FDA advisory committee to discuss safety, efficacy of Trilipix
SILVER SPRING, Md. — A Food and Drug Administration panel will discuss findings in a clinical trial that has raised concerns about the safety and efficacy of Abbott’s cholesterol-lowering drug when it’s combined with similar drugs, according to an FDA announcement.
The FDA Endocrinologic and Metabolic Drugs Advisory Committee will discuss results of the “ACCORD Lipid” study, which examined Abbott’s drug Trilipix (fenofibric acid) delayed-release capsules, which belongs to the drug class known as fibrates, in combination with the drug simvastatin in patients with Type 2 diabetes.
According to the announcement, the trial found no significant difference between patients treated with Trilipix and simvastatin vs. placebo and simvastatin in terms of the proportion that experienced heart attacks. In addition, an analysis of female patients found that those who took Trilipix and simvastatin experienced more heart attacks than those in the placebo group, but the announcement stated that the clinical significance of the finding was unclear.
The committee will vote on whether to maintain the drug’s approval for use with a statin, change the labeling to include information from the study or withdraw the approval. FDA advisory committee rulings are not considered binding, but the FDA takes them into consideration and usually follows them.
“We believe that the body of evidence clearly supports the use of fibrate treatment in appropriate patients … and that the data from ‘ACCORD Lipid’ is supportive of the indication for co-administration with a statin,” Abbott spokeswoman Elizabeth Hoff told Drug Store News.
Trilipix also is approved for use as a stand-alone therapy.
Court in France wants Mylan to pay Ipsen $24 million
PARIS — A court in France has ordered generic drug maker Mylan to pay French drug maker Ipsen $24 million for allegedly misleading marketing of a drug, according to published reports.
Bloomberg reported that Mylan had allegedly marketed the drug Vitalogink as a generic version of Ipsen’s Tanakan rather than as a “therapeutic equivalent.” Both drugs are derived from ginkgo biloba and are used to improve memory.
Mylan has said it will appeal the decision, Bloomberg reported.
CVS Caremark develops ePA capability for PBM clients
WOONSOCKET, R.I. — CVS Caremark announced on Monday that it will be launching a pilot of a real-time, integrated electronic prior authorization capability, available to its PBM clients, to help speed access to prescription medications.
Obtaining prior authorization for prescription medications is a time-consuming process for prescribers, patients and pharmacists that currently requires phone calls, faxes and hardcopy request forms. While some online solutions are available, they do not provide both a real-time solution and one that is integrated with available e-prescribing or electronic health record tools. Recognizing this gap in the marketplace, CVS Caremark has developed the ePA capability. A successful pilot would represent a significant first step toward the development of a technical standard the industry could use to achieve broad adoption of ePA.
The CVS Caremark ePA pilot aims to enable prescribers that use a variety of available e-prescribing and EHR tools to coordinate a real-time ePA request when initiating a prescription for a patient. Prescribers also will have the option to access the process through a client portal. The prescriber will be able to send an ePA request detailing the coverage criteria related to a prior authorization request and receive a real-time status update regarding an approval for the medication. Requests that are denied will be communicated following manual review by clinical staff.
"CVS Caremark understands the opportunities that innovations such as electronic prior authorization provide to prescribers and patients looking to embrace a more efficient and effective way to share critical prescribing information," stated Troyen Brennan, chief medical officer of CVS Caremark. "The prior authorization process is currently evolving to keep pace as prescribers transition towards electronic prescribing and electronic patient records to better manage their patients’ pharmacy care. This pilot is an important step toward demonstrating how the industry can integrate ePA with e-prescribing to streamline and speed up processing of prior authorizations to ensure that members have quick access to care that is medically appropriate and cost-effective."
Surescripts is participating in the CVS Caremark-led ePA pilot to monitor and understand how what is learned can be applied to the industry. NaviNet, through its NaviNet Mobile Connect platform, will be participating in the ePA pilot, as well as Allscripts, whose client base includes all former users of CVS Caremark’s proprietary iScribe e-prescribing tool, which was transitioned to the Allscripts ePrescribe solution last year. CVS Caremark added that MedPlus has indicated its intent to deliver ePA functionality in a future release of their tool. Additional vendors have expressed their intent to deliver ePA functionality in future product releases upon the successful completion of this pilot.
CVS Caremark stated that it believes the ePA pilot transactions will help lead to the development of standards that will be able to be used by any e-prescribing vendor. The company intends to share both the transactions and the results from the implementation with the market and the appropriate ANSI-accredited standards organizations to help drive the adoption of ePA standards by payer and provider systems. Technical guidelines for the pilot test have been published and are available through CVS Caremark.