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.

Artery diseases and high cholesterol

  • Literature review of burden of illness and cardiovascular risk group identification of symptomatic peripheral artery disease
  • Literature review and payer appraisals in peripheral artery disease
  • Budget impact and economic evaluation of a statin
  • Advisory board on arterial occlusive disease
  • Workshop communicating health economic data of an anticoagulant medication for deep vein thrombosis (DVT)
  • Development of a treatment satisfaction measure for an injectable low-density lipoprotein (LDL) cholesterol lowering medication
  • Costs for psychometric validation of the Injection-Treatment Acceptance Questionnaire (I-TAQ) in an independent observational study in hypercholesterolemia
  • Statistical consultancy to support use of the I-TAQ for a cholesterol-lowering medication
  • Production of a revised heart model for hypercholesterolaemia incorporating additional comments from country affiliates
  • Worldwide database analysis of statins and cholesterol levels
  • Probabilistic analysis of a statin model and advice on a pharmacoeconomic manuscript
  • Endpoint review for FDA-approved flushing claims in atherosclerosis

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
  • Core value dossier in ankylosing spondylitis
  • 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
  • Core value dossier on 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 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

Asthma

  • Systematic literature review on treatment patterns and burden of illness in asthma
  • Literature review, analysis and communications for asthma costs
  • Literature review of critical handling errors in asthma
  • Real-world evidence literature review in asthma
  • Landscape analysis in asthma and model assessment to support positioning paper
  • Structured literature reviews for paediatric wheeze detection
  • Rapid structured literature review of nebulisation inhalation efficiency in paediatric asthma and other respiratory conditions
  • Competitor literature review for real world evidence in asthma
  • Advisory board meeting on a literature review in asthma
  • Simple cost-utility model and targeted literature review for the treatment of asthma
  • Budget impact model and manuscript on asthma
  • Consultancy on exploratory economic modelling in severe asthma
  • Update to the pilot inference model for an inhaler used in the treatment of asthma
  • Health economic model in asthma
  • Economic model of asthma therapies for NICE
  • Economic model of combination asthma therapies for NICE
  • Resource use costing in asthma and communicating product value to a local payer audience
  • Global value dossier update on paediatric asthma
  • Global value dossier update and e-v@luate upload for an asthma device
  • Development of a mini global value dossier for an asthma device
  • e-v@luate platform development for paediatric asthma
  • Updates to critical handling error manuscript in asthma
  • Development of a manuscript in mild persistent asthma in specific geographies
  • Update to a critical handling errors manuscript in asthma
  • Preparation of a submission dossier for NICE on paediatric inhaled corticosteroid (ICS) drug use in asthma
  • Several conference posters on asthma, an asthma model, and economic analysis for the treatment of asthma
  • Advisory panel in asthma
  • Regulatory strategy consultancy in asthma
  • Consultancy on obtaining FDA approval of a treatment satisfaction claim for a new asthma treatment
  • Confirmation of an endpoint model for patients with asthma currently receiving treatment
  • PRO consulting on an asthma program for labelling
  • Cognitive debriefing to confirm the face and content validity of secondary endpoint questions in asthma
  • Database analysis and manuscript assessing death rate and hospitalisation rate in asthmatics
  • Development of a conceptual model and conceptual framework for the measurement of asthma control
  • Testing of a conceptual model of asthma in adolescents
  • Development of a symptom-based PRO instrument for adults and adolescents with asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Exit interviews on a connected inhaler system for asthma
  • Cognitive debriefing interviews in asthma
  • Validation of the Asthma Control Questionnaire (ACQ) using trial data
  • Manuscript on the psychometric validation of the ACQ report
  • Analyses of the ACQ
  • Conference poster reporting a ROC analysis performed to define cutpoints for the ACQ
  • Development of a questionnaire to assess control in children with paediatric asthma
  • Longitudinal validation of the Childhood Asthma Control Test (C-ACT)
  • Analysis and abstract on the longitudinal validation of the C-ACT
  • Validity assessment of the C-ACT in Japanese children
  • Validity assessment of the C-ACT in Hong Kong Chinese children
  • Complementary analyses on the C-ACT
  • Minimal clinically important differences for the C-ACT and symptom-free days/rescue medication–free days in paediatric asthma populations
  • Consulting on the linguistic validation of the C-ACT
  • Translation of the C-ACT
  • Equivalency testing of the modified Childhood Asthma Control Test (C-ACT) in children with mild to severe asthma
  • Cognitive debriefing of the Asthma Symptom and Control Diary (ASCD)
  • Linguistic validation of the Inhaled Corticosteroid Questionnaire (ICQ) into US English
  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Quantitative study to confirm the content validity of the ADSD
  • Development of a preference-based instrument specific to asthma

