Drug Topics - February 11, 2008 - (Page 8) 8 DRUG TOPICS FEBRUARY 11, 2008 www.drugtopics.com Latebreakers AWP is back from the dead A federal judge has refused to approve a proposed settlement that would have ended the reporting of average wholesale price (AWP) data. In a hearing this week, Judge Patti Saris rejected key portions of the First DataBank and Medi-Span settlement following filings from pharmacy organizations. The suit against First DataBank, Medi-Span, and McKesson alleged that the companies conspired to inflate the average wholesale price for prescription medications. McKesson denies any wrongdoing and is not part of the settlement. Under the terms of the settlement, First DataBank had agreed to adjust its reporting of Blue Book AWP by reducing the 5% markup it had calculated into the prices it reported. The company also agreed to stop reporting AWP in the future. Pharmacy groups charged that the settlement would unfairly impact pharmacists and that contracts had compensated for the inflated AWPs. Although the judge has yet to issue a formal ruling, “it is clear that whatever happens, the judge is not going to be involved in eliminating AWP,” commented John Rector, senior VP and general counsel of the National Community Pharmacists Association, who attended the hearing. (For more on AWP, see page 30.) tion, which said that findings in the ENHANCE trial have been prematurely judged and physicians should not alter their prescribing habits of Vytorin until the study results can be peer-reviewed and presented to the medical community. Vytorin, containing both simvastatin and ezetimibe (Zetia, Merck/Schering-Plough), is approved for the reduction of lipids in both primary hypercholesteremia and homozygous familial hypercholesteremia. CMS seeks comments on 2009 letter The Centers for Medicare & Medicaid Services has released a draft version of its 2009 Call Letter. The letter is sent to Medicare Advantage organizations and prescription drug plan sponsors outlining policy changes in the Medicare Part D program for the 2009 benefit year. The letter includes new requirements for plans to publish prior authorization criteria on their Web sites and calendars containing key dates for the 2009 benefit year. The letter also mandates that Medicare Part D sponsors must list on their formulary “all or substantially all” antiretroviral HIV drugs. January 30 was the deadline for comments to be sent to CMS. New NNRTI antiviral etravirine gets FDA nod A new non-nucleoside reverse transcriptase inhibitor (NNRTI) has received an accelerated approval from the FDA. Etravirine (Intelence, Tibotec) is indicated for the treatment of HIV infection in antiretroviral treatment-experienced adult patients who have evidence of viral replication and strains resistant to a NNRTI and other antiretroviral agents. The approval was based on results from two trials, DUET-1 and DUET-2, which showed significantly more patients taking etravirine achieved an undetectable viral load and a greater increase in CD4+ cell count than patients receiving only the background regimen, darunavir (Prezista, Tibotec) and ritonavir (Norvir, Abbott). Tibotec said a 100-mg tablet of etravirine will have a wholesale cost of $5.45. With a typical regimen of two tablets twice a day, a 30-day supply is estimated to cost $654, or about $8,000 per year. The AIDS Healthcare Foundation has since urged the company to reconsider the steep price. Patients flooding R.Ph.s with Vytorin questions Following release of the ENHANCE trial results that showed treatment with Vytorin was no more effective than simvastatin alone in preventing the accumulation of plaque in arteries, patients have been questioning pharmacists as to the appropriate plan of action. One retail pharmacist in Massachusetts estimates he’s received between 30 and 50 inquiries from patients asking what to do since the trial result news broke. In all cases, the pharmacist said he instructed the patients to continue taking Vytorin and to consult with their physician as to a proper course of action. This advice is backed up by a statement from the National Lipid Associa- Welchol granted approval for glycemic control Colesevelam (Welchol, Daiichi Sankyo) can now be used in adults with Type 2 diabetes to improve glycemic control, as measured by HbA1c. The bile acid sequestrant should be used in combination with metformin, sulfonylureas, or insulin. In clinical studies, the addition of colesevelam to other agents led to significantly greater reductions in HbA1c than the antidiabetic drug alone. Previously, colesevelam was approved for use alone or in combi- http://www.drugtopics.com
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