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Antisecretory medications used to treat gastroesophageal reflux disease GERD ; and peptic ulcer disease PUD ; account for a majority of the utilization and costs in the gastroenterology category. Utilization growth has been moderated by the OTC availability of H2RAs and 20-mg Prilosec OTC. The market for prescription PPIs is increasingly dominated by brandname products, including Nexium and Protonix, as the therapy mix shifts away from generic omeprazole. No new PPIs are likely to be introduced over the next 3 years. Instead, new products in this class are likely to be new dosage forms for existing PPIs. A recent example is Zegerid omeprazole powder for oral suspension ; , an immediate-release formulation approved in June 2004. FDA-approved drugs for the treatment of irritable bowel syndrome IBS ; have only recently become available. Lotronex is restricted by FDA labeling to the treatment of female patients with moderate-to-severe diarrhea-predominant IBS, and safety concerns have significantly limited its use. Zelnorm, which was initially approved for constipation-predominant IBS, has also been approved for chronic constipation. Of these two drugs, Zelnorm is by far the more heavily utilized, and the indication for chronic constipation is likely to spur additional utilization growth. Cilansetron, the next IBS drug in the pipeline, will be indicated for diarrhea-predominant IBS. This new agent may be approved for use in both men and women. If this new drug does not have the same safety concerns as Lotronex, it could quickly replace Lotronex and contribute to a significant increase in utilization for IBS drugs. New therapeutic biologics for the treatment of Crohn's disease will also contribute to increased utilization and costs over the next 3 years. Humira and abatacept are currently in Phase II III clinical development for this indication. Remicade is already FDA-approved for this indication in people with more severe disease. Availability of several more biologic agents for the treatment of Crohn's disease will contribute to rising utilization and costs. These costs may appear in several therapeutic categories, depending on the primary chapter assignment of the drug involved and theo-dur.
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Discussion about the Proton Pump Inhibitor PPI ; class was continued at the last P & T Committee Meeting. The Board members set criteria for one preferred PPI and decided not to require a PA for Prilosec OTC. We believed at the time that the second-line agent would be Prevacid. It is now Protonix. It was decided that the prior authorizations that are in effect would be given a few more months and then terminated. Since both of the preferred agents are tablets, Ms. Cunningham asked if the Board wanted to work out and ventolin.
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For the 20 drugs most frequently prescribed to seniors, VA prices were consistently lower than the lowest base price of any Medicare prescription drug plan. The median percent difference in price for a year of treatment was 48.2 percent Table 1 ; . VA Prices Significantly Lower The lowest VA price was lower than the lowest Medicare prescription drug plan price for 19 of the 20 drugs Table 1 ; . For half of the drugs, the lowest Medicare prescription drug plan price was at least one and one-half times the lowest VA price. For a quarter of the drugs, the lowest Medicare prescription drug plan price was at least twice the lowest VA price. For 15 percent of the drugs, the lowest Medicare prescription drug plan price was at least four times the lowest VA price. Significant Price Differences VA prices were not only consistently lower, but the price differences were often significant. The median price difference was $260.70 for a year of treatment Table 1 ; . For six drugs, the lowest Medicare prescription drug plan price would equal more than $1, 000 for a year of treatment. For these high-cost drugs, the median difference between the lowest Medicare prescription drug plan price and the lowest VA price was $606.30 Table 2 ; . For half of these drugs, the VA price was more than $500 less for a year's therapy than the lowest Medicare prescription drug plan price Table 2 ; . VA Prices Lower for Brand-Name and Generic Drugs VA prices were lower for both generic and brand-name drugs. Eighteen of the 20 drugs were brand-name drugs. For 17 of those, the VA price was lower than the lowest Medicare prescription drug plan price. For those drugs, the median difference between the lowest Medicare prescription drug plan price and the lowest VA price was 44.1 percent Table 3 ; . Two of the top 20 drugs were generic. For those two drugs, the median difference between the lowest Medicare prescription drug plan and the lowest VA price for a year of therapy was 94.5 percent Table 3 ; . Significant Price Ranges No Medicare prescription drug plan in either region had the lowest price for all 20 drugs. The price variations across the plans were significant. The brand-name drug with the smallest percent difference in price across Medicare drug plans was Prktonix 40 mg. There was a 22.3 percent difference in price between the plan with the lowest price and the plan with the highest price, which equals $240.84 for a year's therapy Table 4.
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Cigna Value and Complete Plans and the HOP Basic and Enhanced Rx Options Comparison of Drug Cost Through Initial Coverage Band Rx Name ACTONEL ARICEPT COREG FIORICET * FOSAMAX GABAPENTIN LEXAPRO LIPITOR NEXIUM OMEPRAZOLE PREVACID PROTONIX TOPROL XL ZOCOR ZOLOFT Estimated Cost $ 95.00 133.00 113.00 HOP Basic $ 23.75 33.25 28.25 * 40.75 23.75 16.25 * 18.75 33.25 28.25 HOP Enhanced $ 23.75 33.25 28.25 * 18.75 33.25 28.25 Cigna Value $ 40.00 20.00 * 20.00 4.00 40.00 Cigna Complete $50.00 30.00 55.00 * 30.00 5.00 50.00 Cigna Plus and Complete Plans have the same formulary and Co-Pay structure. * Fioricet is a non-covered Medicare Rx covered by the Enhanced Rx Option * Member cost equals Rx cost if not covered.
