PHARMACY

GPhA: GAO report highlights need for availability of biogenerics

BY Alaric DeArment

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.

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FDA approves extended-release painkiller

BY Alaric DeArment

CAMBRIDGE, Mass. The Food and Drug Administration has approved a regulatory approval application for a pain drug made by CombinatoRx, the drug maker announced Tuesday.

The FDA approved Exalgo (hydromorphone hydrochloride) extended-release tablets, for the management of moderate to severe pain in patients who need continuous pain relief for long periods of time.

Covidien will pay CombinatoRx a $40 million milestone payment for the approval and is eligible to receive tiered royalties on sales of the drug.

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Surescripts: E-prescription use jumps 181%

BY Allison Cerra

ALEXANDRIA, Va. E-prescription adoption and use in the United States has skyrocketed over the past two years, according to a new report developed by an e-prescription network.

Surescripts, which announced the release of its 2009 national progress report on e-prescribing titled “Advancing Healthcare in America,” measures the growth of e-prescribing from 2007 through 2009 across a number of categories. Among the key findings: E-prescription use increased 181%, from 68 million in 2008 to 191 million e-prescriptions in 2009.

Additional findings included:

  • Prescription Benefit Information: The number of electronic requests for prescription benefit information more than tripled, from 79 million in 2008 to 303 million in 2009
  • Prescription History Information: The number of prescription histories delivered to prescribers grew more than five-fold, from 16 million in 2008 to 81 million in 2009
  • Prescribers: The number of prescribers routing prescriptions electronically grew from 74,000 at the end of 2008 to 156,000 by the end of2009 — representing 25 percent of all office-based prescribers
  • Pharmacies: At the end of 2009, approximately 85% of community pharmacies and six of the largest mail-order pharmacies in the United States were able to receive prescriptions electronically

Surescripts president and CEO Harry Totonis said the report emphasizes the benefits of e-prescribing.

“For e-prescription use to jump from 6% to 18% in one year indicates several things,” said Harry Totonis, president and CEO of Surescripts. “First, that the federal government’s leadership and incentive structures are working. Second, that the benefits of e-prescribing — including increased safety, lower costs and increased efficiency — are widely understood. And last, that the nation’s experience with e-prescribing — in building the network and the ecosystem to support it — provides a definitive road map for how to drive adoption of a broader electronic health record for all Americans.”

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