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Methods and criteria for assessing medicinal products
Basis of a recommendation
Given the available data, the Transparency Committee (TC) assesses the following for medicinal products:
- actual clinical benefit
- clinical added
- intended role in the therapeutic strategy for a given disease or condition
- indications and usage (treatment duration, dosage, proper use)
- target population (estimated number of patients affected by the therapeutic indications)
Actual Clinical Benefit (ACB)
Does the medicinal product provide sufficient benefit for coverage by the National Health Insurance Fund?
To respond to this question, the ACB must take into consideration:
- severity of the disease/condition
- efficacy
- adverse effects
- intended role in the therapeutic strategy in comparison with other available therapies
- public health benefits
The 4 ACB levels used for medicinal products are: “Sufficient”: a favourable opinion for inclusion onto the list of reimbursable medicines, with 3 resulting levels:
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Clinical Added Value (CAV)
Does the medicinal product provide clinical added value when compared with available treatments? If yes, to what extent?
To respond to these questions, the CAV must take into consideration:
- comparative efficacy and safety data with regards to available treatments (reference medicinal product or better treatment modalities)
A medicinal product, having no clinical added value, can only be included onto the list of medicines for reimbursement if it offers savings in terms of treatment cost.
The 5 CAV levels used for medicinal products, when compared with existing therapeutic interventions, are:
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HAS tools for health professionals
HAS is responsible for communicating objective and concise information on medicinal products to health professionals. To this aim, HAS offers the following tools:
- Transparency Committee brief summaries on recommendations: intended for general practitioners and specialists, working in private or public practice, and for community and hospital pharmacists, these briefs summarize the recommendations on medicinal products by highlighting key messages issued from the assessments.
- Proper Use Guides for medicinal products: developed for medicinal products whose target population is substantial and/or present a risk of misuse. These guides provide important information for health professionals on the appropriate use of medicinal products, while specifying their intended role in a therapeutic strategy in comparison to available treatment options.
