Experience in Strategic and Methodological Areas

Experience in Strategic and
Methodological Areas

Endpoint Reviews and Briefing Documents

Endpoint reviews with an FDA component

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

Regulatory briefing document/PRO dossier

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

Study endpoint reviews

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

Value Dossiers

HIV
For treatment for stages III, IV, V renal disease
Chronic lymphocytic leukemia (monoclonal antibody)
Cancer breakthrough pain
Hemostasis and sealing in surgery
Schizophrenia
Cardiovascular disease and dyslipidemia
Parkinson's disease
Anemia in patients with chronic kidney disease
Chemotherapy-induced anemia
Chemotherapy-induced neutropenia
Thromboembolism
Influenza vaccine
HPV vaccine
Measles / mumps / rubella / varicella vaccine
Psoriasis (monoclonal antibody)
Fungal infections
Metastatic non-small cell lung cancer
Epilepsy
Post-liver transplant pediatric patients
Stress urinary incontinence
Fibrin sealant for surgical bleeding
Respiratory syncytial virus
Phenylketonuria
Hypertension
Chronic heart failure
Multiple myeloma
Breast cancer
Gastric cancer
Fabry disease
ALFA therapy device

Slide decks were prepared to accompany many of these value dossiers.

HTA / Reimbursement Submissions

Scottish Medicines Consortium (SMC - UK)

Head and neck cancer
Anthracycline extravasation
Advanced gastric cancer
Partial epilepsy
Parkinson’s disease
Ulcerative colitis
Type 2 diabetes
Iron overload
Hepatitis B
HIV
Chronic renal failure
Breast cancer
Non-small cell lung cancer
Secondary hyperparathyroidism in end stage renal disease
Breakthrough cancer pain

National Institute for Health and Clinical Excellence (NICE-UK)

Hepatitis B
Adult and pediatric asthma
Breast cancer
Moderate to severe psoriasis
Type 2 diabetes
Review of submission for secondary hyperparathyroidism in end stage renal disease
Consultancy on submission to NICE for treatment for chemotherapy-induced anemia
Rheumatoid arthritis
Multiple myeloma

College voor zorgverzekeringen (CZV - Netherlands)

Metabolic syndrome
Herpes zoster vaccine
Human papillomavirus vaccine
Heart failure
Type 1 diabetes
Diaper dermatitis complicated by candidiasis in infants
Metastatic soft-tissue sarcoma
Cost-effectiveness assessment for drug to be listed on the hospital 'expensive drug list'
Cost-effectiveness assessment for an orphan drug

Other

All Wales Medicines Strategy Group - iron overload (UK)
Joint Committee on Vaccination and Immunisation for human papillomavirus vaccine (UK)
Reimbursement authorities - heart failure (Belgium)

