Comparing your drug with the real-world standard of care to demonstrate a distinctive value proposition.
LA-SER is a pioneer in the development and practical implementation of unique Relative Effectiveness methodologies in Observational studies and Pragmatic trials.
Professor Lucien Abenhaim, Chairman of LA-SER, championed Relative Effectiveness requirements during his career as Chief Medical Officer of France (1999–2003) leading to the introduction of studies on the real-world impact of drugs on morbidity as part of reimbursement evidence.
Today, Relative Effectiveness is central to shaping the product life cycle with regard to value strategy and evidence requirements for market access and healthcare reimbursement.
Effectiveness is the result of the interaction of the drug’s efficacy with three series of parameters:
- The distribution of treated populations (with their baseline occurrence of outcomes)
- The real use of the drug (doses, pattern, switches)
- The health system into which it is introduced (with the resultant accessibility)
‘Relative’ or ‘comparative’ effectiveness
Payers and clinicians are increasingly demanding to compare new drugs, with the real-world standard of care, to demonstrate a distinctive value proposition.
LA-SER is a pioneer in the development and practical implementation of Relative Effectiveness methodologies in Observational pharmacoepidemiological studies and Pragmatic trials.
Today, Relative Effectiveness is central to shaping the product life cycle with regard to value strategy and evidence requirements for market access and healthcare reimbursement.
Assessment of Relative Effectiveness can be made using three main methodologies:
- Cohorts with dynamic exposure
- Pragmatic trials
- Case-control (prevention studies)
Relative Effectiveness Studies: LA-SER’s experience
LA-SER pioneered the introduction of studies about the real-world impact of drugs on morbidity, as part of reimbursement evidence. As a consequence, LA-SER has extensive experience in this field, having designed and conducted a large number of such studies with significant clinical recruitment, in several European countries, and in the following therapeutic areas: psychiatry, oncology, respiratory medicine, cardiology, diabetes, and musculoskeletal disorders. In certain instances, relative effectiveness can be approached using the information available in electronic health care databases.
LA-SER experience in effectiveness and relative effectiveness studies and methodologies.
- Psychiatry
- Schizophrenia (comparative effectiveness study within disease cohorts; pragmatic trial of an index drug; analysis of electronic health care databases)
- Sleep disorders (comparative clinical cohort study in general practice)
- Anxiety and depression (comparative clinical cohort study in general practice)
- CNS
- Multiple sclerosis (analysis of electronic health care database)
- Pulmonary medicine
- Severe asthma (comparative historic-prospective disease cohort study of an anti-IgE drug)
- Upper respiratory tract infections (comparative cohort study in general practice)
- Rheumatology
- Gonarthrose and coxarthrose (large disease cohort comparing different drugs)
- Back pain and other MSD (comparative cohort study in general practice)
- Cardiology
- Severe hyperlipidaemia (effectiveness index drug cohort with long-term follow-up)
- Statins and primary prevention of MI (Case control study)
- Cancer
- Pragmatic trial of prostate cancer treatment
LA-SER can demonstrate how to use this experience to grant market authorisation for new medicines. The Scientific team at LA-SER welcomes the opportunity to share this expertise with you.
