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Generic drug alternatives crucial to competition, cost control, JAMA says

Threshold of four generic alternatives per brand name drug associated with large price reductions, report says.

Jeff Lagasse, Editor

The more generic alternatives there are to brand-name drugs, the more likely they will drive down costs for patients and providers. That's the word from a new report from the Journal of the American Medical Association.

Competition is essential for preventing price spikes, the report claims. Specifically, at least four generic competitors are needed to ensure healthy markets; the availability of four generics has been associated with brand-name price reductions of about 60 percent compared to fewer or no generic alternatives.

But many areas of treatment fall short of this threshold. Only two-thirds of cancer drugs, for example, have at least one generic.

[Also: Brand name drugs jack up Medicare Part D co-pays by factor of 10, study shows]

Among 417 unique therapeutics, 210 were eligible for generic competition, JAMA found. Thirty-six of them, or 17 percent, had no generic drugs approved, while 174, or 83 percent, had one or more. Sixty-three percent, or 133, had four or more.

The likelihood of having four or more generic drug approvals varied significantly by the type of therapy, with neurological and psychiatric drugs having the highest rates, at 100 and 88 percent respectively. Oncological drugs had the lowest rate, at 27 percent.

Currently marketed drug products were much more likely to have at least one generic approval when compared to discontinued drug products -- 87 versus 68 percent -- whereas drugs that received priority review were less likely to have at least one generic approval than those that received a standard review (74 versus 88 percent).

[Also: States, insurers unlock access to pricey hepatitis C drugs]

Orphan-designated drugs, meanwhile, were less likely to have at least one alternative than non-orphan drugs -- 55 versus 88 percent.

Healthcare Supply Chain Association President and CEO Todd Ebert, R.Ph, issued a statement in reaction to the JAMA study in which he said there was more to be done to increase drug competition.

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"While we are pleased that the U.S. Food and Drug Administration prioritizes abbreviated new drug applications for generic drugs with only one manufacturer -- sometimes referred to as 'sole source' products -- more must be done to increase competition in the generic market and safeguard access to essential medications," said Ebert. "HSCA encourages Congress to mandate that FDA expand their priority review to include generic drugs with two or fewer manufacturers, particularly in the generic injectable market. Generic injectables are the workhorses of acute care facilities -- often used in cases of emergency -- and bring tremendous value to healthcare providers and the patients they serve.

"The JAMA report underscores the urgent need for Congressional and FDA action to expand priority review beyond sole source products," he said. "Doing so will help foster a robust generic drug marketplace that keeps prices in check and preserves patient and provider access to essential medications."

Twitter: @JELagasse