Formulary Watch |

Pharmacy costs and controls loom large in cash-strapped 2002 policy agenda

As health care costs and pharmaceutical expenditures continue to climb, the effect of these trends on health care coverage and economic development is emerging as a central issue for 2002.

Kineret (Anakinra) AMGEN

Biologic: First IL-1 receptor blocker for moderate to severe rheumatoid arthritis

Invanz (Ertapenem for injection) Merck

NME: Once-daily injectable carbapenem for treatment of various infections

Bextra (Valdecoxib tablets) Pharmacia/Pfizer

NME: COX-2 inhibitor for rheumatoid arthritis, osteoarthritis, and dysmenorrhea

Acute migraine therapy: Triptan quantity limit maintains total health care savings 1 year out

Prime Therapeutics, St. Paul, MN-Do quantity limits on abortive migraine medications (ie, triptans) and educational efforts to increase the use of prophylactic therapy reduce total health care costs over the long term?

Conversion to a computerized clinical intervention documentation process: What are the gains?

ValleyCare Health System, Pleasanton, CA-The expansion of decentralized clinical pharmacy services at this health system served as the impetus to improve their clinical intervention documentation process.

Infliximab and etanercept largely comparable in two real-world rheumatoid arthritis studies

Two new real-world comparisons of the tumor necrosis factor (TNF) blockers infliximab (Remicade) and etanercept (Enbrel) show that the two agents are highly comparable treatments for rheumatoid arthritis

Humana launches Web-based tool to alert members to low-cost alternative drugs

While tiered benefit plans aim to spur use of lower-cost alternative drugs, they may leave patients in the dark about what those alternatives are and how much out-of-pocket savings they can bring.

Ranolazine enhances exercise performance when added to standard medications

Ranolazine, the first in a new class of antianginal agents called the partialfatty acid oxidation (pFOX) inhibitors, improves exercise performance andreduces angina frequency in patients who still have symptoms despite treatmentwith other antianginal medications, according to Bernard Chaitman, MD. Hereported the results of a Phase III study called the Combination Assessmentof Ranolazine in Stable Angina (CARISA).

For first time, an antianginal agent shown to improve clinical outcomes

An agent developed specifically for the treatment of angina reduces theincidence of major coronary events, reported Henry Dargie, MD, who presentedthe results of a trial known as the Impact of Nicorandil in Angina (IONA).It is believed to be the first large-scale trial to report on the effectsof a specific antianginal drug on clinical outcome.

Statins found beneficial in wider range of patients, major study finds

Anaheim, CA-The largest trial of cholesterol-lowering therapy ever conducted extends the current indications for statin therapy, reported Rory Collins, MD.

Real-world study finds "unequivocal"lack of difference among SSRIs

The selective serotonin reuptake inhibitors (SSRIs) fluoxetine, sertraline,and paroxetine are equally effective and tolerated in depressed patientsacross a broad range of outcome measures. So finds an open-label, randomizedstudy in 573 patients treated for depression for 9 months in a primary caresetting.

Step-down therapy suceeds in most GERD patients

A step-down approach from proton pump inhibitor (PPI) therapy is successful in most patients with uncomplicated GERD, reducing costs without compromising quality of life. So concludes a new prospective study.

Meta-analysis reveals only small differences among triptans

Differences among oral selective serotonin agonists (triptans) are small but clinically relevant for the individual patient, according to a comprehensive meta-analysis.

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FDA Actions in Brief

FDA Actions in Brief as reported January 1, 2002

Application of probabilistic sensitivity analysis in decision analytic modeling (PDF)

Although sensitivity analysis is a widely used technique for testing the uncertainty in pharmacoeconomic modeling parameters, it does have limitations. This month's column introduces probabilistic sensitivity analysis as an alternative method for examining uncertainty.

Tenofovir: The first nucleotide reverse transcriptase inhibitor for treatment of patients with HIV-1 infection

Tenofovir disoproxil fumarate (Viread) recently gained accelerated FDA approval. It is the first member of a new antiretroviral class and also the first antiretroviral approved on the basis of efficacy trials conducted almost exclusively in treatment-experienced patients. This Focus article reviews these studies and considers how other pending and planned trials may refine tenofovir's role.

Emerging uses of the new anticonvulsants: What's the state of the evidence? (PDF)

Like their older counterparts, the newer anticonvulsants gabapentin, lamotrigine, and topiramate show promise for treating various off-label psychiatric and neurologic disorders. This review examines the quality of current evidence for these new uses, identifies where gaps in the evidence lie, and discusses which emerging uses of individual agents appear most justified.

Automatic interchange of the ACE inhibitors: Decision-making process and initial results (PDF)

Clinicians at Nebraska Methodist Hospital, a not-for-profit acute care facility, developed and implemented an automatic interchange program for the ACE inhibitor class of drugs. This article presents the ACE inhibitor review upon which the formulary decisions were based as well as the initial clinical and economic results of the interchange program. (This pdf version includes an appendix that was not included in the print issue)

FDA Actions in Brief

A once-daily, extended-release form of the amphetamine and dextroamphetamine mixture Adderall (Adderall XR, Shire) has been approved for treatment of attention-deficit/hyperactivity disorder. The new product is supplied in capsules that provide double-pulsed amphetamine delivery, prolonging the amphetamine release compared with immediate-release Adderall.

Focus On: Fondaparinux: A novel synthetic antithrombotic for prevention of venous thromboembolism

Fondaparinux, the first in a new class of antithrombotics that selectively target factor Xa, has been deemed approvable by the FDA for prevention of venous thromboembolism following orthopedic surgery. Four phase III trials have suggested that it may be more effective than enoxaparin in this setting with little to no additional bleeding risk. This Focus review examines data from these trials and others in an effort to sketch out this pending agent's likely therapeutic role.

AccuNeb (Albuterol sulfate inhalation solution) DuoNeb (Albuterol sulfate and ipratropium bromide inhalation solution) Dey

New Formulations/Combinations: Pediatric-specific albuterol formulation; fixed-dose bronchodilator combination

Visudyne (Verteporfin for injection) QLT Phototherapeutics/Novartis

New Indication: Light-activated ophthalmic cleared for CNV due to two additional causes

Protonix I.V. (Pantoprazole sodium for injection) Wyeth-Ayerst

New Indication: Injectable PPI cleared for hypersecretion due to Zollinger-Ellison syndrome

Viread (Tenofovir disoproxil fumarate tablets) Gilead

NMEs/biologics:First nucleotide analog for treatment of HIV-1 infection; dosed once daily

Frova (Frovatriptan succinate tablets) Elan

NMEs/biologics: 5-HT receptor agonist for Tx of migraine

Bioterror response to alter pharmaceutical development and marketing

Uncle Sam is poised to authorize more than $1 billion to buy medicines and vaccines for the national pharmaceutical stockpile, and federal agencies are gearing up to spend millions more on research related to infectious disease. In response, the pharmaceutical industry is assessing how these developments may alter the way it does business.

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FDA actions In Brief

FDA actions in brief reported November 1, 2001