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.

Haemochromatosis (Iron overload)

  • Consulting on a manuscript on a hereditary haemochromatosis and phlebotomy PRO and market research
  • FDA memo for the development and validation of a screening tool to identify patients with haemochromatosis
  • Utility study for treating for iron overload
  • Submission to the All Wales Medicines Strategy Group (AWMSG) for a treatment for chronic iron overload
  • Submission to SMC for a treatment for chronic iron overload
  • Manuscript on the utility of oral versus subcutaneous iron chelation therapy
  • High level consulting: PRO strategy for reimbursement packages in Europe for iron overload
  • Clinician and patient interviews for a PRO in iron overload
  • Abstacts, posters, analyses, report and manuscript on iron overload
  • High level consulting: PRO strategy for reimbursement packages in iron overload for Italy and France, using satisfaction and self-esteem data
  • PRO analyses and validation manuscript in iron overload
  • Development of a PRO augmentation and manuscript in iron overload
  • Analysis and communications of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy
  • Communication of PRO data from a clinical trial in iron-overload patients receiving iron chelation therapy

Haemophilia

  • Literature review and report on haemophilia B
  • Literature review in haemophilia A
  • Value messages and payer testing for treatment of haemophilia A
  • Budget impact model for haemophilia in Japan
  • Consultancy support for a PRO strategy in haemophilia
  • Critical review of PROs to inform a PRO Strategy for anti–tissue factor pathway inhibitor (Anti-TFPI) in haemophilia A
  • Exit interviews to assess the impact of infusion frequency in haemophilia A
  • Consulting work in haemophilia
  • Systematic review of haemophilia treatments
  • IRB submission for haemophilia patient interviews
  • Development of a compliance questionnaire in haemophilia
  • Development of a novel tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Testing of a web-based tool to evaluate patient preference for a reconstitution device for haemophilia A in a real-world setting
  • Development of a content-valid life interference questionnaire for haemophilia
  • Patient expert advice meetings – mode of action (MOA) equivalency for hemophilia bleed and infusion diary
  • Patient expert advice meetings – usability for hemophilia bleed and infusion diary

Head and neck cancer

  • Adaptation of a multi-indication value-based pricing model in head and neck cancer to China
  • Health economic advisory board on a treatment for head and neck cancer
  • Payer tools implementation guide in head & neck cancer
  • Payer value proposition deck in 2nd line head & neck cancer
  • Payer communications strategy and tools in head and neck cancer
  • Payer communication tool and summary in SCCHN
  • Burden of disease deck, payer value dossier deck and frequently asked questions deck in 2nd line head and neck cancer
  • One-pager on HPV in head and neck cancer
  • Market access and pricing tools to support a value proposition in squamous cell carcinoma of the head and neck (SCCHN)
  • Market access payer value tool in head and neck cancer
  • Economic value story in SCCHN
  • Standardization of economic models in head and neck cancer
  • Value-based model in head and neck cancer
  • Multi-indication budget impact model in head and neck cancer
  • Cost-effectiveness model in head and neck cancer
  • Global model update and country adaptations for a multi-indication value-based pricing (VBP) model on head and neck cancer
  • Dossier for a chemotherapy drug for head and neck cancer
  • Reimbursement dossiers in subgroups of head and neck cancer
  • Mini literature review in SCCHN
  • Literature review and payer communication tools in SCCHN
  • Development of an evidence compendium for HPV-related head and neck cancers
  • One-pager on HPV-related head and neck cancer
  • Update to a Belgian value-based pricing model in head and neck cancer
  • Updates to a Health Impact Projection (HIP) model in recurrent or metastatic head and neck cancer
  • Update of market access tools in SCCHN
  • Clinical trial analyses to support health-related quality of life in head and neck cancer
  • Qualitative interviews to assess equivalence of paper and electronically administered questionnaires in head and neck cancer
  • SMC submission of a chemotherapy drug in head and neck cancer
  • Two manuscripts and one mini report for the head and neck cancer models for the UK
  • US costing for a head and neck cancer model
  • Health-related quality of life analyses to support a treatment for head and neck cancer: a Q-TWiST analysis
  • AMNOG and ad hoc analyses to support health-related quality of life in SCCHN

