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Medicare bid to simplify Part D program could shift many seniors, study predicts

BY Jim Frederick

WASHINGTON More than 3 million older Americans may have to switch to a different Medicare drug plan next year, a new study from health research and consulting firm Avalere Health revealed.

The study results, reported by the Associated Press, point to a potential snag in the Obama Administration’s plans for a smooth transition to a reformed healthcare system. According to Avalere and the AP, prescription drug plans serving more than 3 million Medicare Part D beneficiaries may be eliminated in 2011 after the Centers for Medicare and Medicaid Services completes a plan to cull redundant, higher-cost or less-efficient Part D plans from the federal drug benefit program for seniors.

That could force those seniors to choose a new plan, the AP reported, despite assurances from the White House during the long campaign to pass health-reform legislation that Americans could keep their current health plans if they chose to.

Avalere cited one instance where the change already is occurring. Medicare officials, according to the AP, already have notified such major prescription benefit management plans as CVS Caremark and the AARP that they must pare the number of drug plan options they offer Part D members. The goal is to simplify the dizzying array of choices available to Medicare beneficiaries in many regions of the country.

On the plus side, administration officials said, the change doesn’t mean seniors will lose coverage. And the elimination of redundant Part D drug plans — which number some 1,600 in total, according to the AP — also will reduce confusion among Medicare recipients and make it easier for newly eligible members to choose among a smaller array of coverage, cost and drug-formulary options.

Medicare also is trying to smooth the way to a more seamless transition for seniors who will be affected by the elimination of some plans, the AP reported, in part by automatically reassigning some beneficiaries to a similar plan offered by their insurer. The agency reportedly will unveil its approved list of Part D drug plans in late September, and the result, the AP indicated could be as much as a 25% reduction in the number of plans.

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Impax Labs pursuing FDA approval for generic cholesterol-lowering drug

BY Alaric DeArment

HAYWARD, Calif. Generic drug maker Impax Labs is hoping to win approval for a generic cholesterol-lowering drug.

Impax said it had filed an application with the Food and Drug Administration for approval of a version of Merck & Co.’s Vytorin (ezetimibe and simvastatin) in the 10 mg/80 mg strength. Vytorin had sales of around $222 million during the 12-month period ended June 30, according to Wolters Kluwer Health.

Impax’s application contained a paragraph IV certification, a legal assertion that the patents covering Vytorin are invalid, unenforceable or won’t be infringed. In response, under the provisions of the Hatch-Waxman Act of 1984, Merck subsidiaries Schering Corp. and MSP Singapore Co. filed suit for patent infringement against Impax in the U.S. District Court for the District of New Jersey. The suit puts a stay on the FDA’s approval of the drug until Impax goes to trial and wins or until the companies resolve the matter before the court.

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Taro ups sales, profits in first half of 2010

BY Alaric DeArment

HAWTHORNE, N.Y. Taro Pharmaceutical Industries had increases in sales and profits during the first half of the year, the Israeli generic drug maker said.

Taro reported sales of $187.3 million, compared with $181.7 million during the first half of 2009. Profits increased by 24%, to $29.2 million, compared with $23.6 million in the first half of 2009.

For second quarter 2010, sales were $98 million, compared with $96.8 million in second quarter 2009. Profits for the quarter were $18.9 million, a 51% increase over second quarter 2009’s $12.5 million.

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