Related Experiment Video
Updated: Dec 6, 2025
05:10
Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
Published on: December 11, 2016
10.0K
Getting the Right Evidence After Drug Approval.
Rick A Vreman1,2, Hubert G M Leufkens1, Aaron S Kesselheim3
1Division of Pharmacoepidemiology and Clinical Pharmacology, Utrecht Institute for Pharmaceutical Sciences, Utrecht University, Utrecht, Netherlands.
Frontiers in Pharmacology
|October 5, 2020
Summary
Value-based pricing can fund drug development by requiring post-approval evidence generation. This ensures timely access to new medications while gathering crucial real-world data.
Area of Science:
- Health Economics
- Pharmaceutical Policy
- Evidence-Based Medicine
Background:
- Generating comparative evidence for new drugs is crucial for informed decision-making.
- Current drug approval and reimbursement pathways can create delays in accessing innovative therapies.
- Balancing timely patient access with robust evidence generation presents a significant challenge.
Purpose of the Study:
- To propose a framework for value-based pricing and reimbursement.
- To ensure timely generation of comparative evidence for pharmaceuticals.
- To facilitate drug access without compromising evidence quality.
Main Methods:
- Conditioning pricing and reimbursement on a prospective, post-approval evidence generation plan.
- Utilizing value-based agreements tied to real-world data collection.
- Implementing adaptive regulatory and reimbursement strategies.
Main Results:
- Value-based pricing models can incentivize the collection of post-approval data.
- This approach allows for timely market access for new drugs.
- It facilitates the continuous evaluation of drug value and effectiveness.
Conclusions:
- Conditioning value-based pricing on evidence generation plans offers a viable solution.
- This strategy supports timely drug access and robust comparative effectiveness research.
- It aligns incentives for manufacturers, payers, and patients.
Related Concept Videos
01:25Drug Regulation
2.6K
Drug regulation encompasses the management of drug usage by evaluating its safety and efficacy through assessments conducted by regulatory authorities. Regrettably, the history of drug regulation is marred by several catastrophic events. One such incident is the Elixir Sulfanilamide tragedy, in which the toxic compound diethyl glycol was included in a sweet-tasting medication, leading to numerous fatalities. This event prompted the enactment of the Food, Drug, and Cosmetic Act in 1938. Under...
2.6K
01:19Pharmacovigilance
1.5K
Post-marketing surveillance is a critical component of pharmaceutical regulation, often uncovering unanticipated adverse drug reactions (ADRs) once a drug is widely used over an extended period.
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
This process, termed pharmacovigilance, aims to detect, evaluate, and minimize harmful effects related to medication use. The data collection for pharmacovigilance depends on spontaneous reporting systems, where healthcare professionals or patients voluntarily report suspected ADRs.
In some cases, there...
1.5K
01:11Clinical Trials: Overview
4.4K
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...
4.4K
01:16Clinical Trials
10.0K
Clinical trials are prospective experimental studies conducted on humans to determine the safety and efficacy of treatments, drugs, diet methods, and medical devices. Using statistics in clinical trials enables researchers to derive reasonable and accurate conclusions from the collected data, allowing them to make wise decisions in uncertain situations. In medical research, statistical methods are crucial for preventing errors and bias.
There are four phases in a clinical trial. A phase one...
There are four phases in a clinical trial. A phase one...
10.0K
01:26FDA Approved Drugs: Changes to Approved Drugs
107
Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
107
01:09Bioequivalence of Drugs: Drugs with Multiple Indications
79
The concept of therapeutic equivalence (TE) in drugs with multiple indications is complex. A generic drug may be therapeutically equivalent to a brand-name product for one specific indication, but this doesn't necessarily mean it's equivalent for all other indications. Evidence of TE in one patient group and bioequivalence shown in healthy volunteers can support—but not confirm—TE for other indications. However, definitive proof requires individual clinical studies for each...
79