Experience

Adelphi Values has an experienced global team of qualitative researchers, health economists, statisticians, creative scientists, clinicians and strategists with industry experience, who truly understand the need to develop evidence and communicate value throughout the product lifecycle.

Below is a selection of our projects, presented according to therapeutic or strategic/methodological area. It is not exhaustive, and we would be happy to provide further information on request.

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

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