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Pharma companies are looking to the data service as a potential competitive advantage
Advera Health (formerly, Adverse Events, Inc.) has been plugging away for nearly seven years now on methods to make the FDA Adverse Events Reporting System (FAERS) useful to drug purchasers, manufacturers and, ultimately patients. Now the company has reached the point where it says it can quickly translate and data-cleanse FAERS reports (which, usually being manually composed, have many variations in drug names, conditions and outcomes), align them with existing adverse event label warnings, identify new side effects and, with its latest announcement, align drugs with the hospital costs of treating AEs by giving them an “RxScore.” The methodology, and the RxScore for 706 branded and generic drugs, have been published in the current issue of the J. of Managed Care and Specialty Pharmacy (“A Drug Safety Rating System Based on Postmarketing Costs Associated with Adverse Events and Patient Outcomes,” JMCP, 2015;21(12):1134-43).
The Santa Rosa, CA company scored something of a coup in October, when it issued a Drug Safety Monitor Alert (one of its subscription services) on serious AEs associated with AbbVie’s Viekira Pak, the hep C treatment. Six days later (Oct. 22), FDA issued an advisory warning and a call for a label revision, based on liver damage in patients with advanced liver disease. (Viekira, of course, figures in the highly publicized controversy over the pricing of its direct competitor, Gilead’s Sovaldi, and the decision by Express Scripts to predominantly allow only Viekira on its formulary.)
Brian Overstreet, Advera CEO, says that in recent years, Advera’s services have become popular with payers and healthcare providers, who are under the gun not only to control healthcare spending, but also to improve the quality of service they provide. Pharma companies had been relatively indifferent to the service, “but that’s changing now, with some companies seeing that they can create a competitive advantage with better outcomes of their products.” The company is winning some business now from the medical affairs and HEOR (health economics and outcomes research) teams at pharma companies.
The RxScore is one of several monitoring services Advera provides; others simply count up AEs tied to specific drugs, or calculate the medical cost of drugs’ AEs. Overstreet says that the entire FAERs system points to a weakness in the clinical approval process, since many side effects don’t show up until the product is in commercial use. FDA has been developing its Sentinel program since the mid-2000s, but while a “mini-Sentinel” pilot project was successfully concluded a couple years ago, a transition to a full-blown program is still in the offing (FDA and Brookings Institution are holding their annual Sentinel meeting next February.) All this being said, AEs, and the costs associated with them, is still a challenge to track and analyze: while the number of AEs reporting to FDA has more than doubled since the mid-2000s (to almost 1.3 million in 2014), when compared against the 4 billion prescriptions issued annually, signal detection is very difficult.