GPhA: GAO report highlights need for availability of biogenerics

ARLINGTON, Va. An organization representing the generic drug industry is holding up a recent report by the Government Accountability Office as evidence of a need for an abbreviated approval pathway for follow-on biologics.

The Generic Pharmaceutical Association responded to the GAO report, “Medicare Part D: Spending, Beneficiary Cost-Sharing, and Cost-Containment Efforts for High-Cost Drugs Eligible for a Specialty Tier,” which reported that of the $54.4 billion spent on prescription drugs in 2007, $5.6 billion went to specialty drugs, generally meaning those used to treat autoimmune disorders, cancer and chronic viral infections such as HIV and hepatitis C.

Of that $5.6 billion, Medicare beneficiaries who received low-income subsidies accounted for $4 billion, or 70% of the total. Of all beneficiaries who used at least one specialty drug, 55% reached the so-called “catastrophic coverage” threshold, at which point Medicare pays at least 80% of all drug costs. By contrast, 8% of beneficiaries who did not use specialty drugs reached the threshold.

“Americans, particularly older Americans, need access to affordable, life-saving biogeneric medicines sooner rather than later,” GPhA president and CEO Kathleen Jaeger said. “The GAO report is further proof that the longer Congress waits to put biogenerics into the hands of consumers, the more costs will rise and competition and access to life-saving medicines will remain blocked.”

Currently, the United States lacks an approval pathway for follow-on biologics comparable to the one for generic pharmaceutical drugs, though provisions for such a pathway were tacked onto the healthcare-reform bill.