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Related Concept Videos

Prescription, Nonprescription and Orphan Drugs01:02

Prescription, Nonprescription and Orphan Drugs

Prescription drugs require a prescription from a medical practitioner and can only be obtained from a pharmacy. They have many applications, including treating pain, anxiety, and hypertension.
The misuse and addiction to prescription drugs is a growing problem that can affect people of all age groups, specifically teenagers. This can happen when prescription medications are used in ways not intended by the prescriber, such as taking someone else's prescription or using medication for...
Drug Nomenclature01:17

Drug Nomenclature

During the development of a new pharmaceutical, the manufacturer initially assigns a code name to the drug. Once approved, the drug receives a United States Adopted Name (USAN)—a generic, nonproprietary designation. Upon being listed in the United States Pharmacopeia, this nonproprietary name becomes the drug's official name. Additionally, the manufacturer assigns a proprietary name or trademark, which serves as the brand name under which the drug is marketed. It is worth noting that the same...
Drug Products: Biologics, Biosimilars and Interchangeables01:28

Drug Products: Biologics, Biosimilars and Interchangeables

Biologics, derived from living sources such as humans, animals, or microorganisms, represent a significant category of pharmaceuticals. These complex molecules, developed through advanced biotechnological methods or purified from natural sources, include essential medical treatments like insulin and growth hormones. The complexity of biologics arises from their large molecular structures and the intricate processes required for their production, making them distinct from conventional...
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Direct-Acting Cholinergic Agonists: Therapeutic Uses

Direct-acting cholinergic agonists have many therapeutic uses in various medical fields. Choline esters, including acetylcholine, have limited clinical utility due to their non-selectivity and short duration of action. Still, acetylcholine and carbachol are applied topically during ophthalmologic surgery to induce miosis. Pilocarpine, a muscarinic and ganglionic stimulator, effectively treats open-angle glaucoma and alleviates xerostomia and dry mouth caused by radiotherapy or Sjögren syndrome.
Health Information Technology and Healthcare Information System01:30

Health Information Technology and Healthcare Information System

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Cardiovascular Drugs: Classification based on Therapeutic Indications01:18

Cardiovascular Drugs: Classification based on Therapeutic Indications

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Updated: Jun 17, 2026

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
05:10

Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System

Published on: December 11, 2016

Off-label use reimbursement.

Joshua Cohen1, Andrew Wilson, Laura Faden

  • 1Tufts Center for the Study of Drug Development, Tufts University, Boston, MA, USA.

Food and Drug Law Journal
|December 17, 2009
PubMed
Summary
This summary is machine-generated.

Payer reimbursement policies for off-label drug use vary significantly, even among public programs like Medicare and Medicaid. This study reveals ongoing differences in how payers cover unapproved indications, impacting patient access to treatments.

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Optimized Management of Endovascular Treatment for Acute Ischemic Stroke
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Published on: January 18, 2018

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Drug Repurposing Hypothesis Generation Using the "RE:fine Drugs" System
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Published on: December 11, 2016

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Published on: January 18, 2018

Area of Science:

  • Health policy research
  • Pharmaceutical economics
  • Medical reimbursement strategies

Background:

  • Off-label drug use is common, particularly for anti-cancer agents and biologics.
  • Payer reimbursement policies significantly influence patient access to these treatments.
  • Previous research highlighted variations in these policies over a decade ago.

Purpose of the Study:

  • To examine current factors influencing payer off-label use reimbursement policies.
  • To update and compare findings with a study from 14 years prior.
  • To focus on public payers (Medicare and Medicaid) for transparency and policy influence.

Main Methods:

  • Survey of 179 payers administering public pharmacy benefits.
  • Analysis of factors influencing reimbursement decisions.
  • Investigation into the role of primary and secondary sources (compendia, literature, guidelines).

Main Results:

  • Significant variation in off-label use reimbursement policies persists across payers.
  • Public payers (Medicare, Medicaid) are key in setting reimbursement trends.
  • Payers utilize strategies like cost-effectiveness analysis for policy design.

Conclusions:

  • Off-label drug reimbursement policies remain inconsistent among payers.
  • Public sector payers play a critical role in shaping these policies.
  • Understanding these policies is crucial for ensuring equitable patient access to innovative therapies.