High-Cost Generic Drugs — Implications for Patients and Policymakers — NEJM

High-Cost Generic Drugs — Implications for Patients and Policymakers — NEJM.

Excerpt

It is well known that new brand-name drugs are often expensive, but U.S. health care is also witnessing a lesser-known but growing and seemingly paradoxical phenomenon: certain older drugs, many of which are generic and not protected by patents or market exclusivity, are now also extremely expensive. Take the case of albendazole, a broad-spectrum antiparasitic medication. Albendazole was first marketed by a corporate predecessor to GlaxoSmithKline (GSK) outside the United States in 1982 and was approved by the Food and Drug Administration (FDA) in 1996. Its patents have long since expired, but no manufacturer ever sought FDA approval for a generic version. One reason may be that the primary indications for the drug — intestinal parasites, neurocysticercosis, and hydatid disease — occur relatively rarely in the United States and usually only in disadvantaged populations such as immigrants and refugees. In late 2010, the listed average wholesale price (AWP) for albendazole was $5.92 per typical daily dose in the United States and less than $1 per typical daily dose overseas.

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Meanwhile, there is little that individual consumers can do. Some drug companies, such as Amedra, offer assistance programs for indigent patients, but these programs often have complicated enrollment processes, and they do not offer an effective general safety net.5 Some patients instead seek to acquire these drugs in other countries, since many of them are widely and inexpensively available outside the United States, but such foreign sources may be of variable quality. Until regulatory and market solutions are implemented to reduce prices for these older drugs, patients requiring such drugs and the physicians treating them will continue to be faced with difficult choices.

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