Meta-Analyses / Indirect Comparisons / Mixed Treatment Comparisons

Meta-analysis of clinical trial data and PRO endpoints for treatment for anemia in patients with chronic kidney disease
Meta-analysis of published data in stage IIIb and IV non-small cell lung cancer
Meta-analysis in advanced postmenopausal breast cancer
Meta-analysis of PRO endpoints in human papillomavirus and cervical cancer
Meta-analysis in psoriasis
Meta-analysis of safety and efficacy in osteoarthritis and chronic low back pain
Meta-analysis in osteoporosis
Meta-analysis of treatment for Parkinson's disease
Meta-analysis of the safety and efficacy of a cox-2 pain medication
Meta-analysis of observational studies for oral anti-diabetic
Meta-analysis in secondary prevention of stroke
Meta-analysis of joint structural deterioration in DMARD-IR rheumatoid arthritis patients
Mixed treatment comparison of efficacy and safety of treatments in DMARD-IR rheumatoid arthritis patients
Mixed treatment comparison of self-monitoring glucose in type diabetes mellitus
Mixed treatment comparison of disease modifying anti-rheumatic drugs in treatment of rheumatoid arthritis
Mixed treatment comparison of bisphosphonates in the treatment of post-menopausal osteoporosis
Mixed treatment comparison of treatments for ankylosing spondylitis
Mixed treatment comparison of treatment of Crohn’s Disease
Mixed treatment comparison of cox-1 and cox-2 inhibitors for rheumatoid and osteoarthritis
Mixed treatment comparison of topical steroids in psoriasis
Mixed treatment comparisons in Parkinson's disease
Mixed treatment comparison in cancer breakthrough pain
Mixed treatment comparison in chronic lymphocytic leukemia
Mixed treatment comparison to estimate the efficacy of a drug relative to other treatments for patients with elevated triglycerides
Mixed treatment comparison in secondary prevention of stroke
Mixed treatment comparison in multiple myeloma
Mixed treatment comparison in rheumatoid arthritis
Mixed treatment comparison in advanced NSCLC
Mixed treatment comparison for treatment in NSCLC in Spain
Mixed treatment comparison in Chronic Obstructive Pulmonary Disease
Critical analysis of a mixed treatment comparison in Alzheimer disease
Evidence sythesis for treatment in epilepsy
Indirect comparison in type 2 diabetes
Indirect comparison in gastric cancer
Comparative effectiveness of systemic therapies for unresectable stage IIIc and stage IV melanoma – evidence synthesis
Mixed treatment comparison for SMC submission for treatment in psoriasis
Mixed treatment comparison for the treatment of non-small cell lung cancer
Meta-analysis in treatment for posterior cacular opacification
Meta-analysis of cataract treatment procedures Asia
Evidence synthesis for antibiotics in cystic fibrosis
Mixed treatment comparison of adverse events in breast cancer
Mixed treatment comparison for treatment in epilepsy
Meta-analysis for the efficacy of the first line treatment for unresectable stage IIIC/IV in melanoma
Meta-analysis for treatment in metastatic colorectal cancer
Meta-analysis for treatment in Chroinc Obstructive Pulmonary Disease
Network meta-analysis of combination therapies in pulmonary arterial hypertension
Meta-analysis and indirect comparison in rheumatoid arthritis
Indirect comparison of treatment on non-vertebral fractures
Meta-analysis of treatment efficacy and safety in atopic dermatitis

Economic Models

Budget impact model

Development of a budget impact model for primary prophylactic granulocyte-colony stimulating factor in patients receiving adjuvant treatment for breast cancer
Budget impact model in human papillomavirus vaccination to prevent cervical cancer
Budget impact model for head and neck cancer
Budget impact model in non-small cell lung cancer (NSCLC)
Linking of cost-utility model with a budget impact model for erythropoietin use in cancer
Budget impact model for anti-hypertensive
Budget impact model for treatment for weight loss and metabolic syndrome – considering cardiovascular sequelae
Development of a pharmacoeconomic / budget impact model for add on therapy on Parkinson’s disease
Development and adaptation to other countries of budget impact model in schizophrenia
Development of a budget impact model for a long-acting pain medication
Budget impact model in opioid-induced constipation
Development of a budget impact model for primary prophylactic granulocyte-colony stimulating factor in breast cancer
Development of, and training and communication for, a budget impact tool in patients with breakthrough cancer pain
Development of a value-based budget impact tool for HIV treatment
Budget impact tool of a drug for naïve HIV patients
Literature review, meta-analysis, development of core economic model and budget impact model for treatment of juvenile idiopathic arthritis
Critical review of existing economic models, development of economic and budget impact models in type 2 diabetes
Economic modeling for treatment for cancer breakthrough pain
Development of, and communication for, a cost-effectiveness model for treatment for cancer breakthrough pain
Development of budget impact model for treatment in epilepsy
Development of a US value dossier meeting AMCP and WellPoint guidelines and an expanded budget impact model
Development of budget impact model for treatment of advanced breast cancer
Budget impact model adaptation to Portugal for treatment in rheumatoid arthritis