Asthma COPD overlap syndrome

  • Slide deck and manuscript in Asthma COPD Overlap Syndrome (ACOS)
  • Structured literature review on ACOS
  • Adequacy of COPD PROs for patients with ACOS

Atopic keratoconjunctivitis

  • Evaluation of focus groups, item generation, cognitive debriefing and analysis plan in atopic keratoconjunctivitis
  • Poster communication on atopic keratoconjunctivitis
  • Manuscript in atopic keratoconjunctivitis

Atrial fibrillation

  • Payer digital value communication testing in stroke prevention in patients with atrial fibrillation (SPAF)
  • Analysis of atrial fibrillation in the UK
  • Qualitative research on PROs in atrial fibrillation
  • Development of PRO instrument modules and validation research in atrial fibrillation
  • Manuscript on the development of a symptoms questionnaire in atrial fibrillation
  • Decentralised framework for real life data generation in stroke prevention in atrial fibrillation (SPAF)
  • Reporting of development work in atrial fibrillation
  • Indirect comparison of two drugs used in the prevention of thromboembolic events due to atrial fibrillation
  • Analysis of the Anti-Clot Treatment Scale (ACTS), Treatment Satisfaction Questionnaire for Medication (TSQM) and healthcare resource utilization in a clinical trial in atrial fibrillation
  • Manuscript development on the ACTS/TSQM data
  • Manuscript support for statistical results in an observational study measuring outcomes in atrial fibrillation
  • Measurement of resource use, satisfaction, productivity and HRQoL in atrial fibrillation
  • Translation and validation of the ACTS and TSQM in atrial fibrillation in Japan

Autism

  • Equivalency testing of an eCOA version of the Vineland Adaptive Behavior Scales II (VABS-II) for use in autism spectrum disorder

Barth syndrome

  • Concept elicitation interviews in Barth syndrome patients
  • Concept selection meeting for a PRO in Barth syndrome
  • Cognitive debriefing for Barth syndrome PROs
  • Qualitative concept elicitation and case studies documenting the disease progression of Barth Syndrome

Biosimilars

Endocrinology

  • Payer value slide deck for a biosimilar in diabetes
  • Budget impact models for a biosimilar in type 1 and type 2 diabetes mellitus
  • Global value dossier, AMCP and accompanying slide sets for an insulin biosimilar

Immunology

  • Payer value slides for immunology biosimilars
  • Frequently asked questions to support the introduction of a new biosimilar in immunology
  • Frequently asked questions for biosimilar policy in immunology
  • Frequently asked questions on an immunology biosimilar for rheumatoid arthritis
  • Budget impact model for a biosimilar
  • Literature review and update to budget impact model in an immunology biosimilar
  • Updates to a US budget impact model for an immunology biosimilar
  • Update to an AMCP dossier for an immunology biosimilar
  • Originator vs. biosimilar value proposition update in immunology
  • Updates to a global value dossier, AMCP dossier and budget impact model on a rheumatoid arthritis biosimilar

Musculoskeletal diseases

  • Value message testing for a biosimilar in rheumatoid arthritis
  • Budget impact model for a biosimilar in autoimmune disease

Oncology

  • Burden of disease deck and frequently asked questions deck in breast cancer biosimilars
  • Development of a cost-calculator for a biosimilar for breast and gastric cancer
  • One-pager communication in a breast cancer biosimilar
  • Payer value deck update for a breast cancer biosimilar
  • Response to payer questions update for a breast cancer biosimilar
  • Budget impact model for a biosimilar in HER2 breast cancer
  • Budget impact model on an oncology biosimilar

Women’s health

  • Development of a value dossier, health economic model and literature review in an infertility biosimilar to support pricing and reimbursement submissions in 15 EU countries
  • Pricing updates in Europe for a biosimilar hormone treatment for female infertility

