Therapeutic area

Neuromuscular block

  • Local market adaptations of economic models in anaesthesia (for neuromuscular block)
  • Payer value deck in neuromuscular block
  • Development of a conceptual framework and SAP for a treatment for neuromuscular block
  • Treatment effect analyses based on a Quality of Recovery questionnaire (QoR-40) and Reversal Agent Satisfaction Questionnaire (RASQ) in neuromuscular block

Neuropathic/neurological pain

  • Core value dossier update in chronic/neuropathic pain
  • Update of core value dossier and value story in chronic neurological pain
  • Manuscript based on burden of illness study in neuropathic pain for submission to peer-reviewed journal
  • Rapid payer research to support investment decisions in neuropathic pain
  • Payer interviews in neuropathic pain
  • Mapping out and costing of care pathways for neuropathic pain
  • Use of focus groups for the assessment of PROs in neuropathic pain
  • Assessment of PROs in neuropathic pain
  • Consultation on an observational study in neuropathic pain: review of protocol and SAP to ensure that an appropriate PRO strategy can be developed for phase III studies
  • PRO analyses in neuropathic pain
  • Patient focus groups to validate a conceptual model in neuropathic pain
  • Translation of the Neuropathic Pain Symptom Inventory (NPSI)
  • Manuscript on the NPSI

Nocturia and paediatric enuresis

  • Stand-alone quantitative evaluation of the Impact of Nocturia End of Day Questionnaire
  • Creation of CDFs for the Impact of Nocturia End of Day Questionnaire
  • Consulting in a PRO strategy for use in paediatric enuresis (bed wetting)

Opioid addiction

  • Development of a screening tool for opioid dependence
  • Endpoint review and qualitative research in opioid addiction
  • Interviews and Rasch analysis in opioid addiction
  • Psychometric validation of the clinical opiate withdrawal scale (COWS), subjective opiate withdrawal scale (SOWS) and craving visual analog scale (VAS) in opioid withdrawal symptoms

Osteoporosis

  • Manuscript support for a screening model in osteoporosis in Japan
  • Cost-effectiveness model in osteoporosis
  • Cost-effectiveness analysis of a medicine used for the treatment of osteoporosis
  • Assessing the clinical gap by incorporating bone mineral density (BMD) screening into the annual health check-ups for osteoporosis in Japan
  • Indirect comparison of two treatments for non-vertebral fractures in osteoporosis

Other cardiovascular diseases

  • Value proposition development for three Integrated Delivery Networks (IDNs) within the cardiovascular system
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Review of the HTA submissions and economic literature in lipid modification
  • Development of a clinical tool to identify patients at risk of stent thrombosis
  • Update of a budget impact model for an anorectic anti-obesity drug for cardiometabolic risk
  • Service impact model on cardiovascular complications in obesity
  • Budget impact and economic evaluation of a statin
  • Literature review of cardiovascular disease in migraine patients
  • Development of a value proposition for amyloid cardiomyopathy
  • Rapid business development payer research in hypertrophic cardiomyopathy (HCM)
  • Mixed treatment comparison to estimate the efficacy of a drug relative to other treatments for patients with elevated triglycerides
  • General consulting on a new stent device
  • Validation of the Flushing Severity Questionnaire (FSQ) in patients with niacin induced flushing (NIF)
  • Manuscript on a heart model and statins
  • Strategic review of a treatment for atherothrombosis to prevent blood clots following a heart attack or stroke
  • Analysis of the risk of cardiovascular events with an antiplatelet medicine and proton pump inhibitors (PPI) in Japan
  • Protocol review, case report form and analysis plan for a treatment to prevent complications of vascular surgery

Other CNS and neurological experience

  • Socio-economic analysis and phase I of a cost effectiveness analysis model for human cord graft
  • Global value dossier and e-v@luate instance in attention deficit hyperactivity disorder (ADHD)
  • Literature review, consensus meeting and mapping of the treatment pathway in adrenoleukodystrophy
  • Validation of the amyotrophic lateral sclerosis functional rating scale (ALSFRS-R)
  • FDA consultancy and pre-NDA meeting in neurology
  • Literature review, conceptual models and mapping of generic utility instruments in neurology
  • Consultancy on an FDA submission for a central nervous system condition
  • Topline report on a side effect questionnaire in a central nervous system condition for submission

