Drug Topics - November 19, 2007 - (Page 6)

6 DRUG TOPICS NOVEMBER 19, 2007 www.drugtopics.com Latebreakers NCPA, NACDS sue to stop AMP NCPA and NACDS have filed suit in federal court to block CMS from implementing the average manufacturer price rule. “The lawsuit reveals dozens of violations by CMS,” explained Don Bell, general counsel and VP of legal affairs for NACDS. The suit charges that CMS violated numerous aspects of the Social Security Act, including its definition of AMP. CMS has already begun collecting AMP data, and the suit was filed to block the agency from following through on its plans to post the data on its Web site. Officials at both pharmacy organizations stressed a final solution to fixing the AMP reimbursement would have to be created by Congress, but that the suit would stop CMS from implementing the rule before legislation could be passed. Currently two bills in the House and one in the Senate offer different funding formulas. The groups also promised to launch a media and grassroots campaign to pressure lawmakers to pass legislation to fix the rule. According to a GAO study, CMS’ current AMP formula would cut pharmacy reimbursement by 36% on average. drug for adult patients with chronic phase chronic myeloid leukemia (CML). According to the company, the new dose of 100 mg daily reduces the incidence of severe myelosuppression and fluid retention. Also, the product labeling will now include data from a phase II randomized trial of dasatinib and imatinib (Gleevec, Novartis) in patients with previously untreated chronic phase CML. Dasatinib, a kinase inhibitor, is also approved for the treatment of certain types of acute lymphoblastic leukemia. (For more on CML, see page 8.) CMS compromises on payment system rules First, the good news: Hospitals will not have to deduct pharmacy overhead costs from drug acquisition costs on Medicare claims under the outpatient prospective payment system for 2008, nor will they have to report overhead charges as a separate billing line item. Earlier this year, CMS proposed requiring hospitals to break out overhead costs and report those costs on an uncoded revenue code line. ASHP criticized the idea, claiming it would be “extremely difficult, if not impossible,” to accomplish and would require the creation of two separate billing systems. CMS relented but refused to back off its proposal to cut the 2008 reimbursement rate for all separately payable drugs and biologics from average sales price (ASP) plus 6% to ASP plus 5%. The decrease is bad news for hospital pharmacies, claims ASHP, because it does not adequately cover pharmacy costs or the expense of managing medications. CMS’ final rule will be published in the Nov. 27 Federal Register. DT Adolescent use of Abilify granted approval Adolescents aged 13 to 17 with schizophrenia can now use aripiprazole (Abilify, Otsuka). A supplemental New Drug Application (sNDA) was approved for the atypical antipsychotic in November. According to Otsuka, aripiprazole treats both the positive and negative symptoms of schizophrenia, and the approval was based on results of a six-week study that showed significant improvement compared with placebo for the primary end point, Positive And Negative Syndrome Scale (PANSS) Total Score. Aripiprazole was approved in 2002 for the treatment of schizophrenia in adults. (cetirizine HCl 5 mg/pseudoephedrine HCl 120 mg), an allergy drug, for OTC use in adults and children 12 years and older. This drug combines an antihistamine with a nasal decongestant. Available as a prescription drug since 2001, Zyrtec-D is now approved as an OTC for the relief of symptoms due to hay fever or other respiratory allergies such as runny nose; sneezing; itchy, watery eyes; itching of the nose or throat; and nasal congestion. Zyrtec-D is also used for reducing swelling of the nasal passages, relief of sinus congestion and pressure, and restoring freer breathing through the nose. FDA approves lower dose of Sprycel Bristol-Myers Squibb has been granted regulatory approval for a new indication for dasatinib (Sprycel). The agency nod provides for the use of a lower recommended starting dose of the Zyrtec-D for allergies goes OTC The FDA has approved McNeil Consumer Healthcare’s Zyrtec-D http://www.drugtopics.com

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Drug Topics - November 19, 2007 Contents Latebreakers Letters Leukemia Patients Now Have More Options First-in-Class HIV Drug Boon to Patients at End of Tether 150 Years of American Pharmacy Pharmacy Schools Confront New Pressures From Pariah to Patient ACCP Releases Position Paper on Ethical Interactions New Injectable Antibiotic Welcomed with Open Arms NCCN Updates Head and Neck Cancer Guide Improved Phosphate Binder Approved for Dialysis Patients Considering Combination Concern Ensuring Seamless Care Bill Would Create Center for Comparative Effectiveness Hospital Improves Patient Safety with Automatic Drug Distribution System Infection Rates, Patient Stays Drop with New Drug Device How R.Ph.s Helped Three Hospitals Win Quality and Safety Awards A Pharmacist and Dog in Tow are Alzheimer’s Patients’ Best Friends More PBMs Agreeing to Pricing Transparency New Insulins in the Management of Diabetes New Products Advertisers Index Classified VIEWPOINT: Reflections on Pharmacy School After 30 Years

Drug Topics - November 19, 2007

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