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Related Concept Videos

Pharmaceutical Equivalents01:26

Pharmaceutical Equivalents

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As defined by regulatory standards, pharmaceutical equivalents require generic drug products to have identical dosage forms and chemically identical active pharmaceutical ingredients (APIs). They must adhere to compendial or applicable standards for potency, content uniformity, disintegration times, and dissolution rates. In the case of modified-release dosage forms, variations in drug content are permissible as long as the delivered amount remains consistent with the innovator drug product.
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Generic intravenous (IV) drugs are considered bioequivalent to their branded counterparts due to their 100% bioavailability upon administration. However, variations in stability among different drug products can significantly influence their therapeutic performance, even if they are pharmaceutically equivalent.Cefuroxime, a prophylactic antimicrobial, is often used as a single-dose IV injection for patients undergoing coronary artery bypass grafting surgery. A 3 g dose typically provides...
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Body: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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Bioequivalence: Overview01:16

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Pharmaceutical equivalents, by definition, are drug products with the same active ingredient in the same quantities, encapsulated in identical dosage forms, and intended for the same administration routes. These pharmaceutical equivalents are deemed bioequivalent if the bioavailability of the active entity in the drug preparations is similar. Moreover, pharmaceutical equivalents demonstrating bioequivalence are also regarded as therapeutically equivalent. This means that when used as directed,...
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Dosage Regimen: Individualization01:24

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Individualization in dosing regimens is the customization of medication doses for individual patients. Its necessity arises from the goal of maximizing therapeutic benefits while minimizing risks. This approach is pivotal because human responses to drugs can vary widely; what is effective for one person may be inadequate or excessive for another. Interpatient (intersubject) variability refers to differences in drug responses between individuals, while intrapatient (intrasubject) variability...
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Drug Control Governance: Regulatory Bodies and Their Impact01:03

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Drug control governance involves the oversight and regulation of pharmaceuticals to ensure their safety and efficacy while preventing illegal drug use and trafficking. Regulatory bodies, including the US Food and Drug Administration (FDA) and the European Union's European Medicines Agency (EMA), play a central role in this process. These agencies evaluate the safety and efficacy of drugs before they can be marketed. They fund clinical trials and assess the benefits and risks associated with...
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In Vitro Methods for Comparing Target Binding and CDC Induction Between Therapeutic Antibodies: Applications in Biosimilarity Analysis
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Pharmaceutical pricing benchmarks: governmental versus private sector.

Fatema Turkistani1, Aseel Bin Sawad2

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|October 14, 2020
PubMed
Summary
This summary is machine-generated.

The National Average Drug Acquisition Cost (NADAC) is the optimal pricing benchmark for workers' compensation drug reimbursement at retail pharmacies, offering significant cost savings. This analysis utilized California workers' compensation data to evaluate various pricing mechanisms.

Keywords:
CaliforniaMedi-Calpricepricing benchmarkworkers’ compensation

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Area of Science:

  • Health Economics
  • Pharmacy Benefit Management
  • Workers' Compensation

Background:

  • Workers' compensation systems face challenges in establishing fair and cost-effective drug reimbursement benchmarks.
  • Retail pharmacy drug pricing varies significantly across different reimbursement models, impacting overall costs.

Purpose of the Study:

  • To identify the most appropriate pricing benchmark for reimbursing drugs dispensed in retail pharmacies within workers' compensation.
  • To evaluate the cost-effectiveness of different drug pricing mechanisms.

Main Methods:

  • Analysis of California workers' compensation system (CAWCS) pharmacy costs from 2017-2019.
  • Estimation of drug prices using alternative pricing mechanism fee schedules, including Average Wholesale Price (AWP), Medi-Cal, Wholesale Acquisition Cost (WAC), NADAC, and Federal Upper Limit.
  • Calculation of AWP-based formulas for each pricing mechanism.

Main Results:

  • CAWCS paid 65.6% of AWP, 104.1% of Medi-Cal, 122.1% of WAC, 140.1% of NADAC, and 253.5% of the federal upper limit.
  • AWP: 50% for generics and AWP -18.2% for brands were identified as the lowest-paying formulas.
  • Adapting WAC or NADAC could result in estimated median cost savings of $8.7 million and $9.5 million, respectively, across all states.

Conclusions:

  • The National Average Drug Acquisition Cost (NADAC) emerged as the most suitable pricing benchmark for the reimbursement of pharmacy-dispensed drugs in workers' compensation.
  • Implementing NADAC-based reimbursement could lead to substantial cost reductions in the workers' compensation system.