Other dermatology experience

  • Review article on adherence to topical therapies in dermatological conditions
  • HTA and reimbursement surveillance in dermatology
  • Biosimilar payer communications in dermatology
  • Literature and content searches for global value dossiers in dermatology
  • Psychometric evaluation of a PRO in hyperhidrosis
  • Development of a PRO and ClinRo for use in prurigo nodularis
  • Development and validation of a ClinRO to measure changes in peristomal skin
  • Global value dossier for a treatment for tissue management
  • Development and translation of a 6 item dermatology questionnaire into Danish
  • EMA dossier and literature review support in dermatology
  • Development and validation of the Skin Infection Rating Scale (SIRS)

Other endocrinology and metabolic experience

  • Total Brand FAQ deck and Total Brand Workshop in prostate-specific antigen (PsA)
  • Structured literature reviews on the burden of disease of nonalcoholic steatohepatitis (NASH), and development of two publications
  • Abstracts and manuscript on a Japanese willingness to pay study in metabolic disorders
  • Assessment framework of external presentation and a strategic communication plan in metabolic disorders
  • Preparation for and support at FDA meetings on the validation of PROs in a chronic haemodialysis population
  • Questionnaire in halitosis
  • Classification and Regression Tree Analysis in endocrinology
  • Consultation on a protocol and analysis plan in endocrinology
  • Development of PRO strategies in metabolic disorders

Other gastrointestinal experience

  • Development of a global value dossier and budget impact model for capsule endoscopy for colonoscopy
  • Global value dossier for a therapy device in refractory ascites
  • Biosimilar payer communications in gastroenterology
  • Health economics support package in gastroenterology
  • Value proposition on a treatment for heartburn and indigestion
  • Cognitive debriefing and content validation of the diarrhoea symptom assessment measure
  • Cognitive debriefing of the Gastrointestinal Symptom Rating Scale Diarrhoea Domain in patients with Fabry’s disease
  • Support with interviews in paediatric vomiting
  • Managing patients with stoma: Adaptation of a Quality of Life Index (QLI) questionnaire to current needs for colostomy patients
  • Consultation and conduction of a discussion panel at the European Council of Enterostomal Therapy conference
  • Development of a manuscript based on modification of an ostomy study
  • Language validation interview for an ascites impact questionnaire
  • General consulting agreement in gastrointestinal assessments
  • Training work on post-operative nausea and vomiting
  • Strategic consultancy in gastrointestinal symptoms of Fabry’s disease
  • HEOR consulting services including clinical outcomes and regulatory approach

Other genetic disorders

  • Health economic analysis for SMC resubmission in homocystinuria
  • Conference poster on the utility of oral versus subcutaneous iron chelation therapy for beta thalassaemia
  • Real-world evidence toolkit in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)
  • Market access and HEOR consultancy in genetic disorders

Other haematology experience

  • Preparation of three core European value dossiers (for use by affiliates and targeted to regional/local decision makers in key markets) and three value stories in haematology
  • Manuscript on a budget impact model for a biosimilar in haematology
  • Revisions to the Lymphoedema Quality of Life Questionnaire (LYMQOL)
  • EMEA training on PROs in haematology

Other infectious disease experience

  • Payer and pricing research and landscape analysis of hygiene product reimbursement and funding flow in UK hospitals for hospital acquired infections
  • HEOR team capabilities audit and training plan in infectious diseases
  • Literature review and development of a suite of dossiers in anti-infectives (anti-bacterial resistance)
  • Development of an e-v@luate EVIDENCE platform for a vaccines portfolio
  • Literature review of antibiotic resistance
  • Cost effectiveness analysis model for Portugal on a treatment for bacterial diabetic foot infections
  • Suite of dossiers for an anti-infective in gram-negative infections
  • Cost-effectiveness model for cytomegalovirus (CMV) prophylaxis in kidney transplant recipients
  • Pharmacoeconomic and PRO design and analysis for an immunoglobulin product
  • Analysis in an EU study in primary immunodeficiency
  • Pricing reimbursement overview for the UK for a novel anti-viral treatment
  • Cost effectiveness model on a treatment for bacterial infections
  • Cost-effectiveness analysis of a treatment of intra-abdominal infections in the USA
  • Global value dossier, slide deck and FAQs on antibiotic resistance in gram-negative infections
  • Update to an anti-infectives dossier in gram negative bacterial infections
  • Estimating the return on investment from investing in adult immunisation in Europe
  • Strategic access objectives in infectious diseases
  • Development of a manuscript and consultation on economic evaluations alongside a clinical trial in intra-abdominal infections
  • Structured literature review and value strategic insight to understand the prevalence and burden of vaccine-preventable diseases (haemophilus influenzae, hepatitis A & B, HPV-associated cancers, influenza, measles, mumps, rubella, meningococcal disease, pneumonia, tetanus, diphtheria, whooping cough, chicken pox, and shingles) amongst sub-populations identified in the ACIP recommendations
  • Protocol, CRF and distress diary development in infectious diseases
  • COA consultancy support and validation of a nasal congestion scale