Heart disease

  • Global value dossier on cardiovascular disease and dyslipidaemia
  • Literature review of cardiovascular disease in migraine patients
  • Update of a report on the impact of changing total cholesterol targets in the General Medical Services (GMS) contract for heart disease
  • NHS and public health impact of revising General Medical Services (GMS) targets for cholesterol in coronary heart disease
  • Manuscript on the cost-effectiveness and budget impact of a statin treatment for coronary heart disease
  • Targeted literature review and value messages for cardiovascular disease
  • Investigator training and analysis of QoL data in heart disease
  • Analysis of the prevalence of bradycardia and co-morbidities in coronary artery disease
  • Data management and reporting of an outcomes project on a statin drug for the treatment of heart disease
  • Analysis of the SF-ESTQ in the JEWEL studies in heart disease
  • PRO questionnaire development for statin intolerance
  • Demonstrating the value of a transcatheter heart valve in aortic stenosis
  • Report on the cost of diagnosing vascular diseases with an MRA as the primary imaging modality
  • Consultation on an epidemiological quality of life study in cardiovascular disease
  • Development of a PRO best practices document in cardiovascular diseases – interactions with international regulatory and HTA agencies

Heart failure and transthyretin amyloid cardiomyopathy (ATTR-CM)

  • Payer value proposition and communication for a new remote patient monitoring platform in congestive heart failure
  • Objection handlers in transthyretin amyloid cardiomyopathy (ATTR-CM)
  • Objection handler and value story updates in ATTR-CM
  • Disease area review, burden of illness and unmet needs in heart failure (and associated renal dysfunction)
  • Development of a PRO dossier for the Minnesota Living with Heart Failure Questionnaire and selection of a validated dyspnoea questionnaire
  • Content validity of a symptom endpoint and dossier in heart failure with preserved ejection fraction
  • Consultation on the validation of a primary clinical endpoint in heart failure
  • Chart review of heart failure in China
  • Meetings for a heart failure study
  • Heart failure chart review in China
  • Caregiver burden in patients with chronic heart failure
  • Psychometric validation of the chronic heart failure (CHF) caregiver burden questionnaire
  • Support for additional translations of the Heart Failure Compliance Questionnaire (HFCQ) for chronic heart failure
  • Network meta-analysis of pharmacological treatment of heart failure
  • Selection of a caregiver burden questionnaire for acute decompensated heart failure

Hepatitis

Hepatitis A

  • Update to payer value deck in Hepatitis A
  • Payer material development for vaccines in hepatitis A
  • e-v@luate platform on vaccines for hepatitis A
  • Burden of disease literature review on hepatitis A in the UK and Ireland

Hepatitis B

  • Systematic literature review of a treatment for chronic hepatitis B
  • Preparation of a NICE submission for a hepatitis B drug
  • SMC submission for a treatment for chronic hepatitis B
  • Database analysis to calculate the economic burden of hepatitis B in the UK

Hepatitis C

  • Therapeutic area strategy analysis and reporting in chronic hepatitis C virus
  • Biomarkers in the treatment of hepatitis C virus infected patients – personalised medicine
  • Maximizing the use of a treatment for hepatitis C-infected patients through personalised medicine – extending the tool to additional treatments
  • Treatment algorithm for hepatitis C treatment
  • One-pager value communication tool for Hepatitis C
  • Comprehensive literature research in chronic hepatitis C in Asian countries
  • Database development and analysis in hepatitis C
  • Concept elicitation and cognitive debriefing interviews with hepatitis C patients in multiple countries
  • Development of an EMA summary document for several instruments used in hepatitis C trials
  • Development of a PRO outcomes summary document and communications support in hepatitis C trials
  • Description, interpretation and analysis of pooled data related to the use of several questionnaires, scales and screening tests in three hepatitis C clinical trials
  • Conceptual model for patients with hepatitis C
  • Psychometric validation of a hepatitis C symptom checklist using phase III trial data
  • Treatment patterns, healthcare utilization and costs associated with the hepatitis C virus in Japan
  • Selection of PRO measures for hepatitis C trials

Hepatology

  • Value dossier on a treatment for post liver transplant in paediatric patients
  • Development of an economic model for treatment in post-liver transplant in paediatric patients
  • Structured literature reviews on the burden of disease of nonalcoholic steatohepatitis (NASH)
  • Strategic review and recommendations for paediatric endpoints to assess pruritis in colostatic liver disease
  • Written critique of hepatology
  • Measures for use in patients with autosomal dominant polycystic kidney and liver disease: development and validation of a symptom measure and validation of a health survey

