The author analyses the medical problems associated with the proposed reference pricing
system prepared for the 2004 pharmaceutical price and reimbursement negotiations by
the Hungarian National Health Insurance Fund (HNIF). In case of drugs containing identical
active ingredients the author does not consider it acceptable that from the criteria
of reference grouping bioequivalence was omitted, since bioequivalence is the basic
clinical pharmacologic principle underlying the safe utilization of generic drugs.
The proposal introduces in Hungary the therapeutic reference pricing for drugs belonging
to the same ATC 5 level group, having different chemical structures but identical
mechanisms of action. The products are listed according to their defined daily dose
(DDD) and the arithmetic mean of the cheapest products giving together 50% market
share is calculated. Each ATC 5 group has a given per cent reimbursement level and
the fixed amount paid by the HNIF for all drugs in the group is defined as the given
percentage of the mean price. This sum is reimbursed irrespective whether the products
are patent protected or not, furthermore those drugs whose price is three times higher
than the fixed mean price are excluded from the reimbursement system. As a result
the patients' co-payment for the more expensive drugs will be significantly increased
in the future. The basis of the therapeutic reference price is the assumption that
the outcome of the treatment will be the same using drugs with the same mechanism
of action. However, this assumption lacks valid scientific proof. According to the
author, the proposed budget centric reference pricing system, which does not take
into account the differing clinical pharmacologic profiles of the drugs, will significantly
inhibit the use of new, innovative drugs, the establishment and continuous improvement
of truly cost-effective patient care. Several alternative approaches are proposed
for controlling drug budget. Finally the author recommends that a Committee should
be established to develop a comprehensive proposal for the reorganization of the pricing
and reimbursement system of the drugs available for general and/or hospital use, and
for the follow-up of the health care effects of these measures.