Other

  • Global value and reimbursement dossier for a biosimilar in autoimmune disease
  • Biosimilar payer communications in dermatology, gastroenterology and immunology
  • Global value dossiers and budget impact models for biosimilars in ankylosing spondylitis, Crohn’s disease, inflammatory bowel disease (IBD), osteoarthritis, psoriasis and rheumatoid arthritis
  • Manuscript on a budget impact model for a biosimilar in haematology and rheumatology

Bipolar disorder

  • Systematic literature review and manuscript on the burden of illness in bipolar disorder
  • Psychometric validation of the Sheehan Disability Scale in bipolar disorder
  • Support network study to improve compliance in a psychotropic medication used in bipolar disorder
  • FDA PRO dossier on bipolar depression
  • Development of an endpoint model, training and recommendations for endpoint support in bipolar disorder
  • Composition of a PASS report on bipolar disorder, including a review of local physician monitoring guidelines
  • Validation of the Caregiver Strain Questionnaire in paediatric bipolar disease

Bladder cancer

  • Burden of disease deck in bladder cancer
  • Payer value deck in bladder cancer
  • Frequently asked questions in bladder cancer
  • Payer implementation guide in bladder cancer
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in 2nd line bladder cancer
  • Burden of disease deck in non-muscle invasive bladder cancer
  • Payer value deck update in 2nd line bladder cancer
  • Standardization of economic models in bladder cancer
  • Qualitative research in bladder cancer
  • Clinical trial analyses to support health-related quality of life in bladder cancer
  • ‘Fit for purpose’ tools review in bladder cancer
  • Development of a new PRO measure in bladder cancer
  • AMNOG analyses to support health-related quality of life in bladder cancer

Brain metastases

  • Development and validation of a PRO measure in brain metastases
  • Development and validation of a questionnaire to assess brain metastases
  • Linguistic validation of a brain metastases assessment

Brain tumours

  • Health Economics and Translational Advisory Board on paediatric brain tumours
  • Support in personalised medicine health economics on brain tumours

Breast cancer

  • Global value dossier for treatment in breast cancer
  • Data collection of costs associated with breast cancer care
  • Manuscript on the German model for a hormonal drug used in the treatment of breast cancer
  • Development of two budget impact models in breast cancer with population data by city
  • Two budget impact models for Italy for an injectable chemotherapy drug for breast cancer
  • Budget impact model in breast cancer for France
  • Development of a cost-calculator for a biosimilar for breast cancer
  • Payer value deck in breast cancer
  • Payer value deck update for a breast cancer biosimilar
  • Burden of disease deck in breast cancer
  • Response to payer questions in breast cancer
  • Response to payer questions update for a breast cancer biosimilar
  • Burden of disease deck and frequently asked questions deck in breast cancer biosimilars
  • One-pager communication in a breast cancer biosimilar
  • Productivity and QoL study in breast cancer
  • Literature review and consultancy on breast cancer
  • e-v@luate platforms in breast cancer
  • Market access training and workshop on breast cancer

HER2 positive breast cancer

  • Literature review of productivity data in HER2 positive breast cancer
  • Budget impact model for a biosimilar in HER2 breast cancer

Advanced breast cancer

  • Development of a perceived tolerability questionnaire in first line treatment of advanced breast cancer
  • Strategy for an injectable chemotherapy drug for advanced breast cancer and submission to NICE/SMC
  • Budget impact model and analysis for an injectable chemotherapy drug for advanced breast cancer in 5 EU countries
  • Economic evaluation of a therapy for postmenopausal women with advanced breast cancer (with the perspective of 3rd party national and local payers in the UK)
  • Development and population of an economic model in advanced breast cancer
  • Conference poster on a cost utility analysis of two treatments for advanced breast cancer
  • Conference poster on the economic evaluation of a therapy for postmenopausal women with advanced breast cancer
  • Phase IV non-interventional prospective observational study comparing patient reported outcomes in advanced breast cancer
  • PRO label review manuscript development in advanced/metastatic breast cancer

Metastatic breast cancer

  • Value dossier and e-v@luate platform in metastatic breast cancer
  • Scientific communication of cost-effectiveness analysis in metastatic breast cancer
  • PRO knowledge base instruments and methods library for metastatic breast cancer
  • Update to a Health Impact Projection (HIP) model in metastatic triple negative breast cancer