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Cycloheximide treatment compare lanes 13 to lanes 4 6 ; , implicating the direct participation of AR or other co-factors in this induction. In an additional experiment Fig, 6B, lanes 79 ; , DHT was added to LNCaP cells cultured in regular 10% FBS-RPMI 1640 medium, and the induction of hMAK expression was again observed, despite the presence of endogenous androgen in the medium. The results suggest that the observed hMAK induction by androgen is not peculiar to the charcoal dextranstripped fetal bovine serum. hMAK Expression in Prostate Cancer Cells and Its Inducibility by Androgen--To determine whether the androgen inducibility of hMAK is a general phenomenon, we extended our studies to other prostate cells harboring AR, using the same conditions that yielded quantitative results in the real time RT-PCR experiment Fig. 5 ; . The cells cultured in androgenfree medium were treated with 10 nM DHT and harvested at 24 h post-stimulation. LNCaP cells served as a positive control, and the androgen inducibility of hMAK was reproduced in this experiment Fig. 7, lanes 1 and 2 ; . 22Rv1, an AR-positive cell line derived from a relapsed prostate cancer xenograft does not require androgen for growth but is responsive to androgen 26 ; . PrEC are normal prostate epithelial cells, which express much lower level of AR data not shown ; . As shown in Fig. 7 Fig. 7, lanes 3 and 4 ; , the hMAK expression level of the androgenresponsive 22Rv1 prostate cancer cells also increased after DHT treatment. Likewise, PrEC expressed a nearly undetectable level of hMAK in androgen-free medium Fig. 7, lane 5 ; , and its expression was increased after treatment with DHT Fig. 7, lane 6 ; . These experiments provide strong evidence that hMAK is an androgen-inducible gene in AR-positive prostate cells. However, it is noteworthy that both LNCaP and 22Rv1 express a basal level of hMAK even in the absence of androgen. We also analyzed prostate cancer cell lines such as DU145 Fig. 7, lanes 7 and 8 ; and PC-3 Fig. 7, lanes 9 and 10 ; , which are AR-negative. Interestingly, both cell lines express hMAK. The levels of hMAK expression in these cell lines were intermediate between those of the untreated and treated LNCaP and keflex.
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Pharmacy's name: Barnes Health Center #112091. Dispensing CS III-V without a prescription. Action Probation five 5 ; years, $4, 000 fine. Pharmacy's name: Jerry's Pharmacy #105633. Inaccurate records of prescription medications. Action Probation two 2 ; years, $1, 750 fine. Pharmacy's name: Propst Discount Drugs, Inc, #108215. Allowing a technician to work without a current technician registration. Administrative penalty $500. Pharmacist name: Rodney Logan #8045. Dispensing CS Schedule III, IV, and "legend drugs" without a prescription. Action Probation one 1 ; year, $1, 400 fine.
No standard of care exists for people considering a third line regimen, but many researchers use an approach now commonly referred to as megaHAART. MegaHAART essentially involves combining as many anti-HIV drugs as possible without causing severe side effects. Researchers in Vancouver have used this approach with some degree of success. Results from two separate observational studies were presented. In an "observational study" people are not assigned to any rigid protocol and are allowed to take whatever seems appropriate, perhaps under some general guidelines. This type of study then simply collects data on what happened to volunteers. Such studies are not considered very precise or accurate but sometimes provide useful information that is used to guide future study design ; . The first group involved 98 people with a median viral load of about 62, 000 copies HIV RNA and CD4 + cell counts of 175. The second involved 79 people with a median viral load of about 55, 000 copies HIV RNA and CD4 + cell counts of 200. All had previously taken about seven anti-HIV drugs before starting megaHAART regimens. In the first group, people had used antiHIV drugs for about 40 months compared to about 30 months in the second group. During the observation period of the study, participants typically received up to nine anti-HIV drugs including two protease inhibitors, four nucleoside analogue reverse transcriptase inhibitors NARTIs ; , two NNRTIs and hydroxyurea. Where possible, people used therapies they had not previously taken. Results from the first group show that about 40% of the participants had viral loads below 400 copies HIV RNA after 52 weeks of treatment. Those in the second group were not followed as long, but after 20 weeks of megaHAART, 48% achieved viral suppression below 400 copies HIV RNA. In an analysis looking at predictors of anti-HIV response, viral load at study entry the lower your viral load the more likely you would sustain an antiHIV response ; and phenotypic resistance at study entry the more drugs you are sensitive to the more likely you would sustain response ; were correlated with anti-HIV response.
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