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This month we would like to know...
What do you see as the current status of “value-based” drug benefit designs?
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Never gained traction, likely to fade away in the future |
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| b) |
Some initial uptake, but losing momentum rapidly |
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| c) |
Moderate but stable growth, with continued promise for future |
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| d) |
Likely to be the most common standard benefit design of the future |
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Vote in our survey, and see what other P&T committee members have to say.
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Bisphosphonate exposure not linked to esophageal cancer
There appears to be no association between the use of oral bisphosphonates and the risk of esophageal or gastric cancer, according to research published in the Aug. 11 issue of the Journal of the American Medical Association, as reported by HealthDay News. More... |
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AMCP voices support for a national inventory of comparative effectiveness research
The Academy of Managed Care Pharmacy (AMCP) has responded to a request from the Office of the Assistant Secretary for Planning and Evaluation (ASPE) in the Department of Health and Human Services (HHS). In this request, ASPE indicates that it is developing a national inventory of comparative effectiveness research (CER) and CER-related information driven by the American Recovery and Reinvestment Act, signed into law by President Obama in 2009. ASPE indicates that the process of cataloguing CER and infrastructure will be critical to tracking ongoing and future investments in CER. More... |
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Genetic substudy shows fewer major cardiovascular events with ticagrelor, regardless of relevant genetic variability in ACS patients
A new genetic substudy of PLATO (A Study of PLATelet Inhibition and Patient Outcomes) showed that the effects on a combined primary end point of cardiovascular death, myocardial infarction, or stroke seen in patients with acute coronary syndromes (ACS) who received the investigational oral antiplatelet treatment, ticagrelor (Brilinta, AstraZeneca), were maintained, whether or not they had the genetic variability that has been previously shown to affect a patient’s response to clopidogrel (Plavix, Bristol-Myers Squibb/Sanofi Pharmaceuticals). More... |
Data compare dabigatran etexilate to dose-adjusted warfarin across RE-LY trial centers
Boehringer Ingelheim announced Aug. 29 that results from a pre-specified, retrospective, unblinded subanalysis of the RE-LY trial — the largest atrial fibrillation outcomes trial ever conducted — were published in The Lancet. The subanalysis evaluated the primary outcomes of RE-LY in relation to each center’s average time in therapeutic range (cTTR) (INR 2.0–3.0) for patients taking warfarin (Coumadin, Bristol-Myers Squibb). More... |
FDA launches new organizational performance management system to advance transparency
FDA has launched an innovative performance management system designed to advance transparency, public participation, and collaboration in the work of government. More... |
FDA warns lamotrigine likely associated with aseptic meningitis
In mid August, FDA released a safety communication to prescribers and patients warning that lamotrigine (Lamictal, Lamictal ODT, Lamictal CD, Lamictal XR), a medication commonly used for seizures in children ≥2 years of age and bipolar disorder in adults, can cause an inflammation of the meninges (the protective membranes that cover the brain and spinal cord) called aseptic meningitis. More... |
FDA proposes withdrawal of marketing approval for midodrine hydrochloride
In mid August, FDA issued a “Proposal to Withdraw Marketing Approval and Notice of Opportunity for a Hearing” to the companies that manufacture midodrine hydrochloride (ProAmatine, Shire Development Inc., and generics by Apotex Corp., Impax Laboratories Inc., Mylan Pharmaceuticals, Sandoz Inc., and Upsher-Smith Laboratories). Midodrine, a vasopressor used to lower blood pressure, was granted accelerated marketing approval in 1996 because the agency deemed it to be an important drug to treat a serious or life-threatening condition. However, such accelerated approvals by FDA require that manufacturers verify a drug’s clinical benefit to patients by conducting post-approval studies. More... |
New black-boxed warning added to leflunomide prescribing information: warns of severe liver injury
In mid July, FDA released a drug safety communication to rheumatologists and family physicians warning them that the use of leflunomide (Arava, Sanofi-Aventis)—a drug to treat rheumatoid arthritis—has been linked to an increased risk of severe liver injury. This warning is also being included as a second black-boxed warning in leflunomide’s prescribing information; the first, being a contraindication for use in pregnant women or women of childbearing potential who are not using reliable contraception. More... |
Findings of meta-analysis suggest concurrent metformin administration may reduce the metabolic risk of those taking atypical antipsychotic agents
A systematic review and meta-analysis conducted by researchers at the University of Connecticut (UCONN) School of Pharmacy, Storrs, Conn., and Hartford Hospital, Hartford, Conn., suggest that using metformin along with atypical antipsychotic agents (such as olanzapine, risperidone, quetiapine, and clozapine) may result in better anthropometric measurements and decreased insulin resistance. More... |
MoxDuo IR study completion could yield primary pain relief end points
QRxPharma has announced a successful interim analysis of its final MoxDuo IR pivotal phase 3 study required for new drug application (NDA) submission. MoxDuo IR is a patented, immediate-release oral formulation combining morphine and oxycodone intended for the acute management of moderate to severe pain. Upon approval, it will be the first opioid-opioid combination product in the United States or elsewhere. More... |
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| In the Pipeline |
| FDA Pipeline Preview, August 2010 (Naproxcinod, Ticagrelor, Phenoxodiol, CBLB502, TOL101, Oral kinase inhibitor, GVAX CML vaccine, TXA127, Sapacitabine or CYC682, ICT-107, Perifosine or KRX-0401, BiovaxID, Phentermine/topiramate, Dasatinib, Denosumab, Cladribine) |
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