Related Experiment Video
Updated: Jun 16, 2026
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
[Pharmacoeconomic studies - usability for reimbursement decisions].
E S Dietrich1, T Nakashima, S Ahrens
1WINEG, Wissenschaftliches Institut der TK für Nutzen und Effizienz im Gesundheitswesen, Hamburg, Deutschland. pharmacoeconomics@web.de
Deutsche Medizinische Wochenschrift (1946)
|February 19, 2010
Summary
Most pharmacoeconomic studies do not meet international guidelines for health technology assessment. This necessitates in-house analysis by the Institute for Quality and Efficiency in Health Care (IQWiG), leading to time-consuming evaluations.
Area of Science:
- Health Economics
- Pharmacoeconomics
- Health Technology Assessment
Background:
- Germany legally mandates cost-benefit assessments for pharmaceuticals since April 2007.
- Evaluating the alignment of published pharmacoeconomic studies with established guidelines is crucial for reimbursement decisions.
Purpose of the Study:
- To assess whether international pharmacoeconomic studies adhere to the methodological recommendations of the Institute for Quality and Efficiency in Health Care (IQWiG) and global guidelines.
- To determine the usability of existing pharmacoeconomic studies for German reimbursement decisions.
Main Methods:
- A systematic literature review identified relevant pharmacoeconomic studies.
- Studies were compared against the requirements of IQWiG and 15 other international health technology assessment institutions.
- Hypothetical selection processes evaluated study suitability for reimbursement decisions.
Main Results:
- 130 of 1,982 studies were analyzed, with the USA (41%) being the most frequent reference country.
- Standard therapy was the comparator in 63% of studies, and the payer's perspective was primary in 60%.
- Only two studies met the criteria for German reimbursement decisions (G-BA), and only one German study assessed real-life effectiveness.
Conclusions:
- A methodological congruence exists between IQWiG and other international institutions.
- Existing pharmacoeconomic studies frequently deviate from international and German guidelines.
- IQWiG's need for in-house analysis will prolong assessments, limiting short-to-medium term cost savings.
More Related Videos
Related Concept Videos
01:15Impact of Pharmacokinetic–Pharmacodynamic Models: Regulatory Decisions
PK–PD modeling has significantly influenced FDA regulatory decisions, particularly drug approval, dosage optimization, and labeling. These models integrate pharmacokinetics (PK) and pharmacodynamics (PD) to predict drug behavior and effects, aiding in optimizing dosing regimens and enhancing the probability of clinical trial success.One notable example is Nesiritide (Natrecor®), a recombinant human brain natriuretic peptide for treating acute decompensated congestive heart failure (CHF).
01:20Measurement of Bioavailability: Pharmacodynamic Methods
Pharmacodynamic methods provide insights into a drug's effects on physiological processes over time and play a crucial role in understanding bioavailability and therapeutic efficacy. These methods can be broadly classified into acute pharmacological and therapeutic response approaches, each with distinct mechanisms and applications.The acute pharmacological response method directly correlates a drug's physiological effects, such as ECG or pupil diameter changes, to its time course in the body.
01:01Dosage Regimens: Partial Pharmacokinetic Parameters
It is not uncommon for complete drug pharmacokinetic profiles to remain elusive in pharmacokinetics. This necessitates certain educated assumptions by pharmacokineticists to determine appropriate dosage regimens without comprehensive pharmacokinetic data from animal or human studies. One prevalent assumption is setting the bioavailability factor, denoted as F, to 1 or 100%. This assumption caters to the scenario where a drug doesn't achieve full systemic absorption, resulting in the patient...
01:12Analysis of Population Pharmacokinetic Data
Analysis of population pharmacokinetic data involves studying the behavior of drugs within diverse populations to understand their pharmacokinetic parameters. Traditional pharmacokinetic methods typically involve collecting samples from a few individuals and estimating these parameters. While these methods are commonly used, they have limitations in capturing the variability in drug response among individuals or heterogeneous populations. Population pharmacokinetics is employed to address these...
01:23Types of Biopharmaceutical Studies: Controlled and Non-Controlled Approaches
Biopharmaceutical studies constitute a vital field aiming to enhance drug delivery methods and refine therapeutic approaches, drawing upon diverse interdisciplinary knowledge. In research methodologies, the choice between controlled and non-controlled studies significantly influences the study's reliability and accuracy.
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
Non-controlled studies, commonly employed for initial exploration, lack a control group, rendering them susceptible to biases and external influences. In contrast, controlled...
01:30Measurement of Bioavailability: Pharmacokinetic Methods
Pharmacokinetics is a vital branch of pharmacology that examines how drugs are absorbed, distributed, metabolized, and excreted by the body. Two key methodologies in pharmacokinetics are plasma drug concentration studies and urinary drug excretion analyses, both of which provide critical insights into a drug's therapeutic efficacy and bioavailability.Plasma Drug Concentration-Time StudiesPlasma drug concentration-time studies involve analyzing blood samples at specific intervals to quantify...