Biotechnology Healthcare - Summer 2010 - (Page 12)
Managing The Immunomodulators
Dosage and indication “creep” with the new biologics to treat inflammatory diseases have payers enforcing strict utilization policies. Physicians counter that payers can’t dictate treatment. With even more biologics on the horizon, and drug spend spiralling upward, both sides need to seek a middle ground. The question is how?
BY JOHN CARROLL
Senior Contributing Editor
loyd F. Mayer, MD, has spent much of his career honing the cutting edge of medical care in immunology. Co-director of The Immunology Institute at The Mount Sinai Medical Center in New York, Mayer has been a lead player in the field just as the standards of care for inflammatory diseases such as rheumatoid arthritis (RA), multiple sclerosis (MS), Crohn’s disease (CD), and psoriasis have undergone a major treatment shift with the arrival of a new generation of biologics. Treatment standards once revolved around a few key therapeutics that medical and pharmacy specialists knew well — azathioprine, methotrexate, corticosteroids, and 6-mercaptopurine — all used to suppress the body’s immune system so it won’t attack healthy tissue. Then, in the late ’90s, the first biologics — etanercept (Enbrel) and infliximab (Remicade) for RA — gained U.S. Food and Drug Administration approval for treating inflammatory conditions, followed by a burst of biologic approvals as the new century dawned — adalimumab (Humira) and certolizumab pegol (Cimzia) to treat RA and natalizumab (Tysabri) for MS. CD, psoriasis, and psoriatic arthritis were subsequently added to the approval list for these drugs.
With each passing year, physicians and pharmacy benefit managers have been building up their body of knowledge and experience in the day-to-day use of the newer therapeutics, which often are prescribed in combination with the older therapeutics. “I think there’s a greater comfort level with their use,” says Mayer, who prefers to call the new wave of biologics “immunomodulators.” “Evidence is increasing on a yearly basis that the doses we use don’t really suppress the immune system,” Mayer says, who also is chairman of the National Scientific Advisory Committee of the Crohn’s and Colitis Foundation of America (CCFA). “They don’t make patients more susceptible to wide-ranging infections either. They’re like the smart bombs — more targeted.” And when these immunomodulators work as planned, Mayer adds, patients often tell him that it’s as if they’ve been given their life back. Like any new, improved — and very expensive — medical weapon added to the armamentarium, though, a number of health insurers say that physicians are too quick to deploy it. Pharmacy benefit specialists at a slate of health plans say that it’s vitally important to clearly illuminate a pathway for the proper clinical use of all biologics. And with more and more immunomodulators either winning approval or in late-stage development, these
specialists are intent on using what they’ve learned about biologics to encourage the use of the older and less expensive drugs as they try to control their drug spend. For payers, that kind of oversight responsibility has spurred them to guard against what they see as dosage and indication “creep” — where physicians step over the payer’s guidelines on dose maximums or prescribe an immunomodulator for an unapproved use. But what insurers see as common sense can be a daily frustration to physicians like Mayer. A RUBIK’S CUBE “It’s an interesting category,” says Helen Sherman, PharmD, chief pharmacy officer at RegenceRx, a PBM with nearly 3 million members, about the wave of immunomodulators sweeping the field. “We keep track of all the science and potential uses, but this is a complex category. It is a bit like trying to solve a Rubik’s cube when it comes to drawing evidence-based
“There’s not a day that goes by that I don’t have to argue to get prior authorization and face delays in getting the medicine I need,”says Lloyd F. Mayer, MD, at The Mount Sinai Medical Center in New York.
12 BIOTECHNOLOGY HEALTHCARE · SUMMER 2010
Table of Contents for the Digital Edition of Biotechnology Healthcare - Summer 2010
Biotechnology Healthcare - Summer 2010
Editorial/David B. Nash, MD, MBA
Controlling Dose And Indication Creep
Data Are Needed on Real-World Efficacy
The Call For More Measurable Outcomes
Biotechnology Healthcare - Summer 2010
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