The reference price system and socioeconomic differences in ... - KCE

4 Reference Price System KCE reports 126
GLOSSARY
All terms from this glossary are reproduced from different sources:
• Pharmaceutical Pricing and Reimbursement Information (PPRI) Glossary 1
• National Library of Medicine (NLM) 2
3, 4
• EMEA
• NIHDI (National Institute for Health and Disability Insurance; RIZIV/INAMI)
website.
• INN Prescription : Proposition for implementation for General Practice and
Global Medical Records 5
Term Source Explanation
Active Ingredient PPRI The primary chemical substance or compound contained in a
Anatomical Therapeutic
Chemical classification (ATC)
pharmaceutical.
PPRI In this WHO classification system pharmaceuticals are divided into
different groups according to the organ or system on which they act and
their chemical, pharmacological and therapeutic properties.
Bioavailability EMEA Bioavailability means the rate and extent to which the active substance
or active moiety is absorbed from a pharmaceutical form and becomes
available at the site of action.
Bioequivalence EMEA Two medicinal products containing the same active substance are
considered bioequivalent if they are pharmaceutically equivalent or
pharmaceutical alternatives and their bioavailability (rate and extent)
after administration in the same molar dose lie within acceptable
predefined limits. These limits are set to ensure comparable in vivo
performance, i.e. similarity in terms of safety and efficacy.
Co-payment NLM A fixed payment made by the patient to the provider at the time of
service. This does not include the reference supplement.
We use the term “co-payment” to refer to co-payments and coinsurance.
Both are cost-sharing arrangements which require the
individual covered to pay part of the cost of care. A co-payment is a
fixed fee (flat rate) per item or service; in case of co-insurance the
patient pays a fixed proportion of the total cost.
Copy NIHDI A copy is a special type of generic drug, which has exactly the same
active substance, same quantity, same galenic form and same excipients
as the original drug. Copies can only be put on the market for drugs
which are used for more than 10 years in the European Union.
Cost sharing NLM Provisions of an insurance policy that require the insured to pay some
portion of covered expenses. Several forms of sharing are in use, e.g.,
deductibles, co-insurance, and co-payments. Cost sharing neither refers
to nor includes amounts paid in premiums for the coverage.
Defined Daily Dose PPRI The DDD is a unit of measurement defined as the assumed average
maintenance dose per day for a pharmaceutical used for its main
indication in the adult. A DDD will normally not be assigned for a
substance before a product is approved and marketed in at least one
country. The basic principle is to assign only one DDD per route of
administration within an ATC code. DDDs for plain substances are
normally based on monotherapy. Doses for individual patients and
patients groups will often differ from the DDD. DDD does not
necessarily reflect the recommended or Prescribed Daily Dose.
DDDs are not established for topical products, sera, vaccines,
antineoplastic agents, allergen extracts, general and local anaesthetics
Generic EMEA
and PPRI
and contrast media.
A generic medicinal product is a product which has the same qualitative
and quantitative composition in active substances and the same
pharmaceutical form as the reference medicinal product, and whose