Experience

Thalassemia

• Conference poster on the utility of oral versus subcutaneous iron chelation therapy for beta thalassaemia
• In-trial analyses of two treatments in thalassemia (TASTE-PRO)
• Manuscript support in thalassemia (TASTE-PRO)
• Modification of a satisfaction questionnaire for patients with thalassaemia receiving phlebotomy or oral therapy
• Clinical Trial analysis of PRO questionnaires in thalassaemia patients

Thromboembolism and pulmonary embolism

• Utility elicitation in thromboembolism in the UK
• HTA assessment of therapeutic interventions and treatments for venous thromboembolism
• Manuscript on the incidence of venous thromboembolism following major abdominal surgery
• Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
• In-trial cost-consequences analysis of a drug used in venous thromboembolism
• Matched cohort pulmonary embolism evaluation in orthopaedic surgery in Japan
• Consulting on the Anticoagulant Treatment Satisfaction (ACTS) scale as an endpoint for FDA claims in venous thromboembolism and thromboembolism prophylaxis
• Decentralised framework for real life data generation in venous thromboembolism

Transthyretin Familial Amyloid Polyneuropathy

• Real-world evidence toolkit in Transthyretin Familial Amyloid Polyneuropathy (TTR-FAP)

Tuberous sclerosis complex

• Review and input into a statistical analysis plan and two clinical study reports in relation to PRO analyses for a trial of an adjunctive therapy in patients with tuberous sclerosis complex who have refracory partial-onset seizures
• Post hoc analyses for a trial of an adjunctive therapy in patients with tuberous sclerosis complex who have refractory partial-onset seizures
• Review of PRO extension data in a trial of an adjunctive therapy in patients with tuberous sclerosis complex who have refractory partial-onset seizures
• Development of a web-based survey for patients with tuberous sclerosis complex or their caregivers
• Development of a patient and caregiver web-based survey on health state utilities for patients with tuberous sclerosis complex, and communication strategy
• Post-hoc analysis of PRO extension data in an EXIST-3 trial in tuberous sclerosis complex

Typhoid

• Burden of disease literature review on typhoid in the UK and Ireland

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

Upper tract urothelial carcinoma

• HEOR and market access activities in upper tract urothelial carcinoma (UTUC)
• Strategic consultancy for market access support in UTUC
• Updates to a Health Impact Projection (HIP) model in locally advanced or metastatic urothelial cancer
• Health economic data analysis in low-grade urothelial cancer
• Health economic data analysis in upper tract urothelial carcinoma
• Product monograph to support formulary inclusion in low grade upper tract urothelial carcinoma
• Abstract and poster for economic analysis in low-grade up UTUC

Uterine fibroids

• Consultation on the development of a diary to assess uterine fibroids
• Assessment of a minimal clinically important difference in a uterine fibroid symptom and quality of life questionnaire
• Design and pilot testing of an ePRO in uterine fibroids
• Regulatory and statistical support for an FDA claim in women with uterine fibroids
• Development of disease-specific modules for fibroids

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

Value dossiers

We have a vast amount of experience in this area including the creation of global/core value dossiers, AMCP dossiers, payer value/evidence dossiers and reimbursement dossiers.

• Actinic keratosis
• Anaesthesia
• Ankylosing spondylitis
• Aortic stenosis
• Asthma
• Atopic dermatitis
• Attention deficit hyperactivity disorder (ADHD)
• Breast cancer
• Chronic obstructive pulmonary disease (COPD)
• Colonoscopy
• Crohn’s disease
• Dengue fever
• Diabetes
• Fabry disease
• Febrile neutropenia
• Fungal infections
• Gastric cancer
• Glaucoma
• Glioblastoma
• Gram negative infections
• Heart failure
• Heroin addiction
• Hidradenitis suppurativa
• Human papilloma virus (HPV)
• Infertility
• Inflammatory bowel disease
• Influenza
• Insomnia
• Kidney disease/kidney failure
• Leukaemia
• Liver transplant
• Lung cancer (small cell and non-small cell)
• Melanoma
• Multiple myeloma
• Multiple sclerosis (MS)
• Myelodysplastic syndrome
• Myelofibrosis
• Nutritional supplements
• Osteoarthritis
• Pain (acute pain, chronic pain and trauma pain)
• Pancreatic cancer
• Parkinson’s disease
• Phenylketonuria
• Prostate cancer
• Psoriasis
• Psoriatic arthritis
• Refractory ascites
• Respiratory syncytial virus
• Restless leg syndrome
• Rheumatoid arthritis
• Schizophrenia
• Stress urinary incontinence
• Surgery
• Uveitis
• Varicella

