Strategic and methodological areas

College voor zorgverzekeringen (CVZ – Netherlands)

  • Cost-effectiveness assessment for drug to be listed on the hospital ‘expensive drug list’
  • Cost-effectiveness assessment for an orphan drug
  • Diabetes (type 1)
  • Diaper dermatitis complicated by candidiasis in infants
  • Heart failure
  • Herpes zoster vaccine
  • HPV vaccine
  • Metabolic syndrome
  • Metastatic soft-tissue sarcoma

Economic models

We have extensive experience in modelling across a wide range of indications – our model experience includes budget impact models, cost effectiveness models, scenario models, cost calculator models, value-based pricing models, cost offset models, and cost utility models. Our experience is vast in this area and models have been developed for a large number of countries and with adaptations for different markets. We have developed models and model adaptations throughout Europe (including the EU5, eastern Europe and Scandinavia), on a Global scale, and for the US, Canada, Japan, Australia, Mexico and Brazil.

  • Acromegaly
  • Acute bacterial skin and skin structure infections (ABSSSI)
  • Allergies
  • Alzheimer’s disease
  • Anaemia
  • Anaesthesiology
  • Ankylosing spondylitis
  • Asthma
  • Benign prostatic hyperplasia
  • Bladder cancer
  • Breakthrough cancer pain
  • Breast cancer
  • Cardiometabolic risk
  • Chronic obstructive pulmonary disease (COPD)
  • Clostridium difficile infections
  • Colonoscopy
  • Colorectal cancer
  • Crohn’s disease
  • Diabetes (type 1 and 2)
  • Diabetic macular edema
  • Dyslipidaemia
  • Epilepsy
  • Esophogeal cancer
  • Gastric cancer
  • Head and neck cancer
  • Hepatitis C
  • HIV
  • Hormone replacement therapy
  • HPV
  • Human cord graft
  • Hypertension
  • Infection prevention
  • Infertility
  • Inflammatory bowel disease
  • Influenza
  • Leukaemia
  • Lung cancer (small cell and non-small cell)
  • Lymphomas
  • Melanoma
  • Mesothelioma
  • Multiple myeloma
  • Neuroendocrine tumours
  • Neuromuscular block
  • Osteoarthritis
  • Ovarian cancer
  • Pain
  • Parkinson’s disease
  • Phenylketonuria
  • Pneumococcal disease
  • Post-herpetic neuralgia
  • Psoriasis
  • Psoriatic arthritis
  • Renal cell carcinoma
  • Rheumatoid arthritis
  • Surgery and post-operative pain

Endpoint reviews with an FDA component

  • Diabetic foot ulcers
  • Diabetic macular oedema
  • Diarrhoea-predominant irritable bowel syndrome
  • Dysmenorrhea
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Functional digestive disorders (post-prandial distress syndrome)
  • Hereditary angioedema
  • Hypogonadism
  • Major depressive disorder
  • Pain
  • Pulmonary arterial hypertension
  • Retinal vein occlusion
  • Rheumatoid arthritis

Literature reviews

We have a dedicated team of experts with vast experience in literature reviews and research, able to address client challenges and steer your product towards market access success. Our experience of systematic and structured literature reviews covers a wide range of therapeutic indications and topics including:

Structured literature reviews

  • Acne
  • Acromegaly
  • Actinic keratosis
  • Acute bacterial skin and skin structure infections (ABSSSI)
  • Acute myocardial infarction
  • Alcohol dependency
  • Allergic rhinitis
  • Allergies
  • Alzheimer’s disease
  • Ankylosing spondylitis
  • Arthritis
  • Atypical haemolytic uremic syndrome (aHUS)
  • Asthma
  • Asthma COPD Overlap Syndrome (ACOS)
  • Benign prostatic hyperplasia
  • Breast cancer
  • Cervical cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Colorectal cancer
  • Constipation (and chronic constipation)
  • Cough and cold
  • Crohn’s disease
  • Dementia
  • Depression
  • Diabetes (type 2)
  • Diptheria
  • Down’s syndrome
  • Dry eye
  • Dystrophic epidermolysis bullosa
  • Epilepsy
  • Fabry disease
  • Fibromyalgia
  • Fragile X syndrome
  • Gastric cancer
  • Gastric reflux
  • Glioblastoma
  • Glucose transporter type 1 deficiency syndrome
  • Group B streptococcus
  • Growth hormone deficiency
  • Haemophilia A and B
  • Hand eczema
  • Head and neck cancer
  • Heart disease
  • Hepatitis A and C
  • Herpes zoster/shingles
  • Hidradenitis suppurativa
  • HIV and AIDS
  • HPV
  • HRT outcomes in the menopause
  • Hypoparathyroidism
  • Idiopathic pulmonary fibrosis
  • Immune thrombocytopenia
  • Infertility
  • Influenza
  • Interstitial cystitis
  • Interstitial lung disease in systemic sclerosis (SSc-ILD)
  • Irritable bowel syndrome
  • Kidney cancer
  • Kidney disease / kidney failure
  • Leukaemia
  • Lipid modification
  • Liver cancer
  • Lower limb spasticity
  • Lung cancer (small cell and non-small cell)
  • Lupus (systemic lupus erythematosus and lupus nephritis)
  • Lymphomas
  • Macular degeneration
  • Melanoma
  • Migraine
  • Mucopolysaccharidosis I (MPS I)
  • Myocardial infarction
  • Neural tube defects
  • Nonalcoholic steatohepatitis (NASH)
  • Osteoarthritis
  • Osteomyelitis
  • Ovarian cancer
  • Pain (including chronic pain and trauma pain)
  • Parkinson’s disease
  • Peripheral artery disease
  • Peripheral diabetic neuropathy
  • Pertussis
  • Phenylketonuria
  • Polio
  • Post-herpetic neuralgia
  • Post-operative ileus
  • Prostate cancer
  • Psoriasis
  • Rabies
  • Retinitis pigmentosa
  • Retinopathy of prematurity
  • Rheumatoid arthritis
  • Schizophrenia
  • Sjögren’s syndrome
  • Smoking cessation
  • Stroke
  • Tetanus
  • Typhoid
  • Ulcerative colitis
  • Wheezing
  • Yellow fever

Systematic literature reviews

  • Asthma
  • Bipolar disorder
  • Chemotherapy-induced anaemia
  • Epilepsy
  • Hepatitis B
  • Herpes zoster/shingles
  • HPV
  • Leukaemia
  • Lung cancer (small cell and non-small cell)
  • Lymphomas
  • Melanoma
  • Post-herpetic neuralgia
  • Psoriasis
  • Psoriatic arthritis
  • Pulmonary arterial hypertension
  • Renal cell carcinoma

Meta-analyses, indirect comparisons and mixed treatment comparisons

  • Breast cancer
  • Cataracts
  • Cervical cancer
  • Chronic obstructive pulmonary disease (COPD)
  • Colorectal cancer
  • Epilepsy
  • Heart failure
  • HIV
  • HPV
  • Irritable bowel syndrome with constipation
  • Kidney disease
  • Leukaemia
  • Lung cancer (non-small cell)
  • Melanoma
  • Miscarriage
  • Multiple myeloma
  • Posterior cacular opacification
  • Psoriasis
  • Psoriatic arthritis
  • Pulmonary arterial hypertension
  • Rheumatoid arthritis
  • Stroke
  • Wet age-related macular degeneration

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

Qualitative interview methods

Addiction

  • Interviews and Rasch analysis in opioid addiction

Allergic conditions

  • Development of a COA strategy to measure treatment side effects for peanut allergy treatments

Autoimmune diseases

  • Assessing utility for flares in systemic lupus erythematosus in the UK, France, Spain, Australia and Canada, including training and managing local interviewing agencies and providing support to local teams
  • Key opinion leader contracting and additional interviews for assessing utility in various severities of flares in systemic lupus erythematosus

Cardiovascular disease

  • PRO claims for pulmonary arterial hypertension – endpoint review, regulatory support for the FDA and EMEA and qualitative patient interviews
  • Key opinion leader interviews on neurogenic orthostatic hypotension

Central nervous system/neurology

  • Development of an online therapy tool for depression along with a landscape analysis, structured and grey literature review, local language literature review, gap analysis, local language payer interviews and clinician interviews
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Interviews on the development of a composite trial endpoint for Dravet’s syndrome
  • Development of a conceptual framework and endpoint model in insomnia, plus qualitative patient interviews to confirm the validity of the conceptual framework and the psychometric validation of the final conceptual framework
  • Qualitative interviews in chronic migraine headaches
  • Regulatory consulting to support development of a structured diagnostic interview and severity scale in paediatric RLS, along with development of two manuscripts to document the development and validation process
  • Development and validation of a diagnostic interview and severity scale for paediatric RLS
  • Endpoint review and strategic recommendations on the application of the Zarit Burden Interview (ZBI) to assess caregiver burden in schizophrenia