Other men’s health experience

  • Consultation for an FDA submission in andropause
  • Translation of a men’s health questionnaire
  • Patient perspective literature review for chronic pelvic pain in both men and women and premature ejaculation

Other musculoskeletal experience

  • Economic analysis and trial design in hip replacement
  • Payer value slide deck in muscle relaxation management
  • Manuscript on a budget impact model for a biosimilar in rheumatology
  • General consultancy on economic and quality of life endpoints in planned trials in several musculoskeletal disease indications
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)
  • Review adherence questionnaire in a musculoskeletal disease

Other nephrology experience

  • Payer objection handlers to support treatment in secondary hyperparathyroidism (SHPT)
  • Consultation on an FDA PRO claim in nephrology
  • COA strategies to complement a biology and renal/fibrotic portfolio
  • Qualitative literature and instrument review in atypical Haemolytic Uremic Syndrome (aHUS)

Other oncology experience

  • Scenario model and value messages for oncology in Australia, France, Austria, Switzerland, Belgium, Germany, Italy, Slovenia and the Netherlands
  • Scenario model and policy messages in oncology (Health Impact Projection) for Korea, Norway and Germany
  • Development of a slide deck on the Health Impact Projection in oncology for presentation at a conference
  • Development of an evidence evaluation framework in cancer
  • Creative values demonstration in oncology
  • Budget impact model and clinical data update for the Health Impact Projection in oncology
  • Training on a UK budget impact model for a chemotherapy drug
  • External communications for a multi-indication value-based pricing model in oncology
  • Value based pricing model manuscript in oncology
  • Adaptation of a value-based pricing multi-indication global model in oncology to Belgium and the US
  • Cost utility model and pilot version of the Safety Profile Model for oncology
  • Economic model for an erythropoietin treatment in cancer
  • Extension and creation of economic evidence on an erythropoietin treatment in cancer
  • Burden of disease deck on biomarkers in Microsatellite Instability-High (MSI-H) or Mismatch Repair Deficient (dMMR) advanced (stage IV) cancerous tumours
  • Payer value deck on biomarkers in MSI-H or dMMR advanced (stage IV) cancerous tumours
  • Response to payer questions on biomarkers in MSI-H or dMMR advanced (stage IV) cancerous tumours
  • Response to payer questions update on biomarker response in various cancer indications
  • Support for the commercialisation of treatment for an immune-response modifier in oncology
  • Competitor intelligence tracking in oncology
  • Implementation guide in all indications of oncology
  • Frequently asked questions deck in oncology biomarkers and companion diagnostics
  • EU market access training in oncology
  • Steering committee meeting in oncology
  • Face-to-face meeting with external experts for review and validation of scenario policy model in oncology
  • Country-level advisory board for a health impact model in oncology
  • Country specific advisory board for the Health Impact Projection model for the Netherlands
  • One-day workshop on Health Impact Projection in oncology
  • Slovenia-focused advisory board on the Health Impact Projection tool in oncology
  • Literature and reimbursement review of IV versus SC oncology therapies, and development of a conference poster
  • Systematic literature review on oncology drugs that have made the switch from IV to SC formulation
  • Literature review and consultancy on oncology
  • Budget impact model on an oncology biosimilar
  • Budget impact model for a biosimilar in multiple oncology indications
  • Health Economics and Outcomes Research (HEOR) training academy in oncology
  • Development of an abstract to communicate a systematic literature review in oncology
  • Development of a poster on IV and SC therapies in immuno-oncology
  • Health Impact Projection expert meeting on oncology
  • Development of a poster on a systematic review of real-world outcomes of IV and SC therapies in oncology
  • Value-based pricing model in oncology for Belgium
  • Reimbursement scenario analysis for a Korean Health Impact Projection model in oncology
  • Multi-indication budget impact and resource utilisation model in oncology
  • Access landscape analysis for remote care coordination in oral oncotherapy
  • Multi-indication cost-effectiveness model in oncology for Korea
  • HE support for launch of a new immunotherapy dose in oncology
  • Manuscript on a multi-indication cost-effectiveness model in oncology for Korea
  • Value evidence compendium in pan-tumour oncology
  • Development of a Health Impact Projection model in oncology for Korea, Turkey, Australia and other countries in Europe and Globally
  • Adaptations of a Health Impact Projection model to Japan, Turkey, Portugal, Australia, New Zealand and Hong Kong
