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• W98159457 abstract "When the first wave of biologics received U.S. Food and Drug Administration approval for use as first-line agents in newly diagnosed patients, many health plans and specialty pharmacies were quick to react, introducing detailed prior authorization protocols and step therapy algorithms to control utilization and, consequently, overall costs.But the approach to coverage of biologic therapies as second-line agents — either those approved for use only when one or more nonbiologic agents fail or for when a patient is switched from one biologic to another because of inefficacy — lacked protocols that determined the who, when, and how of drug utilization. The rationale was simple: Health plans and specialty pharmacies barely had enough resources to plan for first-line use of biologics, so second-line use just wasn’t something they had the time and money to focus on.“The real opportunity for cost savings lies in appropriate steerage at the point the initial biologic therapy is prescribed,” says Connecti-care’s Jeff Casberg, RPh.Although there hasn’t yet been a sudden rush to develop plans across industry lines, the question of how to best manage second-line biologics is slowly beginning to creep onto the radar screens of health plans and specialty pharmacies, which are seeing the utilization of these drugs rise along with coverage costs.“The challenge is that for most biologic drug classes, there’s more at stake clinically and financially for everyone involved: patients, relatives, doctors, health plans, and employers We’ve been cautious in management but have assigned preferred choices in growth hormones, multiple sclerosis, hepatitis C, and infertility for therapy initiation,” says Jeff Casberg, RPh, director of pharmacy services at ConnectiCare, based in Farmington, Conn. And, Casberg says, rheumatoid arthritis may not be far behind.There are now seven FDA-approved biologic agents for RA on the market. While some of these agents — the anti-tumor necrosis factor (TNF) drugs — are approved as first-line therapy for moderate-to-severe disease, they are all more frequently used as second-line agents in patients whose conditions do not improve after initial treatment with a disease-modifying antirheumatic drug, typically methotrexate. Because none of the biologic agents have shown clear superiority in clinical trials, health plans and specialty pharmacies are taking a greater interest in negotiations that allow them to specifically designate a preferred second-line therapy for their patients.“The treatment of rheumatoid arthritis is a big category with lots of dollars attached to it, and people really want to figure out how to manage it optimally,” says F. Randy Vogenberg, RPh, PhD, cofounder and executive director of the Biologic Finance and Access Council and a principal at the Institute for Integrated Healthcare, in Sharon, Mass.“The dilemma comes when you have to manage the medication process in a high-touch way, and people are only now beginning to figure that out from both a specialty and pharmacy benefits manager perspective. They are doing what they can with the available technology to better manage therapies without forcing their ‘customers’ to go through unnecessary prior approval paperwork. That gives them cost control without sacrificing a customer-friendly approach.“The advantage for specialty pharmacies and PBMs today is that cost control is boomeranging back to the number one issue for employers, so upsetting their employees is no longer as big a concern as long as overall pharmacy costs can be contained or reduced.”Health plans and specialty pharmacies are especially interested in managing the utilization of second-line therapies, such as the anti-TNFs for RA and interferons for hepatitis C, where more than two biologic agents have received FDA approval. Once a therapeutic category matures, as these two have, and multiple options are available, cost negotiations become increasingly important.“Once that third product hits the market, the opportunities open up for directing patients to a primary product for which the health plan or specialty pharmacy has gotten a preferred price,” says Vogenberg. “Doctors are getting used to this by now, so they are generally more willing to follow the health plan’s recommendation.”" @default.
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• W98159457 date "2009-06-01" @default.
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• W98159457 title "Managing Second-line Biologics: Worth the Effort?" @default.
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