Hereditary angioedema

  • Development of the evidence base regarding treatment patterns, cost and burden of disease for patients with hereditary angioedema to support the use of a new treatment
  • Communications package in hereditary angioedema
  • Clinical endpoint review, recommendations and update of an FDA submission package in hereditary angioedema
  • Hereditary angioedema clinical trial endpoint review, recommendations and FDA PRO submission package
  • Pooled clinical trial validation analysis of a PRO primary endpoint in hereditary angioedema to include in FDA submission package
  • FDA meeting support for a hereditary angioedema submission
  • Evaluation of market research reports in hereditary angioedema to support PRO submission package
  • Analysis of Visual Analogue Scale (VAS) summary scores with Last Observation Carried Forward (LOCF) in hereditary angioedema
  • Psychometric validation analysis of VAS summary scores in hereditary angioedema
  • Patient interviews for the face and content validation of the Patient Global Impression in hereditary angioedema
  • Psychometric validation of the 6-item and 8-item composite severity scores in hereditary angioedema
  • Consulting on the linguistic validation of a hereditary angioedema questionnaire into French, German and Portuguese
  • Cognitive debriefing of a questionnaire in hereditary angioedema patients
  • Validation and modifications to a questionnaire in hereditary angioedema patients
  • Consultancy services for linguistic validation of a hereditary angioedema diary
  • Publication strategy to present the results of studies in hereditary angioedema
  • Patient interviews to support a PRO submission package in hereditary angioedema
  • PRO briefing document in hereditary angioedema
  • Strategic consulting and analysis in hereditary angioedema
  • Re-analysis of patient composite score in hereditary angioedema
  • Training materials for a PRO questionnaire in hereditary angioedema
  • Publication strategy on hereditary angioedema

Herpes zoster (shingles)

  • Payer communications on herpes zoster
  • Payer communications on a herpes zoster vaccine
  • A review of HTA guidance in nine countries to determine requirements for indirect costs in herpes zoster
  • Review of cost-effectiveness studies in post-herpetic neuralgia (PHN)
  • PRO literature review, instrumentation, gap analysis and recommendations in herpes zoster and post-herpetic neuralgia (PHN)
  • Development of a conference abstract and poster on herpes zoster and post-herpetic neuralgia
  • Development of two manuscripts on a herpes zoster study
  • Literature review investigating the burden of disease of herpes zoster and post-herpetic neuralgia in Europe
  • Systematic literature review on the caregiver burden in herpes zoster (shingles) and post-herpetic neuralgia
  • Searches to update a critical review of evidence documenting the humanistic, economic and societal burden of herpes zoster in Europe
  • Research study on the impact on quality of life in herpes zoster
  • Systematic literature review report on herpes zoster
  • Validation of the Numerical Rating Scale (NRS) in post-herpetic neuralgia
  • Payer material development for vaccines in shingles
  • e-v@luate platform on vaccines for shingles

Hidradenitis suppurativa

  • Core value dossier to support new treatment in hidradenitis suppurativa
  • Update to a value proposition deck with adolescent data in hidradentis suppurativa
  • Core value dossier, payer value proposition and objection handler update in hidradenitis suppurativa
  • Structured literature review and value dossier updates in a biosimilar for hidradenitis suppurativa
  • Development and validation of a PRO tool in hidradenitis suppurativa
  • Measurement of pain in hidradenitis suppurativa
  • Development of a PRO in hidradenitis suppurativa
  • Development of an investigator training manual in hidradenitis suppurativa
  • Development of FDA response on phase II hidradenitis suppurativa study protocol
  • Poster for a PRO in hidradenitis suppurativa
  • Mechanism of Action (MOA) Equivalency Testing in hidradenitis suppurativa
  • Clinical endpoint guidance and observational study in hidradenitis suppurativa
  • ClinRO inter-rater reliability study in hidradenitis suppurtiva
  • Design, placement and placement of outcomes in registry for hidradenitis suppurativa
  • HEOR strategic consulting in hidradenitis suppurativa
  • Pre- and post-surgery research study in hidradenitis suppurativa
  • Development of three measurement dossiers in hidradenitis suppurativa to support regulatory submissions
  • Psychometric testing of the Hidradenitis Suppurativa Impact Assessment (HSIA) and Hidradenitis Suppurativa Symptom Assessment (HSSA)
  • Summary report and publications for hidradenitis suppurativa pain and relevant tools
  • Evaluating the clinical meaning of defining treatment response based on the Hidradenitis Suppurativa Clinical Response (HiSCR)
  • Statistical analyses of registry data (UNITE) in hidradenitis suppurativa
  • Literature review on hidradenitis suppurativa