  • PRO consulting for regulatory affairs and investigator training slides in malignant ascites
  • PRO endpoint consulting in oncology
  • Clinical investigator PROs for chemotherapy trials
  • Comprehensive PRO strategy in oncology
  • Support in the development of a PRO strategy for four compounds in 6-8 oncology indications
  • PRO booklet review and edits adaptation on cancer
  • Selection and implementation of PROs such as health-related quality of life and symptoms assessment in the clinical development of new compounds in the field of oncology
  • Consultancy in administration of PROs in a clinical oncology trial
  • Statistical review of PRO aspects of an oncology protocol
  • EMEA training on PROs in haematology and oncology
  • Identification of PRO measures suitable for implementation in phase III oncology and immunotherapy trials
  • Strategic consulting on PRO endpoints for FDA approvable claims
  • Development of a PRO best practices document – interactions with international regulatory and HTA agencies in oncology
  • PRO oncology workshop
  • Development of a PRO dossier for the Cancer Therapy Satisfaction Questionnaire (CTSQ) for the FDA
  • Carcinoid protocol review and outcomes strategy in oncology
  • Develop a reimbursement submission checklist in oncology
  • Consulting and participation in an EU/USA payer advisory board meeting on oncology
  • HEOR strategic consulting in oncology
  • Consulting and exploratory analysis of clinical trials of an intravenous drug treatment for cancer
  • Training session on health economics and outcomes research (HEOR) in oncology
  • Advisory board meeting on oncology
  • Strategic consultancy on recommendations of efficacy analyses in oncology using PRO data
  • Symposium oral presentation on clinical trial analyses to support health-related quality of life in oncology
  • Support MRI and qualitative analyses to document conceptual equivalence of an additional linguistic version of the Ascites Impact Measure (AIM) questionnaire
  • Development and validation of a measure of symptomatic malignant ascites leading to paracentesis for relief of abdominal discomfort
  • Assessment of the disease & TX-related symptoms and concepts for 7 oncology indications, and comparison to available measurement tools
  • Development and validation of a generic chemotherapy instrument
  • Psychometric validation of the Cancer Chemotherapy Satisfaction Questionnaire
  • Oncology post trial questionnaire, strategic review and content validation
  • Strategic review and content validation of a measure to evaluate the experience of participating in a clinical trial in oncology
  • Manuscript on the validation of the Cancer Therapy Satisfaction Questionnaire (CTSQ)
  • Literature review on autonomy for an intravenous drug treatment for cancer
  • Preferences and experiences of cancer patients and their families
  • Cognitive debriefing interviews for the development of a generic chemotherapy instrument
  • Team presentation on how to develop a PRO measure and interact with the FDA in oncology
  • Comparison of a generic EQ-5D-3L utility measure to new cancer-specific utility measure (QLU-C10D) and the EQ-5D-3L/5L cross-walks
  • Decision-making survey on granulocyte colony stimulating factor (G-CSF) in oncology
  • Review and confirmation of content validity of an existing cancer quality of life tool
  • Validation and implementation of a cancer tool to asses doctor and patient communication
  • Cognitive debriefing interviews to confirm the face and content validity of the modified cancer care plan communication tools
  • Development of an evidence evaluation framework in cancer
  • Statistical analyses of endpoints in oncology
  • Translations project in oncology

Other ophthalmology experience

  • Slides to outline the intravitreal injection process in the UK
  • Healthcare resource costing study for dry eye disease in the UK
  • Two mini value dossiers in glaucoma
  • Value messages and objection handlers for anti-vascular endothelial growth factor therapy (anti-VEGF) treatment in diabetic retinopathy and retinopathy of prematurity
  • Utility study feasibility assessment in retinitis pigmentosis
  • Health utilities in thyroid disease induced proptosis and diplopia
  • Exploratory analysis of phase II clinical trial data for acute optic neuritis
  • Manuscript on health-related quality of life trial results of a new lens
  • Analysis of focus group results in post-Lasik corneal sensitivity
  • Development and validation of a pterygium instrument
  • Development of a briefing document on a visual function questionnaire
  • PRO review of the subjective eyelid swelling scale for patients with eyelid swelling upon awakening in the morning
  • Analysis and reporting on completed interviews about eyelid swelling
  • Literature review of retinopathy of prematurity
  • Review of PRO measures in diabetic macular edema
  • Development of a PRO measure to assess impacts of full eye rejuvenation