PHARMACY

Part D subscribers likely to see drug choices diminish

BY Adam Kraemer

WASHINGTON Beneficiaries of Medicare Part D are likely to see their drug choices drop next year, as the government has culled hundreds of products from a list of approved drugs.

On average, the number of drugs offered by the 10 insurers with the largest enrollment shrank by 26 percent from this year to next, according to data analyzed by Washington consulting firm Avalere Health. Four of the top five plans have seen their drug coverage cut by at least 30 percent.

UnitedHealth and Humana both saw drops from more than 3,750 drugs to just more than 2,620, Avalere’s analysis shows. Even so, the two insurers still have among the largest drug lists of the 10 biggest insurers. UnitedHealth spokesman Daryl Richard pointed out that even with the drop, the company’s Medicare Rx Preferred plan covers “100 percent of the drugs” on Medicare’s approved list.

The drop came mainly because of changes made by Medicare, which shrank the list of drugs it will pay for, culling those that have been pulled by the FDA, are no longer being made, had duplicative billing codes or were drugs deemed “less than effective” by the FDA.

Medicare officials and the insurers say most beneficiaries are unlikely to be affected. Enrollees taking drugs that were pulled will usually be able to find alternates or can go through an appeals process to try to stay on their current drugs, they said.

“Most of those [removed] drugs were not used,” said Jeff Kelman, chief medical officer for Medicare’s Center for Beneficiary Choices, in a USA Today article.

“As the Part D program develops, the size of the formulary is becoming more aligned with utilization patterns, consumer preferences, health outcomes and value for consumers,” Humana spokesman Tom Noland said.

Avalere’s Jon Glaudemans said the enrollees should check the drug lists of plans they are considering before signing up, to see if the medications they take are included. The deadline for enrolling is Dec. 31. “Every year, insurers revise their formularies, and every year, beneficiaries should reassess their choices,” he said.

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PHARMACY

Mylan’s nebivolol receives approvable letter from FDA, efficacy not at issue

BY Allison Cerra

NEW YORK Mylan’s new anti-hypertension drug has received a nearly green light from the Food and Drug Administration.

While an approvable letter from the FDA did not raise any questions related to safety or efficacy of nebivol, a novel beta blocker, Mylan and its licensing partner, Forest Laboratories, did report that final marketing approval would depend on the duo’s ability to resolve deficiencies in its manufacturing facility in Belgium, issues which the letter addressed.

At this time, the companies and the FDA have agreed upon product labeling text and the proposed brand name is currently Bystolic.

The companies anticipate an expeditious resolution to this issue, and Forest continues to plan for a Jan 2008 launch meeting for Bystolic.

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Caraco receives tentative FDA approval for generic Lexapro

BY Allison Cerra

WASHINGTON The FDA has granted tentative approval for Caraco’s abbreviated new drug application for escitalopram oxalate tablets (escitalopram), 5 mg, 10 mg and 20 mg.

Escitalopram is indicated for the treatment of major depressive disorder and is the generic bioequivalent of Forest Laboratories’ Lexapro.

Caraco and Forest Laboratories have been involved in a patent litigation over the generic Lexapro since July. Lexapro tablets had U.S. sales of approximately $2.5 billion for the 12-month period ending Sept. 30, Caraco said.

“We are extremely pleased to receive this tentative approval,” said Caraco’s chief executive officer, Daniel Movens. “The ANDA was filed with a Paragraph IV certification that we do not infringe Forest’s Lexapro patents or that they are invalid. As previously disclosed, we are currently involved in litigation with Forest Laboratories that will determine whether we may launch our generic product prior to the expiration of these patents. Though the outcome of this litigation is uncertain, we remain confident in our position and continue to expect a favorable conclusion.”

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