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.
Amylin accuses Lilly of anticompetitive activity in diabetes drug development, commercialization
SAN DIEGO — Amylin Pharmaceuticals filed suit against Eli Lilly in federal court Monday concerning an agreement between the latter and German drug maker Boehringer Ingelheim to develop drugs for diabetes.
In a complaint filed in the U.S. District Court for the Southern District of California, Amylin said Lilly engaged in unlawful and anticompetitive activity in its development and commercialization agreement with BI for Tradjenta (linagliptin), an orally administered Type 2 diabetes drug that the Food and Drug Administration recently approved.
Since 2002, Lilly and Amylin have had a global development and commercialization agreement concerning the injectable Type 2 diabetes drug Byetta (exenatide). Amylin said that Tradjenta would directly compete with Byetta and Bydureon, a long-acting form of exenatide currently under FDA review and that Lilly had breached its contractual agreement with Amylin to maximize commercialization of exenatide products.
Amylin is seeking to prevent Lilly from using the same sales staff to sell Tradjenta and Byetta and Bydureon.
“Amylin selected Lilly as a partner to promote development and maximize sales of Amylin’s exenatide products,” a statement by Amylin read. “We are disappointed that we could not resolve this matter amicably and that we were forced to bring legal action to protect our rights our products and our shareholders. Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with Type 2 diabetes. Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialization of exenatide products.”
Lilly rejected Amylin’s allegations in a statement released soon after, saying that injectables, such as Byetta, usually compete against other injectables rather than against such orally administered drugs as Tradjenta and also said that the contract between Lilly and Amylin allows Lilly to develop and market “a full range of diabetes treatment options for patients.”
“We emphatically reject the allegation that we did not meet our contractual obligations under the Lilly and Amylin alliance,” Lilly Diabetes president Enrique Conterno said. “Lilly has been and remains fully committed to fulfilling its obligations under its exenatide collaboration agreement with Amylin, as well as to complying with all laws and regulations.”