[HERA-QUEST: HTA evaluation of generic pharmaceutical products to improve quality, economic efficiency, patient safety and transparency in drug product changes in hospitals]. / HERA-QUEST: HTA-Evaluation generischer Arzneimittel zur Verbesserung von Qualität, Oekonomie, Patientensicherheit und Transparenz bei Produktumstellungen in Kliniken.

In view of the rising cost pressure and an increasing number of drug shortages, switches between generic drug preparations have become a daily routine in hospitals. To ensure consistently high treatment quality and best possible patient safety, the equivalence of the new and the previous drug preparation must be ensured before any change in the purchase of pharmaceutical products takes place. So far, no easily usable, transparent and standardized instrument for this kind of comparison between generic drug products has been available. A group of pharmaceutical experts has developed the drug HTA (health technology assessment) model "HERA" (HTA Evaluation of geneRic phArmaceutical products) through a multi-step process. The instrument is designed to perform both a qualitative and economic comparison of equivalent drug preparations ("aut idem" substitution) before switching products. The economic evaluation does not only consider unit prices and consumption quantity, but also the processing costs associated with a product change process. The qualitative comparison is based on the evaluation of 34 quality criteria belonging to six evaluation fields (e.g., approval status, practical handling, packaging design). The objective evaluation of the quality criteria is complemented by an assessment of special features of the individual hospital for complex drug switches, including the feedback of the physicians utilizing the drug preparation. Thus potentially problematic switches of pharmaceutical products can be avoided at the best possible rate, contributing to the improvement of patient safety. The novel drug HTA model HERA is a tool used in clinical practice that can add to an increase in quality, therapeutic safety and transparency of drug use while simultaneously contributing to the economic optimization of drug procurement in hospitals. Combining these two is essential for hospitals facing the tension between rising cost pressure and at the same time increasing demands on quality and transparency, triggered by, amongst others, current legislation (Hospital Structures Act, anti-corruption legislation).

Changes in lipid profiles after switching to a protease inhibitor-containing cART--unfavourable effect of fosamprenavir in obese patients.

OBJECTIVE: One focus in the medical care of HIV-infected patients today is cardiovascular risk reduction. Metabolic disturbances occur frequently in patients taking protease inhibitors (PI) and are a major risk factor for atherosclerosis. With few published head-to-head studies substance-specific differences concerning metabolic effects are insufficiently defined. Therefore this cohort study directly compared the metabolic profiles of boosted atazanavir (ATV/r), fosamprenavir (FPV/r) and saquinavir (SQV/r). METHODS: Data from a cohort of 124 HIV patients initiating a boosted regimen with one of the PIs at the University of Munich (LMU) infectious diseases outpatient clinic were retrospectively analyzed. The main outcome measures were median absolute total cholesterol levels and median relative change of total cholesterol levels after six months of PI-therapy. A multivariate linear regression model was built to identify and control for potential confounders of the association between PI-therapy and serum cholesterol level. RESULTS: 84 patients were treated with ATV/r, 23 patients received FPV/r and 17 patients SQV/r. Demographically the cohort constituted a representative sample of HIV-infected patients in Germany. There were no statistically significant differences between the comparison groups at baseline. - After six months of therapy median serum cholesterol in the ATV/r group dropped significantly from 204 mg/dl to 186 mg/dl, while in the FPV/r and SQV/r groups a rise in serum cholesterol levels was observed from 179 mg/dl to 204 mg/dl and from 173 mg/dl to 209 mg/dl respectively. The multivariate linear regression model identified a significant interaction between BMI at baseline and treatment with FPV/r: patients with higher BMI showed more prominent increases in serum cholesterol while taking FPV/r compared to patients with lower BMI. CONCLUSION: This cohort study demonstrated the most favourable impact on serum cholesterol levels and thus cardiovascular risk for ATV/r compared to FPV/r and SQV/r under real-life conditions. Given the statistical interaction detected between FPV/r and BMI further studies assessing metabolic profiles of different antiretroviral drugs in specific patient populations are urgently needed.