Cost-effectiveness model

Development of cost-effectiveness model in head and neck cancer and adaptation to various countries
Development of, and communication for a cost-effectiveness model for treatment for cancer breakthrough pain
Interactive cost-effectiveness model for a drug in the treatment of ankylosing spondylitis
Cost-effectiveness model in Parkinson's disease in the US
Manuscript of the Spanish cost-effectiveness model in HPV vaccine
Cost-effectiveness interactive model of an adjuvanted vaccine in influenza in an elderly population and adults at risk in France
Adaptation of the adjuvanted influenza vaccine cost-effectiveness model for Germany, Austria, Italy and Mexico
Cost-effectiveness analysis and model adaptations for treatment of moderate to severe psoriasis
International economic modeling and submissions of hormonal therapy in postmenopausal advanced breast cancer (UK, Spain, Belgium and the Netherlands)
Economic modeling in non-small cell lung cancer (NSCLC)
Review of economic models in NSCLC
Development of technical documentation for an economic model in NSCLC
Development of a manuscript on an economic model in NSCLC
Development of economic model for erythropoietin use in cancer
Economic model in atrial fibrillation
Economic modeling of hypertension for Japan and Korea
Economic modeling for treatment for cancer breakthrough pain
Development of an economic model in juvenile idiopathic arthritis
Meta-analysis and update of economic model in osteoporosis
Development of economic model for erythropoietin use in cancer
Development of the HEMO model: Hemophilia Economic Model of Outcomes in Thailand, Mexico, and the Philippines
Development of core economic model with adaptations for treatment of invasive aspergillosis (US, UK, NL)
Review of economic model and submission to Scottish Medicines Consortium for HIV treatment
Adaptation of the adjuvanted economic model for influenza vaccine to Belgium
Development of cost-effectiveness model model for treatment in epilepsy
Cost-effectiveness analysis of treatment for influenza
Development of a cost-effectiveness model for a transfusion product
Cost-effectiveness analysis for treatment of osteoporosis
Development of a cost effectiveness model for treatment of advanced breast cancer
Markov model in cervical cancer screening
Markov model in human papillomavirus vaccination to prevent cervical cancer
International Markov model in head and neck cancer
Markov model for monotherapy in NSCLC
Decision analytic / Markov model Go / No Go in Alzheimer’s disease
Markov model in depression: programming, costing, report, publication (France)
Early phase Markov model in Crohn’s disease (pricing simulation)
Consultancy on cost-effectiveness model for an anti-epileptic drug for Italy
Cost-effectiveness model for exercise training in patients with pulmonary hypertension
Development and multi-country adaptation of cost-effectiveness model in rheumatoid arthritis
International cost-effectiveness model for treatment of intra-abdominal and diabetic foot ulcer infections taking into account local antimicrobial resistance
Review and refinement of a cost-effectiveness model for an orphan drug in phenylketonuria
Presentation of cost-effectiveness model in type II diabetes to client team
Cost effectiveness analysis for treatment in rheumatoid arthritis in Portugal
Development of cost effectiveness model for treatment in ovarian cancer for the Netherlands
Economic model treatment of medullary thyroid cancer
Review of an economic model to assess utility requirements for treatment in rheumatoid arthritis
Validation of an existing exploratory cost-effectiveness model for the diagnosis and therapy of dementia including Alzheimer's disease

Other

Building an interactive model for treatment of late stage prostate cancer
Development of cost model for basal cell carcinoma
Development of cost model for cervical intraepithelial neoplasia
Development of an interactive model in statins
Cost of illness model for development of a disease management program
Decision analytic model of new anti-depressant versus TCAs and SSRIs in Canada, France, UK, Austria and Hungary
Literature survey, patient interviews, burden of illness model in narcolepsy
Literature survey, pricing model in sleep disorders
Decision analytic model in acute ischemic stroke
Modeling influenza coverage rates
Development of dynamic transmission model for measles / mumps / rubella / varicella (MMRV) vaccine
Adaptation of dynamic transmission model for measles / mumps / rubella / varicella vaccine to other countries
Preparation of an abstract on dynamic transmission model for measles / mumps / rubella / varicella vaccine
Update of an economic model for a vaccine to prevent shingles
Advisory board meetings on dynamic model development for epidemiological and economic impact of malaria and malaria vaccination in sub-Saharan Africa
Economic models in rheumatoid arthritis
Critical review of an economic model for chronic lymphocytic leukemia
Review and adaptation of economic models for the treatment of unresectable melanoma
Adding a comparator to an economic model in ovarian cancer
Data collection for a health economic model in meningitis B