Homocystinuria

  • Health economic analysis for SMC resubmission in homocystinuria

HPV vaccines

  • Value pack for a HPV vaccine
  • Payer value deck update for HPV
  • Literature review of epidemiology and economic data in HPV
  • Systematic literature review on the indirect protection from the HPV vaccination
  • HTA submission for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • Manuscripts on the German and Spanish cost-effectiveness analysis of a HPV vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • Training sales reps on an interactive model for a HPV vaccine
  • Update to European one-pager value communication tool for a nine-valent HPV vaccine
  • One-pager communication tool on cross-protection in HPV
  • Revision of one-pagers in HPV vaccines
  • e-v@luate platform for HPV vaccines
  • Evidence package (literature review and value messages) for HPV vaccination
  • Development of a rationale for the need for a HPV vaccine
  • Development of an evidence compendium for HPV-related head and neck cancers
  • One-pager value communication on discounting approaches to HPV vaccination
  • One-pager on HPV-related head and neck cancer
  • Global value dossier modules for HPV vaccination cohorts
  • Anthropological study on the impact of HPV-related diseases
  • Manuscript on a HPV vaccine acceptance study in middle aged persons
  • HPV vaccination impact model in infectious diseases
  • HPV dossiers workshops and value message development

Human immunodeficiency virus (HIV) / Acquired immune deficiency syndrome (AIDS)

  • Business planning toolkit in HIV
  • Development of a payer value story in HIV
  • Payer value story briefing document in HIV
  • Review of an economic model for HIV and submission to the SMC
  • Budget impact model in HIV
  • Targeted literature review of adherence in HIV
  • Targeted literature review in HIV and inflammation
  • Targeted literature synthesis of viral blips and viremia in patients with HIV
  • Literature review on inflammation in patients with HIV
  • Consulting in a multinational case-control study: Impact of side effects on the quality of life (QoL) of HIV patients
  • Advisory board consultation regarding product status and development in HIV
  • General consultancy on PRO endpoints in HIV/AIDS trials
  • Recommendations for the inclusion of PROs into HIV trials
  • Development of an expert report and FDA meeting on tolerability in HIV
  • Consulting on the development of a PRO strategy for international HIV trials with interviews in the US and Puerto Rico
  • Consulting on study documents and development of SAP for psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Preparation and development of a manuscript on HIV Patient Symptom Profile (HIV PSP)
  • Preliminary psychometric validation of the HIV PSP questionnaire using the UK SWITCH study data
  • Analysis of HIV PSP data from the SWITCH study to compare treatment arms
  • Confirming concept definitions of the HIV Treatment Tolerability Index for translation purposes
  • An evidence synthesis on the efficacy and safety of two drugs and protease inhibitors in treatment‑naïve HIV patients
  • Manuscript network meta-analysis of an antiretroviral drug for the treatment of HIV
  • Budget impact tool for an antiretroviral drug for treatment-naive HIV
  • Literature review of the epidemiology and burden of illness in HIV-related neuropathy
  • Top-up literature review, revised manuscript and presentations on HIV and AIDS
  • Development and psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Two abstracts, two posters and a manuscript on the development and psychometric validation of a PRO instrument of tolerability in patients with HIV
  • Selection of PRO measures for HIV trials

Human papillomavirus (HPV)

  • Value cards for human papillomavirus (HPV)
  • Payer value deck and frequently asked questions for HPV and HPV-related diseases
  • Value pack for a HPV vaccine
  • Brief adaptation of a Markov model for a HPV vaccine
  • Update of a budget impact model for a HPV vaccine
  • Cost-effectiveness analysis of a HPV vaccine for Spain
  • HPV vaccination impact model in infectious diseases
  • HTA submission for a HPV vaccine
  • Manuscript on the German cost-effectiveness analysis of a HPV vaccine
  • Manuscript on the Spanish cost-effectiveness analysis of a HPV vaccine
  • Systematic literature review on the indirect protection from the HPV vaccination
  • Value demonstration and implementation plan for a new HPV test
  • Training sales reps on an interactive model for a HPV vaccine
  • Analysis and reporting on the budget impact of a HPV vaccine
  • One-pager communication tool on cross-protection in HPV
  • One-pager on HPV in head and neck cancer
  • Revision of one-pagers in HPV vaccines
  • Literature review of epidemiology and economic data in HPV
  • Update to European one-pager value communication tools for HPV and for a nine-valent HPV vaccine
  • e-v@luate platform for HPV vaccines
  • Update to a payer value deck in HPV infection
  • Evidence package (literature review and value messages) for HPV vaccination
  • Adaptation of a Markov model on a HPV vaccine to Belgium
  • Development of a rationale for the need for a HPV vaccine
  • Development of an evidence compendium for HPV-related head and neck cancers
  • One-pager value communication on discounting approaches to HPV vaccination
  • Global value dossier modules for HPV vaccination cohorts
  • Anthropological study on the impact of HPV-related diseases
  • Manuscript on a HPV vaccine acceptance study in middle aged persons
  • Value communications for HPV immunisation data systems
  • HPV dossiers workshops and value message development
  • One-pager on HPV-related head and neck cancer
  • Development of a PRO strategy in cervical cancer and HPV
  • Summary report, top-up literature review, meta-analysis, editorial board and manuscripts on HPV infection and cervical cancer

