurement strategy for ichthyosis in Sjögren’s syndrome

Systemic sclerosis

Executive summary slide deck based on an early value evidence dossier in systemic sclerosis
Early value dossier with value message proposition in systemic sclerosis

Systemic sclerosis / Scleroderma

Review of PROs in systemic sclerosis/scleroderma
Brief literature review to inform endpoint strategy recommendations for interstitial lung disease in systemic sclerosis (SSc-ILD)

Ulcerative colitis

Payer objection/question responses in ulcerative colitis
Manuscript reporting the literature review and qualitative research project with ulcerative colitis subjects
Workshop and FAQ development in immunology in ulcerative colitis
Development of a payer value deck in immunology in ulcerative colitis
Payer value deck for a biosimilar in ulcerative colitis
Structured literature review and value dossier updates in a biosimilar for ulcerative colitis
PRO gap analysis and initial PRO dossier development in ulcerative colitis
Support in development and analyses of a patient support programme in ulcerative colitis

Uveitis

Review of evidence requirements in uveitis for national and local reimbursement submissions in five European countries, with reviews of local language guidance
Strategic consultancy meeting on uveitis
Core value dossier in uveitis
Core value dossier in paediatric uveitis
Development of a HEOR strategy for uveitis
Structured literature review and value dossier updates in a biosimilar for uveitis
Payer value deck for a biosimilar in uveitis