Guidelines for ATC classification and DDD assignment - WHOCC
Guidelines for ATC classification and DDD assignment - WHOCC
Guidelines for ATC classification and DDD assignment - WHOCC
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F. Drug costs, pricing <strong>and</strong> reimbursement <strong>and</strong> cost-containment<br />
Basing detailed reimbursement, therapeutic group reference pricing <strong>and</strong> other<br />
specific pricing decisions on the <strong>ATC</strong> <strong>and</strong> <strong>DDD</strong> <strong>assignment</strong>s is a misuse of the<br />
system. This is because the <strong>ATC</strong> <strong>and</strong> <strong>DDD</strong> <strong>assignment</strong>s are designed solely to<br />
maintain a stable system of drug consumption measurement, which can be used to<br />
follow <strong>and</strong> compare trends in the utilization of drugs within <strong>and</strong> across therapeutic<br />
groups. None the less, drug utilization data have a central role in the quality of care<br />
cycle <strong>and</strong> <strong>ATC</strong> <strong>and</strong> <strong>DDD</strong> methodologies can be helpful in following <strong>and</strong> comparing<br />
trends in cost, but need to be used with caution.<br />
The <strong>DDD</strong> is a technical drug use metric. <strong>DDD</strong>s do not necessarily reflect<br />
therapeutically equivalent doses of different drugs <strong>and</strong> there<strong>for</strong>e cannot be assumed<br />
to represent daily doses that produce similar treatment outcomes <strong>for</strong> all products<br />
within an <strong>ATC</strong> category. Such estimates of therapeutic equivalence are very<br />
difficult to establish, particularly to the precision usually required <strong>for</strong> pricing<br />
decisions. <strong>DDD</strong>s, if used with caution can be used to compare, <strong>for</strong> example, the<br />
costs of two <strong>for</strong>mulations of the same drug. However, it is usually not valid to use<br />
this metric to compare costs of different drugs or drug groups. The relationships<br />
between therapeutically equivalent doses, the actual prescribed daily dose (PDD)<br />
<strong>and</strong> <strong>DDD</strong> usually differ between drugs <strong>and</strong>, <strong>for</strong> the same drug, between countries.<br />
Moreover, even though PDDs commonly change over time altering a <strong>DDD</strong><br />
complicates drug utilization research, hence there is a reluctance to alter a <strong>DDD</strong>.<br />
Alterations are not made unless there is evidence that changes in PDD are large, or<br />
there is some particular reason such as a change in the main indication. For these<br />
reasons, <strong>DDD</strong>s are not suitable <strong>for</strong> comparing drugs <strong>for</strong> specific, detailed pricing,<br />
reimbursement <strong>and</strong> cost-containment decisions.<br />
Similarly, basing reimbursement <strong>and</strong> pricing comparisons on inclusion of drugs in<br />
<strong>ATC</strong> groups is not recommended. The main indications <strong>for</strong> drugs (on which <strong>ATC</strong><br />
<strong>assignment</strong>s are based) often differ widely between countries <strong>and</strong>, like the PDD,<br />
can change over time. However, the <strong>ATC</strong> <strong>classification</strong>s can be useful when costs<br />
need to be aggregated into drug groups or therapeutic areas to determine, <strong>for</strong><br />
example, to what extent increased costs can be attributed to increased use of a<br />
therapeutic group over time.<br />
G. Pharmaceutical marketing purposes<br />
It is important to emphasise that the <strong>ATC</strong> <strong>classification</strong> does not necessarily reflect<br />
the recommended therapeutic use in all respects. There<strong>for</strong>e, the <strong>ATC</strong> system<br />
should not be used as a tool <strong>for</strong> marketing purposes concerning efficacy,<br />
mechanism of action or therapeutic profile in relation to other drugs.<br />
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