Triple negative breast cancer

  • Global value dossier and upload to e-v@luate platform in triple negative breast cancer
  • Data analyses on a multi-indication budget impact model and cost utility model in triple negative breast cancer
  • Payer value tool in triple negative breast cancer (TNBC)
  • Standalone budget impact models in triple negative breast cancer
  • Update to a Health Impact Projection (HIP) model in neo-adjuvant triple negative breast cancer

Bronchitis

  • Development of a cough and sputum questionnaire in chronic bronchitis in 7 languages
  • Validation of a cough and sputum questionnaire in chronic bronchitis
  • Development and validation of a patient diary for evaluating acute exacerbation of chronic bronchitis
  • Conducting European focus group sessions for acute exacerbation of chronic bronchitis
  • Validation of a patient diary for evaluating acute exacerbation of chronic bronchitis (AECB)

Cancer-related pain, fatigue and side effects

Cancer-related pain and fatigue

  • Initial consultation to design a study in order to generate health utilities values associated with different levels of cancer-related pain
  • Utility study in breakthrough cancer pain
  • Update of report for utility elicitation in breakthrough cancer pain
  • Abstract, manuscript and budget impact model on breakthrough cancer pain
  • Training in pilot budget impact model for a treatment for patients with breakthrough cancer pain
  • SMC submission in breakthrough cancer pain
  • Development of a breakthrough cancer pain submission to the All Wales Medicines Strategy Group (AWMSG)
  • Attendance at an AWMSG meeting with regards to strategic consultancy in breakthrough cancer pain
  • Expert interviews and amendment project to heath economic model for a treatment for breakthrough cancer pain
  • Economic evaluation of a treatment for breakthrough cancer pain in Canada
  • Budget impact tool for a treatment for patients with breakthrough cancer pain in the UK
  • Consulting support and development of a briefing document to support fatigue symptom claims in cancer pain
  • Recommendation of a measure of chronic cancer pain
  • Assessment of a pain communication tool for advanced cancer patients: a cross-sectional survey
  • Qualitative research for the Cancer-Related Fatigue Consortium
  • Phase II cognitive interviews on Patient-Reported Outcomes of Fatigue – Cancer (PROOF-C)
  • Cancer-related fatigue consortium: qualitative research in the experience of fatigue among cancer patients
  • Qualitative research on the experience of fatigue among cancer patients
  • PRO development, abstracts and posters on cancer-related fatigue

Cancer-related anaemia

  • Linking a cost utility assessment model with a budget impact model for treatment for anaemia in cancer
  • NICE consultancy for a treatment for chemotherapy-induced anaemia
  • Statistical pharmacoeconomic analysis of patient level data for a treatment for anaemia following chemotherapy
  • Phase II cognitive interviews and regulatory support in inflammatory anaemia in cancer
  • Evaluation of the PRO landscape using a systematic literature review on chemo-induced anaemia in oncology

Other cancer-related side effects

  • Value dossier on a drug used to treat febrile neutropenia
  • Plan, execute and follow up a Train-the-Trainer meeting on chemotherapy-induced febrile neutropenia
  • Development of a PRO measure in muscle wasting (cancer cachexia) in prostate cancer, sarcopenia, gastric cancer and colorectal cancer
  • Debriefing of the cancer associated fibroblasts (CaF) PRO
  • SMC re-submission and economic analysis for a treatment for anthracycline extravasation
  • Case control study of costs associated with a treatment for oral mucositis in transplant patients
  • Literature review and recommendations on PROs for peripheral neuropathy due to chemotherapy in cancer patients
  • Review of PRO instruments for use in uveal melanoma and biliary tract cancer

Cataracts

  • Etiology and meta-analysis of posterior cacular opacification comparing two lens types
  • Meta-analysis of phacoemulsification, extracapsular cataract extraction (ECCE) and manual small incision cataract surgery (MSICS) in Asia
  • Formal recommendations on a regulatory briefing document for intraocular cataract lenses
  • Development of a PRO questionnaire to assess implantation of an intraocular lens in cataract patients
  • Cognitive interviews for the development of a PRO to assess intraocular lenses in cataract patients
  • Support on the intraocular lenses Expert Focus Group
  • Quality of life study in cataracts