Search

Pharmaco-economic evaluations become more important for the reimbursement of pharmaceuticals, and will be obligatory for new pharmaceutical drugs for which an added therapeutic value is claimed and a price premium is proposed by the manufacturer. Therefore, it is important to guide purchasers and providers of pharmaceutical care in their efforts related to the evaluation process. Standard Report Format can support the quality, transparency and exhaustiveness of the data submitted. A multidisciplinary task force developed a Standard Report Format for pharmaco-economic evaluations in Belgium.

Two cases of craniopharyngioma with delayed diagnosis are presented. Patient 1 had mild visual loss that initially had been attributed to pigment epithelial detachment in the macular area. Patient 2 had blurred vision in the left eye, although visual acuity was 10/10 at both eyes. She had a history of a posttraumatic neurosurgical procedure and was treated for blepharospasm. Both patients had initially negative CT imaging. Visual field defects suggested a chiasmal lesion and incited to additional neuroradiological investigation. Magnetic resonance imaging revealed a craniopharyngioma in both cases.

The Belgian healthcare system has a tradition of access and equity at affordable prices. As in other countries, the system becomes pressured by increasing healthcare costs. This paper describes the actual situation in Belgium with special focus on pharmaceutical products and the potential role of pharmacoeconomics in decision making on price and reimbursement. Nearly all people in Belgium are covered by compulsory health insurance. The system is paid for by social security, the patients and the federal and regional authorities. The part of the consumption of pharmaceuticals that is charged to insurance was about 62.1 billion Belgian francs (BeF), i.e. about 50% of the pharmaceutical market in 1994. Price setting in Belgium has been rather low due to the positive reimbursement list, where the price of a new drug is compared to existing drugs in a comparable therapeutic class (so-called reimbursement criteria). The expenditure on pharmaceuticals is increasing faster than global funding for public health. In order to control drug budgets, different cost-containment measures have been or are being taken, i.e. a mix of price, reimbursement and volume controls. These cost-containment measures are not necessarily in accordance with a health economic approach. This paper suggests the scope for better implementation of pharmacoeconomic evaluation, which can lead to more flexible reimbursement systems in specific indications. Therefore, a formal recognition of the role of objective economic evaluations is needed for both hospital and ambulatory care. This process should be proceeded by improving the understanding and robustness of pharmacoeconomic evaluations.

Ibopamine (SK & F 100168-A), a new chemical entity, is capable of eliciting positive inotropic effects accompanied by vasodilating, diuretic and saliuretic activity after oral administration. The relative bioavailability and bioequivalence of 3 oral presentations of Ibopamine was examined after a single oral dose. Thirty healthy subjects (15 males and 15 females) received the 3 formulations at one-week intervals according to "single-blind assayer" latin-square crossover design. Two tablets of 100 mg ibopamine (SIMES formulations), 2 tablets of 100 mg ibopamine (UK formulation) and 1 tablet of 200 mg ibopamine (US-Tiltab formulation) were used. In a 4th occasion, all volunteers received again the 200 mg-tablet of the US-Tiltab formulation in order to assess the intra-individual variability of its oral bioavailability. Free epinine plasma levels were measured before and 10, 20, 30, 45, 60, 90, 105 min and 2, 2.5, 3, 4, 6, 8 and 24 h after each oral administration. Free epinine was assayed by HPLC/electrochemical detection method. The amount of drug absorbed as measured by the area under the curve, AUC0-8 h, and the rate of absorption, as measured by Cmax and tmax, were compared by examining the symmetric 95% confidence intervals. If the symmetric 95% confidence interval with respect to AUC is between 80% and 120%, two formulations are considered bioequivalent.(ABSTRACT TRUNCATED AT 250 WORDS)