WBB's Thought Leadership

High Quality and Potential Cost-Savings of Generic Medication

November 20

Use of generic drugs saved the U.S. $1.68 Trillion between 2005 and 2014, but are still underutilized due to patient resistance.

Generic drugs are often 30%-80% lower cost than brand-name equivalents, but a lack of patient understanding of generics is a barrier to higher adoption. Physicians can provide patient education to improve patient understanding and improve savings.

WBB Take: A key aspect of delivering quality healthcare is eliminating waste. Part of an integrated quality management process in healthcare should include continual review of treatments to identify if alternatives exist that have equivalent or better results, at lower or equivalent cost.
Drugs make up a high proportion of total healthcare costs, and should therefore be a focus of a comprehensive quality management plan to reduce waste and improve quality. Where brand-name drugs offer no additional value for the higher price, they can be a suitable target for quality-improvement initiatives, such as identifying and removing barriers to adoption of generics.

Cited by Matthew Loxton

Excerpt: “From 2005 to 2014, generic drugs saved the U.S. health care system 1.68 trillion dollars. Additionally, generics routinely cost 30 to 80 percent less than their brand-name counterparts. While generic drugs can clearly offer substantial cost savings to patients, the U.S. Food and Drug Administration (FDA) recognizes that some patients do not understand what a generic drug is and often resist accepting them in place of their brand-name counterparts.”
“To help physicians talk to their patients about the safety and effectiveness of generic drugs, the FDA has created a range of new and updated education materials including fact sheets, videos, an App and other resources which can be found on the FDA website.”
“FDA-approved generic drugs are required to meet rigorous FDA standards for safety, quality, and effectiveness. The standards are equally demanding whether the FDA is reviewing brand-name or generic drugs.”
“Physicians can find out if a generic version of a brand-name medication is available by using the FDA database Drugs@FDA, which includes a catalog of FDA-approved drugs. Physicians can also search the online version (or use the smartphone app) of the “Orange Book.” For very recent generic drug approvals, healthcare professionals can consult the “First Generics List” on the FDA website.”

“Information on the FDA website that physicians can use to talk to their patients includes:
• FDA-approved generic drugs listed in the FDA resource known as the Orange Book along with their brand-name counterparts for which they can be substituted.
• A generic drug has no significant differences from the brand-name drug.
• Any generic drug must provide the same therapeutic effect as the brand-name drug and must be just as safe.
• A generic drug must have the same active ingredient, strength, dosage form and route of administration as the brand-name product.
• Generic drug manufacturers must prove that their drug’s therapeutic effect and safety is the same as (bioequivalent to) the brand-name drug. In other words, tests must show the levels of the generic drug in the bloodstream are the same as the levels found when using the brand-name product.
• Approved generic drugs are generally only sold after patents and exclusivities protecting the brand-name version end.”


“With the information available from the FDA, physicians can confidently answer questions that help their patients understand that generics are as safe, effective and as high-quality as brand-name drugs ̶ with the added benefit of helping them save money.”

Source: Physician's Weekly


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