Dermatology

  • Concept elicitation interviews in acne vulgaris to reach saturation
  • Analysis, reporting and patient interviews PRO in acne vulgaris
  • Patient interviews for the development of alopecia-related PRO measures
  • Qualitative interviews to evaluate the psychological impact of the brow satisfaction questionnaire and to validate in a post-chemotherapy population
  • Qualitative interviews to support the concept of psychological impact on the facial line outcomes questionnaire
  • Qualitative analysis of patient interviews to identify how subjects describe the severity of crow’s feet
  • Interviews with patient focus groups in psoriasis
  • Patient interviews and reporting on a photoguide in rosacea
  • Consulting on patient qualitative insight blogs with follow-up interviews to explore wound scar healing
  • Development of PRO and ClinRO instruments for alopecia totalis and alopecia universalis

Endocrinology and metabolic diseases

  • Patient interviews in type 2 diabetes for development of a new PRO measure
  • Interviews with patients with diabetes-induced edema in the USA
  • Interview study to understand the experience of walking pain among patients with diabetic peripheral neuropathy
  • Outcomes interviews in phenylketonuria, resource use and impact on patients
  • Development and validation of a patient-reported outcome measure for non-alcoholic steatohepatitis

Gastrointestinal diseases

  • In-depth interviews, instrument development and cognitive debriefing related to measurement of opioid-induced constipation
  • Patient interviews to assess content validity of an instrument for use in opioid-induced constipation
  • Qualitative interviews to develop a symptom measure in adult patients with eosinophilic esophagitis
  • Sub-group analysis of gastroparesis patients interviewed in exploratory phase, Rasch analysis and PCA on a 5 item scale
  • Patient interviews and qualitative work on IBS
  • Independent analysis, evidence saturation and report on 30 interviews in IBS-C
  • Long term safety study and participation interviews in chronic constipation and IBS-C
  • Manuscript based on the findings of the exit interview study of patients taking a treatment for IBS-C within a long term safety study
  • Interviews with clinicians to understand diagnoses of paediatric IBS-C and CC
  • Language validation interview for an ascites impact questionnaire
  • Support with interviews in paediatric vomiting

Genetic disorders

  • Qualitative interviews and development of a COA strategy for Down’s syndrome in adults and children
  • Patient interviews to support a PRO submission package in hereditary angioedema
  • Patient interviews for the face and content validation of the Patient Global Impression in hereditary angioedema
  • Endpoint review and caregiver interviews in Sanfilippo syndrome
  • Concept elicitation interviews in Barth Syndrome patients
  • Qualitative concept elicitation and case studies documenting the disease progression of Barth Syndrome

Haematology

  • Exit interviews to assess the impact of infusion frequency in haemophilia A
  • IRB submission for haemophilia patient interviews
  • Clinician and patient interviews for a PRO in iron overload
  • Caregiver interviews to support content validity of an ObsRO in a paediatric population with severe aplastic anaemia (SAA) and chronic immune thrombocytopenic purpura (CITP)
  • Qualitative interviews with patients with myelodysplastic syndrome

Immunology

  • Cognitive Debriefing of the Eosinophilic Esophagitis Activity Index (EEsAI)

Infectious diseases

  • Concept elicitation and cognitive debriefing interviews with hepatitis C patients in multiple countries
  • Consulting on the development of a PRO strategy for international HIV trials with interviews in the US and Puerto Rico

Men’s health

  • Patient interviews to support the development of an FDA dossier on an erection hardness score questionnaire

Musculoskeletal diseases

  • Patient interviews on rheumatoid arthritis
  • Pilot testing interviews on fibromyalgia fatigue
  • Patient interviews and manuscript on the development of a PRO strategy to support labelling claims in gout
  • Focus group interviews with patients with chronic low back pain
  • Qualitative exit interviews to assess the patient experience of treatment and clinical trial participation among patients with chronic low back pain and osteoarthritis

Nephrology

  • Qualitative interviews, conceptual model and strategic consulting on autosomal dominant polycystic kidney disease (ADPKD)

Oncology

  • Patient interviews to investigate side effects of breast cancer treatment
  • Qualitative interviews to assess equivalence of paper and electronically administered questionnaires in head and neck cancer
  • Qualitative interviews to understand the impact of non-small cell lung cancer (NSCLC) on quality of life
  • Qualitative interviews to understand the impact of NSCLC on caregivers and family members
  • Exploratory qualitative interviews in NSCLC patients to assess progression-free survival
  • Patient interviews in lung cancer
  • Strategic PRO endpoint support, gap analysis and patient interviews in a biological therapy treatment for non-Hodgkin’s lymphoma
  • Pilot patient interviews in melanoma
  • Pre-screen interviews for the relative resource utilization of intravenous and subcutaneous drug administration in metastatic bone disease
  • Patient interviews in multiple myeloma and development of a poster on the results
  • Burden of relapse in multiple myeloma: communicating the findings from patient and physician interviews in the EU5
  • Expert interviews and amendment project to heath economic model for a treatment for breakthrough cancer pain