Orphan Drugs

Protocol review, CRF design and analysis plan in mucopolysaccharidosis (MPS-1)
Relevance and context of pharmacoeconomic information for orphan drug for treatment of chronic kidney disease
PRO analysis for Phase II & III trial in systemic lupus erythematosus
PRO analysis for Phase II trial in systemic lupus erythematosus
PRO analysis of clinical trial: oral contraceptive use in systemic lupus erythematosus patients
PRO analysis of clinical trail: HRT use in systemic lupus erythematosus patients
Endpoint review for orphan drug in multiple sclerosis
SMC submission for an orphan drug for the treatment of anthracycline extravasation
Regulatory approval for orphan drug for hereditary angioedema
Economic evaluation of orphan drug for the treatment of infants with diaper dermatitis complicated by candidiasis
Systematic review and evidence synthesis for orphan drug in Fabry's disease
Market access evidence assessment for a new orphan drug for short bowel syndrome
Submission to CVZ of an orphan drug for treatment of metastatic soft-tissue sarcoma
Review and refinement of a cost-effectiveness model for an orphan drug in phenylketonuria

Medical Devices

Economic evaluation of artificial lumbar intervertebral disc system
Review to evaluate the effectiveness of self-monitoring of blood glucose in diabetes mellitus.
Cost-effectiveness of various joint prostheses in hip replacement, including cemented, non-cemented and hybrid prostheses.
Cost-effectiveness analysis of ultrasound versus standard therapy in treatment of fracture pain
Cost-effectiveness analysis of domiciliary oxygen devices versus standard care
Value dossier for wound patch to aid post-surgical hemostasis and wound sealing
Choice of PRO measure to assess perceived benefit of multi focal intraocular lenses.
Psychometric validation of a satisfaction questionnaire to asses use of pen system for administration of erythropoietin
Managing patients with stoma: adaptations of QLI questionnaire to current needs
Patient preference for administration method of women undergoing IVF treatment evaluated with the conjoint analysis method
Analysis of prevalence of bradycardia and co-morbidities
Analysis of PRO data from clinical trial assessing safety of a coated stent and its delivery system in the treatment of obstructive superficial femoral artery disease
PRO measurement strategy for a device in glaucoma
Values communication strategy plan in wound care treatment

Surgical, Diagnostic and Other Procedures

Matched cohort pharmacoeconomic evaluation of pulmonary embolism following orthopedic surgery in Japan
Incidence of venous thromboemolism following major abdominal surgery
Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
Value dossier for wound patch to aid post-surgical hemostasis and wound sealing
Communication on the health-related quality of life of patients after cataract surgery
Consulting in the development of a satisfaction questionnaire for cataract surgery
Scoring and validation of the FGVS questionnaire in an observational study of intraocular lenses in cataract and presbyopia surgery
Development of a PRO questionnaire to assess (dis)comfort after micro incision vitrectomy surgery
Selection of PRO endpoints for a clinical trial of a long-acting local anesthetic for the treatment of post surgical pain
Development of a PRO questionnaire for use of a fibrant sealant in abdominoplasty
Abdominal surgery cohort study to evaluate the risk of venous thromboembolism
Development of a cost-effectiveness model for a transfusion product
Mixed treatment comparison of self-monitoring glucose in type diabetes mellitus
Value dossier for a treatment for post-liver transplant pediatric patients
Support for value dossier for a fibrin sealant for surgical bleeding
Development of a photonumeric guide and PRO measure of surgical scarring
Investigation of 'trauma' with Delphi Panel for a treatment in wound care