Hunter’s syndrome

  • Exploration of IQ as a relevant endpoint in Hunter’s syndrome
  • Endpoint review in Hunter’s syndrome
  • PRO dossier on the Disease Activity Score (DAS), Scales of Independent Behaviour-Revised (SIB-R), Behaviour Rating Inventory of Executive Function (BRIEF) and Vineland Adaptive Behaviour Scales (VABS) for Hunter’s syndrome
  • Strategic PRO and ObsRO analysis of a Hunter’s Syndrome clinical trial database
  • Regulatory support for questionnaires in Hunter’s syndrome

Hypertension and Hypotension

Hypertension

  • Strategic treatment pathways for treatment in pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH)
  • Update to payer value decks in PAH and CTEPH
  • Framework for real world evidence generation in PAH and CTEPH
  • Strategic plan and real-world evidence toolkit in PAH and CTEPH
  • Consultancy on interpretation of phase III trial endpoints in PAH and CTEPH
  • Meta-analysis, systematic literature review, data extraction and report on an oral combination treatment of PAH
  • Systematic literature review, data extraction & report on sensitivity analyses and a meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral combination treatment of PAH
  • Meta-analysis of an oral treatment of PAH – exploratory analyses on the effect of administering additional PAH-specific therapy upon two additional endpoints
  • Literature review of pulmonary hypertension secondary to chronic obstructive pulmonary disease (COPD)
  • Utility assessment in PAH
  • Literature review of PAH secondary to chronic obstructive pulmonary disease (COPD)
  • Interpretation of clinical trial results in PAH
  • Cognitive debriefing interviews with patients with PAH
  • Network meta-analysis of combination therapies in PAH
  • Psychometric validation of the Living with Pulmonary Hypertension (LPH) questionnaire in PAH
  • PRO claims for PAH – endpoint review and regulatory support for the FDA and EMEA
  • PRO claims for PAH: endpoint review, regulatory support and qualitative patient interviews
  • Qualitative research to explore patient preference for modes of administration in PAH treatments
  • Budget impact model for an anti-hypertensive treatment
  • UK cost offset model of two treatments for hypertension
  • Preparation of an interactive report on a cost-offset model for a treatment for hypertension
  • Asian value dossier for hypertension
  • Heart study economic model in hypertension
  • Advisory board on hypertension
  • Cost model for a direct renin inhibitor medication for the treatment of hypertension
  • Validation of an adherence questionnaire for hypertension patients utilizing administrative data
  • Hypertension database analysis in Japan
  • Data management and reporting on a cardiovascular health outcomes project switching study in hypertension
  • Development of a compliance and persistence screener in hypertensive patients at risk for cardiovascular events
  • Validation of data analysis with an FDA response in orthostatic hypertension
  • Adaptation of a heart study economic model in hypertension to Korea
  • Validation of the hypertension / dyslipidaemia treatment satisfaction survey

Hypotension

  • Defence of the use of the Orthostatic Hypotension Questionnaire (OHQ) to demonstrate treatment benefit and labelling claim in neurogenic orthostatic hypotension
  • Validation of the OHQ in neurogenic orthostatic hypotension using clinical trial data
  • Key opinion leader interviews on neurogenic orthostatic hypotension
  • Evaluation of the current measurement strategy in neurogenic orthostatic hypotension

Hypogonadism

  • Utility evaluation for administration frequency for a drug for hypogonadism
  • Targeted literature review, value proposition and budget impact model in hypogonadism
  • Consultation on an FDA submission hypogonadism
  • Development of a hypogonadism questionnaire
  • Psychometric validation of the hypogonadism questionnaire
  • Consultancy on FDA-related issues on a hypogonadism questionnaire

Hyponatremia

  • Qualitative study to support the content validity of the trail making test and MOS-Cognition in patients with hyponatremia
  • Psychometric validation study of the TMT-B and MOS-Cognition tests in patients with hyponatremia
  • Regulatory support for cognition endpoints of a treatment for hyponatremia
  • FDA advisory committee meeting support for HRQoL endpoints in hyponatraemia

Idiopathic pulmonary fibrosis

  • Landscape economic outcomes data analysis in idiopathic pulmonary fibrosis
  • Assistance with a Delphi panel and consensus statement on idiopathic pulmonary fibrosis