Ophthalmology

  • Patient interviews on glaucoma treatment characteristics and outcomes: unmet patient needs & value drivers
  • Brief literature reviews and patient interviews to inform development of PRO strategies in retinitis pigmentosa – stages 1, 2 and 3
  • Exploratory interviews to confirm the benefits of an experimental treatment in retinitis pigmentosis
  • Analysis and reporting on completed interviews about eyelid swelling

Respiratory diseases

  • Exit interviews and evaluation of the psychometric properties of the Asthma Daily Symptom Diary (ADSD) in severe asthma
  • Exit interviews to provide additional evidence of content validity for a quantitative study in asthma
  • Clinical trial exit interviews to characterise patients’ experience and treatment benefit in patients with activated phosphoinositide 3-kinase delta syndrome (APDS)
  • Content validation of a COA strategy for respiratory syncytial virus (RSV) and influenza in the elderly or in those with respiratory compromise
  • Exit interviews with caregivers and clinicians in a prospective study to assess the Paediatric Respiratory Syncytial Virus (RSV) Electronic Severity and Outcome Rating System (PRESORS)
  • Exit interviews on a connected inhaler system for asthma

Women’s health

  • Patient interviews and analysis/report on the Female Sexual Desire Profile (FSDP) and Female Sexual Encounter Profile (FSEP)
  • Qualitative research to assess the content validity of the dysmenorrhea daily diary (DysDD) in patients with endometriosis

Regulatory briefing documents and PRO dossiers

  • Allergic rhinitis
  • Chronic obstructive pulmonary disease
  • Chronic pain
  • Constipation predominant irritable bowel syndrome
  • Crohn’s disease
  • End stage renal disease patients on haemodialysis
  • Epilepsy
  • Epoietin alfa in chronic kidney disease
  • Erythematous rosacea
  • Eyelash satisfaction questionnaire
  • Facial wrinkling
  • Functional digestive disorders (post-prandial distress syndrome)
  • Glioblastoma
  • Heart failure
  • Hereditary angioedema
  • Hereditary hemochromatosis
  • Hunter’s syndrome
  • Hypogonadism
  • Major depressive disorder
  • Multiple sclerosis
  • Pre-menstrual dysphoric disorder
  • Psoriasis
  • Retinal vein occlusion
  • Rheumatoid arthritis
  • Spinal cord injury
  • Smoking cessation
  • Ulcerative colitis

Scottish Medicines Consortium (SMC – UK)

  • Anthracycline extravasation
  • Breakthrough cancer pain
  • Breast cancer
  • Diabetes (type 2)
  • Epilepsy
  • Gastric cancer
  • Head and neck cancer
  • Hepatitis B
  • HIV
  • Homocystinuria
  • Infertility
  • Iron overload
  • Kidney failure
  • Lung cancer (non-small cell)
  • Parkinson’s disease
  • Psoriatic arthritis
  • Secondary hyperparathyroidism in end stage renal disease
  • Ulcerative colitis

Study endpoint reviews

  • Bone healing
  • Chronic pain in malignant cancer
  • Epilepsy
  • Fatigue and functioning in fibromyalgia
  • Female hypoactive sexual desire disorder
  • Fibromyalgia
  • Heart failure with preserved ejection fraction
  • Goitre
  • Inhaled insulin in type 2 diabetes
  • Opioid addiction
  • Rheumatoid arthritis
  • Review of a protocol and protocol amendment for a Phase II gastroparesis study which includes the CGSI as a primary endpoint

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
  • Diabetes
  • Fabry disease
  • Febrile neutropenia
  • Fungal infections
  • Gastric cancer
  • Glaucoma
  • Glioblastoma
  • Heart failure
  • Heroin addiction
  • Hidradenitis suppurativa
  • Infertility
  • Inflammatory bowel disease
  • Influenza
  • 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
  • Refractory ascites
  • Respiratory syncytial virus
  • Restless leg syndrome
  • Rheumatoid arthritis
  • Schizophrenia
  • Stress urinary incontinence
  • Surgery
  • Uveitis