Autoimmune diseases

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 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
  • 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

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
  • Payer slide kit in non-radiographic axial spondyloarthritis
  • GI tolerability endpoint white paper including literature and instrument reviews on ankylosing spondylitis

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

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
  • 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
  • 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 update 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
  • 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)
  • 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

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)

Multiple sclerosis

  • Global value dossier update in multiple sclerosis (MS)
  • Multiple technology appraisal in MS for NICE
  • Research into UK data sources for 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)

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

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

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
  • 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

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
  • PRO gap analysis and initial PRO dossier development in ulcerative colitis
  • Support in development and analyses of a patient support programme in ulcerative colitis

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

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
  • 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

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
  • 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

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
  • Core value dossier for a treatment in uveitis
  • Update of a core value dossier in uveitis
  • Development of a HEOR strategy for uveitis