Related Experiment Video
Updated: Aug 12, 2026
07:48
A High-throughput Automated Platform for the Development of Manufacturing Cell Lines for Protein Therapeutics
Published on: September 22, 2011
Developing a managed care-pharmaceutical research partnership
B E Lewis1, R Kimmelheim, K Gondek
1Focus Managed Research, Inc., Philadelphia, PA, USA.
Managed Care Interface
|June 3, 1999
Summary
Managed care organizations increasingly require cost-effectiveness data for new medications. This study details a partnership assessing a new osteoarthritis drug
Area of Science:
- Pharmacoeconomics
- Health Services Research
Background:
- Managed care organizations (MCOs) are increasingly demanding evidence of cost-effectiveness for new pharmaceutical products before formulary inclusion.
- Assessing the economic value of novel medications is crucial for MCOs' decision-making processes.
Purpose of the Study:
- To examine a collaborative research partnership between a pharmaceutical company and 14 MCOs.
- To evaluate the cost-effectiveness of a new medication for osteoarthritis (OA).
Main Methods:
- The study involved a partnership between a pharmaceutical manufacturer and 14 MCOs.
- A detailed study protocol was developed to guide research activities.
- Data collection and analysis focused on the cost-effectiveness of the OA medication.
Main Results:
- The research partnership facilitated the assessment of the new OA medication's economic value.
- The study protocol outlined the methodology for evaluating cost-effectiveness.
- Specific research activities were undertaken to gather relevant data.
Conclusions:
- Collaborative research partnerships can effectively evaluate the cost-effectiveness of new drugs.
- Evidence generated through such partnerships aids MCOs in formulary decisions.
- This approach supports informed decision-making regarding pharmaceutical adoption.
Related Concept Videos
01:26Drug Discovery: Overview
Drug discovery is a multifaceted process involving extensive screening, testing, and optimization of lead compounds to identify potential new drugs for therapeutic use. It combines several approaches, including screening large numbers of natural products, chemical modification of known active molecules, identification of new drug targets, and rational design based on biological mechanisms and drug-receptor structure. These approaches are carried out in both academic research laboratories and...
01:11Clinical Trials: Overview
Clinical development focuses on how the drug will interact with the human body and encompasses four key phases of clinical trials, each serving a specific purpose in assessing the safety and effectiveness of new drugs. These phases overlap and build upon one another. Phase I involves a small group of healthy volunteers (typically 20-80 individuals) or, in cases where significant toxicity is expected, patients with the targeted disease, such as cancer or AIDS. The volunteers are tested for...
01:28Preclinical Development: Overview
Preclinical development consists of a series of tests that ensure the safety and efficacy of a new therapeutic compound before it is tested in humans. There are four main phases to this process. First, safety pharmacology tests are conducted to ensure the drug does not produce any acutely harmful effects. These tests examine parameters such as bronchoconstriction, cardiac dysrhythmias, blood pressure changes, and ataxia. Next, preliminary toxicological testing is performed to determine the...
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...
01:26Drug Administration and Therapy Phases: Overview
Drugs, the chemical agents used in diagnosing, treating, or preventing diseases, undergo a four-phase process of development: pharmaceutic, pharmacokinetics, pharmacodynamics, and therapeutic.
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
The pharmaceutical phase focuses on leveraging the physicochemical properties of the drug to design and manufacture an effective product. Variants include orally administered tablets or capsules, topical creams or ointments, and parenteral-delivery solutions or emulsions.
The pharmacokinetic phase...
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).