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.

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 HTA and reimbursement

  • All Wales Medicines Strategy Group – breakthrough cancer pain
  • All Wales Medicines Strategy Group – infertility
  • All Wales Medicines Strategy Group – iron overload
  • Joint Committee on Vaccination and Immunisation – HPV (UK)
  • Reimbursement authorities – heart failure (Belgium)
  • EU market access training workshop

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

Other project experience

  • Development of a payer discussion guide for new in-license opportunities
  • Review of payer advisory board toolkit materials
  • Consultation on the difference between QoL and QoLIES and their usefulness in regulatory submissions and reimbursements
  • Review of evidence requirements for reimbursement submissions in northern and central Europe
  • Advice on ethical issues in health economics
  • Evaluation of the effectiveness of a referral management intervention on GP-referred outpatient planned care
  • Evaluation of the economic section for the Full Applications to a Personalized Medicine Contest
  • Questionnaire design and data analyses for cost of illness in Germany and the UK
  • Cost of illness review for 54 different diseases
  • Training session on health economics and outcomes research (HEOR)
  • Introductory training and slides on a Health Survey
  • Value strategy training on access to medical devices
  • Provision of support materials for the client’s health care sales meeting and training on material usage
  • Stakeholder interviews (KOLs and payers) in Algeria, Costa Rica, Ecuador, Morocco, Panama and Romania
  • Strategic HE advice on early HTA process
  • EU market access training workshop
  • HEOR strategic consulting
  • Landscape assessment of real-world data sources and impact on reimbursement decisions
  • Payer interviews and landscape analysis of real-world data requirements
  • Innovative contracting report
  • Development of an Affordability Toolbox
  • PRO strategy for observational studies
  • Development of a white paper on PROs in labelling and promotion
  • General consulting in PROs
  • Educational programme in productivity and other PROs
  • Statistical educational series for PROs
  • Support for Advisory Board meeting for Patient-Reported Outcome Excellence Project
  • Analysis, reporting and literature research on the influence of PROs in regulatory approval in China and Japan
  • Understanding the regulators perspectives for a successful submission of PRO data
  • Internal lecture on the use of PRO and HE in the development and commercialisation of drugs
  • Generic quality of life questionnaire, protocol review and providing initial feedback
  • Panel and presentation on PRO research on medical devices
  • Literature review of newly developed PROs in 5 specific disease areas
  • Presentation of a paediatric PRO training workshop
  • Consultancy and training in all aspects of PROs
  • Training on the importance of PROs and a slide deck detailing operational issues in PRO assessments
  • Development of a decision algorithm for incorporating PROs into clinical trials
  • PRO training and presentation
  • Training course on PROs in clinical research and regulatory submission
  • Workshop on draft PRO guidance for the FDA
  • PRO guidance presentation to health authorities
  • Development of a patient acceptability questionnaire for oral paediatric drugs
  • Consultancy on the protocol to compare the responsive reaction of patients between a traditional paper-administered questionnaire and an electronic touch screen device
  • Questionnaire development and testing for the iPLEDGE Risk Evaluation and Mitigation Strategy (REMS) program
  • Training in productivity measurement
  • Workshop to provide methods and strategic insights into linguistic validation of clinical outcomes assessments
  • Interviews and development of a patient acceptability questionnaire for oral paediatric drugs
  • Systematic review workshop
  • FDA advisory panel
  • Workshop on the Final Guidance to Industry
  • Development and presentation of an internal webinar on tolerability
  • Lecture on quality of life
  • Workshops at the Worldwide Outcomes Research Forum
  • Lecture on the use of the placebo effect in drug development
  • Mixed methods training session including Rasch and Item Response Theory Methodology
  • Development of a market access toolkit for China, South Korea and Taiwan
  • Analysis of market access knowledge gaps in Asia
  • Critical review of a systematic review report written in NICE submission style
  • Evaluation of the Japan Medical Data Center Database and comparison to medical data vision for combination use
  • Literature review, instrument review and database evaluation in 5 pathologies

Other rare diseases and orphan drugs

  • Literature review, consensus meeting and mapping of the treatment pathway in adrenoleukodystrophy
  • Presentation on the challenges and solutions of selecting and developing endpoints for use in paediatric populations and rare diseases
  • Measurement strategy to demonstrate efficacy of medical devices in patients with pigmented villonodular synovitis (PVNS) or tenosynovial giant cell tumour (dTGCT)

Other respiratory experience

  • Literature search and slide deck for a lung surfactant treatment
  • Cost calculator model for lung surfactant
  • Assessment of the commercial and economic value for the development of new diagnostic tests for respiratory infections
  • Review of existing respiratory compromise safety data
  • Respiratory manuscript editing and submission
  • Reimbursement pathway review in respiratory disease
  • Literature review on the clinical outcome assessment (COA) landscape of bacterial respiratory infections
  • COA landscape review and literature review in a vaccine for respiratory bacterial infections
  • Budget impact model in chronic cough
  • Development and validation of a preference questionnaire in a respiratory disease

Other urology and urogenital experience

  • Worldwide advisory board on a treatment for lower urinary tract symptoms (LUTS)
  • Content validation of a neurogenic detrusor overactivity (NDO) diary in paediatric spina bifida patients
  • Analysis of urology and gynaecology in patient waiting lists
  • Systematic review of lithotripters for ureterolithiasis
  • Presentation of a PRO in urology
  • PRO training in urology

Other vaccines

  • One-pager value communication tool for the measles, mumps and rubella (MMR) vaccine
  • Development of an e-v@luate EVIDENCE platform for a vaccines portfolio
  • Payer material development for vaccines in hepatitis A, rotavirus gastroenteritis (RVGE), shingles and varicella
  • Payer value slides for a varicella vaccine
  • Payer value deck for an MMR and varicella vaccine
  • Payer communications on a herpes zoster vaccine
  • e-v@luate platform on vaccines for HPV, varicella, MMR, shingles, hepatitis A and rotavirus
  • Payer slide deck to support HE models in dengue fever
  • Payer value deck update for a rotavirus vaccine
  • Estimating the return on investment from investing in adult immunisation in Europe
  • Strategic consultancy on physician attitudes and preferences regarding adult vaccinations
  • Payer value deck in adult rotavirus gastroenteritis
  • Payer value deck on the humanistic burden of rotavirus
  • Manuscript, economic model and literature review on the burden of rotavirus and the impact of vaccination on health care utilization in Europe
  • Value communications support and manuscript on parental attitudes and knowledge of the varicella vaccination in Sweden
  • Global value dossier on dengue fever
  • 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
  • Clinical outcome assessment (COA) landscape review and literature review in a vaccine for respiratory bacterial infections