Varicella

• Update to payer value slide deck for varicella
• Payer value deck for a varicella vaccine
• Payer material development for vaccines in varicella
• Response to payer questions deck in varicella
• e-v@luate platform on vaccines for varicella
• Value communication deck in varicella
• Value communications support and manuscript on parental attitudes and knowledge of the varicella vaccination in Sweden

Vertigo

• Communication of the economic burden of vertigo based on the REVERT registry
• Manuscript on clinical outcomes in vertigo

Von Willebrand disease

• Development and validation of a PRO measure in von Willebrand disease and haematology
• Pre-validation work to inform a clinical trial in von Willebrand disease
• In-trial validation of a PRO instrument in von Willebrand disease

Vulval cancer

• Budget impact models in vulval cancer
• Cost calculator to reflect change in patient estimation approach in vulval cancer

Warts

• Development of a paediatric, adolescent and adult QoL measure of viral warts
• ClinRO development for common warts
• Development, evaluation, and regulatory support for the Physician Wart Assessment

Weight loss, weight gain, eating disorders, obesity and nutrition

• Update of a budget impact model for an anorectic anti-obesity drug for cardiometabolic risk
• Service impact model on cardiovascular complications in obesity
• Value evidence story in obesity
• Adaptation of a budget impact model on an anorectic anti-obesity drug for Latin America
• Strategic guidance to support price and reimbursement in the EU in obesity
• Global value dossier on an oral nutritional supplement
• Statistical analysis and dossier development for localized fat reduction and body contouring
• Value evidence story in obesity
• Peripheral parenteral nutrition landscape review and manuscript for a medical device for surgical recovery
• Gap analysis of three PRO questionnaires for obesity trials
• Development of an instrument to assess subject perception of two gastric bands in obesity
• Focus groups for the development of a treatment expectations questionnaire and the face and content validition of a visual analogue scale (VAS) for patients with obesity
• PRO strategy in obesity
• Development and validation of an adherence to diet questionnaire in obesity
• Translation of an adherence to diet questionnaire in obesity
• Outcomes consulting for a treatment in obesity
• Item reduction for a questionnaire in obesity
• Development of a PRO measure in binge eating disorder
• Abstract and poster on binge eating disorder
• Position paper on an adherence questionnaire in weight loss
• Psychometric validation of a cohort study on adherence to lifestyle changes in weight loss and smoking cessation
• Development and validation of a questionnaire to assess well-being changes in people who would like to lose weight and quit smoking
• Manuscript on the development and validation of a lifestyle changes questionnaire for weight loss
• Cognitive interviews for PRO instruments in localized fat reduction and body contouring
• Development of a PRO questionnaire in abdominoplasty (tummy tuck)

Wound care

• Analysis of client’s value research in wound care treatment
• Investigation of ‘Trauma’ for a treatment in wound care
• e-v@luate platform for wound care evidence
• Value demonstration on a new wound care technology and the cost of pain management, allowing data to be tailored for local markets and local payers
• Review of a Japanese pricing submission in wound care
• Development and validation of a ClinRO to measure changes in peristomal skin

X-linked hypophosphatemia (XLH)

• Development of an FDA dossier in X-Linked Hypophosphatemia (XLH)
• Validation activities of an FDA dossier in XLH
• Psychometric validation of the Brief Pain Inventory (BPI) and Western Ontario and McMaster osteoarthritis index (WOMAC) in XLH using online survey data
• Exploration of content validity of PROMIS items for use in children with XLH
• Psychometric evaluation of the BPI-SF and WOMAC in XLH using phase III trial data

Yellow fever

• Burden of disease literature review on yellow fever in the UK and Ireland